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Trial registered on ANZCTR
Registration number
ACTRN12622000980730
Ethics application status
Approved
Date submitted
8/07/2022
Date registered
12/07/2022
Date last updated
2/11/2023
Date data sharing statement initially provided
12/07/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
Effects of an omega-3 rich food on markers of inflammation in people with Achilles tendinopathy.
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Scientific title
Effects of an omega-3 rich food on markers of inflammation in people with Achilles tendinopathy.
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Secondary ID [1]
307518
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Nil
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Universal Trial Number (UTN)
U1111-1275-6031
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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:
Inflammation
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Achilles tendinopathy
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Condition category
Condition code
Musculoskeletal
324133
324133
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0
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Other muscular and skeletal disorders
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Inflammatory and Immune System
324134
324134
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0
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants will be randomised to treatment or control group.
Participants in each group will receive a food product in the form of a pump which dispenses a citrus flavoured sauce. In the treatment group the food product will contain the active omega-3 ingredient derived from algal and NZ Hoki oil.
Participants will consume 9g of the food product a day for 12 weeks (equivalent to 9 pumps of the dispenser), which will equate to ~2.5g omega-3/serve in the treatment group.
Adherence will be self-reported through weekly emails and phone calls.
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Intervention code [1]
323979
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Treatment: Other
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Comparator / control treatment
The comparator will be placebo product that does not contain omega 3.
The placebo product will be made specifcally for use in the clinical trials. For this product, the Algal and Hoki oil will be replaced with a vegetable oil. All other ingredients will remain the same and the taste, texture and appearance will be the same as the main product.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Circulating Il-6 concentration from blood samples
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Assessment method [1]
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Timepoint [1]
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Baseline, 6 weeks and 12 weeks (primary endpoint) post-intervention commencement
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Secondary outcome [1]
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Circulating TNF from blood samples
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Assessment method [1]
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Timepoint [1]
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Baseline, 6 weeks and 12 weeks post-intervention commencement
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Secondary outcome [2]
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Achilles tendon structure determined by ultrasound imaging, grading tendinopathy and the stage of tendinopathy (i.e. reactive-early dysrepair or late-dysrepair-degenerative) (Matthews et al., Staging achilles tendinopathy using ultrasound imaging: the development and investigation of a new ultrasound imaging criteria based on the continuum model of tendon pathology. BMJ Open Sport & Exercise Medicine 2020).
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Assessment method [2]
411687
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Timepoint [2]
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Baseline, 6 and 12 weeks post-intervention commencement
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Secondary outcome [3]
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Self-reported Achilles function and pain as determined by the Victorian Institute Of Sports Assessment – Achilles (VISA-A) questionnaire
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Assessment method [3]
411688
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Timepoint [3]
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Baseline, 6 and 12 weeks post-intervention commencement
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Secondary outcome [4]
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Achilles tendon stiffness determined by shearwave elastography.
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Assessment method [4]
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Timepoint [4]
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Baseline, 6 and 12 weeks post-intervention commencement
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Secondary outcome [5]
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Wellbeing determined by the World Health Organisation- Five Well-Being Index (WHO-5) questionnaire
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Assessment method [5]
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Timepoint [5]
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Baseline, 6 and 12 weeks post-intervention commencement
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Secondary outcome [6]
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Depression, anxiety and stress determined by the Depression, Anxiety and Stress Scale - 21 Items (DASS-21) questionnaire
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Assessment method [6]
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Timepoint [6]
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Baseline, 6 and 12 weeks post-intervention commencement
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Secondary outcome [7]
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Circulating IL-1ß from blood samples
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Assessment method [7]
411807
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Timepoint [7]
411807
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Baseline, 6 weeks and 12 weeks post-intervention commencement
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Secondary outcome [8]
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Circulating CRP from blood samples
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Assessment method [8]
411808
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Timepoint [8]
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Baseline, 6 weeks and 12 weeks post-intervention commencement
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Eligibility
Key inclusion criteria
Diagnosed insertional or mid-portion Achilles tendinopathy by trained physiotherapist with symptoms lasting more than four weeks
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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
Currently taking omega 3 supplements, currently taking NSAIDs, previous injectable treatments, tendinopathy caused by high impact trauma, BMI >30, auto-immune disease.
