R6 Ballot (1st Draft)
AdministrationThis page is part of the FHIR Specification v6.0.0-ballot1: Release 6 Ballot (1st Draft) (see Ballot Notes). The current version is 5.0.0. For a full list of available versions, see the Directory of published versions 
| Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative | Compartments: No defined compartments |
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ClinicalTrials.gov Study Record
{
"resourceType" : "ResearchStudy",
"id" : "example-ctgov-study-record",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ResearchStudy</b><a name=\"example-ctgov-study-record\"> </a></p><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\">Resource ResearchStudy "example-ctgov-study-record" </p></div><p><b>url</b>: <a href=\"https://fevir.net/resources/ResearchStudy/112103\">https://fevir.net/resources/ResearchStudy/112103</a></p><p><b>identifier</b>: FEvIR Object Identifier:\u00a0112103, id:\u00a0NCT05503693\u00a0(use:\u00a0OFFICIAL), id:\u00a0AP303-PK-01</p><p><b>name</b>: NCT05503693_FHIR_Transform</p><p><b>title</b>: A Safety, Tolerability, and Pharmacokinetics Study of AP303 in Healthy Subjects</p><h3>Labels</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Value</b></td></tr><tr><td style=\"display: none\">*</td><td>Official Title <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td>A Single-center Randomized Double-blind Placebo-controlled Study to Investigate the Safety Tolerability and PK of SAD and MAD of AP303 Following Oral Administration and the Effect of Food on the PK of AP303 in Healthy Subjects</td></tr></table><blockquote><p><b>relatedArtifact</b></p><p><b>type</b>: transforms</p><blockquote><p><b>document</b></p></blockquote></blockquote><blockquote><p><b>relatedArtifact</b></p><p><b>type</b>: transformed-with</p><p><b>display</b>: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter</p><blockquote><p><b>document</b></p></blockquote></blockquote><p><b>status</b>: active</p><p><b>primaryPurposeType</b>: Treatment <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.4.0/CodeSystem-research-study-prim-purp-type.html\">ResearchStudyPrimaryPurposeType</a>#treatment)</span></p><p><b>phase</b>: Phase 1 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.4.0/CodeSystem-research-study-phase.html\">ResearchStudyPhase</a>#phase-1)</span></p><p><b>studyDesign</b>: Design Masking: Quadruple <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span>, Design Who Masked: Participant <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span>, Design Who Masked: Care Provider <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span>, Design Who Masked: Investigator <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span>, Design Who Masked: Outcomes Assessor <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span>, Design Allocation: Randomized <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span>, Design Intervention Model: Sequential Assignment <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span>, CT.gov StudyType: INTERVENTIONAL <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>condition</b>: Healthy Subjects <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>keyword</b>: Safety, Tolerability, Pharmacokinetics, AP303, Healthy Subjects <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>descriptionSummary</b>: 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.</p><p><b>description</b>: 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.</p><p><b>site</b>: <a name=\"NCT05503693-Location-0-ResearchStudy\"> </a></p><blockquote><p/><p><a name=\"NCT05503693-Location-0-ResearchStudy\"> </a></p><p><b>partOf</b>: <a href=\"#\">#</a></p><p><b>status</b>: active</p><p><b>site</b>: <a href=\"#NCT05503693-Location-0\">#NCT05503693-Location-0</a></p><h3>ProgressStatuses</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>State</b></td></tr><tr><td style=\"display: none\">*</td><td>Recruiting <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"codesystem-research-study-status.html\">Research Study Status</a>#recruiting)</span></td></tr></table></blockquote><p><b>classifier</b>: Has Results: False <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span>, Oversight Classifier: oversightHasDmc Yes <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span>, Oversight Classifier: isFdaRegulatedDrug No <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span>, Oversight Classifier: isFdaRegulatedDevice No <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><blockquote><p><b>associatedParty</b></p><p><b>name</b>: Alebund Pharmaceuticals</p><p><b>role</b>: Sponsor <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"codesystem-research-study-party-role.html\">Research Study Party Role</a>#sponsor)</span></p><p><b>classifier</b>: INDUSTRY <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>name</b>: Alebund Pty Ltd</p><p><b>role</b>: lead-sponsor <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"codesystem-research-study-party-role.html\">Research Study Party Role</a>#lead-sponsor)</span></p><p><b>classifier</b>: INDUSTRY <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>name</b>: Zhen LIU</p><p><b>role</b>: recruitment-contact <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"codesystem-research-study-party-role.html\">Research Study Party Role</a>#recruitment-contact)</span></p><p><b>classifier</b>: Contact <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>party</b>: <a name=\"NCT05503693-CentralContact-0\"> </a></p><blockquote><p/><p><a name=\"NCT05503693-CentralContact-0\"> </a></p><p><b>name</b>: Zhen LIU</p><p><b>telecom</b>: ph: 86 021-60836212, <a href=\"mailto:clinicaloperation@alebund.com\">clinicaloperation@alebund.com</a></p></blockquote></blockquote><blockquote><p><b>associatedParty</b></p><p><b>name</b>: Sam Francis, Doctor</p><p><b>role</b>: Principal Investigator <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>party</b>: <span>: Nucleus Network</span></p></blockquote><blockquote><p><b>progressStatus</b></p><p><b>state</b>: Recruiting <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"codesystem-research-study-status.html\">Research Study Status</a>#recruiting)</span></p></blockquote><blockquote><p><b>progressStatus</b></p><p><b>state</b>: Overall Study <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"codesystem-research-study-status.html\">Research Study Status</a>#overall-study)</span></p><p><b>actual</b>: false</p><p><b>period</b>: 2022-12-06 --> 2023-06</p></blockquote><h3>Recruitments</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>TargetNumber</b></td><td><b>Eligibility</b></td></tr><tr><td style=\"display: none\">*</td><td>62</td><td><a href=\"broken-link.html\">https://fevir.net/resources/EvidenceVariable/112075</a></td></tr></table><blockquote><p><b>comparisonGroup</b></p><p><b>linkId</b>: ap303</p><p><b>name</b>: AP303</p><p><b>type</b>: Experimental <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>description</b>: AP303</p><p><b>intendedExposure</b>: </p><ul><li><a name=\"NCT05503693-drug------ap303-50-g\"> </a></li><li><a name=\"NCT05503693-drug------ap303-150-g\"> </a></li><li><a name=\"NCT05503693-drug------ap303-300-g\"> </a></li><li><a name=\"NCT05503693-drug------ap303-600-g\"> </a></li></ul><blockquote><p/><p><a name=\"NCT05503693-drug------ap303-50-g\"> </a></p><p><b>name</b>: NCT05503693_drug______ap303_50_g</p><p><b>title</b>: AP303 50 μg</p><p><b>status</b>: active</p><p><b>description</b>: AP303 tablet</p><h3>UseContexts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Intervention Type for CT.gov (Details: https://clinicaltrials.gov code interventionType = 'interventionType', stated as 'Intervention Type for CT.gov')</td><td>DRUG <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"NCT05503693-drug------ap303-150-g\"> </a></p><p><b>name</b>: NCT05503693_drug______ap303_150_g</p><p><b>title</b>: AP303 150 μg</p><p><b>status</b>: active</p><p><b>description</b>: AP303 tablet</p><h3>UseContexts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Intervention Type for CT.gov (Details: https://clinicaltrials.gov code interventionType = 'interventionType', stated as 'Intervention Type for CT.gov')</td><td>DRUG <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"NCT05503693-drug------ap303-300-g\"> </a></p><p><b>name</b>: NCT05503693_drug______ap303_300_g</p><p><b>title</b>: AP303 300 μg</p><p><b>status</b>: active</p><p><b>description</b>: AP303 tablet</p><h3>UseContexts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Intervention Type for CT.gov (Details: https://clinicaltrials.gov code interventionType = 'interventionType', stated as 'Intervention Type for CT.gov')</td><td>DRUG <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"NCT05503693-drug------ap303-600-g\"> </a></p><p><b>name</b>: NCT05503693_drug______ap303_600_g</p><p><b>title</b>: AP303 600 μg</p><p><b>status</b>: active</p><p><b>description</b>: AP303 tablet</p><h3>UseContexts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Intervention Type for CT.gov (Details: https://clinicaltrials.gov code interventionType = 'interventionType', stated as 'Intervention Type for CT.gov')</td><td>DRUG <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote></blockquote><blockquote><p><b>comparisonGroup</b></p><p><b>linkId</b>: placebo</p><p><b>name</b>: Placebo</p><p><b>type</b>: Placebo Comparator <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>description</b>: Placebo</p><p><b>intendedExposure</b>: </p><ul><li><a name=\"NCT05503693-drug------placebo-50-g\"> </a></li><li><a