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<!-- ******************************************************************************* -->
<!-- File: define.xml                                                                -->
<!-- Date: 09JUL2016                                                                -->
<!-- Description: Define.xml file for XYZ123                          -->
<!-- Created by the %make_define2 SAS macro                                          -->
<!-- ******************************************************************************* -->
<ODM
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  xmlns:arm="http://www.cdisc.org/ns/arm/v1.0"
  FileOID="XYZ123"
  FileType="Snapshot"
  CreationDateTime="2016-07-09T22:06:45">
<Study OID="123">
  <GlobalVariables>
    <StudyName>XYZ123</StudyName>
    <StudyDescription>A PHASE IIB, DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED, PARALLEL GROUP TRIAL OF ANALGEZIA HCL FOR THE TREATMENT OF CHRONIC PAIN</StudyDescription>
    <ProtocolName>XYZ123</ProtocolName>
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    Description="XYZ123, ADAM Data Definitions"
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      <!-- def:leaf details for hypertext linking the dataset   -->
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          <TranslatedText xml:lang="en">Study Identifier</TranslatedText>
      </Description>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.STUDYID</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADAE.USUBJID"
      Name="USUBJID"
      SASFieldName="USUBJID"
      DataType="text"
      Length="25"
      def:DisplayFormat="25"
      >
      <Description>
          <TranslatedText xml:lang="en">Unique Subject Identifier</TranslatedText>
      </Description>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.USUBJID</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADAE.SITEID"
      Name="SITEID"
      SASFieldName="SITEID"
      DataType="text"
      Length="7"
      def:DisplayFormat="7"
      >
      <Description>
          <TranslatedText xml:lang="en">Study Site Identifier</TranslatedText>
      </Description>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.SITEID</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADAE.COUNTRY"
      Name="COUNTRY"
      SASFieldName="COUNTRY"
      DataType="text"
      Length="3"
      def:DisplayFormat="3"
      >
      <Description>
          <TranslatedText xml:lang="en">Country</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.COUNTRY"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.COUNTRY</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADAE.AESEQ"
      Name="AESEQ"
      SASFieldName="AESEQ"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Sequence Number</TranslatedText>
      </Description>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">AE.AESEQ</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADAE.AGE"
      Name="AGE"
      SASFieldName="AGE"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Unique Subject Identifier</TranslatedText>
      </Description>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.AGE</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADAE.AGEGR1N"
      Name="AGEGR1N"
      SASFieldName="AGEGR1N"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Pooled Age Group 1 (N)</TranslatedText>
      </Description>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.AGEGR1N</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADAE.AGEGR1"
      Name="AGEGR1"
      SASFieldName="AGEGR1"
      DataType="text"
      Length="20"
      def:DisplayFormat="20"
      >
      <Description>
          <TranslatedText xml:lang="en">Pooled Age Group 1</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.AGEGR1"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.AGEGR1</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADAE.SEX"
      Name="SEX"
      SASFieldName="SEX"
      DataType="text"
      Length="1"
      def:DisplayFormat="1"
      >
      <Description>
          <TranslatedText xml:lang="en">Sex</TranslatedText>
      </Description>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.SEX</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADAE.TRTAN"
      Name="TRTAN"
      SASFieldName="TRTAN"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Actual Treatment (N)</TranslatedText>
      </Description>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.TRT01AN</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADAE.TRTA"
      Name="TRTA"
      SASFieldName="TRTA"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Actual Treatment</TranslatedText>
      </Description>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.TRT01A</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADAE.AETERM"
      Name="AETERM"
      SASFieldName="AETERM"
      DataType="text"
      Length="200"
      def:DisplayFormat="200"
      >
      <Description>
          <TranslatedText xml:lang="en">Reported Term for the Adverse Event</TranslatedText>
      </Description>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">AE.AETERM</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADAE.AEDECOD"
      Name="AEDECOD"
      SASFieldName="AEDECOD"
      DataType="text"
      Length="200"
      def:DisplayFormat="200"
      >
      <Description>
          <TranslatedText xml:lang="en">Dictionary-Derived Term</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.MedDRA"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">AE.AEDECOD</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADAE.AEBODSYS"
      Name="AEBODSYS"
      SASFieldName="AEBODSYS"
      DataType="text"
      Length="200"
      def:DisplayFormat="200"
      >
      <Description>
          <TranslatedText xml:lang="en">Body System or Organ Class</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.MedDRA"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">AE.AEBODSYS</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADAE.ASTDT"
      Name="ASTDT"
      SASFieldName="ASTDT"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Start Date/Time of Adverse Events</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADAE.AENDT"
      Name="AENDT"
      SASFieldName="AENDT"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">End Date/Time of Adverse Events</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADAE.ASTDY"
      Name="ASTDY"
      SASFieldName="ASTDY"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Study Day of Start of Adverse Event</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADAE.AENDY"
      Name="AENDY"
      SASFieldName="AENDY"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Study Day of End of Adverse Event</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADAE.AESEV"
      Name="AESEV"
      SASFieldName="AESEV"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Severity/Intensity</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.AESEV"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">AE.AESEV</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADAE.AESEVN"
      Name="AESEVN"
      SASFieldName="AESEVN"
      DataType="integer"
      Length="8"
      def:DisplayFormat="1"
      >
      <Description>
          <TranslatedText xml:lang="en">Severity/Intensity (N)</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.AESEVN"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADAE.AESER"
      Name="AESER"
      SASFieldName="AESER"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Serious Event</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.YN"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">AE.AESER</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADAE.AEACN"
      Name="AEACN"
      SASFieldName="AEACN"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Action Taken with Study Treatment</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.ACN"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">AE.AEACN</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADAE.AEREL"
      Name="AEREL"
      SASFieldName="AEREL"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Causality</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.AEREL"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">AE.AEREL</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADAE.AERELN"
      Name="AERELN"
      SASFieldName="AERELN"
      DataType="integer"
      Length="8"
      def:DisplayFormat="1"
      >
      <Description>
          <TranslatedText xml:lang="en">Causality (N)</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.AERELN"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADAE.CQ01NAM"
      Name="CQ01NAM"
      SASFieldName="CQ01NAM"
      DataType="text"
      Length="200"
      def:DisplayFormat="200"
      >
      <Description>
          <TranslatedText xml:lang="en">CQ 01 Name</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADAE.RELGR1"
      Name="RELGR1"
      SASFieldName="RELGR1"
      DataType="text"
      Length="15"
      def:DisplayFormat="15"
      >
      <Description>
          <TranslatedText xml:lang="en">Pooled Causality Group 1</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.RELGR1"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADAE.RELGR1N"
      Name="RELGR1N"
      SASFieldName="RELGR1N"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Pooled Causality Group 1 (N)</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.RELGR1N"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADAE.TRTEMFL"
      Name="TRTEMFL"
      SASFieldName="TRTEMFL"
      DataType="text"
      Length="1"
      def:DisplayFormat="1"
      >
      <Description>
          <TranslatedText xml:lang="en">Treatment Emergent Flag</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.FLAGS"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADAE.SAFFL"
      Name="SAFFL"
      SASFieldName="SAFFL"
      DataType="text"
      Length="1"
      def:DisplayFormat="1"
      >
      <Description>
          <TranslatedText xml:lang="en">Safety Population Flag</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.FLAGS"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.SAFFL</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADEF.STUDYID"
      Name="STUDYID"
      SASFieldName="STUDYID"
      DataType="text"
      Length="15"
      def:DisplayFormat="15"
      >
      <Description>
          <TranslatedText xml:lang="en">Study Identifier</TranslatedText>
      </Description>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.STUDYID</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADEF.USUBJID"
      Name="USUBJID"
      SASFieldName="USUBJID"
      DataType="text"
      Length="25"
      def:DisplayFormat="25"
      >
      <Description>
          <TranslatedText xml:lang="en">Unique Subject Identifier</TranslatedText>
      </Description>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.USUBJID</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADEF.SITEID"
      Name="SITEID"
      SASFieldName="SITEID"
      DataType="text"
      Length="7"
      def:DisplayFormat="7"
      >
      <Description>
          <TranslatedText xml:lang="en">Study Site Identifier</TranslatedText>
      </Description>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.SITEID</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADEF.COUNTRY"
      Name="COUNTRY"
      SASFieldName="COUNTRY"
      DataType="text"
      Length="3"
      def:DisplayFormat="3"
      >
      <Description>
          <TranslatedText xml:lang="en">Country</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.COUNTRY"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.COUNTRY</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADEF.RANDDT"
      Name="RANDDT"
      SASFieldName="RANDDT"
      DataType="integer"
      Length="8"
      def:DisplayFormat="date9."
      >
      <Description>
          <TranslatedText xml:lang="en">Date of Randomization</TranslatedText>
      </Description>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.RANDDT</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADEF.AGE"
      Name="AGE"
      SASFieldName="AGE"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Age</TranslatedText>
