Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2

Clinical Study Protocol - Downloaded Version 1.0.0-ballot2 See the Directory of published versions

## : START HERE: Exemplar Research Study with narrative

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    @prefix fhir: <http://hl7.org/fhir/> .
    @prefix owl: <http://www.w3.org/2002/07/owl#> .
    @prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
    @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
    @prefix sct: <http://snomed.info/id/> .
    @prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

    # - resource -------------------------------------------------------------------

     a fhir:ResearchStudy ;
      fhir:nodeRole fhir:treeRoot ;
      fhir:id [ fhir:v "Exemplar-ResearchStudy-001"] ; #
      fhir:meta [
        ( fhir:profile [
    fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile>     ] )
      ] ; #
      fhir:language [ fhir:v "en"] ; #
      fhir:text [
    fhir:status [ fhir:v "extensions" ] ;
    fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"en\" lang=\"en\"><p class=\"res-header-id\"><b>Generated Narrative: ResearchStudy Exemplar-ResearchStudy-001</b></p><a name=\"Exemplar-ResearchStudy-001\"> </a><a name=\"hcExemplar-ResearchStudy-001\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Language: en</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-m11-research-study-profile.html\">M11 Research Study Profile</a></p></div><p><b>M11_ConfidentialityStatement</b>: All data is confidential</p><blockquote><p><b>M11 Research Study Extension</b></p><ul><li>originalProtocol: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C218488}\">Protocol Previously Amended See Summary of Changes Before the Table of Contents</span></li><li>versionDate: 2017-10-01</li></ul></blockquote><blockquote><p><b>M11_Approval</b></p><ul><li>approvalDate: 2017-10-05</li><li>signature: No display for Signature  (data:  )</li><li>signatureUrl: <a href=\"https://somelocation\">https://somelocation</a></li><li>signatureMethod: electronic and wet ink copy</li></ul></blockquote><p><b>Narrative Elements</b>: <a href=\"Composition-Exemplar-Narrative.html\">Composition Exemplar Protocol Narratives</a></p><p><b>Narrative Elements</b>: <a href=\"Composition-Exemplar-Narrative-2.1.html\">Composition Exemplar Protocol Narrative 2.1</a></p><p><b>identifier</b>: Sponsor Protocol Identifier/ABC-Exemplar, EU CT Number/EU-1234, Other Regulatory or Clinical Trial Identifier/ERA1234, Amendment Identifier/ABC-Exemplar(a)</p><p><b>version</b>: (a)</p><p><b>title</b>: A Phase 3 Study of Inhaled Exoticillin compared to Intramuscular Exoticillin for Treatment of Bronchtis Japanese Patients with Iatrogenic Diabetes Mellitus</p><blockquote><p><b>label</b></p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C207646}\">Study Acronym</span></p><p><b>value</b>: Inhaled vs IM Exoticillin</p></blockquote><blockquote><p><b>label</b></p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C207615}\">Brief Study Title</span></p><p><b>value</b>: A Phase 3 Study of Inhaled versus Intramuscular Exoticillin for Bronchtis in Diabetic Japanese Patients</p></blockquote><h3>RelatesTos</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Target[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Justification</td><td><a href=\"ResearchStudy-Exemplar-ResearchStudy-Current-Amendment.html\">ResearchStudy: extension = ,,; identifier = Sponsor Protocol Identifier: ABC-Exemplar (use: usual, ); version = (a); status = active</a></td></tr></table><p><b>status</b>: Active</p><p><b>phase</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C15602}\">Phase III Trial</span></p><h3>Focus</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"MedicinalProductDefinition-Exemplar-MedicinalProduct.html\">MedicinalProductDefinition: identifier = Sponsor's Investigational Product Code: EX2015/03</a></td></tr></table><p><b>condition</b>: <span title=\"Codes:{http://snomed.info/sct 1137328006}\">Iatrogenic hypoglycaemia</span></p><blockquote><p><b>associatedParty</b></p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C70793}\">Clinical Study Sponsor</span></p><p><b>party</b>: <a href=\"Organization-Exemplar-Sponsor-Organization.html\">Organization Exemplar Pharmaceuticals Co.