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       &nbsp;
       <span style="font-family:Times New Roman;font-size:22pt;">INVESTIGATOR SITE FILE</span>
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       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
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       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
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       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
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       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">Principal Investigator</span>
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       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
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   <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
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       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">SECTION</span>
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       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">1</span>
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       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">Contact Details</span>
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       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
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       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
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    <tr style=" height:11.50pt; "> 
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       <span style="font-family:Times New Roman;font-size:11pt;">1.1</span>
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       <span style="font-family:Times New Roman;font-size:11pt;">Contact list of study personnel</span>
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       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
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     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> <a name="bm_Text1"></a>
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       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
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       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
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     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
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       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
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     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
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       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
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       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
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     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 63.45pt; "> 
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       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">2</span>
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       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">Investigator’s Brochure/ Product Information</span>
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     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 58.95pt; "> 
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       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 61.35pt; "> 
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       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
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       <span style="font-family:Times New Roman;font-size:11pt;">2.1</span>
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     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
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       <span style="font-family:Times New Roman;font-size:11pt;">Current Version</span>
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     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
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     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
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       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
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    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">2.2</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">All Previous Submitted Versions </span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">3</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">Protocol </span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">3.1</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Current Approved Version </span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">3.2</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">All Previous Approved Versions</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">3.3</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Protocol Signature Page(s)</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">4</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">Participant Information &amp; Consent Form (PICF)</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">4.1</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Current Approved Version(s) </span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">4.2</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">All Previous Approved Versions </span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">4.3</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Signed Informed Consent Forms </span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">4.4</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Signed Informed Consent Tracking Log</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">5</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">Participant Tools </span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;font-style:italic;">Patient Card/ Patient Diary/ Questionnaires (if applicable)</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">5.1</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Current Approved Version (including all applicable translations)</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">5.2</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">All Previous Approved Versions (including all applicable translations)</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">6</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">Advertisements </span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">6.1</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Current Approved Version </span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">6.2</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">All Previous Approved Versions </span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">7</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">Case Report Form (CRF)</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">7.1</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Current CRF Version (Blank)</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">7.2</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Previous CRF Version (Blank)</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">7.3</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">CRF Completion Guidelines</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">7.4</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Signed, dated and completed CRFs</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">9</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">Ethics </span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">9.1</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Initial Submission &nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">9.2</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Amendments &nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">9.3</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Progress Reports &nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">9.4</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Ethics Composition</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">9.5</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Notification of Safety Reports </span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">9.6</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Notification of Non-compliance / Protocol Deviations </span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">9.7</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Correspondence</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;background-color:#f2f2f2; width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">10</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;background-color:#f2f2f2; width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">Governance </span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;background-color:#f2f2f2; width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;background-color:#f2f2f2; width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">10.1</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Site Authorisation Letter</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">10.2</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Post Authorisation Submission/Authorisation Letters</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">10</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">Regulatory Documents</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">10.1</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">CTN or CTX</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">10.2</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">TGA Acknowledgment Letter</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">10.3</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Correspondence </span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">11</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">Study Personnel </span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">11.1</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Delegation Log </span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">11.2</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Curriculum Vitae (including GCP, Medical License, DCSI )</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">11.3</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Training Log/ Documentation</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">12</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">Agreements</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">12.1</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Signed Confidentiality Agreement</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">12.2</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Signed Clinical Trial Agreement</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">12.3</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Other Relevant Agreement/ Contracts</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">12.4</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Insurance Certificate</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">12.5</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Indemnity </span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">13</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">Participant Logs</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:7.55pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">13.1</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Participant Screening Log</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">13.2</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Participant Enrolment Log</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">13.3</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Participant Identification Log</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">14</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">Investigational Product (IP) </span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">14.1</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Instructions for Handling of IP (if not included in protocol)</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">14.2</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">IP Shipping and Receipt Records </span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">14.3</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">IP Dispensing and Accountability Logs</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">14.4</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">IP Destruction Log</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">14.5</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">IP Storage &amp; Temperature Logs</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">14.6</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Decoding and Un-blinding Procedure</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">14.7</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Sample of Label(s) attached to IP Container(s)</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">15</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">Randomisation </span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">15.1</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Instructions </span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">15.2</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Un-blinding procedure</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">16</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">Monitoring</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">16.1</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Site Visit Log</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">16.2</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Correspondence</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;background-color:#f2f2f2; width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">17</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;background-color:#f2f2f2; width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">Audit</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;background-color:#f2f2f2; width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;background-color:#f2f2f2; width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">17.1</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Report</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">17.2</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Correspondences (e.g. visit confirmation/ follow up letters)</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">18</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">Laboratory </span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">18.1</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Normal ranges </span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">18.2</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Certification / Accreditation (NATA)</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">19</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">Biological Samples </span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">19.1</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Biological Sample Storage/Destruction Log</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">19.2</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Biological Samples Shipping Records</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">19.3</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Laboratory Manual &amp; Certification</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">19.4</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Shipping Materials</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">20</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">Safety Reports</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">20.1</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Serious Adverse Event (SAE) Tracking Log</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">20.2</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">SAE Reports Submitted to Sponsor </span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">20.3</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Safety Reports </span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">21</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">Study Reports/ Publications</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">21.1</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Interim Report/ DSMB Reports</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">21.2</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Final Clinical Study Report</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">21.3</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Relevant Study Publications/ References</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">22</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">Study Meetings</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">22.1</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Site Initiation Visit (e.g. Agenda, Presentations, Attendance List, Report)</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">22.2</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Other Relevant Meeting Documentation</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">23</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;font-weight:bold;">Correspondence</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;background-color:#f2f2f2; width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">23.1</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Correspondence with sponsor (if applicable)</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">23.2</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Correspondence with site(s)</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">23.3</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">Newsletters</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:MS Gothic;font-size:11pt;font-weight:bold;">☐</span>
      </div> </td> 
     <td style=" border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;border-bottom:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">&nbsp;</span>
       <span style="font-family:Times New Roman;font-size:11pt;">     </span>
      </div> </td> 
    </tr> 
    <tr style=" height:11.50pt; "> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 63.45pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 287.15pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 58.95pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
     <td style=" border-bottom:solid 1px #000000;border-left:solid 1px #000000;border-right:solid 1px #000000;border-top:solid 1px #000000;width: 61.35pt; "> 
      <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:center;padding-bottom:0pt;padding-top:0pt;line-height: 1.15; ">
       <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
      </div> </td> 
    </tr> 
   </tbody>
  </table> 
  <div class="cstlDefaultStyle cstlNormal" style=" position: relative; text-align:left;">
   <span style="font-family:Calibri;font-size:22pt;">&nbsp;&nbsp;&nbsp;</span>
  </div> 
  <p style="margin-bottom:5px;background-color:#E7EAEF;">&nbsp;</p>
  <div class="cstlDefaultStyle cstlHeader" style="padding-top: 0pt; padding-bottom: 1pt; font-size: 10pt; font-family: Times New Roman; line-height: 1; position: relative; text-align: left;">
   &nbsp;
  </div> 
  <p style="border-bottom:2px solid #E7EAEF;">&nbsp;</p>
  <div class="cstlDefaultStyle cstlFooter" style="text-indent: 0pt; padding-left: 10pt; font-size: 10pt; padding-bottom: 1pt; font-family: Times New Roman; line-height: 1; position: relative; text-align: left;">
   <span style="font-size:11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Page </span>
   <span style="font-size:11pt;font-weight:bold;">&nbsp;</span>
   <span style="font-size:11pt;font-weight:bold;">&nbsp;</span>
   <span style="font-size:11pt;font-weight:bold;">&nbsp;</span>
   <span style="font-size:11pt;font-weight:bold;">1</span>
   <span style="font-size:11pt;">&nbsp;of </span>
   <span style="font-size:11pt;font-weight:bold;">&nbsp;</span>
   <span style="font-size:11pt;font-weight:bold;">&nbsp;</span>
   <span style="font-size:11pt;font-weight:bold;">&nbsp;</span>
   <span style="font-size:11pt;font-weight:bold;">4</span>
  </div> 
  <div class="cstlDefaultStyle cstlFooter" style="font-size: 10pt; padding-bottom: 1pt; font-family: Times New Roman; line-height: 1; position: relative; text-align: left;">
   <span style="font-size:8pt;">ISF Table of Contents, Version 1.0, 20160804</span>
  </div> 
  <p style="border-bottom:2px solid #E7EAEF;">&nbsp;</p>  
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