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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.Under development

Code Block
languagexml
themeConfluence
titleTemplatelinenumberstrueODM v2.0 Template
<?xml version="1.0" encoding="UTF-8"?>
<ODM 
	xmlns:ds    xmlns="http://www.w3cdisc.org/2000ns/09odm/xmldsig#v2.0" 
	    xmlns:xsixhtml="http://www.w3.org/20011999/XMLSchema-instancexhtml" 
    xmlns:xlink="http://www.w3.org/1999/xlink"
	xmlns    xmlns:xsi="http://www.cdiscw3.org/ns/odm/v2.0" 
	xsi:schemaLocation=""
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    FileType="" 
	    Granularity="" 
	    Context="" 
	    FileOID=""
	    CreationDateTime="20222023-07-11"
	08-23T00:00:00" 
    PriorFileOID="" 
	    AsOfDateTime="2023-08-23T00:00:00"
	    ODMVersion="2.0-R1" 
	    Originator="CDISC Data Exchange Standards ODM v2.0 Team" - Template Authored by Mike Hamidi" 	 
	
    SourceSystem=""
    
	SourceSystemVersion="">
	Description="CDISC ODM v2.0 Abstract Template" 
	ID="">
	 <Description>
        <TranslatedText xml:lang="" Type="">
            <xhtml:div>CDISC ODM v2.0 Template</xhtml:div>
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    <Study OID="" StudyName="" ProtocolName="">
		<Description>
			<TranslatedText></TranslatedText>
		</Description>
		<MetaDataVersion OID VersionId="" NameVersionName="" CommentOIDStatus="">
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			<Include StudyOID>
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			<Protocol>
				<Description>
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            <Description>
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				<Alias Context="" Name=""/>
				<StudyStructure>
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					<Arm OID="" Name="">
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							<WorkflowRef WorkflowOID=""/>
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					<Epoch OID="" Name="" SequenceNumber="">
						<Description>
							<TranslatedText xml:lang="" type=""></TranslatedText>
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					<WorkflowRef WorkflowOID=""/>
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				<StudySummary>
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						<ParameterValue Value="">
							<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
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				<StudyEventGroupRef StudyEventGroupOID="" Mandatory="" OrderNumber="" CollectionExceptionConditionOID="">
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								<TranslatedText xml:lang="" type=""></TranslatedText>
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				<StudyEndPoints>
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							                    <CheckValue/>
                    <!-- 
                    <MethodSignature> </MethodSignature>
                    <FormalExpression Context="">
                        <Code></Code>
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                    <ErrorMessage>
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						<StudyTargetPopulationRef StudyTargetPopulationOID=""/>
						<StudyInterventionRef StudyInterventionOID=""/>
						<StudyEndPointRef StudyEndPointOID="" OrderNumber=""/>	
						<InterCurrentEvent>	
							<Description>
								<TranslatedText xml:lang="" type=""></TranslatedText>
							</Description>		
						</InterCurrentEvent>		
						<SummaryMeasure>	
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            <Protocol>
                <Description>
                    <TranslatedText xml:lang="" typeType=""><> </TranslatedText>
							                </Description>		
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				<StudyEstimands>
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                <StudySummary>
                    <StudyParameter OID="" NameTerm="">
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							<TranslatedText xml:lang ShortName="" type=""></TranslatedText>
						</Description>
						<FormalExpression Context="">
							<Code></Code>
							<ExternalCodeLib Library="" Method="" Version>
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                            <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" hrefCommentOID=""/>
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				<StudyObjectives>
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						<StudyEndPointRef StudyEndPointOID="" OrderNumber=""/>	
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					<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
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						<ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
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				</StudyTargetPopulation>
				<InclusionExclusionCriteria>
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                        <Description>
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					<ExclusionCriteria>
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								<TranslatedText xml:lang="" type=""></TranslatedText>
