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  "type" : "transaction",
  "timestamp" : "2025-12-04T12:00:00+00:00",
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        "profile" : ["https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-dokument"],
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          "code" : "HTEST",
          "display" : "test health data"
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      },
      "language" : "en",
      "text" : {
        "status" : "generated"
      },
      "status" : "current",
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      "custodian" : {
        "reference" : "Organization/mii-exa-studie-custodian"
      },
      "content" : [{
        "attachment" : {
          "contentType" : "application/pdf",
          "url" : "https://example.com/fhir/Binary/document",
          "size" : 2000,
          "title" : "Beispiel Dokument"
        }
      }],
      "context" : {
        "related" : [{
          "reference" : "ResearchStudy/mii-exa-studie-cohort"
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    },
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      "method" : "POST",
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      "meta" : {
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      "language" : "en",
      "text" : {
        "status" : "extensions"
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      "status" : "active",
      "characteristic" : [{
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            "reference" : "EvidenceVariable/mii-exa-studie-evidence-variable-age-restriction"
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        }],
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        "definitionCodeableConcept" : {
          "text" : "Altersbeschränkung"
        }
      },
      {
        "extension" : [{
          "url" : "http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.definitionCanonical",
          "valueCanonical" : "https://www.medizininformatik-initiative.de/fhir/EvidenceVariable/administrative-gender"
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        "description" : "Geschlecht",
        "definitionCodeableConcept" : {
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        },
        "exclude" : false
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            "system" : "http://terminology.hl7.org/CodeSystem/data-absent-reason",
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      },
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        "extension" : [{
          "url" : "http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.linkId",
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        "definitionCodeableConcept" : {
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/data-absent-reason",
            "code" : "unknown"
          }]
        },
        "exclude" : false
      },
      {
        "extension" : [{
          "extension" : [{
            "url" : "code",
            "valueCode" : "any-of"
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            "url" : "characteristic",
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          {
            "url" : "characteristic",
            "valueId" : "8e8f63ff-65f1-40cd-bf79-da83d7fb4e09"
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          "url" : "http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.definitionByCombination"
        }],
        "description" : "Weitere Einschlusskriterien",
        "definitionCodeableConcept" : {
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/data-absent-reason",
            "code" : "unknown"
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        },
        "exclude" : false
      },
      {
        "description" : "diagnostizierte Depressionen, Angststörungen, andere psychiatrische Erkrankungen",
        "definitionCodeableConcept" : {
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/data-absent-reason",
            "code" : "unknown"
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        },
        "exclude" : true
      },
      {
        "description" : "Einnahme von Antidepressiva, Opioiden, Antikonvulsiva",
        "definitionCodeableConcept" : {
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/data-absent-reason",
            "code" : "unknown"
          }]
        },
        "exclude" : true
      },
      {
        "description" : "weitere neurologische Erkrankungen",
        "definitionCodeableConcept" : {
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/data-absent-reason",
            "code" : "unknown"
          }]
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        "exclude" : true
      },
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        "extension" : [{
          "extension" : [{
            "url" : "type",
            "valueCodeableConcept" : {
              "coding" : [{
                "system" : "http://snomed.info/sct",
                "code" : "424144002",
                "display" : "Current chronological age"
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            }
          },
          {
            "url" : "value",