      </Description>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.AGE</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADEF.AGEGR1N"
      Name="AGEGR1N"
      SASFieldName="AGEGR1N"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Pooled Age Group 1 (N)</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.AGEGR1N"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.AGEGR1N</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADEF.AGEGR1"
      Name="AGEGR1"
      SASFieldName="AGEGR1"
      DataType="text"
      Length="20"
      def:DisplayFormat="20"
      >
      <Description>
          <TranslatedText xml:lang="en">Pooled Age Group 1</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.AGEGR1"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.AGEGR1</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADEF.SEX"
      Name="SEX"
      SASFieldName="SEX"
      DataType="text"
      Length="1"
      def:DisplayFormat="1"
      >
      <Description>
          <TranslatedText xml:lang="en">Sex</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.SEX"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.SEX</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADEF.RACE"
      Name="RACE"
      SASFieldName="RACE"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Race</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.RACE"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.RACE</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADEF.TRTPN"
      Name="TRTPN"
      SASFieldName="TRTPN"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Planned Treatment (N)</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.ARMN"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.TRT01PN</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADEF.TRTP"
      Name="TRTP"
      SASFieldName="TRTP"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Planned Treatment</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.ARM"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.TRT01P</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADEF.PARAMCD"
      Name="PARAMCD"
      SASFieldName="PARAMCD"
      DataType="text"
      Length="8"
      def:DisplayFormat="8"
      def:CommentOID="COM.SEECODELIST"
      >
      <Description>
          <TranslatedText xml:lang="en">Parameter Code</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.ADEF.PARAMCD"/>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADEF.PARAM"
      Name="PARAM"
      SASFieldName="PARAM"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      def:CommentOID="COM.SEECODELIST"
      >
      <Description>
          <TranslatedText xml:lang="en">Parameter</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.ADEF.PARAM"/>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADEF.AVISIT"
      Name="AVISIT"
      SASFieldName="AVISIT"
      DataType="text"
      Length="16"
      def:DisplayFormat="16"
      >
      <Description>
          <TranslatedText xml:lang="en">Analysis Visit</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.VISIT"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">XP.VISIT</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADEF.AVISITN"
      Name="AVISITN"
      SASFieldName="AVISITN"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Analysis Visit (N)</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.AVISITN"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADEF.ABLFL"
      Name="ABLFL"
      SASFieldName="ABLFL"
      DataType="text"
      Length="1"
      def:DisplayFormat="1"
      >
      <Description>
          <TranslatedText xml:lang="en">Baseline Record Flag</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.FLAGS"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADEF.XPSEQ"
      Name="XPSEQ"
      SASFieldName="XPSEQ"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Sequence Number</TranslatedText>
      </Description>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">XP.XPSEQ</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADEF.VISITNUM"
      Name="VISITNUM"
      SASFieldName="VISITNUM"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Visit Number</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.VISITNUM"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">XP.VISITNUM</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADEF.ADT"
      Name="ADT"
      SASFieldName="ADT"
      DataType="integer"
      Length="8"
      def:DisplayFormat="date9."
      >
      <Description>
          <TranslatedText xml:lang="en">Analysis Date</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADEF.ADY"
      Name="ADY"
      SASFieldName="ADY"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Analysis Relative Day</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADEF.AVAL"
      Name="AVAL"
      SASFieldName="AVAL"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Analysis Value</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
      <def:ValueListRef ValueListOID="VL.ADEF.AVAL"/>
    </ItemDef>
    <ItemDef OID="ADEF.AVALC"
      Name="AVALC"
      SASFieldName="AVALC"
      DataType="text"
      Length="12"
      def:DisplayFormat="12"
      >
      <Description>
          <TranslatedText xml:lang="en">Analysis Value (C)</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADEF.BASE"
      Name="BASE"
      SASFieldName="BASE"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Baseline Value</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADEF.CHG"
      Name="CHG"
      SASFieldName="CHG"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Change from Baseline</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADEF.CRIT1FL"
      Name="CRIT1FL"
      SASFieldName="CRIT1FL"
      DataType="text"
      Length="1"
      def:DisplayFormat="1"
      >
      <Description>
          <TranslatedText xml:lang="en">Criterion 1 Evaluation Result Flag</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.YN"/>
      <def:Origin Type="Derived">
      </def:Origin>
      <def:ValueListRef ValueListOID="VL.ADEF.CRIT1FL"/>
    </ItemDef>
    <ItemDef OID="ADEF.CRIT1"
      Name="CRIT1"
      SASFieldName="CRIT1"
      DataType="text"
      Length="60"
      def:DisplayFormat="60"
      >
      <Description>
          <TranslatedText xml:lang="en">Analysis Criterion 1</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
      <def:ValueListRef ValueListOID="VL.ADEF.CRIT1"/>
    </ItemDef>
    <ItemDef OID="ADEF.ITTFL"
      Name="ITTFL"
      SASFieldName="ITTFL"
      DataType="text"
      Length="1"
      def:DisplayFormat="1"
      >
      <Description>
          <TranslatedText xml:lang="en">Intent-to-Treat Flag</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.FLAGS"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.ITTFL</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADSL.STUDYID"
      Name="STUDYID"
      SASFieldName="STUDYID"
      DataType="text"
      Length="15"
      def:DisplayFormat="15"
      >
      <Description>
          <TranslatedText xml:lang="en">Study Identifier</TranslatedText>
      </Description>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">DM.STUDYID</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADSL.USUBJID"
      Name="USUBJID"
      SASFieldName="USUBJID"
      DataType="text"
      Length="25"
      def:DisplayFormat="25"
      >
      <Description>
          <TranslatedText xml:lang="en">Unique Subject Identifier</TranslatedText>
      </Description>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">DM.USUBJID</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADSL.SUBJID"
      Name="SUBJID"
      SASFieldName="SUBJID"
      DataType="text"
      Length="7"
      def:DisplayFormat="7"
      >
      <Description>
          <TranslatedText xml:lang="en">Subject Identifier for the Study</TranslatedText>
      </Description>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">DM.SUBJID</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADSL.SITEID"
      Name="SITEID"
      SASFieldName="SITEID"
      DataType="text"
      Length="7"
      def:DisplayFormat="7"
      >
      <Description>
          <TranslatedText xml:lang="en">Study Site Identifier</TranslatedText>
      </Description>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">DM.SITEID</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADSL.COUNTRY"
      Name="COUNTRY"
      SASFieldName="COUNTRY"
      DataType="text"
      Length="3"
      def:DisplayFormat="3"
      >
      <Description>
          <TranslatedText xml:lang="en">Country</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.COUNTRY"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">DM.COUNTRY</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADSL.BRTHDT"
      Name="BRTHDT"
      SASFieldName="BRTHDT"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Date of Birth</TranslatedText>
      </Description>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">DM.BIRTHDTC</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADSL.AGE"
      Name="AGE"
      SASFieldName="AGE"
      DataType="integer"
      Length="8"
      def:DisplayFormat="3.0"
      >
      <Description>
          <TranslatedText xml:lang="en">Age</TranslatedText>
      </Description>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">DM.AGE</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADSL.AGEU"
      Name="AGEU"
      SASFieldName="AGEU"
      DataType="text"
      Length="5"
      def:DisplayFormat="5"
      >
      <Description>
          <TranslatedText xml:lang="en">Age Units</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.AGEU"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">DM.AGEU</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADSL.AGEGR1"
      Name="AGEGR1"
      SASFieldName="AGEGR1"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Pooled Age Group 1</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.AGEGR1"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADSL.AGEGR1N"
      Name="AGEGR1N"
      SASFieldName="AGEGR1N"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Pooled Age Group 1 (N)</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.AGEGR1N"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADSL.SEX"
      Name="SEX"
      SASFieldName="SEX"
      DataType="text"
      Length="1"
      def:DisplayFormat="1"
      >
      <Description>
          <TranslatedText xml:lang="en">Sex</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.SEX"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">DM.SEX</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADSL.RACE"
      Name="RACE"
      SASFieldName="RACE"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Race</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.RACE"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">DM.RACE</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADSL.RACEOTH"
      Name="RACEOTH"
      SASFieldName="RACEOTH"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Race, Other, Specify</TranslatedText>
      </Description>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">DM.RACEOTH</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADSL.RANDDT"
      Name="RANDDT"
      SASFieldName="RANDDT"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Date of Randomization</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADSL.TRTSDT"
      Name="TRTSDT"
      SASFieldName="TRTSDT"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Date of First Exposure to Treatment</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADSL.TRTEDT"
      Name="TRTEDT"
      SASFieldName="TRTEDT"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Date of Last Exposure to Treatment</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADSL.ARM"
      Name="ARM"
      SASFieldName="ARM"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Description of Planned Arm</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.ARM"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">DM.ARM</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADSL.TRT01P"
      Name="TRT01P"