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				<WorkflowStart StartOID=""/>
				<Transition OID="" Name="" SourceOID="" TargetOID="" StartConditionOID="" EndConditionOID=""/>
				<Branching OID="" Name>
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                        <TranslatedText xml:lang="" Type="">
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					<DefaultTransition TargetTransitionOID=""/>
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                        <AbsoluteTimingConstraint OID="" Name="" typeStudyEventGroupOID=""></TranslatedText>
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				<StudyEventGroupRef StudyEventGroupOID
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				</StudyEventGroupRef>
				<StudyEventRef StudyEventOID="" Mandatory="" OrderNumber="" CollectionExceptionConditionOID=""/>
				<WorkflowRef WorkflowOID=""/>
				<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
			</StudyEventGroupDef>
			<StudyEventDef/>
                        <RelativeTimingConstraint OID="" Name="" Type="" PredecessorOID=""
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                        <TransitionTimingConstraint OID="" Name="" RepeatingTransitionOID="" TypeMethodOID="" Category
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				</Description>
				<Alias Context>
                        <DurationTimingConstraint OID="" Name=""/>
				<ItemGroupRef ItemGroupOID DurationPostWindow="" Mandatory="" OrderNumber="" CollectionExceptionConditionOID=""/>
				<WorkflowRef WorkflowOID=""/>
				<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID
                            DurationPreWindow="" DurationTarget="" StructuralElementOID=""/>
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			<ItemGroupDef OID="" Name="" Repeating="" IsReferenceData="" DatasetName="" Domain="" Type="" Purpose="" CommentOID="" MethodOID="">
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					<TranslatedText xml:lang="" type=""></TranslatedText>
				</Description>
				<Alias Context="" Name=""/>
				<ItemGroupRef ItemGroupOID="" Mandatory="" OrderNumber="" CollectionExceptionConditionOID=""/>
				<ItemRef ItemOID="" Mandatory="" OrderNumber="" KeySequence="" MethodOID="" UnitsItemOID="" Repeat="" Other="" Role="" RoleCodeListOID="" CollectionExceptionConditionOID="">
					<Origin Type="" Source="">
						<Description>
							<TranslatedText xml:lang="" type=""></TranslatedText>
						</Description>
						<Source>
							<SourceItem ItemOID="" ItemGroupOID="" leafID="" Label="">
								<Resource Type="" Name="" Attribute="">
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							</SourceItem>
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					</Origin>
				</ItemRef>
				<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
				<WorkflowRef WorkflowOID=""/>
				<Origin Type="" Source="">
					<Description>
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                <StudyIndications>
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                        <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""/>
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                <StudyInterventions>
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                        <Description>
                            <TranslatedText xml:lang="" typeType=""><> </TranslatedText>
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					<Source>
						<SourceItem ItemOID="" ItemGroupOID="" leafID="" Label="">
							<Resource Type="" Name="" Attribute="">
								<Selection Path=""/>
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					</Source>
				</Origin>
			</ItemGroupDef>
			<ItemDef                        </Description>
                        <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""/>
                    </StudyIntervention>
                </StudyInterventions>
                <StudyObjectives>
                    <StudyObjective OID="" Name="" DataTypeType="" Length="" CommentOID="">
				<Description>
					<TranslatedText xml>
                        <Description>
                            <TranslatedText xml:lang="" typeType=""><> </TranslatedText>
				</Description>
				<Alias Context="" Name=""/>
				<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID                        </Description>
                        <StudyEndPointRef StudyEndPointOID="" OrderNumber=""/>
				<Question> 
					<TranslatedText xml:lang="" type=""></TranslatedText>
				</Question>
				<RangeCheck Comparator="" SoftHard="" ItemOID="">
					<CheckValue></CheckValue>
					<ErrorMessage>
						                    </StudyObjective>
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                <StudyEndPoints>
                    <StudyEndPoint OID="" Name="" Type="" Level="">
                        <Description>
                            <TranslatedText xml:lang="" typeType=""><> </TranslatedText>
					</ErrorMessage>
					<MethodSignature>
						<Parameter Name="" DataType="" Definition="" OrderNumber=""/>
