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This template shows all ODM v2.0 elements and attributes, including those that are optional. XML files would typically not include attributes with an empty string as value. Empty elements can sometimes have meaning. For example, An empty MethodSignature may be used to explicitly indicate that the method does not take any input parameters or return any values.

Attributes and elements within the <xhtml:div> element are not displayed in this template.

Code Block
languagexml
themeConfluence
titleODM v2.0 Template
<?xml version="1.0" encoding="UTF-8"?>
<ODM 
    xmlns="http://www.cdisc.org/ns/odm/v2.0" 
    xmlns:xhtml="http://www.w3.org/1999/xhtml"
    xmlns:xlink="http://www.w3.org/1999/xlink"
    xmlns:nci="http://ncicb.nci.nih.gov/xml/odm/EVS/CDISC"
    xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
    xsi:schemaLocation="http://www.cdisc.org/ns/odm/v2.0 file:/C:/_github/cdisc-org/DataExchange-ODM/schema/ODM.xsd"FileType="" 
    Granularity="" 
    FileTypeContext="Snapshot" Granularity="All" Context="Exchange"
    FileOID="ODMv2.0"
    CreationDateTime="20222023-1008-11T0023T00:00:00" 
    PriorFileOID="ODMv2.0" 
    AsOfDateTime="20222023-1008-11T0023T00:00:00"
    ODMVersion="2.0" 
    Originator="CDISC Data Exchange Standards ODM v2.0 Team" 
    SourceSystem=""
    SourceSystemVersion="">
    <Description>
        <TranslatedText xml:lang="" type="">Type="">
            <xhtml:div>CDISC ODM v2.0 Template</xhtml:div>
        </TranslatedText>
    </Description>
    <Study OID="" StudyName="" ProtocolName="" VersionId="" VersionName="" Status="">
        <Description>
            <TranslatedText xml:lang="" Type="">
                <xhtml:div> </xhtml:div>
            </TranslatedText>
        </Description>
        <MetaDataVersion OID="" Name="" CommentOID="">
            <Description>
                <TranslatedText xml:lang="" Type="">
                    <xhtml:div> </xhtml:div>
                </TranslatedText>
            </Description>
            <Include StudyOID="" MetaDataVersionOID="" href=""> </Include>
            <Standards>
                <Standard OID="" Name="" Type="" PublishingSet="" Version="" Status="Draft" CommentOID=""> </Standard>
            </Standards>
            <AnnotatedCRF>
                <DocumentRef LeafID="">
                    <PDFPageRef PageRefs="" FirstPage="" LastPage="" Type="" Title=""/>
                </DocumentRef>
            <xhtml:div>CDISC ODM v2.0 Abstract Template</xhtml:div>
</AnnotatedCRF>
            </TranslatedText>
<SupplementalDoc>
       </Description>
       <Study OID="ODMv2.0" StudyName="ODMv2.0" ProtocolName="ODMv2.0 <DocumentRef LeafID="">
         <Description>
            <TranslatedText xml:lang<PDFPageRef PageRefs="" FirstPage="" LastPage="" Type="" typeTitle=""/>
                <xhtml:div> </xhtml:div>DocumentRef>
            </TranslatedText>SupplementalDoc>
        </Description>
       <ValueListDef <MetaDataVersion OID="" Name="" CommentOID="">
>
                <Description>
                    <TranslatedText xml:lang="" typeType="">
                    <xhtml:div> </xhtml:div>TranslatedText>
                </TranslatedText>
       Description>
     </Description>
           <ItemRef <Include StudyOIDItemOID="" KeySequence="" MetaDataVersionOIDIsNonStandard="" hrefHasNoData=""> </Include>
  MethodOID=""
           <Standards>
                <Standard OIDUnitsItemOID="" NameRepeat="" TypeOther="" PublishingSetRole="" VersionRoleCodeListOID="" StatusOrderNumber="Draft"
                    Mandatory=""  CommentOIDCollectionExceptionConditionOID="" PreSpecifiedValue="" Core=""> </Standard>
            </Standards>
        <Origin Type="" Source=""> </Origin>
   <AnnotatedCRF>
                 <DocumentRef<WhereClauseRef leafIDWhereClauseOID=""> </WhereClauseRef>
                </ItemRef>
       <PDFPageRef PageRefs="" FirstPage="" LastPage="" Type="" Title=""/> </ValueListDef>
            <WhereClauseDef    </DocumentRef>OID="" CommentOID="">
            </AnnotatedCRF>
    <RangeCheck    Comparator="" SoftHard="" ItemOID="">