name=\"NCT05503693-drug------placebo-150-g\"> </a></li><li><a name=\"NCT05503693-drug------placebo-300-g\"> </a></li><li><a name=\"NCT05503693-drug------placebo-600-g\"> </a></li></ul><blockquote><p/><p><a name=\"NCT05503693-drug------placebo-50-g\"> </a></p><p><b>name</b>: NCT05503693_drug______placebo_50_g</p><p><b>title</b>: Placebo 50 μg</p><p><b>status</b>: active</p><p><b>description</b>: Placebo tablet</p><h3>UseContexts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Intervention Type for CT.gov (Details: https://clinicaltrials.gov code interventionType = 'interventionType', stated as 'Intervention Type for CT.gov')</td><td>DRUG <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"NCT05503693-drug------placebo-150-g\"> </a></p><p><b>name</b>: NCT05503693_drug______placebo_150_g</p><p><b>title</b>: Placebo 150 μg</p><p><b>status</b>: active</p><p><b>description</b>: Placebo tablet</p><h3>UseContexts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Intervention Type for CT.gov (Details: https://clinicaltrials.gov code interventionType = 'interventionType', stated as 'Intervention Type for CT.gov')</td><td>DRUG <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"NCT05503693-drug------placebo-300-g\"> </a></p><p><b>name</b>: NCT05503693_drug______placebo_300_g</p><p><b>title</b>: Placebo 300 μg</p><p><b>status</b>: active</p><p><b>description</b>: Placebo tablet</p><h3>UseContexts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Intervention Type for CT.gov (Details: https://clinicaltrials.gov code interventionType = 'interventionType', stated as 'Intervention Type for CT.gov')</td><td>DRUG <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"NCT05503693-drug------placebo-600-g\"> </a></p><p><b>name</b>: NCT05503693_drug______placebo_600_g</p><p><b>title</b>: Placebo 600 μg</p><p><b>status</b>: active</p><p><b>description</b>: Placebo tablet</p><h3>UseContexts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Intervention Type for CT.gov (Details: https://clinicaltrials.gov code interventionType = 'interventionType', stated as 'Intervention Type for CT.gov')</td><td>DRUG <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Single Dose and Food Effect Safety Outcome Measures</p><p><b>type</b>: Primary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#primary)</span></p><p><b>description</b>: Incidence and severity of adverse events (AEs), laboratory, ECG, and vital sign changes</p><p><b>reference</b>: <span>FEvIR Linking Identifier:\u00a0NCT05503693-primaryOutcome-0</span></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Multiple Dose Safety Outcome Measures</p><p><b>type</b>: Primary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#primary)</span></p><p><b>description</b>: Incidence and severity of AEs, laboratory, ECG, and vital sign changes.</p><p><b>reference</b>: <span>FEvIR Linking Identifier:\u00a0NCT05503693-primaryOutcome-1</span></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Cmax after single dose</p><p><b>type</b>: Primary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#primary)</span></p><p><b>description</b>: PK characteristics after single dose</p><p><b>reference</b>: <span>FEvIR Linking Identifier:\u00a0NCT05503693-primaryOutcome-2</span></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Tmax after single dose</p><p><b>type</b>: Primary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#primary)</span></p><p><b>description</b>: PK characteristics after single dose</p><p><b>reference</b>: <span>FEvIR Linking Identifier:\u00a0NCT05503693-primaryOutcome-3</span></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: AUC0-last after single dose</p><p><b>type</b>: Primary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#primary)</span></p><p><b>description</b>: PK characteristics after single dose</p><p><b>reference</b>: <span>FEvIR Linking Identifier:\u00a0NCT05503693-primaryOutcome-4</span></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: AUC0-inf after single dose</p><p><b>type</b>: Primary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#primary)</span></p><p><b>description</b>: PK characteristics after single dose</p><p><b>reference</b>: <span>FEvIR Linking Identifier:\u00a0NCT05503693-primaryOutcome-5</span></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: t1/2 after single dose</p><p><b>type</b>: Primary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#primary)</span></p><p><b>description</b>: PK characteristics after single dose</p><p><b>reference</b>: <span>FEvIR Linking Identifier:\u00a0NCT05503693-primaryOutcome-6</span></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: CL/F after single dose</p><p><b>type</b>: Primary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#primary)</span></p><p><b>description</b>: PK characteristics after single dose</p><p><b>reference</b>: <span>FEvIR Linking Identifier:\u00a0NCT05503693-primaryOutcome-7</span></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Ae and CLR (if warranted) after single dose</p><p><b>type</b>: Primary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#primary)</span></p><p><b>description</b>: PK characteristics after single dose</p><p><b>reference</b>: <span>FEvIR Linking Identifier:\u00a0NCT05503693-primaryOutcome-8</span></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: V/F after single dose</p><p><b>type</b>: Primary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#primary)</span></p><p><b>description</b>: PK characteristics after single dose</p><p><b>reference</b>: <span>FEvIR Linking Identifier:\u00a0NCT05503693-primaryOutcome-9</span></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Cmax after multiple dose</p><p><b>type</b>: Primary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#primary)</span></p><p><b>description</b>: PK characteristics after multiple dose</p><p><b>reference</b>: <span>FEvIR Linking Identifier:\u00a0NCT05503693-primaryOutcome-10</span></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Tmax after multiple dose</p><p><b>type</b>: Primary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#primary)</span></p><p><b>description</b>: PK characteristics after multiple dose</p><p><b>reference</b>: <span>FEvIR Linking Identifier:\u00a0NCT05503693-primaryOutcome-11</span></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: AUC0-τ after multiple dose</p><p><b>type</b>: Primary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#primary)</span></p><p><b>description</b>: PK characteristics after multiple dose</p><p><b>reference</b>: <span>FEvIR Linking Identifier:\u00a0NCT05503693-primaryOutcome-12</span></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Cav after multiple dose</p><p><b>type</b>: Primary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#primary)</span></p><p><b>description</b>: PK characteristics after multiple dose</p><p><b>reference</b>: <span>FEvIR Linking Identifier:\u00a0NCT05503693-primaryOutcome-13</span></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: t1/2 after multiple dose</p><p><b>type</b>: Primary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#primary)</span></p><p><b>description</b>: PK characteristics after multiple dose</p><p><b>reference</b>: <span>FEvIR Linking Identifier:\u00a0NCT05503693-primaryOutcome-14</span></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Rac after multiple dose</p><p><b>type</b>: Primary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#primary)</span></p><p><b>description</b>: PK characteristics after multiple dose</p><p><b>reference</b>: <span>FEvIR Linking Identifier:\u00a0NCT05503693-primaryOutcome-15</span></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Ae and CLR (if warranted) after multiple dose</p><p><b>type</b>: Primary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#primary)</span></p><p><b>description</b>: PK characteristics after multiple dose</p><p><b>reference</b>: <span>FEvIR Linking Identifier:\u00a0NCT05503693-primaryOutcome-16</span></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: V/F after multiple dose</p><p><b>type</b>: Primary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#primary)</span></p><p><b>description</b>: PK characteristics after multiple dose</p><p><b>reference</b>: <span>FEvIR Linking Identifier:\u00a0NCT05503693-primaryOutcome-17</span></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Ctrough after multiple dose</p><p><b>type</b>: Primary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#primary)</span></p><p><b>description</b>: PK characteristics after multiple dose</p><p><b>reference</b>: <span>FEvIR Linking Identifier:\u00a0NCT05503693-primaryOutcome-18</span></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Effect of Food on the single dose Cmax</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p><p><b>description</b>: Effect of food on the single dose PK</p><p><b>reference</b>: <span>FEvIR Linking Identifier:\u00a0NCT05503693-secondaryOutcome-0</span></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Effect of Food on the single dose Tmax</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p><p><b>description</b>: Effect of food on the single dose PK</p><p><b>reference</b>: <span>FEvIR Linking Identifier:\u00a0NCT05503693-secondaryOutcome-1</span></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Effect of Food on the single dose AUC0-last</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p><p><b>description</b>: Effect of food on the single dose PK</p><p><b>reference</b>: <span>FEvIR Linking