            "valueQuantity" : {
              "value" : 18,
              "comparator" : ">=",
              "unit" : "year",
              "system" : "http://unitsofmeasure.org",
              "code" : "a"
            }
          }],
          "url" : "http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.definitionByTypeAndValue"
        }],
        "description" : "Alter mindestens 18 Jahre",
        "definitionCodeableConcept" : {
          "text" : "Mindestalter"
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        "exclude" : false
      }]
    },
    "request" : {
      "method" : "POST",
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            "text" : "Öffentlicher Titel"
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        "url" : "http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label"
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        "url" : "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-akronym",
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          "url" : "rekrutierungsstart",
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        },
        {
          "url" : "rekrutierungsstand-datum",
          "valueDate" : "2023-02-17"
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        "url" : "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-rekrutierung"
      },
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        "url" : "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung",
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          "url" : "kommission",
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      "identifier" : [{
        "system" : "https://example.com/fhir/sid/drks",
        "value" : "DRKS00031294"
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        "text" : "Zufallszuteilung"
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        "name" : "frontale anodale tDCS  (verum condition)",
        "description" : "vier Stimulationen, jeweils 30 Minuten, 1.5mA über dem linken dlPFC"
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        "name" : "frontale sham tDCS",
        "description" : "vier Stimulationen, jeweils 30 Minuten"
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  },
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        "profile" : ["https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-studie"],
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          "display" : "test health data"
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      "language" : "en",
      "text" : {
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          "valueString" : "MII Modul Studie"
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        "url" : "http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label"
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        "extension" : [{
          "url" : "role",
          "valueCodeableConcept" : {
            "coding" : [{
              "system" : "http://example.org/fhir/CodeSystem/associated-party-role",
              "code" : "sponsor"
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          "url" : "party",
          "valueReference" : {
            "reference" : "Organization/mii-exa-studie-author"
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        "url" : "http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty"
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        "extension" : [{
          "url" : "status",
          "valueString" : "genehmigt"
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      },
      {
        "url" : "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-studienregister",
        "valueReference" : {
          "reference" : "Library/mii-exa-studie-register"
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      },
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        "url" : "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-eligibility",
        "valueReference" : {
          "reference" : "EvidenceVariable/mii-exa-studie-ein-auschluss-kriterium"
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        "url" : "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-akronym",
        "valueString" : "LIFE ADULT"
      },
      {
        "extension" : [{
          "url" : "rekrutierungsstart",
          "valueDate" : "2009-01-01"
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        {
          "url" : "rekrutierungsziel",
          "valueInteger" : 10000
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        {
          "url" : "rekrutierungsstand",
          "valueInteger" : 10000
        },
        {
          "url" : "rekrutierungsstand-genauigkeit",
          "valueString" : "good"
        },
        {
          "url" : "rekrutierungsstand-datum",
          "valueDate" : "2022-05-28"
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        "url" : "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-rekrutierung"
      },
      {
        "url" : "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung",
        "valueString" : "Deutsches Bundesministerium für Bildung und Forschung (BMBF)"
      }],
      "identifier" : [{