    <SupplementalDoc>
                <DocumentRef leafID=""<CheckValue/>
                    <!-- <PDFPageRef
 PageRefs="" FirstPage="" LastPage="" Type="" Title=""/>
               <MethodSignature> </DocumentRef>MethodSignature>
            </SupplementalDoc>
         <FormalExpression   <ValueListDef OIDContext="">
                 <Description>
       <Code></Code>
                 <TranslatedText xml:lang="" type=""> </TranslatedText>FormalExpression>
                    </Description>
-->
                    <ItemRef ItemOID="" KeySequence="" IsNonStandard="" HasNoData="" MethodOID=""
<ErrorMessage>
                        <TranslatedText UnitsItemOIDxml:lang="" RepeatType="" Other="" Role="" RoleCodeListOID="" OrderNumber=""
> </TranslatedText>
                    </ErrorMessage>
    Mandatory="" CollectionExceptionConditionOID="">
           </RangeCheck>
         <Origin Type="" Source=""> </Origin>WhereClauseDef>
            <Protocol>
        <WhereClauseRef  WhereClauseOID=""> </WhereClauseRef>
     <Description>
           </ItemRef>
         <TranslatedText xml:lang="" Type=""> </ValueListDef>TranslatedText>
              <WhereClauseDef OID="" CommentOID=""> </Description>
                <RangeCheck Comparator="" SoftHard="" ItemOID="">
<StudySummary>
                    <StudyParameter OID=""  <CheckValue/Term="" ShortName="">
                    <!-- 
   <ParameterValue Value="">
                <MethodSignature>
            <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href=""  </MethodSignature>
 ref="" CommentOID=""/>
                   <FormalExpression Context="">
    </ParameterValue>
                    <Code><</Code>StudyParameter>
                    </FormalExpression>StudySummary>
                    --><StudyStructure>
                    <ErrorMessage><Description>
                        <TranslatedText xml:lang="" typeType=""> </TranslatedText>
                    </ErrorMessage>Description>
                </RangeCheck>
    <Arm OID="" Name="">
      </WhereClauseDef>
            <Protocol>
        <Description>
        <Description>
                    <TranslatedText xml:lang="" typeType=""/> </TranslatedText>
                </Description>
        </Description>
        <StudySummary>
                <WorkflowRef WorkflowOID=""/>
   <StudyParameter OID="" Term="" ShortName="">
              </Arm>
          <ParameterValue Value="">
         <Epoch OID="" Name="" SequenceNumber="">
                <Coding Code="" System="" SystemName="" SystemVersion="" Label=""
   <Description>
                            <TranslatedText hrefxml:lang="" CommentOIDType=""/>
                        </ParameterValue>Description>
                    </StudyParameter>Epoch>
                    <WorkflowRef WorkflowOID=""> </WorkflowRef>
                </StudySummary>StudyStructure>
                <TrialPhase <StudyStructure>Value="">
                    <Description>
                        <TranslatedText xml:lang="" typeType=""> </TranslatedText>
                    </Description>
                    <Arm OID="" Name=""></TrialPhase>
                        <Description><StudyTimings>
                            <TranslatedText xml:lang<StudyTiming OID="" typeName=""/>
                        </Description>
                        <WorkflowRef WorkflowOID=""/>
   <AbsoluteTimingConstraint OID="" Name="" StudyEventGroupOID=""
                 </Arm>
                    <Epoch OIDStudyEventOID="" NameTimepointTarget="" SequenceNumberTimepointPreWindow="">
                          <Description>
  TimepointPostWindow=""/>
                        <RelativeTimingConstraint  <TranslatedText xml:langOID="" Name="" Type="" typePredecessorOID=""/>
                        </Description>    SuccessorOID="" TimepointRelativeTarget="" TimepointPreWindow=""
                    </Epoch>        TimepointPostWindow=""/>
                    <WorkflowRef WorkflowOID    <TransitionTimingConstraint OID=""> </WorkflowRef>
   Name="" TransitionOID="" MethodOID=""
              </StudyStructure>
              Type=""  <TrialPhase Value="PHASE 0 TRIAL">