      SASFieldName="TRT01P"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Planned Treatment for Period 01</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.ARM"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">DM.ARM</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADSL.TRT01A"
      Name="TRT01A"
      SASFieldName="TRT01A"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Actual Treatment for Period 01</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.ARM"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">DM.ARM</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADSL.TRT01PN"
      Name="TRT01PN"
      SASFieldName="TRT01PN"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Planned Treatment for Period 01 (N)</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.ARMN"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADSL.TRT01AN"
      Name="TRT01AN"
      SASFieldName="TRT01AN"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Actual Treatment for Period 01 (N)</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.ARMN"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADSL.ITTFL"
      Name="ITTFL"
      SASFieldName="ITTFL"
      DataType="text"
      Length="1"
      def:DisplayFormat="1"
      >
      <Description>
          <TranslatedText xml:lang="en">Intent-To-Treat Population Flag</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.FLAGS"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADSL.SAFFL"
      Name="SAFFL"
      SASFieldName="SAFFL"
      DataType="text"
      Length="1"
      def:DisplayFormat="1"
      >
      <Description>
          <TranslatedText xml:lang="en">Safety Population Flag</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.FLAGS"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADSL.RESPFL"
      Name="RESPFL"
      SASFieldName="RESPFL"
      DataType="text"
      Length="1"
      def:DisplayFormat="1"
      >
      <Description>
          <TranslatedText xml:lang="en">Efficacy Responder Flag</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.YN"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADTTE.STUDYID"
      Name="STUDYID"
      SASFieldName="STUDYID"
      DataType="text"
      Length="15"
      def:DisplayFormat="15"
      >
      <Description>
          <TranslatedText xml:lang="en">Study Identifier</TranslatedText>
      </Description>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.STUDYID</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADTTE.USUBJID"
      Name="USUBJID"
      SASFieldName="USUBJID"
      DataType="text"
      Length="25"
      def:DisplayFormat="25"
      >
      <Description>
          <TranslatedText xml:lang="en">Domain Abbreviation</TranslatedText>
      </Description>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.USUBJID</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADTTE.SITEID"
      Name="SITEID"
      SASFieldName="SITEID"
      DataType="text"
      Length="7"
      def:DisplayFormat="7"
      >
      <Description>
          <TranslatedText xml:lang="en">Study Site Identifier</TranslatedText>
      </Description>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.SITEID</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADTTE.COUNTRY"
      Name="COUNTRY"
      SASFieldName="COUNTRY"
      DataType="text"
      Length="3"
      def:DisplayFormat="3"
      >
      <Description>
          <TranslatedText xml:lang="en">Country</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.COUNTRY"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.COUNTRY</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADTTE.AGE"
      Name="AGE"
      SASFieldName="AGE"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Unique Subject Identifier</TranslatedText>
      </Description>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.AGE</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADTTE.AGEGR1N"
      Name="AGEGR1N"
      SASFieldName="AGEGR1N"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Pooled Age Group 1 (N)</TranslatedText>
      </Description>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.AGEGR1N</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADTTE.AGEGR1"
      Name="AGEGR1"
      SASFieldName="AGEGR1"
      DataType="text"
      Length="20"
      def:DisplayFormat="20"
      >
      <Description>
          <TranslatedText xml:lang="en">Pooled Age Group 1</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.AGEGR1"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.AGEGR1</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADTTE.SEX"
      Name="SEX"
      SASFieldName="SEX"
      DataType="text"
      Length="1"
      def:DisplayFormat="1"
      >
      <Description>
          <TranslatedText xml:lang="en">Sex</TranslatedText>
      </Description>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.SEX</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADTTE.RACE"
      Name="RACE"
      SASFieldName="RACE"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Race</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.RACE"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.RACE</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADTTE.TRTPN"
      Name="TRTPN"
      SASFieldName="TRTPN"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Planned Treatment (N)</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.ARMN"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.TRT01PN</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADTTE.TRTP"
      Name="TRTP"
      SASFieldName="TRTP"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Planned Treatment</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.ARM"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.TRT01P</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADTTE.PARAMCD"
      Name="PARAMCD"
      SASFieldName="PARAMCD"
      DataType="text"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Parameter Code</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.ADTTE.PARAMCD"/>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADTTE.PARAM"
      Name="PARAM"
      SASFieldName="PARAM"
      DataType="text"
      Length="40"
      def:DisplayFormat="40"
      >
      <Description>
          <TranslatedText xml:lang="en">Parameter</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.ADTTE.PARAM"/>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADTTE.ADT"
      Name="ADT"
      SASFieldName="ADT"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Analysis Date</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADTTE.STARTDT"
      Name="STARTDT"
      SASFieldName="STARTDT"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Time to Event Origin Date for Subject</TranslatedText>
      </Description>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.RANDDT</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADTTE.AVAL"
      Name="AVAL"
      SASFieldName="AVAL"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Analysis Value</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
      <def:ValueListRef ValueListOID="VL.ADTTE.AVAL"/>
    </ItemDef>
    <ItemDef OID="ADTTE.CNSR"
      Name="CNSR"
      SASFieldName="CNSR"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Censor</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
      <def:ValueListRef ValueListOID="VL.ADTTE.CNSR"/>
    </ItemDef>
    <ItemDef OID="ADTTE.EVNTDESC"
      Name="EVNTDESC"
      SASFieldName="EVNTDESC"
      DataType="text"
      Length="50"
      def:DisplayFormat="50"
      >
      <Description>
          <TranslatedText xml:lang="en">Event description</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
      <def:ValueListRef ValueListOID="VL.ADTTE.EVNTDESC"/>
    </ItemDef>
    <ItemDef OID="ADTTE.SRCDOM"
      Name="SRCDOM"
      SASFieldName="SRCDOM"
      DataType="text"
      Length="6"
      def:DisplayFormat="6"
      >
      <Description>
          <TranslatedText xml:lang="en">Source Domain</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADTTE.SRCVAR"
      Name="SRCVAR"
      SASFieldName="SRCVAR"
      DataType="text"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Source Variable</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADTTE.SRCSEQ"
      Name="SRCSEQ"
      SASFieldName="SRCSEQ"
      DataType="integer"
      Length="8"
      def:DisplayFormat="8"
      >
      <Description>
          <TranslatedText xml:lang="en">Source Sequence Number</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="ADTTE.ITTFL"
      Name="ITTFL"
      SASFieldName="ITTFL"
      DataType="text"
      Length="1"
      def:DisplayFormat="1"
      >
      <Description>
          <TranslatedText xml:lang="en">Intent-to-Treat Flag</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.FLAGS"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">ADSL.ITTFL</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <!-- ************************************************************ -->
    <!-- The details of value level items are here                    -->
    <!-- ************************************************************ -->
    <ItemDef OID="VL.ADEF.AVAL.XPPAIN"
      Name="XPPAIN"
      DataType="integer"
      SASFieldName="XPPAIN"
      Length="8"
      def:DisplayFormat="1."
      >
      <Description>
        <TranslatedText xml:lang="en">Pain Score</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.PAINSCORE"/>
      <def:Origin Type="Predecessor">
        <Description>
          <TranslatedText xml:lang="en">XP.XPSTRESN</TranslatedText>
        </Description>
      </def:Origin>
    </ItemDef>
    <ItemDef OID="VL.ADEF.CRIT1.XPPAIN"
      Name="XPPAIN"
      DataType="text"
      SASFieldName="XPPAIN"
      Length="51"
      def:DisplayFormat="$52."
      >
      <Description>
        <TranslatedText xml:lang="en">Pain Score</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.ADEF.CRIT1"/>
      <def:Origin Type="Assigned">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="VL.ADEF.CRIT1FL.XPPAIN"
      Name="XPPAIN"
      DataType="text"
      SASFieldName="XPPAIN"
      Length="1"
      def:DisplayFormat="$1."
      >
      <Description>
        <TranslatedText xml:lang="en">Pain Score</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.YN"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="VL.ADTTE.AVAL.TTPNRELF"
      Name="TTPNRELF"
      DataType="integer"
      SASFieldName="TTPNRELF"
      Length="8"
      def:DisplayFormat="8."
      >
      <Description>
        <TranslatedText xml:lang="en">Time to First Pain Relief</TranslatedText>
      </Description>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="VL.ADTTE.CNSR.TTPNRELF"
      Name="TTPNRELF"
      DataType="integer"
      SASFieldName="TTPNRELF"
      Length="8"
      def:DisplayFormat="8."
      >
      <Description>
        <TranslatedText xml:lang="en">Censor</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.CENSOR"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <ItemDef OID="VL.ADTTE.EVNTDESC.XPPAIN"
      Name="XPPAIN"
      DataType="text"
      SASFieldName="XPPAIN"
      Length="50"
      def:DisplayFormat="$50"
      >
      <Description>
        <TranslatedText xml:lang="en">Event or Censoring Description</TranslatedText>
      </Description>
      <CodeListRef CodeListOID="CodeList.EVNTDESC"/>
      <def:Origin Type="Derived">
      </def:Origin>
    </ItemDef>
    <!-- ************************************************************ -->
    <!-- Codelists are presented below                                -->
    <!-- ************************************************************ -->
    <CodeList OID="CodeList.ACN"
      Name="ACN"
      DataType="text">
      <CodeListItem CodedValue="DOSE INCREASED" OrderNumber="1">
        <Decode>
          <TranslatedText>DOSE INCREASED</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="DOSE NOT CHANGED" OrderNumber="2">
        <Decode>
          <TranslatedText>DOSE NOT CHANGED</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="DOSE REDUCED" OrderNumber="3">
        <Decode>
          <TranslatedText>DOSE REDUCED</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="DRUG INTERRUPTED" OrderNumber="4">
        <Decode>
          <TranslatedText>DRUG INTERRUPTED</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="DRUG WITHDRAWN" OrderNumber="5">
