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Trial registered on ANZCTR
Registration number
ACTRN12625000668404p
Ethics application status
Submitted, not yet approved
Date submitted
6/06/2025
Date registered
25/06/2025
Date last updated
25/06/2025
Date data sharing statement initially provided
25/06/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Anterior Cruciate Ligament Stratified Accelerated Repair or Reconstruction (ACL STARR Aus)
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Scientific title
Anterior Cruciate Ligament Stratified Accelerated Repair or Reconstruction (ACL STARR-AUS): Single-blind randomised controlled trial for patients with proximal ACL injuries treatment with ACL Repair v ACL Reconstruction
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Secondary ID [1]
314565
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None
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Universal Trial Number (UTN)
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Trial acronym
ACL STARR Aus
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Linked study record
The mirror UK ACL STARR trial is registered under ISRCTN24078391.
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Health condition
Health condition(s) or problem(s) studied:
Anterior cruciate ligament injuries
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Condition category
Condition code
Surgery
334044
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0
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Surgical techniques
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Musculoskeletal
334141
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0
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Other muscular and skeletal disorders
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Injuries and Accidents
334142
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0
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Other injuries and accidents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
ACL Repair - is conducted with the ligament being stitched back onto the bone.
An orthopaedic surgeon will do this procedure, with surgery time anticipated to be ~1-2 hours.
Investigators will complete study-specific report forms related to the surgery which can be verified against operative reports.
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Intervention code [1]
331218
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Treatment: Surgery
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Comparator / control treatment
ACL Reconstruction - is conducted by replacing the torn ACL with other tissue (e.g. hamstring graft), to act as a replacement.
An orthopaedic surgeon will do this procedure, with surgery time anticipated to be ~1-2 hours.
Investigators will complete study-specific report forms related to the surgery which can be verified against operative reports.
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Control group
Active
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Outcomes
Primary outcome [1]
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Knee functional outcome (self-reported)
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Assessment method [1]
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Knee Injury and Osteoarthritis Outcome Score (KOOS)-4
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Timepoint [1]
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24 months post-surgery
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Secondary outcome [1]
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Determine the cost-effectiveness of ACL Repair compared with ACL Reconstruction from a health system perspective, in patients with recent proximal ACL ruptures
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Assessment method [1]
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Measured using healthcare use including surgery, additional procedures, rehabilitation data, compilation/readmission following surgery, rehabilitation sessions, complications or readmissions, visits to healthcare professionals, and medicines & quality-adjusted survival (QALYs) These will be sources both as patient reported outcomes and from the medical record/MBS data
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Timepoint [1]
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baseline (pre-surgery), 6, 12 & 24 months post-surgery.
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Secondary outcome [2]
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Knee related emotional functioning following ACL Repair or Reconstruction surgery
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Assessment method [2]
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Emotional functioning questions 6-item questionnaire (adapted from Knee Quality of Life [KQoL]-26)
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Timepoint [2]
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baseline (pre-surgery), 6, 12 & 24 months post-surgery.
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Secondary outcome [3]
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Surgeon confidence in the ACL surgery performed
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Assessment method [3]
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a single question with the answer recorded on a scale of 1-10
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Timepoint [3]
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day of surgery
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Secondary outcome [4]
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Post-operative pain following ACL Repair and Reconstruction
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Assessment method [4]
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Pain visual analogue scale (VAS)
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Timepoint [4]
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3 and 6 weeks post-surgery
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Secondary outcome [5]
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Return to activity / level of sports following ACL Repair or Reconstruction surgery and time to return to sport
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Assessment method [5]
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Modified Tegner score at baseline, and the Tegner score.
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Timepoint [5]
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baseline (pre-surgery), 6, 12 & 24 months post-surgery.
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Secondary outcome [6]
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Patient satisfaction with the outcome of treatment following ACL Repair or Reconstruction surgery
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Assessment method [6]
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2 Likert scale questions
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Timepoint [6]
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12 & 24 months post-surgery
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Secondary outcome [7]
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Complication profile and rate for ACL Repair and Reconstruction in the management of recent proximal ACL tears.