TimepointPostWindow="" TimepointPreWindow="" TimepointTarget=""/>
                        <Description> <DurationTimingConstraint OID="" Name="" DurationPostWindow=""
                        <TranslatedText xml:lang    DurationPreWindow="" DurationTarget="" typeStructuralElementOID=""/> </TranslatedText>
                    </Description>StudyTiming>
                </TrialPhase>StudyTimings>
                <StudyTimings><StudyIndications>
                    <StudyTiming<StudyIndication OID="" Name="">
                        <AbsoluteTimingConstraint OID="" Name="" StudyEventGroupOID=""
<Description>
                               StudyEventOID<TranslatedText xml:lang="" TimepointTargetType="" TimepointPreWindow=""> </TranslatedText>
                            TimepointPostWindow=""/></Description>
                        <RelativeTimingConstraint<Coding OIDCode="" NameSystem="" TypeSystemName="" PredecessorOIDSystemVersion=""
                            SuccessorOIDLabel="" href="" TimepointRelativeTargetref="" TimepointPreWindowCommentOID=""/>
                            TimepointPostWindow=""/></StudyIndication>
                </StudyIndications>
        <TransitionTimingConstraint OID="" Name="" TransitionOID="" MethodOID=""
           <StudyInterventions>
                  Type="" TimepointPostWindow="" TimepointPreWindow="" TimepointTarget <StudyIntervention OID=""/>
                        <DurationTimingConstraint OID="" Name="" DurationPostWindow=""
<Description>
                               DurationPreWindow<TranslatedText xml:lang="" DurationTargetType=""> StructuralElementOID=""/>
 </TranslatedText>
                   </StudyTiming>
                </StudyTimings>Description>
                <StudyIndications>
        <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href=""      <StudyIndication OIDref="" CommentOID=""/>
                      </StudyIntervention>
  <Description>
              </StudyInterventions>
              <TranslatedText xml:lang="" type=""> </TranslatedText> <StudyObjectives>
                    <StudyObjective OID=""   </Description>Name="" Type="">
                        <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href=""
<Description>
                            <TranslatedText    CommentOIDxml:lang="" Type=""> </>TranslatedText>
                    </StudyIndication>
    </Description>
            </StudyIndications>
            <StudyEndPointRef StudyEndPointOID="" OrderNumber=""/>
  <StudyInterventions>
                  </StudyObjective>
  <StudyIntervention OID="">
             </StudyObjectives>
           <Description>
     <StudyEndPoints>
                    <StudyEndPoint OID=""  <TranslatedText xml:langName="" Type="" typeLevel=""> </TranslatedText>
                        </Description><Description>
                         <Coding Code="" System="" SystemName="" SystemVersion <TranslatedText xml:lang="" LabelType="" href=""> </TranslatedText>
                        </Description>
    CommentOID=""/>
                      </StudyIntervention><FormalExpression Context="">
                </StudyInterventions>
            <Code/>
     <StudyObjectives>
                    <StudyObjective OID="" Name="" Type="">
 <!--                        <Description>
                            <ExternalCodeLib  <TranslatedText xml:langLibrary="" Method="" Version="" typeref=""> </TranslatedText>href=""/>
                        </Description>-->
                        <StudyEndPointRef StudyEndPointOID="" OrderNumber=""/></FormalExpression>
                    </StudyObjective>StudyEndPoint>
                </StudyObjectives>StudyEndPoints>
                <StudyEndPoints>
                    <StudyEndPoint<StudyTargetPopulation OID="" Name="" Type="">
                        <Description>
                            <TranslatedText xml:lang="" typeType="">> </TranslatedText>
                    </TranslatedText>Description>
                    <Coding Code="" System=""  </Description>
    SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
                    <FormalExpression Context="">
                            <Code/>