        <Decode>
          <TranslatedText>DRUG WITHDRAWN</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="NOT APPLICABLE" OrderNumber="6">
        <Decode>
          <TranslatedText>NA</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="UNKNOWN" OrderNumber="7">
        <Decode>
          <TranslatedText>U; Unknown</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.ADEF.CRIT1"
      Name="ADEF.CRIT1"
      DataType="text">
      <CodeListItem CodedValue="Pain improvement from baseline of at least 2 points" OrderNumber="1">
        <Decode>
          <TranslatedText>Pain improvement from baseline of at least 2 points</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.ADEF.PARAM"
      Name="ADEF.PARAM"
      DataType="text">
      <CodeListItem CodedValue="Pain Score" OrderNumber="1">
        <Decode>
          <TranslatedText>Pain Score</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.ADEF.PARAMCD"
      Name="ADEF.PARAMCD"
      DataType="text">
      <CodeListItem CodedValue="XPPAIN" OrderNumber="1">
        <Decode>
          <TranslatedText>Pain Score</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.ADTTE.PARAM"
      Name="ADTTE.PARAM"
      DataType="text">
      <CodeListItem CodedValue="Time to first pain relief" OrderNumber="1">
        <Decode>
          <TranslatedText>Time to first pain relief</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.ADTTE.PARAMCD"
      Name="ADTTE.PARAMCD"
      DataType="text">
      <CodeListItem CodedValue="TTPNRELF" OrderNumber="1">
        <Decode>
          <TranslatedText>Time to first pain relief</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.AEREL"
      Name="AEREL"
      DataType="text">
      <CodeListItem CodedValue="NOT RELATED" OrderNumber="1">
        <Decode>
          <TranslatedText>NOT RELATED</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="POSSIBLY RELATED" OrderNumber="2">
        <Decode>
          <TranslatedText>POSSIBLY RELATED</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="PROBABLY RELATED" OrderNumber="3">
        <Decode>
          <TranslatedText>PROBABLY RELATED</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.AERELN"
      Name="AERELN"
      DataType="integer">
      <CodeListItem CodedValue="0" OrderNumber="1">
        <Decode>
          <TranslatedText>NOT RELATED</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="1" OrderNumber="2">
        <Decode>
          <TranslatedText>POSSIBLY RELATED</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="2" OrderNumber="3">
        <Decode>
          <TranslatedText>PROBABLY RELATED</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.AESEV"
      Name="AESEV"
      DataType="text">
      <CodeListItem CodedValue="MILD" OrderNumber="1">
        <Decode>
          <TranslatedText>Grade 1; 1</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="MODERATE" OrderNumber="2">
        <Decode>
          <TranslatedText>Grade 2; 2</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="SEVERE" OrderNumber="3">
        <Decode>
          <TranslatedText>Grade 3; 3</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.AESEVN"
      Name="AESEVN"
      DataType="integer">
      <CodeListItem CodedValue="1" OrderNumber="1">
        <Decode>
          <TranslatedText>Mild</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="2" OrderNumber="2">
        <Decode>
          <TranslatedText>Moderate</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="3" OrderNumber="3">
        <Decode>
          <TranslatedText>Severe</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.AGEGR1"
      Name="AGEGR1"
      DataType="text">
      <CodeListItem CodedValue="&lt;55 YEARS" OrderNumber="1">
        <Decode>
          <TranslatedText>&lt;55 Years</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="&gt;=55 YEARS" OrderNumber="2">
        <Decode>
          <TranslatedText>&gt;=55 Years</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.AGEGR1N"
      Name="AGEGR1N"
      DataType="integer">
      <CodeListItem CodedValue="1" OrderNumber="1">
        <Decode>
          <TranslatedText>&lt;55 Years</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="2" OrderNumber="2">
        <Decode>
          <TranslatedText>&gt;=55 Years</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.AGEU"
      Name="AGEU"
      DataType="text">
      <CodeListItem CodedValue="YEARS" OrderNumber="1">
        <Decode>
          <TranslatedText>YEARS</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.ARM"
      Name="ARM"
      DataType="text">
      <CodeListItem CodedValue="Analgezia HCL 30 mg" OrderNumber="1">
        <Decode>
          <TranslatedText>Analgezia HCL 30 mg</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Placebo" OrderNumber="2">
        <Decode>
          <TranslatedText>Placebo</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.ARMCD"
      Name="ARMCD"
      DataType="text">
      <CodeListItem CodedValue="ALG123" OrderNumber="1">
        <Decode>
          <TranslatedText>Analgezia HCL 30 mg</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="PLACEBO" OrderNumber="2">
        <Decode>
          <TranslatedText>Placebo</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.ARMN"
      Name="ARMN"
      DataType="integer">
      <CodeListItem CodedValue="1" OrderNumber="1">
        <Decode>
          <TranslatedText>Analgezia HCL 30 mg</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="0" OrderNumber="2">
        <Decode>
          <TranslatedText>Placebo</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.AVISITN"
      Name="AVISITN"
      DataType="integer">
      <CodeListItem CodedValue="0" OrderNumber="1">
        <Decode>
          <TranslatedText>Baseline</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="3" OrderNumber="2">
        <Decode>
          <TranslatedText>Month 3</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="6" OrderNumber="3">
        <Decode>
          <TranslatedText>Month 6</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.CENSOR"
      Name="CENSOR"
      DataType="integer">
      <CodeListItem CodedValue="0" OrderNumber="1">
        <Decode>
          <TranslatedText>Pain relief</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="1" OrderNumber="2">
        <Decode>
          <TranslatedText>Pain worsening prior to relief</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="2" OrderNumber="3">
        <Decode>
          <TranslatedText>Pain adverse event prior to relief</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="3" OrderNumber="4">
        <Decode>
          <TranslatedText>No relief and no worsening at last assessment</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.COUNTRY"
      Name="COUNTRY"
      DataType="text">
      <CodeListItem CodedValue="USA" OrderNumber="1">
        <Decode>
          <TranslatedText>UNITED STATES</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.CRIT1VALUES"
      Name="CRIT1VALUES"
      DataType="text">
      <CodeListItem CodedValue="Pain improvement from baseline of at least 2 points" OrderNumber="1">
        <Decode>
          <TranslatedText>Pain improvement from baseline of at least 2 points</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.EVNTDESC"
      Name="EVNTDESC"
      DataType="text">
      <CodeListItem CodedValue="PAIN RELIEF" OrderNumber="1">
        <Decode>
          <TranslatedText>Pain relief</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="PAIN WORSENING PRIOR TO RELIEF" OrderNumber="2">
        <Decode>
          <TranslatedText>Pain worsening prior to relief</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="PAIN ADVERSE EVENT PRIOR TO RELIEF" OrderNumber="3">
        <Decode>
          <TranslatedText>Pain adverse event prior to relief</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="NO RELIEF AND NO WORSENING AT LAST ASSESSMENT" OrderNumber="4">
        <Decode>
          <TranslatedText>No relief and no worsening at last assessment</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.FLAGS"
      Name="FLAGS"
      DataType="text">
      <CodeListItem CodedValue="Y" OrderNumber="1">
        <Decode>
          <TranslatedText>Yes</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.PAINSCORE"
      Name="PAINSCORE"
      DataType="integer">
      <CodeListItem CodedValue="0" OrderNumber="0">
        <Decode>
          <TranslatedText>None</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="1" OrderNumber="1">
        <Decode>
          <TranslatedText>Mild</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="2" OrderNumber="2">
        <Decode>
          <TranslatedText>Moderate</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="3" OrderNumber="3">
        <Decode>
          <TranslatedText>Severe</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.RACE"
      Name="RACE"
      DataType="text">
      <CodeListItem CodedValue="BLACK OR AFRICAN AMERICAN" OrderNumber="1">
        <Decode>
          <TranslatedText>BLACK OR AFRICAN AMERICAN</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="ASIAN" OrderNumber="2">
        <Decode>
          <TranslatedText>ASIAN</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="WHITE" OrderNumber="3">
        <Decode>
          <TranslatedText>WHITE</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.RELGR1"
      Name="RELGR1"
      DataType="text">
      <CodeListItem CodedValue="Not related" OrderNumber="1">
        <Decode>
          <TranslatedText>Not related</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Related" OrderNumber="2">
        <Decode>
          <TranslatedText>Related</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.RELGR1N"
      Name="RELGR1N"
      DataType="integer">
      <CodeListItem CodedValue="0" OrderNumber="1">
        <Decode>
          <TranslatedText>Not related</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="1" OrderNumber="1">
        <Decode>
          <TranslatedText>Related</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.SEX"
      Name="SEX"
      DataType="text">
      <CodeListItem CodedValue="F" OrderNumber="1">
        <Decode>
          <TranslatedText>FEMALE</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="M" OrderNumber="2">
        <Decode>
          <TranslatedText>MALE</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="U" OrderNumber="3">
        <Decode>
          <TranslatedText>UNKNOWN</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.TRT01PN"
      Name="TRT01PN"
      DataType="integer">
      <CodeListItem CodedValue="0" OrderNumber="1">
        <Decode>
          <TranslatedText>Placebo</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="1" OrderNumber="2">
        <Decode>
          <TranslatedText>Analgezia HCL 30 mg</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.VISIT"
      Name="VISIT"
      DataType="text">
      <CodeListItem CodedValue="Baseline" OrderNumber="1">
        <Decode>
          <TranslatedText>Baseline</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Month 3" OrderNumber="2">
        <Decode>
          <TranslatedText>Month 3</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Month 6" OrderNumber="3">
        <Decode>
          <TranslatedText>Month 6</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.VISITNUM"
      Name="VISITNUM"
      DataType="text">
      <CodeListItem CodedValue="0" OrderNumber="1">
        <Decode>
          <TranslatedText>Baseline</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="1" OrderNumber="2">
        <Decode>
          <TranslatedText>Month 3</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="2" OrderNumber="3">
        <Decode>
          <TranslatedText>Month 6</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>
    <CodeList OID="CodeList.YN"
      Name="YN"
      DataType="text">
      <CodeListItem CodedValue="N" OrderNumber="1">
        <Decode>
          <TranslatedText>NO</TranslatedText>
        </Decode>
      </CodeListItem>
      <CodeListItem CodedValue="Y" OrderNumber="2">
        <Decode>
          <TranslatedText>YES</TranslatedText>
        </Decode>
      </CodeListItem>
    </CodeList>

