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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12623001080617
Ethics application status
Approved
Date submitted
29/08/2023
Date registered
10/10/2023
Date last updated
13/04/2024
Date data sharing statement initially provided
10/10/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
An Open Label Safety and Efficacy Study of XW10508 Modified Release (MR) in Patients with Major Depressive Disorder
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Scientific title
A Phase 2 Open Label Pilot Study of XW10508 Modified Release Tablets Assessing Safety and Efficacy in Patients with Major Depressive Disorder
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Secondary ID [1]
310409
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XW10508-102
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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:
Major Depressive Disorder
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Condition category
Condition code
Mental Health
327936
327936
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0
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Depression
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Cohort 1: 200 mg XW10508 MR oral tablets daily for 15 days; Cohort 2: 300 mg XW10508 MR oral tablets daily for 15 days; Cohort 3: 200 mg XW10508 MR oral tablets twice per week (Monday and Thursday) for 15 days; Cohort 4: 300 mg XW10508 MR oral tablets twice per week (Monday and Thursday) for 15 days. N=6 per cohort for a total of N=24. Participants are not allowed to participate in multiple cohorts. All cohorts will be started sequentially.
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Intervention code [1]
326807
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Treatment: Drugs
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Change in Montgomery–Åsberg Depression Rating Scale (MADRS) score from baseline
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Assessment method [1]
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Timepoint [1]
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Baseline and Day 16 post-intervention commencement
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Secondary outcome [1]
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Assess patient's depression severity through change in Clinician Global Impression of Severity (CGI-S) from baseline
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Assessment method [1]
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Timepoint [1]
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Baseline and Day 16 post-intervention commencement
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Secondary outcome [2]
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Assess disease severity through Change in Patient Global Impression of Severity (PGI-S) from baseline
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Assessment method [2]
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Timepoint [2]
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Baseline and Day 16 post-intervention commencement
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Secondary outcome [3]
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Assess clinician's impression of disease improvement through Clinician Global Impression of Improvement (CGI-I) from baseline
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Assessment method [3]
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Timepoint [3]
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Baseline and Day 16 post-intervention commencement
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Secondary outcome [4]
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Assess patient's perception of improvement in depression through Patient Global Impression of Improvement (PGI-I)
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Assessment method [4]
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Timepoint [4]
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Baseline and Day 16 post-intervention commencement
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Secondary outcome [5]
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Frequency of self reported adverse events. Possible adverse events are nausea, dizziness, headache, somnolence.
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Assessment method [5]
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Timepoint [5]
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For 16 days upon intervention commencement
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Secondary outcome [6]
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Assess treatment-emergent dissociative symptoms through Clinician Administered Dissociative States Scale (CADSS)
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Assessment method [6]
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Timepoint [6]
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For 16 days upon intervention commencement
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Secondary outcome [7]
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Assess suicidal behavior through Columbia-Suicide Severity Rating Scale (C-SSRS)
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Assessment method [7]
426634
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Timepoint [7]
426634
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For 16 days upon intervention commencement
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Secondary outcome [8]
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Monitor vital signs (blood pressure and heart rate assessed using a blood pressure monitor, body temperature, respiratory rate assessed using a pulse oximeter).
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Assessment method [8]
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Timepoint [8]
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For 16 days upon intervention commencement
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Secondary outcome [9]
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Blood levels of esketamine.
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Assessment method [9]
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Timepoint [9]
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Day 16 post-intervention commencement
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Secondary outcome [10]
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Blood levels of noresketamine.
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Assessment method [10]
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Timepoint [10]
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Day 16 post-intervention commencement
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Eligibility
Key inclusion criteria
Diagnosis of Major Depressive Disorder without psychotic features diagnosed by two Structured Clinical Interview for Axis I Disorders (SCID-I) or Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) with symptoms present for at least 28 days.
MADRS total score of greater than or equal to 24 at screening.
Patients with an inadequate response to an adequate trial of 1, 2 or 3 antidepressants in the current Major Depressive Episode.
Current antidepressant treatment stable for at least 30 days prior to screening and will remain unchanged throughout the study.
Female participants of childbearing potential must test negative in a serum pregnancy test at Screening and have a negative urine pregnancy test at the Baseline Visit. Women with childbearing potential must use an acceptable method of contraception during the study and for at least 30 days after completion of dosing.
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Significant medical conditions (e.g., history of bipolar disorder, schizophrenia, cognitive disorder, PTSD, panic disorder).
History of suicide attempt or risk of suicide associated with the current episode of MDD.
Psychiatric hospitalization during current Major Depressive Disorder episode.
Inadequate response to an adequate trial of 4 or more antidepressants in the current Major Depressive Episode.
History of substance abuse per DSM-5.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 2
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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
16/10/2023
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Actual
4/12/2023
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Date of last participant enrolment
Anticipated
30/08/2024
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Actual
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Date of last data collection
Anticipated
13/09/2024
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Actual
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Sample size
Target
24
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Accrual to date
8
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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The Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
41148
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5000 - Adelaide
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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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XW Laboratories (Australia) Pty Ltd
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Address [1]
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58 Gipps Street Collingwood, VIC 3066
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Country [1]
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
XW Laboratories (Australia) Pty Ltd
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Address
58 Gipps Street Collingwood, VIC 3066
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Country
Australia
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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]
316581
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Country [1]
316581
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Central Adelaide Local Health Network (CALHN) HREC
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Ethics committee address [1]
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Port RoadAdelaide SA 5000
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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31/07/2023
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Approval date [1]
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06/09/2023
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Ethics approval number [1]
313642
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Summary
Brief summary
This is an open-label pilot study to assess XW10508 MR safety, tolerability and efficacy in patients with Major Depressive Disorder. The hypothesis is oral XW10508 MR tablets will rapidly improve and maintain the treatment of depression symptoms without significant adverse effects and with good patient tolerability.
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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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Prof Guy Ludbrook, MBBS, FANZCA, PhD, GAICD
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Address
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PARC Clinical Research - Royal Adelaide HospitalLevel 4C, Wayfinding 4C610, Port Road, Adelaide, SA 5000
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Country
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Australia
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Phone
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+61 0882222712
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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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Mrs Beth Zib
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Address
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XWPharma, 303 Twin Dolphin Drive, Suite 600 Redwood City, CA 94065
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Country
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United States of America
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Phone
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+1 650 996 7838
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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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Mrs Beth Zib
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Address
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XWPharma, 303 Twin Dolphin Drive, Suite 600 Redwood City, CA 94065
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Country
128848
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United States of America
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Phone
128848
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+1 650 996 7838
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Fax
128848
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Email
128848
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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
N.A.
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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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