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Trial registered on ANZCTR
Registration number
ACTRN12619000902190p
Ethics application status
Submitted, not yet approved
Date submitted
18/01/2019
Date registered
27/06/2019
Date last updated
27/06/2019
Date data sharing statement initially provided
27/06/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Hyperbaric oxygen therapy for lower limb burns in diabetic patients
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Scientific title
Effect of hyperbaric oxygen on wound healing and scar outcome in diabetic patients with lower limb burns
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Secondary ID [1]
297137
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Nil
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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:
Diabetes
311169
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Burn Injury
311170
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Condition category
Condition code
Metabolic and Endocrine
309789
309789
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0
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Diabetes
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Injuries and Accidents
311778
311778
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0
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Burns
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This project aims to see whether hyperbaric oxygen therapy (HBOT) after debridement and skin grafting of a diabetic lower limb burn improves healing and scar outcome.
Diabetic patients with lower limb burns who require debridement and skin grafting would be randomised to receive either:
HBOT post-operatively
OR sham HBOT
This treatment of sham treatment would be delivered at Fiona Stanley Hyperbaric medicine department by trained hyperbaric technicians.
These treatments would be delivered daily for 2-4 weeks.
After the treatment or sham treatment, the patient would receive standard care for all wounds.
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Intervention code [1]
313403
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Treatment: Other
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Comparator / control treatment
Control group would receive exactly the same treatment apart from the dive in the hyperbaric chamber would be a sham dive, not delivering the hyperbaric oxygen
Treatment arm – 111minutes of 140kPa Oxygen filled chamber
Control arm – 111 minutes of 30kPa air filled chamber
Follow up = same for both arms
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Control group
Placebo
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Outcomes
Primary outcome [1]
318748
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Percentage wound healing assessed by a clinician blinded to treatment to assess the percentage healing of the wound, using a 3D camera to map the area of the healed/unhealed area of wound to form a ratio.
Primary timepoint: 4 weeks (primary timepoint), 3months, 6 months and 12 months
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Assessment method [1]
318748
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Timepoint [1]
318748
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4 weeks post surgery
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Secondary outcome [1]
365914
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Scar quality:
Vancouver Scar Scale
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Assessment method [1]
365914
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Timepoint [1]
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6 weeks post-surgery,
3 months post-surgery
6 months post-surgery
1 year post-surgery
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Secondary outcome [2]
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Scar quality:
Patient and Observer Assessment scar score
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Assessment method [2]
371887
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Timepoint [2]
371887
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6 weeks post-surgery,
3 months post-surgery
6 months post-surgery
1 year post-surgery
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Secondary outcome [3]
371888
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Scar quality:
Dermalab measurements (pigmentation, vascularity, scar thickness and elastography)
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Assessment method [3]
371888
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Timepoint [3]
371888
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6 weeks post-surgery,
3 months post-surgery
6 months post-surgery
1 year post-surgery
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Secondary outcome [4]
371889
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Quality of life:
SF36
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Assessment method [4]
371889
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Timepoint [4]
371889
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3 months post-surgery
6 months post-surgery
1 year post-surgery
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Secondary outcome [5]
371890
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Quality of life: Brisbane Burn Scar Impact Profile
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Assessment method [5]
371890
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Timepoint [5]
371890
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3 months post-surgery
6 months post-surgery
1 year post-surgery
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Secondary outcome [6]
371891
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Quality of life:
Structured interviews - 30 minutes by telephone, one-on-one, audio recorded and transcribed
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Assessment method [6]
371891
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Timepoint [6]
371891
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3 months post-surgery
6 months post-surgery
1 year post-surgery
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Eligibility
Key inclusion criteria
Adults 18+ years of age
Burn below knee on one or both legs
First presentation with burn on index limb
Type I or II diabetes mellitus
Able to consent to trial
Fluent in verbal and written English
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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
Pregnant or lactating women
Patients who fail the pre-hyperbaric treatment ear pressure test for barotrauma and would require tympanostomy tubes (grommets)
Patients who would not pass the screening process for standard hyperbaric treatment (those treated with Bleomycin (increases risk of pulmonary fibrosis); patients with current brain tumours or carbon monoxide poisoning (increased risk of oxygen toxicity) or with existing cataracts (can increase progression)
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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)
Sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation using factors of age, gender and ethnicity
Computerised sequence generation using random number generator assignation
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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 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
Efficacy
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Statistical methods / analysis
Pilot study trial of 30 patients as not enough data known on healing percentage/times of diabetic burn lower limbs with and without hyperbaric oxygen to determine standard deviations
Non-parametric tests used for smaller number of group - Kruksall-Wallis tests
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
2/09/2019
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Actual
