FHIR CI-Build
AdministrationThis is the Continuous Integration Build of FHIR (will be incorrect/inconsistent at times).
See the Directory of published versions
| Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative | Compartments: No defined compartments |
Raw JSON (canonical form + also see JSON Format Specification)
ClinicalTrials.gov Study Record
{
"resourceType" : "ResearchStudy",
"id" : "example-ctgov-study-record",
"contained" : [{
"resourceType" : "EvidenceVariable",
"id" : "NCT05503693-drug------ap303-50-g",
"name" : "NCT05503693_drug______ap303_50_g",
"title" : "AP303 50 μg",
"status" : "active",
"description" : "AP303 tablet",
"useContext" : [{
"code" : {
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"code" : "interventionType",
"display" : "Intervention Type for ClinicalTrials.gov"
},
"valueCodeableConcept" : {
"text" : "DRUG"
}
}]
},
{
"resourceType" : "EvidenceVariable",
"id" : "NCT05503693-drug------ap303-150-g",
"name" : "NCT05503693_drug______ap303_150_g",
"title" : "AP303 150 μg",
"status" : "active",
"description" : "AP303 tablet",
"useContext" : [{
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"display" : "Intervention Type for ClinicalTrials.gov"
},
"valueCodeableConcept" : {
"text" : "DRUG"
}
}]
},
{
"resourceType" : "EvidenceVariable",
"id" : "NCT05503693-drug------ap303-300-g",
"name" : "NCT05503693_drug______ap303_300_g",
"title" : "AP303 300 μg",
"status" : "active",
"description" : "AP303 tablet",
"useContext" : [{
"code" : {
"system" : "https://clinicaltrials.gov/data-about-studies/study-data-structure#enum-InterventionType",
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"display" : "Intervention Type for ClinicalTrials.gov"
},
"valueCodeableConcept" : {
"text" : "DRUG"
}
}]
},
{
"resourceType" : "EvidenceVariable",
"id" : "NCT05503693-drug------ap303-600-g",
"name" : "NCT05503693_drug______ap303_600_g",
"title" : "AP303 600 μg",
"status" : "active",
"description" : "AP303 tablet",
"useContext" : [{
"code" : {
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"display" : "Intervention Type for ClinicalTrials.gov"
},
"valueCodeableConcept" : {
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}]
},
{
"resourceType" : "EvidenceVariable",
"id" : "NCT05503693-drug------placebo-50-g",
"name" : "NCT05503693_drug______placebo_50_g",
"title" : "Placebo 50 μg",
"status" : "active",
"description" : "Placebo tablet",
"useContext" : [{
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},
"valueCodeableConcept" : {
"text" : "DRUG"
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}]
},
{
"resourceType" : "EvidenceVariable",
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"name" : "NCT05503693_drug______placebo_150_g",
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{
"resourceType" : "EvidenceVariable",
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"status" : "active",
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},
{
"resourceType" : "EvidenceVariable",
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},
{
"resourceType" : "Group",
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"identifier" : [{
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},
"system" : "https://fevir.net/FLI",
"value" : "NCT05503693-comparison-group-0",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}],
"title" : "NCT05503693 Comparison Group: AP303",
"status" : "active",
"description" : "AP303",
"useContext" : [{
"code" : {
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"membership" : "conceptual",
"combinationMethod" : "all-of",
"characteristic" : [{
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},
"valueReference" : {
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"type" : "EvidenceVariable",
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"exclude" : false
},
{
"code" : {
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{
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},
{
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"assigner" : {
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}
}],
"title" : "NCT05503693 Comparison Group: Placebo",
"status" : "active",
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{
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}]
},
{
"resourceType" : "Location",
"id" : "NCT05503693-Location-0",
"name" : "Nucleus Network Pty Ltd",
"address" : {
"city" : "Melbourne",
"state" : "Victoria",
"postalCode" : "3004",
"country" : "Australia"
},
"position" : {
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"latitude" : -37.814
}
}],
"url" : "https://fevir.net/resources/ResearchStudy/112103",
"identifier" : [{
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},
"system" : "urn:ietf:rfc:3986",
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"assigner" : {
"display" : "Computable Publishing LLC"
}
},
{
"use" : "official",
"system" : "https://clinicaltrials.gov",
"value" : "NCT05503693"
},
{
"value" : "AP303-PK-01",
"assigner" : {
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}
}],
"name" : "NCT05503693_FHIR_Transform",
"title" : "A Safety, Tolerability, and Pharmacokinetics Study of AP303 in Healthy Subjects",
"label" : [{
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}],
"relatedArtifact" : [{
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},
{
"type" : "transformed-with",
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"primaryPurposeType" : {
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"studyDesign" : [{
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{
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{
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{