    <!-- ******************************************* -->
    <!-- COMPUTATIONAL METHOD INFORMATION        *** -->
    <!-- ******************************************* -->
    <MethodDef OID="BASE" Name="Baseline value derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">Last non-missing value of AVAL prior to first dose</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="CHANGEFROMBASELINE" Name="Change from baseline calculation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">AVAL-BASE</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="RESPONDER" Name="Responder derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">IF (.Z&lt;CHG&lt;=-2) THEN CRIT1FL='Y' ELSE CRIT1FL='N'</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="TTPNRELF" Name="Time to first pain relief without worsening derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">Derived from ADEF.ADY (where PARAMCD=XPPAIN and ADY&gt;1) or ADAE.ASDY where CQ01NAM=PAIN EVENT.  Value is the earliest day when ADEF.CHG&lt;0 (for an event) or (ADEF.CHG&gt;0 or ADAE.ASDY&gt;0) (for subjects censored due to pain worsening) or the last record where ADEF.CHG=0 (for subjects censored due to no improvement or worsening by the time of the last</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="TTPNRELF.CNSR" Name="Censoring algorithm for Time to First Pain Relief" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">if pain relief occurs before worsening, then CNSR=0; else if worsening from pain data, then CNSR=1; else if worsening from AE data, then CNSR=3; else if no relief and no worsening at time of last observation, then CNSR=4</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="TTPNRELF.EVNTDESC" Name="Event descriptions for Time to First Pain Relief" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">if CNSR=0, then EVNTDESC=PAIN RELIEF; if CNSR=1, then EVNTDESC=PAIN WORSENING PRIOR TO RELIEF; if CNSR=2, then EVNTDESC=PAIN ADVERSE EVENT PRIOR TO RELIEF; if CNSR=3, then EVNTDESC=NO RELIEF AND NO WORSENING AT LAST ASSESSMENT</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="TRTSDT" Name="Date of first exposure to treatment derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">EX.EXSTDTC where EXSEQ=1, converted to a SAS date.  See SAP for missing or partial value imputations.</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="TRTEDT" Name="Date of last exposure to treatment derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">EX.EXENDTC converted to a SAS date for the last record in EX.  See SAP for missing or partial value imputations.</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="ITTFL" Name="Intent-to-Treat flag derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">If ADSL.RANDDT ^= missing then Y, else Null</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="SAFFL" Name="Safety population flag derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">If ADSL.TRTSDT^=missing then Y, else Null</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="RESPFL" Name="Responder population flag derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">If XP.VISIT='Month 6' and XPSTRESN represents at least a two-point improvement from the baseline record then Y, else N</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="RANDDT" Name="Randomization date derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">SUPPDM.QVAL where SUPPDM.QNAM=RANDDTC, converted to a SAS date</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="ABLFL" Name="Analysis baseline record flag" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">Last visit with a non-missing record prior to first dose</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="ADT" Name="Analysis date calculation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">XPDTC converted to a SAS date.  See SAP for missing or partial value imputations</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="ADY" Name="Analysis day calculation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">ADT - ADSL.RANDDT + 1</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="ADAE.ASTDT" Name="Analysis start date calculation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">AESTDTC converted to a SAS date.  See SAP for missing or partial value imputations</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="ADAE.AENDT" Name="Analysis end date calculation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">AEENDTC converted to a SAS date.  See SAP for missing or partial value imputations</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="ADAE.ASTDY" Name="Analysis start day calculation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">ASTDT - ADSL.TRTSDT + 1</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="ADAE.AENDY" Name="Analysis end day calculation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">AENDT - ADSL.TRTEDT + 1</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="ADTTE.SRCVAR" Name="SRCVAR algorithm" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">SRCVAR = ADEF if first event is a negative pain score or if worsening occurs before an improvement.  SRCVAR = ADAE if ADAE.CQ01NAM is non-missing on a date prior to a pain improvement or worsening.</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="ADTTE.SRCSEQ" Name="SRCSEQ algorithm" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">if SRCVAR=ADEF then SRCSEQ=ADEF.XPSEQ from the corresponding record; else if SRCVAR=ADAE then SRCSEQ=ADAE.AESEQ from the corresponding record.</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="COMP.SEECODELIST" Name="See codelist" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">See codelist</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="COMP.SEEVALUELEVEL" Name="See parameter value-level metadata" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">See parameter value-level metadata</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="RELGR1" Name="AE relatedness derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">If AEREL=NOT RELATED  then NOT RELATED; Otherwise RELATED</TranslatedText>
      </Description>
    </MethodDef>
    <MethodDef OID="AGEGR1" Name="Age group derivation" Type="Computation">
      <Description>
        <TranslatedText xml:lang="en">If age&lt;55 then "&lt;55 years"; else if age&gt;=55 then "&gt;=55 YEARS"</TranslatedText>
      </Description>
    </MethodDef>