                            <!--                        
                            <ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
                        -->
                        </FormalExpression>
                    </StudyEndPoint>StudyTargetPopulation>
                </StudyEndPoints><StudyEstimands>
                <StudyTargetPopulation OID="" Name="">
                    <Description>
                        <TranslatedText xml:lang<StudyEstimand OID="" typeName=""> </TranslatedText>
                    </Description>
                    <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href=""
 <Description>
                            <TranslatedText CommentOIDxml:lang=""> </Coding>Type=""/>
                    <FormalExpression Context="">    </Description>
                        <Code <StudyTargetPopulationRef StudyTargetPopulationOID=""/>
                        <!-- <StudyInterventionRef StudyInterventionOID=""/>
                       
 <StudyEndPointRef StudyEndPointOID="" OrderNumber=""/>
                        <IntercurrentEvent>
 <ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
                        --><Description>
                    </FormalExpression>
             <TranslatedText   </StudyTargetPopulation>xml:lang="" Type=""/>
                <StudyEstimands>
             </Description>
       <StudyEstimand OID="" Name="">
                  </IntercurrentEvent>
       <Description>
                 <SummaryMeasure>
           <TranslatedText xml:lang="" type=""/>
               <Description>
         </Description>
                        <StudyTargetPopulationRef StudyTargetPopulationOID<TranslatedText xml:lang="" Type=""/>
                        <StudyInterventionRef StudyInterventionOID=""/>    </Description>
                        <StudyEndPointRef StudyEndPointOID="" OrderNumber=""/></SummaryMeasure>
                    </StudyEstimand>
    <IntercurrentEvent>
            </StudyEstimands>
                <Description><InclusionExclusionCriteria>
                    <InclusionCriteria>
            <TranslatedText xml:lang="" type=""/>
          <Criterion OID="" Name="" ConditionOID=""> 
              </Description>
              <Description>
          </IntercurrentEvent>
                      <TranslatedText  <SummaryMeasure>xml:lang="" Type=""/>
                            <Description></Description>
                                       <TranslatedText xml:lang             <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" typeCommentOID=""> </>Coding>
                        </Criterion>
     </Description>
               </InclusionCriteria>
         </SummaryMeasure>
           <ExclusionCriteria>
         </StudyEstimand>
               <Criterion  </StudyEstimands>OID="" Name="" ConditionOID=""> 
                <InclusionExclusionCriteria>
            <Description>
        <InclusionCriteria>
                        <Criterion<TranslatedText OIDxml:lang="" NameType="" ConditionOID=""> </Criterion>
/>
                            </InclusionCriteria>Description>
                            <Coding Code="" System="" SystemName="" SystemVersion=""  <ExclusionCriteria>
     Label="" href="" ref="" CommentOID=""> </Coding>
                   <Criterion OID="" Name="" ConditionOID=""> </Criterion>
                            <   </ExclusionCriteria>
                </InclusionExclusionCriteria>
                <StudyEventGroupRef StudyEventGroupOID="" OrderNumber="" Mandatory=""
                    CollectionExceptionConditionOID="">
                    <Description>
                        <TranslatedText xml:lang="" typeType=""> </TranslatedText>
                    </Description>
                </StudyEventGroupRef>
                <WorkflowRef WorkflowOID=""> </WorkflowRef>
                <Alias Context="" Name=""> </Alias>
            </Protocol>
            <WorkflowDef OID="" Name="">
                <Description>
                    <TranslatedText xml:lang="" typeType=""> </TranslatedText>
                </Description>
                <WorkflowStart StartOID=""> </WorkflowStart>
