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Trial registered on ANZCTR
Registration number
ACTRN12623001054606
Ethics application status
Approved
Date submitted
28/07/2023
Date registered
29/09/2023
Date last updated
30/10/2023
Date data sharing statement initially provided
29/09/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
To evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TX000045 (single ascending dose) in Healthy Volunteers
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Scientific title
A double-blind, randomized, placebo-controlled, single ascending dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of TX000045 in healthy participants
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Secondary ID [1]
310185
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TX000045-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cardiovascular
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Condition category
Condition code
Cardiovascular
327640
327640
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0
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Other cardiovascular diseases
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Respiratory
328162
328162
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
TX000045 is a biologic Fc-fusion relaxin therapeutic.
Investigational product : TX000045 or Matching placebo
Approximately 48 participants will be enrolled in this study.
Single ascending dose of TX000045 or Matching placebo will be administered to study participants via Intravenous infusion (IV) or subcutaneous (SC) injection in the proposed doses as mentioned below by the site staff. 6 participants will receive TX000045 and 2 participants will receive placebo. The infusion will be between 30 to 60 minutes.
• Cohort A: 0.3 mg/kg IV of TX000045 or matching placebo
• Cohort B: 1 mg/kg IV of TX000045 or matching placebo
• Cohort C: 300 mg SC of TX000045 or matching placebo; Cohort C may be dosed concurrently with Cohort B
• Cohort D: 3 mg/kg IV of TX000045 or matching placebo
• Cohort E: 600 mg SC of TX000045 or matching placebo; Cohort E may
be dosed concurrently with Cohort D
• Cohort F: 10 mg/kg IV of TX000045 or matching placebo
Adherence to the intervention will be monitored by study staff, CRO staff and Sponsor Staff.
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Intervention code [1]
326585
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Treatment: Drugs
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Comparator / control treatment
Placebo: Buffer identical to TX000045 active without addition of TX000045.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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To evaluate the safety and tolerability of TX000045 after single ascending doses
To be assessed by monitoring
Incidence of adverse events (AEs) and serious adverse events (SAEs): Adverse events will be assessed by clinical examination, review of patient data and self-reporting. Adverse events will be collected via verbal interview by clinic staff during the study period either in person during confinement or clinic visits or via telephone during remote contacts
Changes in clinical laboratory safety parameters including blood test results for Hematology, Serum Chemistry, Coagulation Studies.
Changes in vital signs measurements. Vital signs will include measurements of resting heart rate, systolic and diastolic blood pressure (BP) using standard manual or electronic clinical procedures.
Changes in electrocardiogram (ECG) findings
These procedures are completed using standard nursing practices or in the case of the ECG, the instructions provided by the manufacturer. These individual data are utilized to determine safety by physician assessment. Additionally, the totality of the data presented will also be factored into the determination of safety
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Assessment method [1]
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Timepoint [1]
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Adverse Events (AEs) and Serious Adverse events (SAEs) : At Screening, Day -1, Day 1, Day 2, Day 3, Day 6, Day 8, Day 15, Day 29, Day 43, Day 57 post dose administration
Safety Laboratory assessments: At Screening, Day -1, Day 1, Day 2, Day 8, Day 15, Day 29, Day 43, Day 57 post dose administration
ECG: At Screening, Day -1, Day 1 and Day 2 post dose administration
Vital Signs: At Screening, Day -1, Day 1, Day 2, Day 3, Day 6, Day 8, Day 15, Day 29, Day 43, Day 57 post dose administration
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Secondary outcome [1]
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Characterize the pharmacokinetic (PK) profile of TX000045 in healthy participants after single ascending doses of TX000045.
Standard PK parameters will be described: Cmax, Tmax, AUC last (AUC from 0 to the last measurable concentration), AUCinf (AUC from 0 to infinity), t1/2, CL (clearance), and Vz (terminal phase volume of distribution).
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Assessment method [1]
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Timepoint [1]
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Blood sampling for PK parameters will be collected Predose, End of infusion, 6 hrs, 12 hrs post dose on Day 1, 24 hrs post dose on Day 2, 48 hours post dose on Day 3, 120 hours post dose on Day 6, 168 hours post dose on Day 8, Day 15, Day 29, Day 43 and Day 57 post dose.
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Secondary outcome [2]
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Evaluate the pharmacodynamic (PD) effect of single ascending doses of TX000045 in healthy participants.
Change from baseline to day 2 in the following:
Renal plasma flow (RPF), as measured by change in plasma para-aminohippurate (PAH) over time
Renal blood flow (RBF)
Filtration fraction (FF), as calculated by GFR divided by RPF
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Assessment method [2]
424709
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Timepoint [2]
424709
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Blood Sampling for RPF/GFR will be collected on Days 2, 8 and 15 for IV Cohorts A, B and D and on Days 15 and 29 for IV cohort F.