        "system" : "https://example.com/fhir/sid/lha",
        "value" : "7Q6PJD8NV3-2"
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      "title" : "LIFE-Adult-Study",
      "partOf" : [{
        "reference" : "ResearchStudy/mii-exa-studie-reference-study"
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      "category" : [{
        "coding" : [{
          "system" : "http://example.org/fhir/CodeSystem/research-study-category",
          "code" : "observational"
        }]
      }],
      "focus" : [{
        "text" : "Erwachsene der Stadt Leipzig"
      }],
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        "text" : "Bevölkerung, Leipzig, Erwachsene"
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      "arm" : [{
        "name" : "LIFE-Adult-Kohorte"
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    },
    "request" : {
      "method" : "POST",
      "url" : "MII_PR_Studie_Cohort"
    }
  },
  {
    "fullUrl" : "https://www.medizininformatik-initiative.de/MII_PR_Studie_Proband/mii-exa-studie-proband",
    "resource" : {
      "resourceType" : "ResearchSubject",
      "id" : "mii-exa-studie-proband",
      "meta" : {
        "profile" : ["https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-proband"],
        "security" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/v3-ActReason",
          "code" : "HTEST",
          "display" : "test health data"
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      },
      "language" : "en",
      "text" : {
        "status" : "generated"
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      "identifier" : [{
        "type" : {
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
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        },
        "system" : "https://www.medizininformatik-initiative.de/fhir/sid/patienten",
        "value" : "321123456"
      }],
      "status" : "candidate",
      "period" : {
        "start" : "2023-01-01",
        "end" : "2023-12-31"
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        "reference" : "ResearchStudy/mii-exa-studie-cohort"
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      "individual" : {
        "reference" : "Patient/mii-exa-studie-patient"
      },
      "consent" : {
        "reference" : "Consent/mii-exa-studie-consent"
      }
    },
    "request" : {
      "method" : "POST",
      "url" : "MII_PR_Studie_Proband"
    }
  },
  {
    "fullUrl" : "https://www.medizininformatik-initiative.de/MII_PR_Studie_Beteiligte_Person/mii-exa-studie-beteiligte-person",
    "resource" : {
      "resourceType" : "PractitionerRole",
      "id" : "mii-exa-studie-beteiligte-person",
      "meta" : {
        "profile" : ["https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-beteiligte-person"],
        "security" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/v3-ActReason",
          "code" : "HTEST",
          "display" : "test health data"
        }]
      },
      "language" : "en",
      "text" : {
        "status" : "generated"
      },
      "practitioner" : {
        "reference" : "Practitioner/mii-exa-studie-practitioner"
      },
      "organization" : {
        "reference" : "Organization/mii-exa-studie-practitioner-organization"
      },
      "code" : [{
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/practitioner-role",
          "code" : "doctor"
        }]
      }],
      "telecom" : [{
        "system" : "phone",
        "value" : "0123456789"
      }]
    },
    "request" : {
      "method" : "POST",
      "url" : "MII_PR_Studie_Beteiligte_Person"
    }
  },
  {
    "fullUrl" : "https://www.medizininformatik-initiative.de/MII_PR_Studie_Register/mii-exa-studie-register",
    "resource" : {
      "resourceType" : "Library",
      "id" : "mii-exa-studie-register",
      "meta" : {
        "profile" : ["https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-register"],
        "security" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/v3-ActReason",
          "code" : "HTEST",
          "display" : "test health data"
        }]
      },
      "language" : "en",
      "text" : {
        "status" : "extensions",
        "div" : "<div xml:lang=\"de\" lang=\"de\"><hr/><p><b>German</b></p><hr/><a name=\"Library_mii-exa-studie-register\"> </a><p><b style=\"color: maroon\">Exception parsing generated Narrative (see /tmp/liquid-5a2d0579-448d-44ee-8a2c-6f4b5b9ff49b.html): unexpected non-end of element null::a  at line 105 column 50</b></p></div>"
      },
      "identifier" : [{
        "system" : "https://example.com/fhir/sid/drks",
        "value" : "DRKS"
      }],
      "name" : "DRKS - Deutsches Register Klinischer Studien",
      "status" : "active",
      "type" : {
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/library-type",
          "code" : "asset-collection"
        }]
      },
      "relatedArtifact" : [{
        "type" : "documentation",
        "url" : "https://drks.de/",
        "document" : {
          "url" : "https://drks.de/"
        }
      }]
    },
    "request" : {
      "method" : "POST",
      "url" : "MII_PR_Studie_Register"
    }
  },
  {
    "fullUrl" : "https://www.medizininformatik-initiative.de/Organization/mii-exa-studie-author",