                <Transition OID="" Name="" SourceOID="" TargetOID="" StartConditionOID=""
                    EndConditionOID=""> </Transition>
                <Branching OID="" Name="" Type="">
                    <TargetTransition TargetTransitionOID="" ConditionOID=""> </TargetTransition>
                    <DefaultTransition TargetTransitionOID=""> </DefaultTransition>
                </Branching>
                <WorkflowEnd EndOID=""/>
            </WorkflowDef>
            <StudyEventGroupDef OID="" Name="" ArmOID="" EpochOID="" CommentOID="">
                <Description>
                    <TranslatedText xml:lang="" typeType=""> </TranslatedText>
                </Description>
                <StudyEventGroupRef StudyEventGroupOID="" OrderNumber="" Mandatory=""
                    CollectionExceptionConditionOID="">
                    <Description>
                        <TranslatedText xml:lang="" typeType=""> </TranslatedText>
                    </Description>
                </StudyEventGroupRef>
                <StudyEventRef StudyEventOID="" OrderNumber="" Mandatory=""
                    CollectionExceptionConditionOID=""> </StudyEventRef>
                <WorkflowRef WorkflowOID=""> </WorkflowRef>
                <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href=""
                     ref="" CommentOID=""> </Coding>
            </StudyEventGroupDef>
            <StudyEventDef OID="" Name="" Repeating="" Type="" Category="" CommentOID="">
                <Description>
                    <TranslatedText xml:lang="" typeType=""> </TranslatedText>
                </Description>
                <ItemGroupRef ItemGroupOID="" MethodOID="" OrderNumber="" Mandatory=""
                    CollectionExceptionConditionOID=""> </ItemGroupRef>
                <WorkflowRef WorkflowOID=""> </WorkflowRef>
                <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href=""
                     ref="" CommentOID=""> </Coding>
                <Alias Context="" Name=""> </Alias>
            </StudyEventDef>
            <ItemGroupDef OID="" Name="" Repeating="" RepeatingLimit="" IsReferenceData=""
                Structure="" ArchiveLocationID="" DatasetName="" Domain="" Type="Concept" Purpose=""
                StandardOID="" IsNonStandard="" HasNoData="" CommentOID="">
                <Description>
                    <TranslatedText xml:lang="" typeType=""> </TranslatedText>
                </Description>
                <Class Name="">
                    <SubClass Name="" ParentClass="ADAM OTHER"/>
                </Class>
                <ItemGroupRef ItemGroupOID="" MethodOID="" OrderNumber="" Mandatory=""
                    CollectionExceptionConditionOID=""> </ItemGroupRef>
                <ItemRef ItemOID="" KeySequence="" IsNonStandard="" HasNoData="" MethodOID=""
                    UnitsItemOID="" Repeat="" Other="" Role="" RoleCodeListOID="" OrderNumber=""
                    Mandatory="" CollectionExceptionConditionOID="" PreSpecifiedValue="" Core="">
                    <Origin Type="" Source=""> </Origin>
                    <WhereClauseRef WhereClauseOID=""> </WhereClauseRef>
                </ItemRef>
                <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href=""
                    SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
                <WorkflowRef WorkflowOID=""> </WorkflowRef>
                <Origin Type="" Source="">
                    <Description>
                        <TranslatedText xml:lang="" typeType=""> </TranslatedText>
                    </Description>
                    <SourceItems>
                        <SourceItem ItemOID="" ItemGroupOID="" MetaDataVersionOID="" StudyOID=""
                            leafIDLeafID="" Name="">
                            <Resource Type="" Name="" Attribute="" Label="">
                                <Selection Path=""/>
                            </Resource>
                        </SourceItem>
                    </SourceItems>
                    <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href=""
                         ref="" CommentOID=""> </Coding>