						<ReturnValue Name="" DataType="" Definition="" OrderNumber=""/>
					</MethodSignature>
					                        </Description>
                        <FormalExpression Context="">
						<Code></Code>
						<ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
					</FormalExpression>
				</RangeCheck>
				<CodeListRef CodeListOID=""/>
			</ItemDef>
			<CodeList OID="" Name="" DataType="" CommentOID="">
				<Description>
					<TranslatedText xml:lang="" type=""></TranslatedText>
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				<Alias Context="" Name=""/>
				<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
				<CodeListItem CodedValue="" Rank="" Other="" OrderNumber="" CommentOID=""> 
					<Decode>
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					<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
					<Alias Context                            <Code/>
                            <!--                        
                            <ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
                        -->
                        </FormalExpression>
                    </StudyEndPoint>
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                <StudyTargetPopulation OID="" Name=""/>
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				<EnumeratedItem CodedValue="" Rank="" Other="" OrderNumber="" CommentOID                    <Description>
                        <TranslatedText xml:lang="" Type=""> 
					<Alias Context="" Name=""/>
					</TranslatedText>
                    </Description>
                    <Coding Code="" System="" SystemName="" SystemVersion="" hrefLabel="" CommentOIDhref=""/>
				</EnumeratedItem>
				<ExternalCodeList Dictionary="" Version=""  ref="" hrefCommentOID=""/>
			 </CodeList>
			<ConditionDef OID="" Name="" CommentOID="">
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					<TranslatedText xml:lang="" type=""></TranslatedText>
				</Description>
				<Alias Context="" Name=""/>
				<MethodSignature>
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					<ReturnValue Name="" DataType="" Definition="" OrderNumber=""/>
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				<FormalExpression Context="">
					<Code></Code>
					<ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
				</FormalExpression>
			</ConditionDef>
			<MethodDef OID="" Name="" Type="" CommentOID="">
				<Description>
					Coding>
                    <FormalExpression Context="">
                        <Code/>
                        <!--                        
                            <ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
                        -->
                    </FormalExpression>
                </StudyTargetPopulation>
                <StudyEstimands>
                    <StudyEstimand OID="" Name="">
                        <Description>
                            <TranslatedText xml:lang="" typeType=""></TranslatedText>
				</Description>
				<Alias Context="" Name=""/>
				<MethodSignature>
					<Parameter Name="" DataType="" Definition>
                        </Description>
                        <StudyTargetPopulationRef StudyTargetPopulationOID=""/>
                        <StudyInterventionRef StudyInterventionOID=""/>
                        <StudyEndPointRef StudyEndPointOID="" OrderNumber=""/>
					<ReturnValue Name="" DataType="" Definition="" OrderNumber=""/>
				</MethodSignature>
				<FormalExpression Context="">
					<Code></Code>
					<ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
				</FormalExpression>
			</MethodDef>
			<CommentDef OID="">
				<Description>
					<TranslatedText xml:lang="" type=""></TranslatedText>
				</Description>
			</CommentDef>
		</MetaDataVersion>
    </Study>   
	<AdminData StudyOID="">
		<User OID="" UserType="" OrganizationOID="" LocationOID="">
			<UserName></UserName>
			<Prefix></Prefix>
			<Suffix></Suffix>
			<FullName></FullName>
			<GivenName></GivenName>
			<FamilyName></FamilyName>
			<Image ImageFileName="" href="" MimeType=""/>
			<Address>
				<HouseNumber></HouseNumber>
				<StreetName></StreetName>
				<City></City>
				<StateProv></StateProv>
				<Country></Country>				
				<PostalCode></PostalCode>
				<OtherText></OtherText>		
				<GeoPosition Longitude="" Latitude="" Altitude=""/>	
			</Address>
			<Telecom TelecomType="" Value=""/>
		</User>
		<Location OID="" Name="" Role="" OrganizationOID="">
			<Description>
				<TranslatedText xml:lang="" type=""></TranslatedText>
			</Description>
			<MetaDataVersionRef StudyOID="" MetaDataVersionOID="" EffectiveDate=""/>
			<Address>
				<HouseNumber></HouseNumber>
				<StreetName></StreetName>
				<City></City>
				<StateProv></StateProv>
				<Country></Country>				
				<PostalCode></PostalCode>
				<OtherText></OtherText>		
				<GeoPosition Longitude="" Latitude="" Altitude=""/>	
			</Address>
			<Telecom TelecomType="" Value=""/>
			<Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
				<Value SeqNum=""></Value>
				<AuditRecord EditPoint="" UsedMethod="">
					<DateTimeStamp></DateTimeStamp>