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Assessment method [7]
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Composite Measured as 1. intervention related complications including reoperation at operative period, postoperatively up to 24 months post randomisation.via participant medical records 2. Objective evidence of graft/repair failure up to 24 months. Graft/Repair re-rupture (Y/N) via participant medical records
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Timepoint [7]
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day of surgery, 6, 12, 24 months post-surgery
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Secondary outcome [8]
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Evaluate outcomes related to the knee and changes to scores over time
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Assessment method [8]
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KOOS score (all 5 dimensions)
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Timepoint [8]
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6, 12 & 24 months post-surgery
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Secondary outcome [9]
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Surgical complications
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Assessment method [9]
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Clavien-Dindo Classification of Surgical Complications
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Timepoint [9]
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day of surgery, 6, 12, 24 months post-surgery
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Secondary outcome [10]
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Return to sport
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Assessment method [10]
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one question designed for this study
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Timepoint [10]
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12 & 24 months post-surgery
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Eligibility
Key inclusion criteria
1. Patients aged 14 years and above
2. Willing & able to provide informed consent and comply with study procedures
3. Proximal ACL tear pattern diagnosed by MRI suitable for both repair or reconstruction*
4. Willing to accept either study arm allocation
*A proximal tear will be diagnosed on review of the MRI scan, and eligibility will be confirmed intra-operatively on arthroscopic inspection, to confirm a Sherman Type 1 or Type 2 tear and acceptable tissue quality for repair (i.e. an intact synovial sheath surrounding the torn ACL as a single unit).
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Minimum age
14
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
A patient with not be eligible for the study if ANY of the following apply:
1. History of knee major soft tissue surgery
a. Have had previous knee surgery (other than diagnostic arthroscopy or partial meniscectomy) to the index knee,
2. Concomitant severe injury to the contra-lateral knee
3. High grade multi ligament injury
a. High grade injuries to other ligaments (i.e. medial collateral, lateral collateral, posterior cruciate) in the knee (Grade >2).
4. Surgeon decision – patient not considered clinically appropriate for ACL Repair (for any reason)
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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)
central randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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Masking / blinding
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Who is / are masked / blinded?
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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
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
4/08/2025
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Actual
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Date of last participant enrolment
Anticipated
30/09/2026
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Actual
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Date of last data collection
Anticipated
30/09/2028
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Actual
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Sample size
Target
214
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA,VIC
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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NHMRC
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
University
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Name
University of Sydney
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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]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
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Sydney Local Health District Ethics Review Committee (RPAH Zone)
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Ethics committee address [1]
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https://www.slhd.nsw.gov.au/rpa/research/
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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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23/06/2025
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Approval date [1]
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Ethics approval number [1]
317709
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Summary
Brief summary
There are different surgical options for people with an ACL injury. The most common is reconstruction, which uses tissue from other parts of the body, such as the hamstrings, to act as a replacement. This is a successful operation but does involve damage to bones from drilling holes, removal of tissue from elsewhere in the body, and does not keep any of the torn ligament which has potentially useful nerve endings. Modern ACL repair (stitching) is relatively new and, despite clear potential, has not been fully evaluated. It remains unknown whether it confers any of the theoretical benefits. We aim to conduct a comparative study to find out which is the best technique, reconstructing the ligament or repairing it. The research question is: For patients with recent proximal ACL ruptures (where the ligament has pulled directly off the bone), is ACL repair superior to ACL reconstruction at 24 months post-surgery? This will be measured by a questionnaire relating to the knee called KOOS-4.
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Trial website
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Trial related presentations / publications
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Public notes
This study is a mirror study to the UK-based ACL Repair vs Reconstruction Study (ACL STARR). The current study will be undertaken as funded by the NHMRC (conducted to the same core protocol) in Australia, coordinated within the NHMRC Clinical Trials Centre (CTC), Sydney. This study will be conducted and reported separately from ACL STARR (UK), with a view to combining de-identified data for a meta-analysis.
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Contacts
Principal investigator
Name
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Prof David Beard
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Address
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NHMRC Clinical Trials Centre (CTC), Level 6, Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050
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Country
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Australia
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Phone
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+61 2 9562 5000
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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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Ms Clare Toms
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Address
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NHMRC Clinical Trials Centre (CTC), Level 6, Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050
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Country
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Australia
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Phone
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+61 2 9562 5000
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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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David Beard
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Address
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NHMRC Clinical Trials Centre (CTC), Level 6, Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050
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Country
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Australia
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Phone
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+61 2 9562 5000
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Fax
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
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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