                    <DocumentRef leafIDLeafID=""> </DocumentRef>
                </Origin>
                <Alias Context="" Name=""> </Alias>
                <leaf<Leaf ID="" xlink:href="">
                    <title><Title> </title>Title>
                </leaf>Leaf>
            </ItemGroupDef>
            <ItemDef OID="" Name="" DataType="" Length="" DisplayFormat="" CommentOID="">
                <Description>
                    <TranslatedText xml:lang="" typeType=""> </TranslatedText>
                </Description>
                <Question>
                    <TranslatedText xml:lang="" typeType=""> </TranslatedText>
                </Question>
                <RangeCheck Comparator<Prompt>
                    <TranslatedText xml:lang="" SoftHardType="" ItemOID="">
> </TranslatedText>
                </Prompt>
                <CRFCompletionInstructions >
                    <TranslatedText  <CheckValue/>xml:lang="" Type=""> </TranslatedText>
                </CRFCompletionInstructions >
   <!--             <ImplementationNotes >
      
              <TranslatedText xml:lang="" Type=""> </TranslatedText>
       <MethodSignature>
         </ImplementationNotes >
              </MethodSignature>
  <Definition>
                    <TranslatedText  <FormalExpression Contextxml:lang="" Type=""> </TranslatedText>
                </Definition>
          <Code></Code>
      <VariableSet >
                 </FormalExpression>
   <TranslatedText xml:lang="" Type=""> </TranslatedText>
              -->
  </VariableSet >
                <CDISCNotes <ErrorMessage>>
                        <TranslatedText xml:lang="" typeType=""> </TranslatedText>
                    </ErrorMessage>
                </RangeCheck>CDISCNotes >
                <RangeCheck       <CodeListRef CodeListOIDComparator="" SoftHard="" ItemOID="">
  </CodeListRef>
                <ValueListRef ValueListOID=""> <<CheckValue/ValueListRef>>
                <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href=""
  <!--                    CommentOID=""> </Coding>
                <Alias Context="" Name=""> </Alias>
     <MethodSignature>
       </ItemDef>
            <CodeList OID="" Name="" DataType="" CommentOID="" StandardOID="" IsNonStandard=""> </MethodSignature>
                <Description>
        <FormalExpression Context="">
           <TranslatedText xml:lang="" type=""> </TranslatedText>
            <Code></Code>
    </Description>
                <CodeListItem CodedValue="" Rank="" Other="" OrderNumber="" ExtendedValue=""    </FormalExpression>
                    CommentOID=""-->
                    <Description><ErrorMessage>
                        <TranslatedText xml:lang="" typeType=""> </TranslatedText>
                    </Description>ErrorMessage>
                    <Decode></RangeCheck>
                        <TranslatedText xml:lang="" type<CodeListRef CodeListOID=""> </TranslatedText>CodeListRef>
                <ValueListRef ValueListOID="">   </Decode>ValueListRef>
                    <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href=""
 ref="" CommentOID=""> </Coding>
                <Alias     CommentOIDContext="" Name=""> </Coding>Alias>
            </ItemDef>
        <Alias Context    <CodeList OID="" Name="" DataType="" CommentOID="" StandardOID="" IsNonStandard=""> </Alias>
                </CodeListItem><Description>
                <!--        <TranslatedText xml:lang="" Type=""> </TranslatedText>
            
    </Description>
                <EnumeratedItem<CodeListItem CodedValue="" Rank="" Other="" OrderNumber="" ExtendedValue=""
                    CommentOID="">
                    <Description>
                        <TranslatedText xml:lang="" typeType="">
    </TranslatedText>
                     </TranslatedText>Description>
                    </Description><Decode>
                    <Coding Code="" System="" SystemName="" SystemVersion="" Label <TranslatedText xml:lang="" hrefType="" CommentOID="">> </TranslatedText>
                    </Coding>Decode>
                    <Alias<Coding ContextCode="" NameSystem="">
