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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12624000413527
Ethics application status
Approved
Date submitted
21/02/2024
Date registered
4/04/2024
Date last updated
4/04/2024
Date data sharing statement initially provided
4/04/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
Return to sport following shoulder stabilisation surgery
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Scientific title
Return to play post anterior shoulder stabilisation, a prospective observational trial assessing physical and psychological parameters affecting post operative outcomes
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Secondary ID [1]
311583
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None
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Universal Trial Number (UTN)
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Trial acronym
RTPPASS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Anterior shoulder dislocation
332964
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Condition category
Condition code
Musculoskeletal
329677
329677
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0
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Other muscular and skeletal disorders
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Injuries and Accidents
329878
329878
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0
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Other injuries and accidents
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Physical testing and questionnaires
At 6 months post operatively participants will undergo physical strength testing of their shoulder, using previously validated assessment measures. These include ASH (Athletic Shoulder Test) test, SARTs (Return to sport) testing, hand held dynamometry strength testing of internal and external rotation. The questionnaires that will be used are the SIRSI (shoulder instability-return to sport after injury) and the Western Ontario Shoulder Instability Index (WOSI). The testing and questionnaires are completed within 60 minutes.
Then at 12 and 24 months participants complete a 5 minute online questionnaire assessing return to play, recurrent instability and a quality of life questionnaire (WOSI).
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Intervention code [1]
328035
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Not applicable
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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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Recurrent dislocation
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Assessment method [1]
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- Recurrent instability - participant selects one of the following responses. The results will be recorded as yes or no based on the response (No if select responses 1 or 2 and Yes is select responses 3, 4 or 5).
Recurrent shoulder instability event
1. No - Participant has had no further episodes of shoulder instability
2. No - Participant has had pain or felt increased movement in shoulder, but shoulder has not come out of its socket
3. Yes - Shoulder has come of out its socket and was relocated without the application of external force
4. Yes - Shoulder has come out of its socket and has required assistance/the application of external force from non-medical personnel (family or friends) to relocate shoulder
5. Yes - Shoulder has come out of its socket and has required assistance of doctor (or other medical personnel) to relocate shoulder
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Timepoint [1]
337459
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12 months and 24 months operatively
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Secondary outcome [1]
431953
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Return to sport
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Assessment method [1]
431953
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- Return to sport - questionnaire made for study assessing if participant has returned to sport and if it is at a lower, same or higher level compared to preoperatively
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Timepoint [1]
431953
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12 and 24 months post-operatively
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Secondary outcome [2]
433371
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Self assessment of shoulder function for patients with a background of shoulder instability
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Assessment method [2]
433371
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WOSI questionnaire
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Timepoint [2]
433371
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baseline, 6, 12 and 24 months
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Secondary outcome [3]
433591
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Shoulder strength
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Assessment method [3]
433591
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ASH (Athletic Shoulder Test) test - this is a shoulder strength test
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Timepoint [3]
433591
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6 months only
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Secondary outcome [4]
433592
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Strength and function of shoulder
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Assessment method [4]
433592
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SARTs (Return to sport) testing - reliable and reproducible battery of 4 physical tests (line hops, push up claps, side hold rotation and ball holds with press
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Timepoint [4]
433592
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6 months only
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Secondary outcome [5]
433593
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Strength of shoulder in internal and external rotation
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Assessment method [5]
433593
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Hand held dynamometry strength testing of internal and external rotation of shoulder at both 0 and 90 degrees of abduction - reliable and reproducible
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Timepoint [5]
433593
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6 months only
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Secondary outcome [6]
433594
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Psychological readiness to return to sport
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Assessment method [6]
433594
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Shoulder Instability-Return to Sport after Injury (SIRSI) Questionnaire - validated
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Timepoint [6]
433594
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6 months only
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Eligibility
Key inclusion criteria
- One or more previous traumatic anterior dislocation
- Age 16 to 40 years inclusive
- Involved in weekly sport before injury
- Intending to return to weekly sport following surgery
- Undergoing anterior shoulder stabilization surgery (Arthroscopic, Open, Latarjet)
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Minimum age
16
Years
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Maximum age
40
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
- Patient unable to provide informed consent
- Previous operation to the affected joint
- HAGL repair
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Study design
Purpose
Screening
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Duration
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Selection
Defined population
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Timing
Prospective
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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
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Actual
1/08/2022
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Date of last participant enrolment
Anticipated
1/12/2024
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Actual
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Date of last data collection
Anticipated
1/12/2026
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Actual
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Sample size
Target
165
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Accrual to date
45
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Final
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Recruitment outside Australia
Country [1]
26162
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New Zealand
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State/province [1]
26162
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Funding & Sponsors
Funding source category [1]
315886
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Charities/Societies/Foundations
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Name [1]
315886
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Taranaki Medical Foundation
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Address [1]
315886
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Country [1]
315886
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New Zealand
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Funding source category [2]
315887
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Charities/Societies/Foundations
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Name [2]
315887
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Wishbone Orthopaedic Rsearch Foundation
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Address [2]
315887
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Country [2]
315887
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New Zealand
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Funding source category [3]
315888
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Charities/Societies/Foundations
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Name [3]
315888
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New Zealand Physiotherapy Society
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Address [3]
315888
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Country [3]
315888
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New Zealand
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Primary sponsor type
Charities/Societies/Foundations
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Name
Taranaki Medical Foundation
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Address
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Country
New Zealand
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Secondary sponsor category [1]
318031
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Charities/Societies/Foundations
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Name [1]
318031
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Wishbone Orthopaedic Research Foundation
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Address [1]
318031
0
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Country [1]
318031
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New Zealand
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Secondary sponsor category [2]
318032
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Charities/Societies/Foundations
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Name [2]
318032
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New Zealand Physiotherapy Society
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Address [2]
318032
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Country [2]
318032
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
314731
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University of Otago Human Ethics Committee
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Ethics committee address [1]
314731
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https://www.otago.ac.nz/council/committees/committees/humanethicscommittees
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Ethics committee country [1]
314731
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New Zealand
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Date submitted for ethics approval [1]
314731
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29/03/2022
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Approval date [1]
314731
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30/03/2022
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Ethics approval number [1]
314731
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H22/022
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Summary
Brief summary
Following surgery for recurrent dislocations some people re-dislocate their shoulder. This study aims to find different testing methods after the operation to help inform when it is safe for someone to return to sport and when they need to do further strengthening/ rehabilitation.
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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 Rachel Basevi
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Address
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Taranaki Base Hospital, David Street, Westown, New Plymouth 4310
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Country
132554
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New Zealand
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Phone
132554
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+64 2108709924
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Fax
132554
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Email
132554
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[email protected]
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Contact person for public queries
Name
132555
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Rachel Basevi
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Address
132555
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Taranaki Base Hospital, David Street, Westown, New Plymouth 4310
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Country
132555
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New Zealand
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Phone
132555
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+64 2108709924
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Fax
132555
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Email
132555
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[email protected]
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Contact person for scientific queries
Name
132556
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Rachel Basevi
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Address
132556
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Taranaki Base Hospital, David Street, Westown, New Plymouth 4310
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Country
132556
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New Zealand
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Phone
132556
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+64 2108709924
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Fax
132556
0
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Email
132556
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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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