					<ReasonForChange></ReasonForChange>
					<SourceID></SourceID>
					<UserRef UserOID=""/>
					<LocationRef LocationOID=""/>
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		</Location>
		<Organization OID="" Name="" Role="" Type="" LocationOID="" PartOfOrganizationOID="">
			<Description>
				                        <IntercurrentEvent>
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                        <SummaryMeasure>
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                            <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
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                            <Description>
                                <TranslatedText xml:lang="" typeType=""></TranslatedText>
			>
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			<Address>
				<HouseNumber></HouseNumber>
				<StreetName></StreetName>
				<City></City>
				<StateProv></StateProv>
				<Country></Country>				
				<PostalCode></PostalCode>
				<OtherText></OtherText>		
				<GeoPosition Longitude="" Latitude="" Altitude=""/>	
			</Address>
			<Telecom TelecomType="" Value=""/>
		</Organization>
		<SignatureDef OID="" Methodology="">
			<Meaning></Meaning>	
			<LegalReason></LegalReason>	
		</SignatureDef>
	</AdminData>
	<ReferenceData StudyOID="" MetaDataVersionOID="">
		<ItemGroupData ItemGroupOID="" ItemGroupRepeatKey="" TransactionType="" ItemGroupDataSeq="">
			
                            <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
                       </Criterion>
                     </ExclusionCriteria>
                </InclusionExclusionCriteria>
                <StudyEventGroupRef StudyEventGroupOID="" OrderNumber="" Mandatory=""
                    CollectionExceptionConditionOID="">
                    <Description>
                        <TranslatedText xml:lang="" Type=""> </TranslatedText>
                    </Description>
                </StudyEventGroupRef>
                <WorkflowRef WorkflowOID=""> </WorkflowRef>
                <Alias Context="" Name=""> </Alias>
            </Protocol>
            <WorkflowDef OID="" Name="">
                <Description>
                    <TranslatedText xml:lang="" Type=""> </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="" Type=""> </TranslatedText>
                </Description>
                <StudyEventGroupRef StudyEventGroupOID="" OrderNumber="" Mandatory=""
                    CollectionExceptionConditionOID="">
                    <Description>
                        <TranslatedText xml:lang="" Type=""> </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="" Type=""> </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="" Purpose=""
                StandardOID="" IsNonStandard="" HasNoData="" CommentOID="">
                <Description>
                    <TranslatedText xml:lang="" Type=""> </TranslatedText>
                </Description>
                <Class Name="">
                    <SubClass Name="" ParentClass=""/>
                </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="" ref="" CommentOID=""> </Coding>
                <WorkflowRef WorkflowOID=""> </WorkflowRef>
                <Origin Type="" Source="">
                    <Description>
                        <TranslatedText xml:lang="" Type=""> </TranslatedText>
                    </Description>
                    <SourceItems>
                        <SourceItem ItemOID="" ItemGroupOID="" MetaDataVersionOID="" StudyOID=""
                            LeafID="" Name="">
                            <Resource Type="" Name="" Attribute="" Label="">
                                <Selection Path=""/>
                            </Resource>
                        </SourceItem>
                    </SourceItems>
                    <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
                    <DocumentRef LeafID=""> </DocumentRef>
                </Origin>
                <Alias Context="" Name=""> </Alias>
                <Leaf ID="" xlink:href="">
                    <Title> </Title>
                </Leaf>
            </ItemGroupDef>
            <ItemDef OID="" Name="" DataType="" Length="" DisplayFormat="" CommentOID="">
                <Description>
                    <TranslatedText xml:lang="" Type=""> </TranslatedText>
                </Description>
                <Question>
                    <TranslatedText xml:lang="" Type=""> </TranslatedText>
                </Question>
                <Prompt>
                    <TranslatedText xml:lang="" Type=""> </TranslatedText>
                </Prompt>
                <CRFCompletionInstructions >
                    <TranslatedText xml:lang="" Type=""> </TranslatedText>
                </CRFCompletionInstructions >
                <ImplementationNotes >
                    <TranslatedText xml:lang="" Type=""> </TranslatedText>
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                <Definition>
                    <TranslatedText xml:lang="" Type=""> </TranslatedText>