 SystemName="" SystemVersion="" Label="" href=""               ref="" CommentOID=""> </Alias>Coding>
                </EnumeratedItem>
    <Alias            -->
      Context="" Name=""> </Alias>
          <ExternalCodeList Dictionary="CDISC CT" Version="" href="" ref=""> </ExternalCodeList>CodeListItem>
                <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href=""
                     ref="" CommentOID=""> </Coding>
                <Alias Context="" Name=""> </Alias>
            </CodeList>
            <ConditionDef OID="" Name="" CommentOID="">
                <Description>
                    <TranslatedText xml:lang="" typeType=""> </TranslatedText>
                </Description>
                <MethodSignature>
                    <Parameter Name="" DataType="" Definition="" OrderNumber=""> </Parameter>
                    <ReturnValue Name="" DataType="" Definition="" OrderNumber=""> </ReturnValue>
                </MethodSignature>
                <FormalExpression Context="">
                    <Code/>
                    <!--
                        <ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
                    -->
                </FormalExpression>
                <Alias Context="" Name=""> </Alias>
            </ConditionDef>
            <MethodDef OID="" Name="" Type="" CommentOID="">
                <Description>
                    <TranslatedText xml:lang="" typeType=""> </TranslatedText>
                </Description>
                <MethodSignature>
                    <Parameter Name="" DataType="" Definition="" OrderNumber=""> </Parameter>
                    <ReturnValue Name="" DataType="" Definition="" OrderNumber=""> </ReturnValue>
                </MethodSignature>
                <FormalExpression Context="">
                    <Code/>
                    <!--
                        <ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
                    -->
                </FormalExpression>
                <Alias Context="" Name=""> </Alias>
                <DocumentRef leafIDLeafID="">
                    <PDFPageRef PageRefs="" FirstPage="" LastPage="" Type="" Title=""/>
                </DocumentRef>
            </MethodDef>
            <CommentDef OID="">
                <Description>
                    <TranslatedText xml:lang="" typeType=""> </TranslatedText>
                </Description>
                <DocumentRef leafIDLeafID="">
                    <PDFPageRef PageRefs="" FirstPage="" LastPage="" Type="" Title=""/>
                </DocumentRef>
            </CommentDef>
            <leaf<Leaf ID="" xlink:href="">
                <title> </title>
            </leaf>Leaf>
        </MetaDataVersion>
    </Study>
    <AdminData StudyOID="">
        <User OID="" UserType="" OrganizationOID="" LocationOID="">
            <UserName/>
            <Prefix/>
            <Suffix/>
            <FullName/>
            <GivenName/>
            <FamilyName/>
            <Image ImageFileName="" href="" MimeType=""> </Image>
            <Address>
                <StreetName/>
                <HouseNumber/>
                <City/>
                <StateProv/>
                <Country/>
                <PostalCode/>
                <GeoPosition Longitude="" Latitude="" Altitude=""> </GeoPosition>
                <OtherText/>
            </Address>
            <Telecom TelecomType="" Value=""> </Telecom>
        </User>
        <Organization OID="" Name="" Role="" Type="" LocationOID="" PartOfOrganizationOID="">
            <Description>
                <TranslatedText xml:lang="" typeType="">
                    <xhtml:div> </xhtml:div>
                </TranslatedText>
            </Description>
            <Address>
                <StreetName/>
                <HouseNumber/>
                <City/>
                <StateProv/>
                <Country/>
                <PostalCode/>
                <GeoPosition Longitude="" Latitude="" Altitude=""> </GeoPosition>
                <OtherText/>
            </Address>
            <Telecom TelecomType="" Value=""> </Telecom>
        </Organization>
        <Location OID="" Name="" Role="" OrganizationOID="">