Identifier:\u00a0NCT05503693-secondaryOutcome-2</span></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Effect of Food on the single dose AUC0-inf</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p><p><b>description</b>: Effect of food on the single dose PK</p><p><b>reference</b>: <span>FEvIR Linking Identifier:\u00a0NCT05503693-secondaryOutcome-3</span></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Effect of Food on the single dose t1/2</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p><p><b>description</b>: Effect of food on the single dose PK</p><p><b>reference</b>: <span>FEvIR Linking Identifier:\u00a0NCT05503693-secondaryOutcome-4</span></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Effect of Food on the single dose CL/F</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p><p><b>description</b>: Effect of food on the single dose PK</p><p><b>reference</b>: <span>FEvIR Linking Identifier:\u00a0NCT05503693-secondaryOutcome-5</span></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Effect of Food on the single dose Ae and CLR (if warranted)</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p><p><b>description</b>: Effect of food on the single dose PK</p><p><b>reference</b>: <span>FEvIR Linking Identifier:\u00a0NCT05503693-secondaryOutcome-6</span></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Effect of Food on the single dose V/F</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p><p><b>description</b>: Effect of food on the single dose PK</p><p><b>reference</b>: <span>FEvIR Linking Identifier:\u00a0NCT05503693-secondaryOutcome-7</span></p></blockquote></div>"
},
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{
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},
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},
{
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"reference" : {
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT05503693-primaryOutcome-2",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}
}
},
{
"name" : "Tmax 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",
"reference" : {
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT05503693-primaryOutcome-3",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}
}
},
{
"name" : "AUC0-last 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",
"reference" : {
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT05503693-primaryOutcome-4",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}
}
},
{
"name" : "AUC0-inf 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",
"reference" : {
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT05503693-primaryOutcome-5",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}
}
},
{
"name" : "t1/2 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",
"reference" : {
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT05503693-primaryOutcome-6",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}
}
},
{
"name" : "CL/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",
"reference" : {
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT05503693-primaryOutcome-7",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}
}
},
{
"name" : "Ae and CLR (if warranted) 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",
"reference" : {
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"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",
"reference" : {
"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",
"reference" : {
"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",
"reference" : {
"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",
"reference" : {
"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",
"reference" : {
"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",
"reference" : {
"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",
"reference" : {
"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",
"reference" : {
"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",
"reference" : {
"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",
"reference" : {
"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",
"reference" : {
"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",
"reference" : {
"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",
"reference" : {
"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",
"reference" : {
"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",
"reference" : {
"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",
"reference" : {
"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",
"reference" : {
"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",
"reference" : {
"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-ballot1 generated on Mon, Dec 18, 2023 15:18+1100.
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