</a></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C70793}\">Clinical Study Sponsor</span></p><p><b>party</b>: <a href=\"Practitioner-Exemplar-Sponsor-Practitioner.html\">Practitioner Dr Exemplar Practitioner</a></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C215669}\">Study Co-Sponsor</span></p><p><b>party</b>: <a href=\"Organization-Exemplar-CoSponsor-Organization.html\">Organization Exemplar Pharmazeutika GmBH.</a></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C215669}\">Study Co-Sponsor</span></p><p><b>party</b>: <a href=\"Practitioner-Exemplar-CoSponsor-Practitioner.html\">Practitioner Dr Exemplar von Practitioner</a></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C215670}\">Local Legal Sponsor</span></p><p><b>party</b>: <a href=\"Organization-Exemplar-Local-Sponsor-Organization.html\">Organization Fictive Pharmaceuticals (Australia) Pty</a></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C215670}\">Local Legal Sponsor</span></p><p><b>party</b>: <a href=\"Practitioner-Exemplar-Local-Sponsor-Practitioner.html\">Practitioner Bruce Exemplar</a></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C156625}\">Device Manufacturer</span></p><p><b>party</b>: <a href=\"Organization-Exemplar-Devices-Organization.html\">Organization Exemplar Devices Ltd</a></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C51876}\">Sponsor Medical Expert</span></p><p><b>party</b>: <a href=\"Practitioner-Exemplar-Sponsor-Expert-Practitioner.html\">Practitioner Dr Exemplar Consultant</a></p></blockquote></div>"^^rdf:XMLLiteral ]
      ] ; #
      fhir:extension ( [
    fhir:url [
    fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-confidentiality-statement"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-confidentiality-statement>     ] ;
    fhir:value [
    a fhir:String ;
    fhir:v "All data is confidential"     ]
      ] [
        ( fhir:extension [
    fhir:url [
    fhir:v "originalProtocol"^^xsd:anyURI ;
    fhir:l fhir:originalProtocol       ] ;
    fhir:value [
    a fhir:CodeableConcept ;
            ( fhir:coding [
    fhir:system [
    fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
    fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>           ] ;
    fhir:code [ fhir:v "C218488" ] ;
    fhir:display [ fhir:v "Protocol Previously Amended See Summary of Changes Before the Table of Contents" ]         ] )       ]     ] [
    fhir:url [
    fhir:v "versionDate"^^xsd:anyURI ;
    fhir:l fhir:versionDate       ] ;
    fhir:value [
    a fhir:Date ;
    fhir:v "2017-10-01"^^xsd:date       ]     ] ) ;
    fhir:url [
    fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study>     ]
      ] [
        ( fhir:extension [
    fhir:url [
    fhir:v "approvalDate"^^xsd:anyURI ;
    fhir:l fhir:approvalDate       ] ;
    fhir:value [
    a fhir:Date ;
    fhir:v "2017-10-05"^^xsd:date       ]     ] [
    fhir:url [
    fhir:v "signature"^^xsd:anyURI ;
    fhir:l fhir:signature       ] ;
    fhir:value [
    a fhir:Signature ;
    fhir:data [ fhir:v " "^^xsd:base64Binary ]       ]     ] [
    fhir:url [
    fhir:v "signatureUrl"^^xsd:anyURI ;
    fhir:l fhir:signatureUrl       ] ;
    fhir:value [
    a fhir:Url ;
    fhir:v "https://somelocation"^^xsd:anyURI ;
    fhir:l <https://somelocation>       ]     ] [
    fhir:url [
    fhir:v "signatureMethod"^^xsd:anyURI ;
    fhir:l fhir:signatureMethod       ] ;
    fhir:value [
    a fhir:String ;
    fhir:v "electronic and wet ink copy"       ]     ] ) ;
    fhir:url [
    fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval>     ]
      ] [
    fhir:url [
    fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements>     ] ;
    fhir:value [
    a fhir:Reference ;
    fhir:l fhir:Composition/Exemplar-Narrative ;
    fhir:reference [ fhir:v "Composition/Exemplar-Narrative" ]     ]
      ] [
    fhir:url [
    fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements>     ] ;
    fhir:value [
    a fhir:Reference ;
    fhir:l fhir:Composition/Exemplar-Narrative-2.1 ;