    "resource" : {
      "resourceType" : "Organization",
      "id" : "mii-exa-studie-author",
      "meta" : {
        "security" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/v3-ActReason",
          "code" : "HTEST",
          "display" : "test health data"
        }]
      },
      "language" : "en",
      "text" : {
        "status" : "generated"
      },
      "name" : "Example Organization for Author"
    },
    "request" : {
      "method" : "POST",
      "url" : "Organization"
    }
  },
  {
    "fullUrl" : "https://www.medizininformatik-initiative.de/Organization/mii-exa-studie-custodian",
    "resource" : {
      "resourceType" : "Organization",
      "id" : "mii-exa-studie-custodian",
      "meta" : {
        "security" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/v3-ActReason",
          "code" : "HTEST",
          "display" : "test health data"
        }]
      },
      "language" : "en",
      "text" : {
        "status" : "generated"
      },
      "name" : "Example Organization for Custodian"
    },
    "request" : {
      "method" : "POST",
      "url" : "Organization"
    }
  },
  {
    "fullUrl" : "https://www.medizininformatik-initiative.de/Organization/mii-exa-studie-practitioner-organization",
    "resource" : {
      "resourceType" : "Organization",
      "id" : "mii-exa-studie-practitioner-organization",
      "meta" : {
        "security" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/v3-ActReason",
          "code" : "HTEST",
          "display" : "test health data"
        }]
      },
      "language" : "en",
      "text" : {
        "status" : "generated"
      },
      "name" : "Example Organization for Practitioner"
    },
    "request" : {
      "method" : "POST",
      "url" : "Organization"
    }
  },
  {
    "fullUrl" : "https://www.medizininformatik-initiative.de/Practitioner/mii-exa-studie-practitioner",
    "resource" : {
      "resourceType" : "Practitioner",
      "id" : "mii-exa-studie-practitioner",
      "meta" : {
        "security" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/v3-ActReason",
          "code" : "HTEST",
          "display" : "test health data"
        }]
      },
      "language" : "en",
      "text" : {
        "status" : "generated"
      },
      "name" : [{
        "family" : "Mustermann",
        "given" : ["Max"]
      }]
    },
    "request" : {
      "method" : "POST",
      "url" : "Practitioner"
    }
  },
  {
    "fullUrl" : "https://www.medizininformatik-initiative.de/ResearchStudy/mii-exa-studie-reference-study",
    "resource" : {
      "resourceType" : "ResearchStudy",
      "id" : "mii-exa-studie-reference-study",
      "meta" : {
        "security" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/v3-ActReason",
          "code" : "HTEST",
          "display" : "test health data"
        }]
      },
      "language" : "en",
      "text" : {
        "status" : "generated"
      },
      "title" : "Example Reference Study",
      "status" : "completed"
    },
    "request" : {
      "method" : "POST",
      "url" : "ResearchStudy"
    }
  },
  {
    "fullUrl" : "https://www.medizininformatik-initiative.de/Patient/mii-exa-studie-patient",
    "resource" : {
      "resourceType" : "Patient",
      "id" : "mii-exa-studie-patient",
      "meta" : {
        "profile" : ["http://fhir.de/ConsentManagement/StructureDefinition/Patient"],
        "security" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/v3-ActReason",
          "code" : "HTEST",
          "display" : "test health data"
        }]
      },
      "language" : "en",
      "text" : {
        "status" : "generated"
      },
      "identifier" : [{
        "use" : "official",
        "type" : {
          "coding" : [{
            "system" : "http://fhir.de/CodeSystem/identifier-type-de-basis",
            "code" : "KVZ10"
          }]
        },
        "system" : "http://fhir.de/sid/gkv/kvid-10",
        "value" : "D92345678"
      }],
      "name" : [{
        "family" : "Doe",
        "given" : ["Jane"]
      }],
      "gender" : "female",
      "birthDate" : "1980-11-12",
      "deceasedBoolean" : false
    },
    "request" : {
      "method" : "POST",
      "url" : "Patient"
    }
  },
  {
    "fullUrl" : "https://www.medizininformatik-initiative.de/Consent/mii-exa-studie-consent",
    "resource" : {
      "resourceType" : "Consent",
      "id" : "mii-exa-studie-consent",
      "meta" : {
        "security" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/v3-ActReason",
          "code" : "HTEST",
          "display" : "test health data"
        }]
      },
      "language" : "en",
      "text" : {
        "status" : "generated"
      },
      "status" : "active",
      "scope" : {
        "coding" : [{
          "code" : "research"
        }]
      },
      "category" : [{
        "coding" : [{
          "system" : "http://loinc.org",
          "code" : "59284-0"
        }]
      }],
      "patient" : {
        "reference" : "Patient/mii-exa-studie-patient"
      },
      "policy" : [{
        "uri" : "urn:oid:2.16.840.1.113883.3.1937.777.24.2.1791"
      }]
    },
    "request" : {
      "method" : "POST",
      "url" : "Consent"
    }
  }]
}