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Trial registered on ANZCTR
Registration number
ACTRN12624001232527p
Ethics application status
Not yet submitted
Date submitted
27/08/2024
Date registered
9/10/2024
Date last updated
9/10/2024
Date data sharing statement initially provided
9/10/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Stroke Thrombectomy Access: does it Yield better Home Outcomes and decreased Morbidity in Elderly versus standard thrombolysis? (STAY-HOME trial)
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Scientific title
Stroke Thrombectomy Access: does it Yield better Home Outcomes and decreased Morbidity in Elderly versus standard thrombolysis? (STAY-HOME trial)
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Secondary ID [1]
312827
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None
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Universal Trial Number (UTN)
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Trial acronym
STAY-HOME
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Stroke
334935
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Condition category
Condition code
Stroke
331473
331473
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0
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Ischaemic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Patients randomized to the thrombectomy arm will have clot extraction or aspiration catheter in the angiographic suite. This procedure may be performed under general anaesthesia. This decision is up to the interventional radiologists performing the procedure. The procedure may take 1 hour but can be longer for complex anatomy or clot. Following the procedure the interventional neuroradiologists will document the procedure in electronic medical record. Post-intervention: A non-contrast Computed Tomography (CT) and CT Angiography will be performed 24-to-48-hour post intervention. At the investigator’s discretion, a repeat CT Perfusion or Magnetic Resonance IMaging (MRI) may be performed at 24-to-48 hr.
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Intervention code [1]
329374
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Treatment: Devices
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Comparator / control treatment
The standard care arm is either intravenous Alteplase or Tenecteplase (TNK) within 4.5 hours, or between 4.5-9 hours or best medical therapy according to local guidelines and drug availability. The dose for alteplase is 0.9 mg/kg and for tenecteplase it is 0.25mg/kg. The local site can choose between these two drugs. The best medical therapy option recognizes that between 4.5 - 9 hours, thrombolytic drug is not yet widely adopted in Asia. From 9- 24 hours, it’s best medical therapy. The type of therapy used will be verified by checking electronic medical record.
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Control group
Active
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Outcomes
Primary outcome [1]
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Hierarchical outcome of return to baseline modified Rankin score 3 if baseline was modified Rankin of 3 or return to baseline modified Rankin of 4 if baseline was modified Rankin of 4.
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Assessment method [1]
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modified Rankin score
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Timepoint [1]
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3 months post-baseline
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Primary outcome [2]
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Each dimension of European Quality of life (EQ-5D-5L)
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Assessment method [2]
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European Quality of life (EQ-5D-5L)
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Timepoint [2]
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3 months post-baseline
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Primary outcome [3]
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return home if from home, return nursing home if from nursing home
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Assessment method [3]
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assessment by clinician
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Timepoint [3]
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3 months post-baseline
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Secondary outcome [1]
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Return to baseline status
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Assessment method [1]
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clinical assessment
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Timepoint [1]
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3 months post-baseline
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Eligibility
Key inclusion criteria
1. Patients presenting with acute ischaemic stroke within 24 hours of stroke onset (in line with current criteria for thrombolysis).
2. National Institute of Health Stroke Scale (NIHSS)>4
3. Pre-stroke modified Rankin Score (mRS) score of 3 or 4
4. Patient’s age is 18 years and over (or as per local requirements)
5. Endovascular therapy (arterial puncture) within 90 minutes of initial CT brain.
6. Arterial occlusion on CT Angiography or MR Angiography (MRA) of large vessel occlusion (LVO)
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Minimum age
18
Years
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Maximum age
No limit
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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