    <!-- ******************************** -->
    <!-- COMMENTS DEFINITION SECTION      -->
    <!-- ******************************** -->
    <def:CommentDef OID="COM.CRIT1">
      <Description>
        <TranslatedText xml:lang="en">Assignment per the codelist</TranslatedText>
      </Description>
    </def:CommentDef>
    <def:CommentDef OID="COM.CQ01NAME">
      <Description>
        <TranslatedText xml:lang="en">if non-null then PAIN EVENT</TranslatedText>
      </Description>
    </def:CommentDef>
    <def:CommentDef OID="COM.SEECODELIST">
      <Description>
        <TranslatedText xml:lang="en">See codelist</TranslatedText>
      </Description>
    </def:CommentDef>
    <def:CommentDef OID="COM.SEEVALUELEVEL">
      <Description>
        <TranslatedText xml:lang="en">See parameter value-level metadata</TranslatedText>
      </Description>
    </def:CommentDef>
    <def:CommentDef OID="COM.ADAE">
      <Description>
        <TranslatedText xml:lang="en">Primarily derived from SDTM.AE</TranslatedText>
      </Description>
    </def:CommentDef>
    <def:CommentDef OID="COM.ADSL">
      <Description>
        <TranslatedText xml:lang="en">Derived from multiple SDTM domains</TranslatedText>
      </Description>
    </def:CommentDef>
    <def:CommentDef OID="COM.ADEF">
      <Description>
        <TranslatedText xml:lang="en">Primarily derived from SDTM.XP</TranslatedText>
      </Description>
    </def:CommentDef>
    <def:CommentDef OID="COM.ADTTE">
      <Description>
        <TranslatedText xml:lang="en">Primarily derived from ADaM.ADAE</TranslatedText>
      </Description>
    </def:CommentDef>