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                <VariableSet >
                    <TranslatedText xml:lang="" Type=""> </TranslatedText>
                </VariableSet >
                <CDISCNotes >
                    <TranslatedText xml:lang="" Type=""> </TranslatedText>
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                        <FormalExpression Context="">
                          <Code></Code>
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                    <ErrorMessage>
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                <CodeListRef CodeListOID=""> </CodeListRef>
                <ValueListRef ValueListOID=""> </ValueListRef>
                <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
                <Alias Context="" Name=""> </Alias>
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                <Description>
                    <TranslatedText xml:lang="" Type=""> </TranslatedText>
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                <CodeListItem CodedValue="" Rank="" Other="" OrderNumber="" ExtendedValue=""
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                    <Decode>
                        <TranslatedText xml:lang="" Type=""> </TranslatedText>
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                <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
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                    <TranslatedText xml:lang="" Type=""> </TranslatedText>
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                <MethodSignature>
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                    <ReturnValue Name="" DataType="" Definition="" OrderNumber=""> </ReturnValue>
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                <FormalExpression Context="">
                    <Code/>
                    <!--
                        <ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
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                <Alias Context="" Name=""> </Alias>
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            <MethodDef OID="" Name="" Type="" CommentOID="">
                <Description>
                    <TranslatedText xml:lang="" Type=""> </TranslatedText>
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                    <ReturnValue Name="" DataType="" Definition="" OrderNumber=""> </ReturnValue>
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                <FormalExpression Context="">
                    <Code/>
                    <!--
                        <ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
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                <Alias Context="" Name=""> </Alias>
                <DocumentRef LeafID="">
                    <PDFPageRef PageRefs="" FirstPage="" LastPage="" Type="" Title=""/>
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            <Leaf ID="" xlink:href="">
                <title> </title>
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        </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/>
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            <Telecom TelecomType="" Value=""> </Telecom>
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        <Organization OID="" Name="" Role="" Type="" LocationOID="" PartOfOrganizationOID="">
            <Description>
                <TranslatedText xml:lang="" Type="">
                    <xhtml:div> </xhtml:div>
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            <Address>
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                <HouseNumber/>
                <City/>
                <StateProv/>
                <Country/>
                <PostalCode/>
                <GeoPosition Longitude="" Latitude="" Altitude=""> </GeoPosition>
                <OtherText/>
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            <Telecom TelecomType="" Value=""> </Telecom>
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            <Description>
                <TranslatedText xml:lang="" Type="">
                    <xhtml:div> </xhtml:div>
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            <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>
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    <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="" Type=""> </TranslatedText>
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                    <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
                    <Flag>
                        <FlagValue CodeListOID=""/>
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                </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=""/>
                <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="" Type=""> </TranslatedText>
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                    <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
                    <Flag>
                        <FlagValue CodeListOID=""/>