1. Patients presenting with acute ischaemic stroke >24 hours of stroke onset.
2. Intracranial haemorrhage identified by CT or MRI.
3. Rapidly improving symptoms at the discretion of the investigator
4. Pre-stroke modified Rankin Score (mRS) score of <3 (indicating previous disability)
5. Hypodensity in >1/2 MCA or ACA territory on non-contrast CT.
6. Contraindication to imaging with contrast agents (requirement for performing thrombectomy)
7. Any terminal illness such that the patient has life expectance less than 1 year.
8. Patients with active cancer and undergoing treatment for cancer are excluded.
9. Any condition that, in the judgment of the investigator, could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
10. Pregnancy
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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)
Yes. Allocation concealment is performed by central randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The analysis will be based on intention-to-treat. The analysis uses the win ratio hierarchy of outcomes: return to baseline modified Rankin score 3 if baseline was modified Rankin of 3 or return to baseline modified Rankin of 4 if baseline was modified Rankin of 4, return home if from home, return nursing home if from nursing home, and each dimension of EQ-5D-5L. The Wins are declared when one is clearly better and if there is a tie then the assessment is moved down to the next level and so. The Win Ratio is the ratio of winners and losers with associated 95% confidence interval.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
10/01/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
240
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
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Recruitment hospital [1]
27016
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Royal Melbourne Hospital - City campus - Parkville
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Recruitment hospital [2]
27017
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The Alfred - Melbourne
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Recruitment hospital [3]
27018
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The Royal Adelaide Hospital - Adelaide
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Recruitment hospital [4]
27019
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Liverpool Hospital - Liverpool
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Recruitment hospital [5]
27020
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
43087
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3050 - Parkville
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Recruitment postcode(s) [2]
43088
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3004 - Melbourne
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Recruitment postcode(s) [3]
43089
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5000 - Adelaide
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Recruitment postcode(s) [4]
43090
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2170 - Liverpool
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Recruitment postcode(s) [5]
43091
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4102 - Woolloongabba
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Recruitment outside Australia
Country [1]
26529
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Viet Nam
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State/province [1]
26529
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Ho Chi Minh
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Country [2]
26530
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New Zealand
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State/province [2]
26530
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canterbury
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Funding & Sponsors
Funding source category [1]
317266
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Government body
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Name [1]
317266
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National Health and Medical Research Council Clinical Trial and Cohort Studies Grant
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Address [1]
317266
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Country [1]
317266
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Australia
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Primary sponsor type
Government body
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Name
National Health and Medical Research Council
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Address
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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]
319544
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Address [1]
319544
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Country [1]
319544
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
316005
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Monash Health Human Research Ethics Committee A
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Ethics committee address [1]
316005
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https://monashhealth.org/research/resources/resource-library/
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Ethics committee country [1]
316005
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Australia
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Date submitted for ethics approval [1]
316005
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28/10/2024
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Approval date [1]
316005
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Ethics approval number [1]
316005
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Summary
Brief summary
Thrombectomy for large vessel occlusion (LVO) has been the mainstay since publications of 5 landmark trials in 2015. However, these trials had very restrictive inclusion criteria and excluded elderly patients or those with premorbid disability. The aim of this trial is to deliver high quality evidence of the effectiveness of LVO thrombectomy in patients with premorbid disability.
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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 Thanh Phan
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Address
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246 Clayton Rd Clayton, VIC3168 Australia, Monash Medical Centre
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Country
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Australia
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Phone
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+61 385722612
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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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Thanh Phan
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Address
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246 Clayton Rd Clayton VIC 3168 Australia, Monash Medical Centre
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Country
136475
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Australia
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Phone
136475
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+61 385722612
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Fax
136475
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Email
136475
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[email protected]
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Contact person for scientific queries
Name
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Thanh Phan
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Address
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246 Clayton Rd Clayton, VIC 3168, Australia, Monash Medical Centre
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Country
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Australia
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Phone
136476
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+61 385722612
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Fax
136476
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Email
136476
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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)?
Yes
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What data in particular will be shared?
anonymised trial data including randomisation allocation, baseline characteristics and outcome
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When will data be available (start and end dates)?
The data will be available 24 months after publication of trial results and for 5 years
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Available to whom?
trialists on request
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Available for what types of analyses?
individual data metaanalysis
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How or where can data be obtained?
from principal investigators
[email protected]
(Thanh Phan) or
[email protected]
(Bernard Yan)
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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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