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Date of last participant enrolment
Anticipated
1/09/2020
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Actual
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Date of last data collection
Anticipated
6/09/2021
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
12963
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
25441
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6150 - Murdoch
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Funding & Sponsors
Funding source category [1]
301697
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Charities/Societies/Foundations
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Name [1]
301697
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Fiona Wood Foundation
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Address [1]
301697
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Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, 6158 WA
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Country [1]
301697
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Australia
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Primary sponsor type
Hospital
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Name
Fiona Stanley Hospital
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Address
Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, 6158 WA
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Country
Australia
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Secondary sponsor category [1]
301422
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None
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Name [1]
301422
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None
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Address [1]
301422
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None
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Country [1]
301422
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
302416
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Department of Health WA Human research ethics committee
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Ethics committee address [1]
302416
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PO Box 8172
Perth Business Centre
Perth WA 6849
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Ethics committee country [1]
302416
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Australia
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Date submitted for ethics approval [1]
302416
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25/06/2019
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Approval date [1]
302416
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Ethics approval number [1]
302416
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Summary
Brief summary
This project aims to see whether hyperbaric oxygen therapy (HBOT) after debridement and skin grafting of a diabetic lower limb burn improves healing.
Diabetic lower limb burns are very common - a recent audit performed in our service revealed 35 such injuries over the past 18 months, 75% of which required debridement and skin grafting. It also identified that these patient stay on average 2.5 times longer in hospital than our normal average length of stay. In addition a third require a second operation and due to poor healing 23% proceeded to some form of amputation.
Hyperbaric oxygen therapy has been used increasingly to assist with healing of complex and chronic wounds, however robust evidence for its use, particularly in burns, is still lacking. At Fiona Stanley Hospital we have a HBOT unit and are the adult tertiary referral service for burn injuries. We therefore propose to perform a double blind randomised controlled trial looking at diabetic lower limb burns which required debridement and skin grafting. All diabetic patients with deep lower limb burns would be considered for the trial and would have debridement, skin grafting and VAC therapy within 72 hours of presentation to our service. Immediately post-operatively they would be randomised to receive either HBOT post-operatively OR sham HBOT. These treatments would be delivered daily for 2-4 weeks. After the treatment or sham treatment, the patient would receive standard care for all wounds.
At 4 weeks the wounds would be assessed by a clinician blinded to treatment to assess the percentage healing of the wound, using a camera to map the area of the healed/unhealed area of wound to form a ratio.
At 3, 6 and 12 months the wounds would be assessed for healing, time in dressings, episodes of breakdown, requirements for secondary surgery and QoL
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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 Helen Douglas
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Address
90170
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State Adult Burns Unit
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch 6158
WA
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Country
90170
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Australia
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Phone
90170
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+61 861522222
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Fax
90170
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Email
90170
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[email protected]
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Contact person for public queries
Name
90171
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Dr Helen Douglas
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Address
90171
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State Adult Burns Unit
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch 6158
WA
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Country
90171
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Australia
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Phone
90171
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+61 861522222
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Fax
90171
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Email
90171
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[email protected]
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Contact person for scientific queries
Name
90172
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Dr Helen Douglas
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Address
90172
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State Adult Burns Unit
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch 6158
WA
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Country
90172
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Australia
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Phone
90172
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+61 861522222
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Fax
90172
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Email
90172
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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?
De-identified patient data would be considered for sharing on request, but not automatically
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When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
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Available to whom?
Other researchers in the field with methodologically sound proposals whose research may benefit from our de-identified data - at the discretion of study investigators and sponsor
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Available for what types of analyses?
Any purpose
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How or where can data be obtained?
access subject to approvals by Principal Investigator to be emailed at
[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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