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{
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{
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{
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{
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{
"coding" : [{
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{
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{
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{
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{
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"condition" : [{
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"keyword" : [{
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"descriptionSummary" : "This is a single-center, randomized, double-blind, placebo-controlled, first-in-human study in which the safety, tolerability, and pharmacokinetics of orally administered AP303 will be assessed in healthy adult subjects.",
"description" : "The study will consist of 2 parts: Part A is a single ascending doses (SAD) phase enrolling a total of 4 cohorts of healthy subjects; Part B is a multiple ascending doses (MAD) phase enrolling 3 cohorts of healthy subjects. One cohort of Part A will receive AP303 under both fasted and fed conditions to investigate the effect of food.",
"site" : [{
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}],
"classifier" : [{
"text" : "Has Results: False"
},
{
"text" : "Oversight Classifier: oversightHasDmc True"
},
{
"text" : "Oversight Classifier: isFdaRegulatedDrug False"
},
{
"text" : "Oversight Classifier: isFdaRegulatedDevice False"
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},
{
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{
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},
"actual" : true,
"period" : {
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"end" : "2023-07-21"
}
}],
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}
}
},
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},
{
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"display" : "Placebo"
}
}],
"objective" : [{
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},
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{
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}
},
{
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},
{
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},
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}
}
},
{
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},
{
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},
{
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},
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"value" : "NCT05503693-primaryOutcome-6",
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},
{
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}
},
{
"name" : "Ae and CLR (if warranted) after single dose",
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},
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"identifier" : {
"type" : {
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},
"system" : "https://fevir.net/FLI",
"value" : "NCT05503693-primaryOutcome-8",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}
}
},
{
"name" : "V/F after single dose",
"type" : {
"coding" : [{
"system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
"code" : "primary",
"display" : "Primary"
}]
},
"description" : "PK characteristics after single dose",
"endpoint" : {
"reference" : "EvidenceVariable/112085",
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT05503693-primaryOutcome-9",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}
}
},
{
"name" : "Cmax after multiple dose",
"type" : {
"coding" : [{
"system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
"code" : "primary",
"display" : "Primary"
}]
},
"description" : "PK characteristics after multiple dose",
"endpoint" : {
"reference" : "EvidenceVariable/112086",
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT05503693-primaryOutcome-10",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}
}
},
{
"name" : "Tmax after multiple dose",
"type" : {
"coding" : [{
"system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
"code" : "primary",
"display" : "Primary"
}]
},
"description" : "PK characteristics after multiple dose",
"endpoint" : {
"reference" : "EvidenceVariable/112087",
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT05503693-primaryOutcome-11",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}
}
},
{
"name" : "AUC0-τ after multiple dose",
"type" : {
"coding" : [{
"system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
"code" : "primary",
"display" : "Primary"
}]
},
"description" : "PK characteristics after multiple dose",
"endpoint" : {
"reference" : "EvidenceVariable/112088",
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT05503693-primaryOutcome-12",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}
}
},
{
"name" : "Cav after multiple dose",
"type" : {
"coding" : [{
"system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
"code" : "primary",
"display" : "Primary"
}]
},
"description" : "PK characteristics after multiple dose",
"endpoint" : {
"reference" : "EvidenceVariable/112089",
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT05503693-primaryOutcome-13",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}
}
},
{
"name" : "t1/2 after multiple dose",
"type" : {
"coding" : [{
"system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
"code" : "primary",
"display" : "Primary"
}]
},
"description" : "PK characteristics after multiple dose",
"endpoint" : {
"reference" : "EvidenceVariable/112090",