    fhir:reference [ fhir:v "Composition/Exemplar-Narrative-2.1" ]     ]
      ] ) ; #
      fhir:identifier ( [
    fhir:type [
          ( fhir:coding [
    fhir:system [
    fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
    fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>         ] ;
    fhir:code [ fhir:v "C132351" ] ;
    fhir:display [ fhir:v "Sponsor Protocol Identifier" ]       ] )     ] ;
    fhir:system [
    fhir:v "https://exemplarSponsor.com/sponsor-identifier"^^xsd:anyURI ;
    fhir:l <https://exemplarSponsor.com/sponsor-identifier>     ] ;
    fhir:value [ fhir:v "ABC-Exemplar" ]
      ] [
    fhir:type [
          ( fhir:coding [
    fhir:system [
    fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
    fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>         ] ;
    fhir:code [ fhir:v "C218684" ]       ] ) ;
    fhir:text [ fhir:v "EU CT Number" ]     ] ;
    fhir:system [
    fhir:v "https://exemplarEMA.org/registry-identifier"^^xsd:anyURI ;
    fhir:l <https://exemplarEMA.org/registry-identifier>     ] ;
    fhir:value [ fhir:v "EU-1234" ]
      ] [
    fhir:type [
          ( fhir:coding [
    fhir:system [
    fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
    fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>         ] ;
    fhir:code [ fhir:v "C218690" ]       ] ) ;
    fhir:text [ fhir:v "Other Regulatory or Clinical Trial Identifier" ]     ] ;
    fhir:system [
    fhir:v "https://exemplarRegulator.org/registry-identifier"^^xsd:anyURI ;
    fhir:l <https://exemplarRegulator.org/registry-identifier>     ] ;
    fhir:value [ fhir:v "ERA1234" ] ;
    fhir:assigner [
    fhir:l fhir:Organization/Exemplar-Regulator-Organization ;
    fhir:reference [ fhir:v "Organization/Exemplar-Regulator-Organization" ]     ]
      ] [
    fhir:type [
          ( fhir:coding [
    fhir:system [
    fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
    fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>         ] ;
    fhir:code [ fhir:v "C218477" ]       ] ) ;
    fhir:text [ fhir:v "Amendment Identifier" ]     ] ;
    fhir:system [
    fhir:v "https://example.org/amendment-identifier"^^xsd:anyURI ;
    fhir:l <https://example.org/amendment-identifier>     ] ;
    fhir:value [ fhir:v "ABC-Exemplar(a)" ]
      ] ) ; #
      fhir:version [ fhir:v "(a)"] ; #
      fhir:title [ fhir:v "A Phase 3 Study of Inhaled Exoticillin compared to Intramuscular Exoticillin for Treatment of Bronchtis Japanese Patients with Iatrogenic Diabetes Mellitus"] ; #
      fhir:label ( [
    fhir:type [
          ( fhir:coding [
    fhir:system [
    fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
    fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>         ] ;
    fhir:code [ fhir:v "C207646" ] ;
    fhir:display [ fhir:v "Study Acronym" ]       ] )     ] ;
    fhir:value [ fhir:v "Inhaled vs IM Exoticillin" ]
      ] [
    fhir:type [
          ( fhir:coding [
    fhir:system [
    fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
    fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>         ] ;
    fhir:code [ fhir:v "C207615" ] ;
    fhir:display [ fhir:v "Brief Study Title" ]       ] )     ] ;
    fhir:value [ fhir:v "A Phase 3 Study of Inhaled versus Intramuscular Exoticillin for Bronchtis in Diabetic Japanese Patients" ]
      ] ) ; #
      fhir:relatesTo ( [
    fhir:type [ fhir:v "justification" ] ;
    fhir:target [
    a fhir:Reference ;
    fhir:l fhir:ResearchStudy/Exemplar-ResearchStudy-Current-Amendment ;
    fhir:reference [ fhir:v "ResearchStudy/Exemplar-ResearchStudy-Current-Amendment" ]     ]
      ] ) ; #
      fhir:status [ fhir:v "active"] ; #
      fhir:phase [
        ( fhir:coding [
    fhir:system [
    fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
    fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>       ] ;
    fhir:code [ fhir:v "C15602" ] ;
    fhir:display [ fhir:v "Phase III Trial" ]     ] )
      ] ; #
      fhir:focus ( [
    fhir:reference [
    fhir:l fhir:MedicinalProductDefinition/Exemplar-MedicinalProduct ;
    fhir:reference [ fhir:v "MedicinalProductDefinition/Exemplar-MedicinalProduct" ]     ]