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                </Annotation>
                <Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
                    <Value SeqNum=""/>
                    <AuditRecord EditPoint="" UsedMethod="">
                        <UserRef UserOID=""> </UserRef>
                        <LocationRef LocationOID=""> </LocationRef>
                        <DateTimeStamp/>
                    </AuditRecord>
                </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="" Type=""> </TranslatedText>
                </Comment>
                <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
                <Flag>
                    <FlagValue CodeListOID=""/>
                    <FlagType CodeListOID=""/>
                </Flag>
            </Annotation>
            <Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
                <Value SeqNum=""/>
                <AuditRecord EditPoint="" UsedMethod="">
                    <UserRef UserOID=""> </UserRef>
                    <LocationRef LocationOID=""> </LocationRef>
                    <DateTimeStamp/>
                    <ReasonForChange/>
                    <SourceID/>
                </AuditRecord>
            </Query>
        </ItemGroupData>
        <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="" Type="">
                    <xhtml:div> </xhtml:div>
                </TranslatedText>
            </Comment>
            <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
            <Flag>
                <FlagValue CodeListOID=""/>
                <FlagType CodeListOID=""/>
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        </Annotation>
    </ReferenceData>
    <ClinicalData StudyOID="" MetaDataVersionOID="">
        <SubjectData SubjectKey="" TransactionType="">
            <InvestigatorRef UserOID=""> </InvestigatorRef>
            <SiteRef LocationOID=""> </SiteRef>
            <StudyEventData StudyEventOID="" StudyEventRepeatKey="" TransactionType="">
                <ItemGroupData ItemGroupOID="" ItemGroupRepeatKey="" TransactionType=""
                    ItemGroupDataSeq="">
                    <ItemGroupData ItemGroupOID="" ItemGroupRepeatKey="" TransactionType=""
                        ItemGroupDataSeq=""> </ItemGroupData>
                    <ItemData ItemOID="" TransactionType="" IsNull=""> </ItemData>
                    <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>
                </ItemGroupData>
                <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="" Type=""> </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>
            </StudyEventData>
            <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="" Type=""> </TranslatedText>
                </Comment>
                <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
                <Flag>
                    <FlagValue CodeListOID=""/>
                    <FlagType CodeListOID=""/>
                </Flag>
            </Annotation>
            <Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
                <Value SeqNum=""/>
                <AuditRecord EditPoint="" UsedMethod="">
                    <UserRef UserOID=""> </UserRef>
                    <LocationRef LocationOID=""> </LocationRef>
                    <DateTimeStamp/>
                    <ReasonForChange/>
                    <SourceID/>
                </AuditRecord>
            </Query>
        </SubjectData>
        <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="" Type=""> </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=""/>
                <AuditRecord EditPoint="" UsedMethod="">
				<DateTimeStamp></DateTimeStamp>
				<ReasonForChange></ReasonForChange>
				<SourceID></SourceID>
				                    <UserRef UserOID=""/>
				<LocationRef LocationOID=""/>
			</AuditRecord>
			<Signature>
				<SignatureRef SignatureOID=""/>
				<DateTimeStamp></DateTimeStamp>
				<UserRef UserOID=""/>
				UserRef>
                    <LocationRef LocationOID=""/>
			 </Signature>		
			<Annotation SeqNum="" TransactionType="">
				<Comment></Comment>
				<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
				<Flag> 
					<FlagValue CodeListOID=""/>
					<FlagType CodeListOID=""/>
				</Flag>
			</Annotation>
			<ItemData ItemOID="" TransactionType="" IsNull="">
				<Value SeqNum=""></Value>
				<Query OID="" Source="" Target="" Type="" LastUpdateDatetime="" Name="">
					<Value SeqNum=""></Value>
					<AuditRecord EditPoint="" UsedMethod="">
						<DateTimeStamp></DateTimeStamp>
						<ReasonForChange></ReasonForChange>
						<SourceID></SourceID>
						<UserRef UserOID=""/>
						<LocationRef LocationOID=""/>
					</AuditRecord>
				</Query>
				<AuditRecord EditPoint="" UsedMethod="">
						<DateTimeStamp></DateTimeStamp>
						<ReasonForChange></ReasonForChange>
						<SourceID></SourceID>
						<UserRef UserOID=""/>
						<LocationRef LocationOID=""/>
				</AuditRecord>
				<Signature>
					<SignatureRef SignatureOID=""/>
					<DateTimeStamp></DateTimeStamp>
					<UserRef UserOID=""/>