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT05503693-primaryOutcome-14",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}
}
},
{
"name" : "Rac after multiple dose",
"type" : {
"coding" : [{
"system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
"code" : "primary",
"display" : "Primary"
}]
},
"description" : "PK characteristics after multiple dose",
"endpoint" : {
"reference" : "EvidenceVariable/112091",
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT05503693-primaryOutcome-15",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}
}
},
{
"name" : "Ae and CLR (if warranted) after multiple dose",
"type" : {
"coding" : [{
"system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
"code" : "primary",
"display" : "Primary"
}]
},
"description" : "PK characteristics after multiple dose",
"endpoint" : {
"reference" : "EvidenceVariable/112092",
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT05503693-primaryOutcome-16",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}
}
},
{
"name" : "V/F after multiple dose",
"type" : {
"coding" : [{
"system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
"code" : "primary",
"display" : "Primary"
}]
},
"description" : "PK characteristics after multiple dose",
"endpoint" : {
"reference" : "EvidenceVariable/112093",
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT05503693-primaryOutcome-17",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}
}
},
{
"name" : "Ctrough after multiple dose",
"type" : {
"coding" : [{
"system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
"code" : "primary",
"display" : "Primary"
}]
},
"description" : "PK characteristics after multiple dose",
"endpoint" : {
"reference" : "EvidenceVariable/112094",
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT05503693-primaryOutcome-18",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}
}
},
{
"name" : "Effect of Food on the single dose Cmax",
"type" : {
"coding" : [{
"system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
"code" : "secondary",
"display" : "Secondary"
}]
},
"description" : "Effect of food on the single dose PK",
"endpoint" : {
"reference" : "EvidenceVariable/112095",
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT05503693-secondaryOutcome-0",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}
}
},
{
"name" : "Effect of Food on the single dose Tmax",
"type" : {
"coding" : [{
"system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
"code" : "secondary",
"display" : "Secondary"
}]
},
"description" : "Effect of food on the single dose PK",
"endpoint" : {
"reference" : "EvidenceVariable/112096",
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT05503693-secondaryOutcome-1",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}
}
},
{
"name" : "Effect of Food on the single dose AUC0-last",
"type" : {
"coding" : [{
"system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
"code" : "secondary",
"display" : "Secondary"
}]
},
"description" : "Effect of food on the single dose PK",
"endpoint" : {
"reference" : "EvidenceVariable/112097",
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT05503693-secondaryOutcome-2",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}
}
},
{
"name" : "Effect of Food on the single dose AUC0-inf",
"type" : {
"coding" : [{
"system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
"code" : "secondary",
"display" : "Secondary"
}]
},
"description" : "Effect of food on the single dose PK",
"endpoint" : {
"reference" : "EvidenceVariable/112098",
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT05503693-secondaryOutcome-3",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}
}
},
{
"name" : "Effect of Food on the single dose t1/2",
"type" : {
"coding" : [{
"system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
"code" : "secondary",
"display" : "Secondary"
}]
},
"description" : "Effect of food on the single dose PK",
"endpoint" : {
"reference" : "EvidenceVariable/112099",
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT05503693-secondaryOutcome-4",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}
}
},
{
"name" : "Effect of Food on the single dose CL/F",
"type" : {
"coding" : [{
"system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
"code" : "secondary",
"display" : "Secondary"
}]
},
"description" : "Effect of food on the single dose PK",
"endpoint" : {
"reference" : "EvidenceVariable/112100",
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT05503693-secondaryOutcome-5",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}
}
},
{
"name" : "Effect of Food on the single dose Ae and CLR (if warranted)",
"type" : {
"coding" : [{
"system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
"code" : "secondary",
"display" : "Secondary"
}]
},
"description" : "Effect of food on the single dose PK",
"endpoint" : {
"reference" : "EvidenceVariable/112101",
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT05503693-secondaryOutcome-6",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}
}
},
{
"name" : "Effect of Food on the single dose V/F",
"type" : {
"coding" : [{
"system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
"code" : "secondary",
"display" : "Secondary"
}]
},
"description" : "Effect of food on the single dose PK",
"endpoint" : {
"reference" : "EvidenceVariable/112102",
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT05503693-secondaryOutcome-7",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}
}
}]
}]
}
Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.
FHIR ®© HL7.org 2011+. FHIR R6 hl7.fhir.core#6.0.0-ballot2 generated on Thu, Dec 12, 2024 19:29+0000.
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