            <Description>
                <TranslatedText xml:lang="" typeType="">
                    <xhtml:div> </xhtml:div>
                </TranslatedText>
            </Description>
            <MetaDataVersionRef StudyOID="" MetaDataVersionOID="" EffectiveDate=""> </MetaDataVersionRef>
            <Address>
                <StreetName/>
                <HouseNumber/>
                <City/>
                <StateProv/>
                <Country/>
                <PostalCode/>
                <GeoPosition Longitude="" Latitude="" Altitude=""> </GeoPosition>
                <OtherText/>
            </Address>
            <Telecom TelecomType="" Value=""> </Telecom>
            <Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
                <Value SeqNum=""/>
                <AuditRecord EditPoint="" UsedMethod="">
                    <UserRef UserOID=""> </UserRef>
                    <LocationRef LocationOID=""> </LocationRef>
                    <DateTimeStamp/>
                    <ReasonForChange/>
                    <SourceID/>
                </AuditRecord>
            </Query>
        </Location>
        <SignatureDef OID="" Methodology="">
            <Meaning/>
            <LegalReason/>
        </SignatureDef>
    </AdminData>
    <ReferenceData StudyOID="" MetaDataVersionOID="">
        <ItemGroupData ItemGroupOID="" ItemGroupRepeatKey="" TransactionType="" ItemGroupDataSeq="">
            <ItemGroupData ItemGroupOID="" ItemGroupRepeatKey="" TransactionType=""
                ItemGroupDataSeq="">
                <ItemData ItemOID="" TransactionType="" IsNull="">
                    <Value SeqNum=""/>
                    <AuditRecord EditPoint="" UsedMethod="">
                        <UserRef UserOID=""> </UserRef>
                        <LocationRef LocationOID=""> </LocationRef>
                        <DateTimeStamp/>
                    </AuditRecord>
                    <Signature ID="">
                        <UserRef UserOID=""> </UserRef>
                        <LocationRef LocationOID=""> </LocationRef>
                        <SignatureRef SignatureOID=""> </SignatureRef>
                        <DateTimeStamp/>
                    </Signature>
                    <Annotation SeqNum="" TransactionType="" ID=""> </Annotation>
                    <Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
                        <Value SeqNum=""/>
                    </Query>
                </ItemData>
                <AuditRecord EditPoint="" UsedMethod="">
                    <UserRef UserOID=""> </UserRef>
                    <LocationRef LocationOID=""> </LocationRef>
                    <DateTimeStamp/>
                    <ReasonForChange/>
                    <SourceID/>
                </AuditRecord>
                <Signature ID="">
                    <UserRef UserOID=""> </UserRef>
                    <LocationRef LocationOID=""> </LocationRef>
                    <SignatureRef SignatureOID=""> </SignatureRef>
                    <DateTimeStamp/>
                </Signature>
                <Annotation SeqNum="" TransactionType="" ID="">
                    <Comment SponsorOrSite="">
                        <TranslatedText xml:lang="" typeType=""> </TranslatedText>
                    </Comment>
                    <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href=""
                        ref="" CommentOID=""> </Coding>
                    <Flag>
                        <FlagValue CodeListOID=""/>
                    </Flag>
                </Annotation>
                <Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
                    <Value SeqNum=""/>
                    <AuditRecord EditPoint="" UsedMethod="">
                        <UserRef UserOID=""> </UserRef>
                        <LocationRef LocationOID=""> </LocationRef>
                        <DateTimeStamp/>
                    </AuditRecord>
                </Query>
            </ItemGroupData>
            <ItemData ItemOID="" TransactionType="" IsNull="">
                <Value SeqNum=""/>
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</ODM>