					<LocationRef LocationOID=""/>
				</Signature>	
				<Annotation SeqNum="" TransactionType="">
					<Comment></Comment>
					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="" Type=""> </TranslatedText>
                    </Comment>
                    <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </>
					<Flag> 
						<FlagValue CodeListOID=""/>
						<FlagTypeCoding>
                    <Flag>
                        <FlagValue CodeListOID=""/>
					                    </Flag>
				                </Annotation>
			</ItemData>  
			                <Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
				<Value SeqNum=""></Value>
				                    <Value SeqNum=""/>
                    <AuditRecord EditPoint="" UsedMethod="">
					<DateTimeStamp></DateTimeStamp>
					<ReasonForChange></ReasonForChange>
					<SourceID></SourceID>
					                        <UserRef UserOID=""/>
					<LocationRef LocationOID=""/>
				</AuditRecord>
			</Query>
		</ItemGroupData>
	</ReferenceData>
	<ClinicalData StudyOID="" MetaDataVersionOID="">
		<Annotation SeqNum="" TransactionType="">
			<Comment></Comment>
			<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
			<Flag> 
				<FlagValue CodeListOID=""/>
				<FlagType CodeListOID=""/>
			</Flag>
		</Annotation>
		UserRef>
                        <LocationRef LocationOID=""> </LocationRef>
                        <DateTimeStamp/>
                    </AuditRecord>
                </Query>
            </ItemData>
            <AuditRecord EditPoint="" UsedMethod="">
			<DateTimeStamp></DateTimeStamp>
			<ReasonForChange></ReasonForChange>
			<SourceID></SourceID>
			<UserRef UserOID=""/>
			<LocationRef LocationOID=""/>
		</AuditRecord>
		<Signature>
			<SignatureRef SignatureOID=""/>
			<DateTimeStamp></DateTimeStamp>
			                <UserRef UserOID=""> </>
			UserRef>
                <LocationRef LocationOID=""> </>
		</Signature>
		<SubjectData SubjectKey="" TransactionType="">
			<AuditRecord EditPoint="" UsedMethod="">
				<DateTimeStamp></DateTimeStamp>
				<ReasonForChange></ReasonForChange>
				<SourceID></SourceID>
				LocationRef>
                <DateTimeStamp/>
                <ReasonForChange/>
                <SourceID/>
            </AuditRecord>
            <Signature ID="">
                <UserRef UserOID=""> </>
				UserRef>
                <LocationRef LocationOID=""> </>
			</AuditRecord>
			<Signature>
				<SignatureRef SignatureOID=""/>
				<DateTimeStamp></DateTimeStamp>
				<UserRef UserOID=""/>
				<LocationRef LocationOID=""/>
			</Signature>
			<InvestigatorRef UserOID=""/>
			<SiteRef LocationOID=""/>
			<Annotation SeqNum="" TransactionType="">
				<Comment></Comment>
				LocationRef>
                <SignatureRef SignatureOID=""> </SignatureRef>
                <DateTimeStamp/>
            </Signature>
            <Annotation SeqNum="" TransactionType="" ID="">
                <Comment SponsorOrSite="">
                    <TranslatedText xml:lang="" Type=""> </TranslatedText>
                </Comment>
                <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </>
				<Flag> 
					Coding>
                <Flag>
                    <FlagValue CodeListOID=""/>
					                    <FlagType CodeListOID=""/>
				                </Flag>
			</Annotation>	
			<Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
				<Value SeqNum=""></Value>
				<AuditRecord EditPoint="" UsedMethod="">
					<DateTimeStamp></DateTimeStamp>
					<ReasonForChange></ReasonForChange>
					<SourceID></SourceID>
					<UserRef UserOID=""/>
					<LocationRef LocationOID=""/>
				</AuditRecord>
			</Query>
			<StudyEventData StudyEventOID="" StudyEventRepeatKey="" TransactionType="">
				<AuditRecord EditPoint="" UsedMethod="">
					<DateTimeStamp></DateTimeStamp>
					<ReasonForChange></ReasonForChange>
					<SourceID></SourceID>
					<UserRef UserOID=""/>
					<LocationRef LocationOID=""/>
				</AuditRecord>
				<Signature>
					<SignatureRef SignatureOID=""/>
					<DateTimeStamp></DateTimeStamp>
					<UserRef UserOID=""/>
					<LocationRef LocationOID=""/>
				</Signature>		
				<Annotation SeqNum="" TransactionType="">
					<Comment></Comment>
					<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
					<Flag> 
						<FlagValue CodeListOID=""/>
						<FlagType CodeListOID=""/>
					</Flag>
				</Annotation>
				<Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
					<Value SeqNum=""></Value>
					<AuditRecord EditPoint="" UsedMethod="">
						<DateTimeStamp></DateTimeStamp>
						<ReasonForChange></ReasonForChange>
						<SourceID></SourceID>
						<UserRef UserOID=""/>
						<LocationRef LocationOID=""/>
					</AuditRecord>
				</Query>
				<ItemGroupData ItemGroupOID="" ItemGroupRepeatKey="" TransactionType="" ItemGroupDataSeq="">
					<AuditRecord EditPoint="" UsedMethod="">
						<DateTimeStamp></DateTimeStamp>
						<ReasonForChange></ReasonForChange>
						<SourceID></SourceID>
						<UserRef UserOID=""/>
						<LocationRef LocationOID=""/>
					</AuditRecord>
					<Signature>
						<SignatureRef SignatureOID=""/>
						<DateTimeStamp></DateTimeStamp>