    <!-- ******************************************* -->
    <!-- LEAF DEFINITION SECTION                 *** -->
    <!-- ******************************************* -->
    <def:leaf ID="ADRG"
      xlink:href="reviewersguide.pdf">
      <def:title>Analysis Data Reviewer's Guide </def:title>
    </def:leaf>

    <def:leaf ID="SAP_Section_9.1.1"
      xlink:href="..\..\..\..\53-clin-stud-rep\535-rep-effic-safety-stud\5351-stud-rep-contr\studyxyz123\studyxyz123_csr.pdf">
      <def:title>SAP Section 9.1.1 </def:title>
    </def:leaf>

    <def:leaf ID="SAP_Section_9.2.1"
      xlink:href="..\..\..\..\53-clin-stud-rep\535-rep-effic-safety-stud\5351-stud-rep-contr\studyxyz123\studyxyz123_csr.pdf">
      <def:title>SAP Section 9.2.1 </def:title>
    </def:leaf>

    <def:leaf ID="SAP_Section_9.2.2"
      xlink:href="..\..\..\..\53-clin-stud-rep\535-rep-effic-safety-stud\5351-stud-rep-contr\studyxyz123\studyxyz123_csr.pdf">
      <def:title>SAP Section 9.2.2 </def:title>
    </def:leaf>

    <def:leaf ID="SAP_Section_9.3.1"
      xlink:href="..\..\..\..\53-clin-stud-rep\535-rep-effic-safety-stud\5351-stud-rep-contr\studyxyz123\studyxyz123_csr.pdf">
      <def:title>SAP Section 9.3.1 </def:title>
    </def:leaf>

    <def:leaf ID="Table_14.1.1"
      xlink:href="..\..\..\..\53-clin-stud-rep\535-rep-effic-safety-stud\5351-stud-rep-contr\studyxyz123\studyxyz123_csr.pdf">
      <def:title>Table 14.1.1 </def:title>
    </def:leaf>

    <def:leaf ID="Table_14.2.1"
      xlink:href="..\..\..\..\53-clin-stud-rep\535-rep-effic-safety-stud\5351-stud-rep-contr\studyxyz123\studyxyz123_csr.pdf">
      <def:title>Table 14.2.1 </def:title>
    </def:leaf>

    <def:leaf ID="Table_14.2.2"
      xlink:href="..\..\..\..\53-clin-stud-rep\535-rep-effic-safety-stud\5351-stud-rep-contr\studyxyz123\studyxyz123_csr.pdf">
      <def:title>Table 14.2.2 </def:title>
    </def:leaf>

    <def:leaf ID="Figure_14.2.1"
      xlink:href="..\..\..\..\53-clin-stud-rep\535-rep-effic-safety-stud\5351-stud-rep-contr\studyxyz123\studyxyz123_csr.pdf">
      <def:title>Figure 14.2.1 </def:title>
    </def:leaf>

    <def:leaf ID="ae-t14-3-02"
      xlink:href="ae-t14-3-02.sas">
      <def:title>AE Analysis Program </def:title>
    </def:leaf>

    <!-- ************************************************************ -->
    <!-- Analysis Results MetaData are Presented Below                -->
    <!-- ************************************************************ -->
    <arm:AnalysisResultDisplays> 

    <arm:ResultDisplay OID="RD.Table_14.1.1" Name="Table 14.1.1"> 
      <Description>
          <TranslatedText xml:lang="en">Summary of Demographics (ITT Population)</TranslatedText>
      </Description>
      <def:DocumentRef leafID="Table_14.1.1">
        <def:PDFPageRef PageRefs="302" Type="PhysicalRef"/>
      </def:DocumentRef>
      <arm:AnalysisResult 
        OID="Table_14.1.1"
        ParameterOID="ADSL.PARAMCD"
        ResultIdentifier="Table_14.1.1"
        AnalysisReason="SPECIFIED IN SAP"
        AnalysisPurpose="Comparisons of baseline characteristics by treatment group">
        <Description>
          <TranslatedText xml:lang="en">Summary of Demographics</TranslatedText>
        </Description>
        <arm:AnalysisDatasets>
          <arm:AnalysisDataset ItemGroupOID="ADSL" >
          <def:WhereClauseRef WhereClauseOID="WC.ITTFL" />

          <arm:AnalysisVariable ItemOID="ADSL.AGE"/>
          <arm:AnalysisVariable ItemOID="ADSL.AGEGR1"/>
          <arm:AnalysisVariable ItemOID="ADSL.SEX"/>
          <arm:AnalysisVariable ItemOID="ADSL.RACE"/>
          </arm:AnalysisDataset>
        </arm:AnalysisDatasets>
        <arm:Documentation>
        <Description>
          <TranslatedText xml:lang="en">Rates and chi-squared tests of categorical demographic variables </TranslatedText>
        </Description>
        <def:DocumentRef  leafID="SAP_Section_9.1.1">
        </def:DocumentRef>
        </arm:Documentation>

        <arm:ProgrammingCode Context="SAS Version 9.4">
        <arm:Code>
PROC FREQ DATA=ADSL;
  where ittfl=&quot;Y&quot;;
  tables trt01pn * (agegr1 sex race) / cmh;
  run;
        </arm:Code>
        </arm:ProgrammingCode>
      </arm:AnalysisResult>
    </arm:ResultDisplay>
    <arm:ResultDisplay OID="RD.Table_14.2.1" Name="Table 14.2.1"> 
      <Description>
          <TranslatedText xml:lang="en">Responder Analysis by Visit</TranslatedText>
      </Description>
      <def:DocumentRef leafID="Table_14.2.1">
        <def:PDFPageRef PageRefs="352" Type="PhysicalRef"/>
      </def:DocumentRef>
      <arm:AnalysisResult 
        OID="Table_14.2.1"
        ParameterOID="ADEF.PARAMCD"
        ResultIdentifier="Table_14.2.1"
        AnalysisReason="SPECIFIED IN SAP"
        AnalysisPurpose="Primary efficacy endpoint">
        <Description>
          <TranslatedText xml:lang="en">Responder Analysis by Visit</TranslatedText>
        </Description>
        <arm:AnalysisDatasets>
          <arm:AnalysisDataset ItemGroupOID="ADEF" >
          <def:WhereClauseRef WhereClauseOID="WC.Table_14.2.1.1" />

          <arm:AnalysisVariable ItemOID="ADEF.CRIT1FL"/>
          </arm:AnalysisDataset>
        </arm:AnalysisDatasets>
        <arm:Documentation>
        <Description>
          <TranslatedText xml:lang="en">Chi-squared test of responder rates by treatment group </TranslatedText>
        </Description>
        <def:DocumentRef  leafID="SAP_Section_9.2.1">
        </def:DocumentRef>
        </arm:Documentation>