Blood sampling for RPF/GFR will be collected on Days 2, 15 and 29 for SC Cohorts C and E.
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Eligibility
Key inclusion criteria
Inclusion criteria:
Participants must meet the following criteria to be enrolled in this study:
• Is a male or a female of non–childbearing potential between the ages of 18 and 55 years.
• Is judged to be in good health based upon medical history, physical examination, vital signs, ECGs, and routine laboratory tests.
• Has a BMI (body mass index) between 18 and 32 kg per meter square at screening.
• Understands the study procedures and agrees to participate in the study by giving written informed consent.
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply:
• Is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of significant psychiatric disorders at the discretion of the investigator.
• Has any clinically significant physical examination abnormalities observed during the screening visit or would not be a good candidate for participation in the study in the opinion of the investigator.
• Has clinically significant abnormal complete blood count, clinical chemistry, or urine analysis at screening or Day -1. In asymptomatic participants, any abnormal laboratory results, including creatine phosphokinase within 3 times the upper limit of normal with suspected cause due to rigorous physical activities, may be repeated once during the screening period.
• Was hospitalized for any reason within 30 days of the screening visit.
• Has any history of clinically significant renal, neurologic, gastrointestinal, hepatic, or respiratory disease. Note that subjects with fully resolved childhood asthma with no recurrence in adulthood may be enrolled.
• Has a history of anaphylaxis or other significant allergy in the opinion of the investigator.
• Has a history of clinically significant cardiovascular disease including arrhythmias, conduction abnormalities, or clinically significant abnormal vital signs.
• Was previously administered relaxin or relaxin fusion proteins.
• Was dosed in any clinical research study evaluating another investigational drug (including biologics) or therapy (including specific immunotherapy) within 90 days or less than or equal to 5 half-lives (whichever is longer) of an investigational biologic drug, or less than or equal to 4 weeks for other investigational products, before the screening visit.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be enrolled after signing the Informed Consent Form. The Contract Research Organisation will create a master randomisation schedule and code break envelopes, which will be delivered to the site's unblinded pharmacy before dosing. The active and placebo products will be infused through a line that is covered to conceal active from placebo.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A printed randomisation schedule will be generated using permuted blocked fixed method.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
10/10/2023
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Actual
10/10/2023
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Date of last participant enrolment
Anticipated
30/01/2024
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Actual
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Date of last data collection
Anticipated
25/03/2024
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Actual
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Sample size
Target
48
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Accrual to date
56
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Tectonic Therapeutic
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Address [1]
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490 Arsenal Way, Suite 210Watertown, MA 02472
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Country [1]
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United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
Tectonic Therapeutic
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Address
490 Arsenal Way, Suite 210Watertown, MA 02472
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Country
United States of America
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
316304
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Novotech Australia Pty Limited
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Address [1]
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Level 3, 235 Pyrmont Street, Pyrmont, NSW 2009
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Alfred Hospital Ethics Committee
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Ethics committee address [1]
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55 Commercial Road, Melbourne VIC 3004, Australia
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Ethics committee country [1]
313448
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Australia
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Date submitted for ethics approval [1]
313448
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24/07/2023
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Approval date [1]
313448
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25/08/2023
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Ethics approval number [1]
313448
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Summary
Brief summary
This double blind, placebo controlled, first-in-human (FIH) study will assess the safety, tolerability, PK, PD, and immunogenicity of TX000045 in healthy men or women of non-childbearing potential. This study will establish doses of TX000045 that are safe, well tolerated, and exhibit appropriate PD effects to warrant further clinical investigation.
Who is it for?
You may be eligible for this study if you are a healthy adult aged between 18 and 55 years old.
Approximately 48 healthy participants will be enrolled in the study.
The duration of participation in this study is approximately 3 months (inclusive of a 27-day screening window, 1-day baseline period, and a 57- day follow-up period after dosing) across 6 cohorts of 8 participants each.
Each participant will receive a single dose of TX000045 or matching placebo, randomized in a 3:1 ratio per cohort, via at least a 30-minute intravenous (IV) infusion or subcutaneous (SC) injection.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Kristi Mclendon
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Address
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Level 5 Clive Berghofer Cancer Centre Research Centre, 300 Herston Road, Herston, QLD 4006
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Country
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Australia
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Phone
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+61 073707 2720
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Cary Zhang
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Address
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Nucleus Network Brisbane, Level 5 Clive Berghofer Cancer Centre Research Centre, 300 Herston Road, Herston, QLD 4006
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Country
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Australia
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Phone
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+611411317839
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Kristi Mclendon
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Address
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Level 5 Clive Berghofer Cancer Centre Research Centre, 300 Herston Road, Herston, QLD 4006
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Country
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Australia
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Phone
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+61 073707 2720
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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