						<UserRef UserOID=""/>
						<LocationRef LocationOID=""/>
					</Signature>		
					            </Annotation>
            <Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
                <Value SeqNum=""/>
                <AuditRecord EditPoint="" UsedMethod="">
                    <UserRef UserOID=""> </UserRef>
                    <LocationRef LocationOID=""> </LocationRef>
                    <DateTimeStamp/>
                    <ReasonForChange/>
                    <SourceID/>
                </AuditRecord>
            </Query>
        </ItemGroupData>
        <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="">
						<Comment></Comment>
						<Coding Code ID="" System="" SystemName>
            <Comment SponsorOrSite="" SystemVersion="" href>
                <TranslatedText xml:lang="" CommentOIDType=""/>
						<Flag> 
							<FlagValue CodeListOID=""/>
							<FlagType CodeListOID=""/>
						</Flag>
					</Annotation>
					<ItemData ItemOID="" TransactionType="" IsNull="">
						<Value SeqNum=""></Value>
						<Query OID="" Source="" Target="" Type="" LastUpdateDatetime="" Name="">
							<Value SeqNum=""></Value>
							<AuditRecord EditPoint="" UsedMethod="">
								<DateTimeStamp></DateTimeStamp>
								<ReasonForChange></ReasonForChange>
								<SourceID></SourceID>
								<UserRef UserOID=""/>
								<LocationRef LocationOID=""/>
							</AuditRecord>
						</Query>
						<AuditRecord EditPoint="" UsedMethod="">
								<DateTimeStamp></DateTimeStamp>
								<ReasonForChange></ReasonForChange>
								<SourceID></SourceID>
								<UserRef UserOID=""/>
								<LocationRef LocationOID=""/>
						</AuditRecord>
						<Signature>
							<SignatureRef SignatureOID=""/>
							<DateTimeStamp></DateTimeStamp>
							<UserRef UserOID=""/>
							<LocationRef LocationOID=""/>
						</Signature>	
						<Annotation SeqNum="" TransactionType="">
							<Comment></Comment>
							<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
							<Flag> 
								<FlagValue CodeListOID=""/>
								<FlagType CodeListOID=""/>
							</Flag>
						</Annotation>
					</ItemData>  
					<Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
						<Value SeqNum=""></Value>
						<AuditRecord EditPoint="" UsedMethod="">
							<DateTimeStamp></DateTimeStamp>
							<ReasonForChange></ReasonForChange>
							<SourceID></SourceID>
							<UserRef UserOID=""/>
							<LocationRef LocationOID=""/>
						</AuditRecord>
					</Query>
				</ItemGroupData>
			</StudyEventData>
		</SubjectData>
		<Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
			<Value SeqNum=""></Value>
			<AuditRecord EditPoint="" UsedMethod="">
				<DateTimeStamp></DateTimeStamp>
				<ReasonForChange></ReasonForChange>
				<SourceID></SourceID>
				<UserRef UserOID=""/>
				<LocationRef LocationOID=""/>
			</AuditRecord>
		</Query>
	</ClinicalData>
	<Association StudyOID="" MetaDataVersionOID="">
		<KeySet StudyOID="" SubjectKey="" StudyEventOID="" StudyEventRepeatKey="" ItemGroupOID="" ItemGroupRepeatKey="" ItemOID=""/>
		<Annotation SeqNum="" TransactionType="">
			<Comment></Comment>
			<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
			<Flag> 
				<FlagValue CodeListOID=""/>
				<FlagType CodeListOID=""/>
			</Flag>
		</Annotation>
	</Association>
	<ds:Signature xmlns="http://www.w3.org/2000/09/xmldsig#" Id="1">
		<SignedInfo></SignedInfo>
		<SignatureValue></SignatureValue>
		<KeyInfo></KeyInfo>
		<Object></Object>
	</ds:Signature>>
                    <xhtml:div> </xhtml:div>
                </TranslatedText>
            </Comment>
            <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
            <Flag>
                <FlagValue CodeListOID=""/>
                <FlagType CodeListOID=""/>
            </Flag>
        </Annotation>
        <Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
            <Value SeqNum=""/>
            <AuditRecord EditPoint="" UsedMethod="">
                <UserRef UserOID=""> </UserRef>
                <LocationRef LocationOID=""> </LocationRef>
                <DateTimeStamp/>
                <ReasonForChange/>
                <SourceID/>
            </AuditRecord>
        </Query>
    </ClinicalData>
    <Association StudyOID="" MetaDataVersionOID="">
        <KeySet StudyOID="" SubjectKey="" MetaDataVersionOID="" StudyEventOID=""
            StudyEventRepeatKey="" ItemGroupOID="" ItemGroupRepeatKey="" ItemOID=""> </KeySet>
        <KeySet StudyOID="" SubjectKey="" MetaDataVersionOID="" StudyEventOID=""
            StudyEventRepeatKey="" ItemGroupOID="" ItemGroupRepeatKey="" ItemOID=""> </KeySet>
        <Annotation SeqNum="" TransactionType="" ID="">
            <Comment SponsorOrSite="">
                <TranslatedText xml:lang="" Type="">
                    <xhtml:div> </xhtml:div>
                </TranslatedText>
            </Comment>
            <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
            <Flag>
                <FlagValue CodeListOID=""/>
                <FlagType CodeListOID=""/>
            </Flag>
        </Annotation>
    </Association>
</ODM>