        <arm:ProgrammingCode Context="SAS Version 9.4">
        <arm:Code>
proc freq data = adef;
  by crit1 avisitn;
  where ittfl=&quot;Y&quot;;
  tables trtpn * crit1fl / chisq;
        </arm:Code>
        </arm:ProgrammingCode>
      </arm:AnalysisResult>
    </arm:ResultDisplay>
    <arm:ResultDisplay OID="RD.Table_14.2.2" Name="Table 14.2.2"> 
      <Description>
          <TranslatedText xml:lang="en">Mean Pain Assessments and Changes from Baseline</TranslatedText>
      </Description>
      <def:DocumentRef leafID="Table_14.2.2">
        <def:PDFPageRef PageRefs="353" Type="PhysicalRef"/>
      </def:DocumentRef>
      <arm:AnalysisResult 
        OID="Table_14.2.2"
        ParameterOID="ADEF.PARAMCD"
        ResultIdentifier="Table_14.2.2"
        AnalysisReason="SPECIFIED IN SAP"
        AnalysisPurpose="Secondary efficacy endpoint">
        <Description>
          <TranslatedText xml:lang="en">Summary of Pain Relief</TranslatedText>
        </Description>
        <arm:AnalysisDatasets>
          <arm:AnalysisDataset ItemGroupOID="ADEF" >
          <def:WhereClauseRef WhereClauseOID="WC.Table_14.2.1.1" />

          <arm:AnalysisVariable ItemOID="ADEF.AVAL"/>
          <arm:AnalysisVariable ItemOID="ADEF.CHG"/>
          </arm:AnalysisDataset>
        </arm:AnalysisDatasets>
        <arm:Documentation>
        <Description>
          <TranslatedText xml:lang="en">ANCOVA analysis of the treatment group effect with a baseline covariate, by visit </TranslatedText>
        </Description>
        <def:DocumentRef  leafID="SAP_Section_9.2.1">
        </def:DocumentRef>
        </arm:Documentation>

        <arm:ProgrammingCode Context="SAS Version 9.4">
        <arm:Code>
proc glm data = adef;
  by avisitn avisit;
  class trtpn;
  model aval = trtpn base;
  run;
        </arm:Code>
        </arm:ProgrammingCode>
      </arm:AnalysisResult>
    </arm:ResultDisplay>
    <arm:ResultDisplay OID="RD.Figure_14.2.1" Name="Figure 14.2.1"> 
      <Description>
          <TranslatedText xml:lang="en">Time to Pain Relief Analysis by Treatment Group</TranslatedText>
      </Description>
      <def:DocumentRef leafID="Figure_14.2.1">
        <def:PDFPageRef PageRefs="354" Type="PhysicalRef"/>
      </def:DocumentRef>
      <arm:AnalysisResult 
        OID="Figure_14.2.1.R.01"
        ParameterOID="ADTTE.PARAMCD"
        ResultIdentifier="Figure_14.2.1.R.01"
        AnalysisReason="SPECIFIED IN SAP"
        AnalysisPurpose="Secondary efficacy endpoint">
        <Description>
          <TranslatedText xml:lang="en">Time to Pain Relief Kaplan Meier Analysis</TranslatedText>
        </Description>
        <arm:AnalysisDatasets>
          <arm:AnalysisDataset ItemGroupOID="ADTTE" >
          <def:WhereClauseRef WhereClauseOID="WC.Figure_14.2.1.1" />

          <arm:AnalysisVariable ItemOID="ADTTE.AVAL"/>
          </arm:AnalysisDataset>
        </arm:AnalysisDatasets>
        <arm:Documentation>
        <Description>
          <TranslatedText xml:lang="en">Kaplan-Meier estimates and log-rank test for the treatment effect </TranslatedText>
        </Description>
        <def:DocumentRef  leafID="SAP_Section_9.2.2">
        </def:DocumentRef>
        </arm:Documentation>

        <arm:ProgrammingCode Context="SAS Version 9.4">
        <arm:Code>
proc lifetest  data = adtte plots=s;
  where ittfl = &quot;Y&quot; and paramcd = &quot;TTPNRELF&quot;;
        </arm:Code>
        </arm:ProgrammingCode>
      </arm:AnalysisResult>
      <arm:AnalysisResult 
        OID="Figure_14.2.1.R.02"
        ParameterOID="ADTTE.PARAMCD"
        ResultIdentifier="Figure_14.2.1.R.02"
        AnalysisReason="SPECIFIED IN SAP"
        AnalysisPurpose="Secondary efficacy endpoint">
        <Description>
          <TranslatedText xml:lang="en">Time to Pain Relief Hazard Ratio Derivation</TranslatedText>
        </Description>
        <arm:AnalysisDatasets>
          <arm:AnalysisDataset ItemGroupOID="ADTTE" >
          <def:WhereClauseRef WhereClauseOID="WC.Figure_14.2.1.1" />

          <arm:AnalysisVariable ItemOID="ADTTE.AVAL"/>
          </arm:AnalysisDataset>
        </arm:AnalysisDatasets>
        <arm:Documentation>
        <Description>
          <TranslatedText xml:lang="en">Cox proportional hazards model used to derive the hazard ratio for the treatment group effect </TranslatedText>
        </Description>
        <def:DocumentRef  leafID="SAP_Section_9.2.2">
        </def:DocumentRef>
        </arm:Documentation>

        <arm:ProgrammingCode Context="SAS Version 9.4">
        <arm:Code>
proc phreg data = adtte;
  model aval*cnsr(1, 2, 3) = trtpn;
  run;
        </arm:Code>
        </arm:ProgrammingCode>
      </arm:AnalysisResult>
    </arm:ResultDisplay>
    <arm:ResultDisplay OID="RD.Table_14.3.2.1" Name=" "> 
      <Description>
          <TranslatedText xml:lang="en">Incidence Rates of TEAEs by System Organ Class and Preferred Term</TranslatedText>
      </Description>
      <def:DocumentRef leafID="Table_14.3.2.1">
        <def:PDFPageRef PageRefs=" " Type=" "/>
      </def:DocumentRef>
      <arm:AnalysisResult 
        OID="Table_14.3.2.1"
        ParameterOID="ADAE.PARAMCD"
        ResultIdentifier="Table_14.3.2.1"
        AnalysisReason="SPECIFIED IN SAP"
        AnalysisPurpose="Secondary safety endpoint">
        <Description>
          <TranslatedText xml:lang="en">Incidence Rates of TEAEs by System Organ Class and Preferred Term</TranslatedText>
        </Description>
        <arm:AnalysisDatasets>
          <arm:AnalysisDataset ItemGroupOID="ADAE" >
          <def:WhereClauseRef WhereClauseOID="WC.Table_14.3.2.1" />

          <arm:AnalysisVariable ItemOID="ADAE.AEBODSYS"/>
          <arm:AnalysisVariable ItemOID="ADAE.AEDECOD"/>
          </arm:AnalysisDataset>
        </arm:AnalysisDatasets>
        <arm:Documentation>
        <Description>
          <TranslatedText xml:lang="en">Incidence rates of TEAEs by System Organ Class and Preferred Term </TranslatedText>
        </Description>
        <def:DocumentRef  leafID="SAP_Section_9.3.1">
        </def:DocumentRef>
        </arm:Documentation>

        <arm:ProgrammingCode Context="SAS Version 9.4">
          <def:DocumentRef leafID="ae-t14-3-02" />
        </arm:ProgrammingCode>
      </arm:AnalysisResult>
    </arm:ResultDisplay>
    </arm:AnalysisResultDisplays>
  </MetaDataVersion>
</Study>
</ODM>