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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)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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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 assessing the outcomes
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
Not Applicable
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Type of endpoint/s
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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
16/12/2022
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Actual
16/12/2022
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Date of last participant enrolment
Anticipated
30/11/2023
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Actual
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Date of last data collection
Anticipated
29/02/2024
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Actual
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Sample size
Target
60
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Accrual to date
35
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Final
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Recruitment outside Australia
Country [1]
24883
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New Zealand
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State/province [1]
24883
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Auckland
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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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Ministry of Business, Innovation and Employment - High Value Nutrition Science Challenge
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Address [1]
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Building 505
85 Park Road
Grafton
Auckland, New Zealand
1023
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Country [1]
311799
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New Zealand
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Primary sponsor type
University
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Name
University of Auckland
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Address
Private Bag 92019
Auckland Mail Centre
Auckland, 1142
New Zealand
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
313270
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Address [1]
313270
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Country [1]
313270
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Central Health and Disability Ethics Committee
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Ethics committee address [1]
311243
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Ministry of Health Health and Disability Ethics Committees PO Box 5013 Wellington 6140
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Ethics committee country [1]
311243
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New Zealand
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Date submitted for ethics approval [1]
311243
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01/07/2022
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Approval date [1]
311243
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28/07/2022
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Ethics approval number [1]
311243
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Summary
Brief summary
Inflammation is fundamental in maintaining health, and in many healing processes. However, unresolved inflammation has severe health consequences. Unresolved inflammation plays a key role in several chronic diseases, such as cardiovascular disease (CVD), auto-immune diseases such as rheumatoid arthritis, and diabetes and other metabolic-related diseases. Thus, the ability to regulate inflammatory processes is fundamental to maintaining wellbeing. Based on this, the concept of therapeutically targeting systemic inflammation to improve health outcomes is a growing and promising area of research, targeted to improve the wellbeing of people with chronic health disorders. Supplementation with omega-3 has demonstrable effects on lowering biomarkers of inflammation. This trial builds on existing scientific literature demonstrating a role for omega-3 supplementation in improving inflammation. This is a a randomised, placebo-controlled clinical trial to explore the effects of a novel, omega-3-rich food product on markers of inflammation in people with Achilles tendinopathy. Sixty participants will be recruited from physiotherapy clinics across the Auckland region who are presenting with chronic Achilles tendinopathy. Participants will be randomised into treatment and control groups (30/group), and prior to intervention will have blood samples taken for analysis of circulating inflammatory cytokines to study systemic inflammation, take a self-reported questionnaire of tendinopathy severity and undergo ultrasound with elastography to assess symptoms, structure and function of the Achilles tendon, and take questionnaires related to mood and wellbeing. Participants in each group will then receive a food product, with the treatment group product containing the active omega-3 ingredient derived from algal and NZ Hoki oil, and the placebo group product containing a vegetable-derived oil that contains no omega-3. Participants will consume 9g of the food product a day for 12 weeks, which will equate to ~2.5g omega-3/serve in the treatment group. After 6 weeks, and at the end of the study (12 weeks), all outcome measures will be re-assessed. Overall, this trial has the potential to demonstrate a role for omega-3 rich foods in alleviating systemic inflammation, improving musculoskeletal outcomes and improving wellbeing.
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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 David Musson
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Address
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Private Bag 92019
Auckland Mail Centre
Auckland, 1142
New Zealand
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Country
120430
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New Zealand
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Phone
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+64 99237514
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Fax
120430
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Email
120430
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[email protected]
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Contact person for public queries
Name
120431
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David Musson
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Address
120431
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Private Bag 92019
Auckland Mail Centre
Auckland, 1142
New Zealand
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Country
120431
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New Zealand
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Phone
120431
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+64 99237514
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Fax
120431
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Email
120431
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[email protected]
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Contact person for scientific queries
Name
120432
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David Musson
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Address
120432
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Private Bag 92019
Auckland Mail Centre
Auckland, 1142
New Zealand
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Country
120432
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New Zealand
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Phone
120432
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+64 99237514
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Fax
120432
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Email
120432
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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?
All of the de-identified individual participant data collected during the trial
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When will data be available (start and end dates)?
Immediately following publication until 10 years post study
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Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
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Available for what types of analyses?
For IPD meta-analyses
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How or where can data be obtained?
Access subject to approvals by Principal Investigator (
[email protected]
)
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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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