      ] ) ; #
      fhir:condition ( [
        ( fhir:coding [
    a sct:1137328006 ;
    fhir:system [
    fhir:v "http://snomed.info/sct"^^xsd:anyURI ;
    fhir:l <http://snomed.info/sct>       ] ;
    fhir:code [ fhir:v "1137328006" ] ;
    fhir:display [ fhir:v "Iatrogenic hypoglycaemia" ]     ] )
      ] ) ; #
      fhir:associatedParty ( [
    fhir:role [
          ( fhir:coding [
    fhir:system [
    fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
    fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>         ] ;
    fhir:code [ fhir:v "C70793" ] ;
    fhir:display [ fhir:v "Clinical Study Sponsor" ]       ] )     ] ;
    fhir:party [
    fhir:l fhir:Organization/Exemplar-Sponsor-Organization ;
    fhir:reference [ fhir:v "Organization/Exemplar-Sponsor-Organization" ]     ]
      ] [
    fhir:role [
          ( fhir:coding [
    fhir:system [
    fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
    fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>         ] ;
    fhir:code [ fhir:v "C70793" ] ;
    fhir:display [ fhir:v "Clinical Study Sponsor" ]       ] )     ] ;
    fhir:party [
    fhir:l fhir:Practitioner/Exemplar-Sponsor-Practitioner ;
    fhir:reference [ fhir:v "Practitioner/Exemplar-Sponsor-Practitioner" ]     ]
      ] [
    fhir:role [
          ( fhir:coding [
    fhir:system [
    fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
    fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>         ] ;
    fhir:code [ fhir:v "C215669" ] ;
    fhir:display [ fhir:v "Study Co-Sponsor" ]       ] )     ] ;
    fhir:party [
    fhir:l fhir:Organization/Exemplar-CoSponsor-Organization ;
    fhir:reference [ fhir:v "Organization/Exemplar-CoSponsor-Organization" ]     ]
      ] [
    fhir:role [
          ( fhir:coding [
    fhir:system [
    fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
    fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>         ] ;
    fhir:code [ fhir:v "C215669" ] ;
    fhir:display [ fhir:v "Study Co-Sponsor" ]       ] )     ] ;
    fhir:party [
    fhir:l fhir:Practitioner/Exemplar-CoSponsor-Practitioner ;
    fhir:reference [ fhir:v "Practitioner/Exemplar-CoSponsor-Practitioner" ]     ]
      ] [
    fhir:role [
          ( fhir:coding [
    fhir:system [
    fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
    fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>         ] ;
    fhir:code [ fhir:v "C215670" ] ;
    fhir:display [ fhir:v "Local Legal Sponsor" ]       ] )     ] ;
    fhir:party [
    fhir:l fhir:Organization/Exemplar-Local-Sponsor-Organization ;
    fhir:reference [ fhir:v "Organization/Exemplar-Local-Sponsor-Organization" ]     ]
      ] [
    fhir:role [
          ( fhir:coding [
    fhir:system [
    fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
    fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>         ] ;
    fhir:code [ fhir:v "C215670" ] ;
    fhir:display [ fhir:v "Local Legal Sponsor" ]       ] )     ] ;
    fhir:party [
    fhir:l fhir:Practitioner/Exemplar-Local-Sponsor-Practitioner ;
    fhir:reference [ fhir:v "Practitioner/Exemplar-Local-Sponsor-Practitioner" ]     ]
      ] [
    fhir:role [
          ( fhir:coding [
    fhir:system [
    fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
    fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>         ] ;
    fhir:code [ fhir:v "C156625" ] ;
    fhir:display [ fhir:v "Device Manufacturer" ]       ] )     ] ;
    fhir:party [
    fhir:l fhir:Organization/Exemplar-Devices-Organization ;
    fhir:reference [ fhir:v "Organization/Exemplar-Devices-Organization" ]     ]
      ] [
    fhir:role [
          ( fhir:coding [
    fhir:system [
    fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
    fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>         ] ;
    fhir:code [ fhir:v "C51876" ] ;
    fhir:display [ fhir:v "Sponsor Medical Expert" ]       ] )     ] ;
    fhir:party [
    fhir:l fhir:Practitioner/Exemplar-Sponsor-Expert-Practitioner ;
    fhir:reference [ fhir:v "Practitioner/Exemplar-Sponsor-Expert-Practitioner" ]     ]
      ] ) . #