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<?xml version="1.0" encoding="UTF-8" standalone="yes"?>
<tns:CompleteTrialAmendment 
    xmlns:tns="gov.nih.nci.pa.webservices.types"
    xmlns:tns1="gov.nih.nci.po.webservices.types.trimmed" 
    xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
    xsi:schemaLocation="gov.nih.nci.pa.webservices.types ../../src/resources/ws.xsd ">

    
    <tns:leadOrgTrialID>REST00001</tns:leadOrgTrialID>
    <tns:clinicalTrialsDotGovTrialID>NCT12345678</tns:clinicalTrialsDotGovTrialID>
    <tns:dcpIdentifier>DCP999999999999</tns:dcpIdentifier>
    <tns:otherTrialID>OTHER00000000001</tns:otherTrialID>
    <tns:title>A Phase I Study of REST Trial Amendment</tns:title>
    <tns:phase>I</tns:phase>
    <tns:pilot>false</tns:pilot>
    <tns:accrualDiseaseTerminology>SDC</tns:accrualDiseaseTerminology>
    <tns:primaryPurpose>Other</tns:primaryPurpose>
    <tns:primaryPurposeOtherDescription>Additional description of the trial's purpose</tns:primaryPurposeOtherDescription>
    <tns:interventionalDesign>
        <tns:secondaryPurpose>Other</tns:secondaryPurpose>
        <tns:secondaryPurposeOtherDescription>Additional description of the trial's purpose</tns:secondaryPurposeOtherDescription>
    </tns:interventionalDesign>
    <tns:leadOrganization>
        <tns:existingOrganization>
            <tns:poID>1</tns:poID>
        </tns:existingOrganization>
    </tns:leadOrganization>
    <tns:pi>
        <tns:existingPerson>
            <tns:poID>10</tns:poID>
        </tns:existingPerson>
    </tns:pi>
    <tns:sponsor>
        <tns:existingOrganization>
            <tns:poID>2</tns:poID>
        </tns:existingOrganization>
    </tns:sponsor>
    <tns:responsibleParty>
        <tns:type>Sponsor</tns:type>
    </tns:responsibleParty>
    <tns:summary4FundingSponsor>
        <tns:existingOrganization>
            <tns:poID>3</tns:poID>
        </tns:existingOrganization>
    </tns:summary4FundingSponsor>
    <tns:programCode>PG00002</tns:programCode>
    <tns:fundedByNciGrant>false</tns:fundedByNciGrant>
    <tns:grant>
        <tns:fundingMechanism>B01</tns:fundingMechanism>
        <tns:nihInstitutionCode>AA</tns:nihInstitutionCode>
        <tns:serialNumber>111111</tns:serialNumber>
        <tns:nciDivisionProgramCode>CCR</tns:nciDivisionProgramCode>
        <tns:fundingPercentage>100.0</tns:fundingPercentage>
    </tns:grant>
    <tns:trialStatus>In Review</tns:trialStatus>
    <tns:whyStopped>If study stopped, enter the reason why.</tns:whyStopped>
    <tns:trialStatusDate>2014-07-15</tns:trialStatusDate>
    <tns:trialStartDate type="Actual">2014-07-15</tns:trialStartDate>
    <tns:primaryCompletionDate type="Anticipated">2018-07-15</tns:primaryCompletionDate>
    <tns:completionDate type="Anticipated">2018-07-15</tns:completionDate>
    <tns:ind>
        <tns:number>111111</tns:number>
        <tns:grantor>CDER</tns:grantor>
        <tns:holderType>NIH</tns:holderType>
        <tns:nihInstitution>NEI</tns:nihInstitution>
        <tns:expandedAccess>true</tns:expandedAccess>
        <tns:expandedAccessRecord>NCT12345688</tns:expandedAccessRecord>
    </tns:ind>
    <tns:ide>
        <tns:number>222222</tns:number>
        <tns:grantor>CDRH</tns:grantor>
        <tns:holderType>NCI</tns:holderType>
        <tns:nciDivisionProgramCode>CCR</tns:nciDivisionProgramCode>
        <tns:expandedAccess>unknown</tns:expandedAccess>
    </tns:ide>
    <tns:regulatoryInformation>
        <tns:fdaRegulatedDrug>true</tns:fdaRegulatedDrug>
        <tns:fdaRegulatedDevice>true</tns:fdaRegulatedDevice>
        <tns:approvalClearance>true</tns:approvalClearance>
        <tns:marketSurveillance>true</tns:marketSurveillance>
        <tns:usaExport>true</tns:usaExport>
        <tns:fdaRegulated>true</tns:fdaRegulated>
        <tns:section801>true</tns:section801>
        <tns:delayedPosting>false</tns:delayedPosting>
        <tns:dataMonitoringCommitteeAppointed>true</tns:dataMonitoringCommitteeAppointed>
    </tns:regulatoryInformation>
    <tns:protocolDocument filename="protocol.pdf">dGVzdA==</tns:protocolDocument>
    <tns:irbApprovalDocument filename="irb.pdf">dGVzdA==</tns:irbApprovalDocument>
    <tns:participatingSitesDocument
        filename="sites.pdf">dGVzdA==</tns:participatingSitesDocument>
    <tns:informedConsentDocument filename="consent.pdf">dGVzdA==</tns:informedConsentDocument>
    <tns:otherDocument filename="other.pdf">dGVzdA==</tns:otherDocument>
    <tns:amendmentNumber>99</tns:amendmentNumber>
    <tns:amendmentDate>2014-08-01</tns:amendmentDate>
    <tns:ctepIdentifier>CTEP99999999</tns:ctepIdentifier>
    <tns:changeMemoDocument filename="memo.pdf">dGVzdA==</tns:changeMemoDocument>
    <tns:protocolHighlightDocument filename="high.pdf">dGVzdA==</tns:protocolHighlightDocument>
</tns:CompleteTrialAmendment>

<?xml version="1.0" encoding="UTF-8" standalone="yes"?>
<TrialRegistrationConfirmation xmlns="gov.nih.nci.pa.webservices.types"
    xmlns:ns2="gov.nih.nci.po.webservices.types.trimmed">
    <paTrialID>137908558</paTrialID>
    <nciTrialID>NCI-2014-00496</nciTrialID>
</TrialRegistrationConfirmation>