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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03829631
Registration number
NCT03829631
Ethics application status
Date submitted
24/01/2019
Date registered
4/02/2019
Date last updated
25/03/2025
Titles & IDs
Public title
Lumbar Brace Deployment in the Emergency Department for Benign Low Back Pain
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Scientific title
Lumbar Brace Deployment in The Emergency Department for Benign Low Back Pain: Effectiveness and Impact on Pain, Spine Function, Analgesic Use and Community Resources
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Secondary ID [1]
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Pro00085904
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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:
Low Back Pain
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Brace
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Emergencies
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Pain
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Health Care Resources
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Horizon 627 Lumbar Brace, Aspen Medical Company, Oak Canyon, Irvine, CA 92618
Experimental: Intervention - Participants will be instructed to follow their current low back pain management program, in addition, they will be instructed to wear a lumbar brace (Horizon 627 Lumbar Brace) during the day for four weeks only when they are in pain in addition to their current management program.
No intervention: Control - Participants will be instructed to follow their current low back pain management program.
Treatment: Devices: Horizon 627 Lumbar Brace, Aspen Medical Company, Oak Canyon, Irvine, CA 92618
The brace is an FDA Class I, one-size adjustable design to fit waists ranging from 24-70 inches. Participants will be instructed to wear the brace for six weeks during the daytime
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in the pain level
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Assessment method [1]
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The change in the pain level between the baseline and 6-week follow-up will be evaluated using the Numeric Pain Rating Scale \[0-10\]. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing the "worst pain imaginable".
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Timepoint [1]
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Week 6
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Primary outcome [2]
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Change in the pain level
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Assessment method [2]
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The change in the pain level between the baseline and 4-month follow-up will be evaluated using the Numeric Pain Rating Scale \[0-10\]. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing the "worst pain imaginable".
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Timepoint [2]
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Month 4
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Primary outcome [3]
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Change in the pain level
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Assessment method [3]
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The change in the pain level between the baseline and 8-month follow-up will be evaluated using the Numeric Pain Rating Scale \[0-10\]. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing the "worst pain imaginable".
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Timepoint [3]
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Month 8
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Primary outcome [4]
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Change in the pain level
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Assessment method [4]
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The change in the pain level between the baseline and 12-month follow-up will be evaluated using the Numeric Pain Rating Scale \[0-10\]. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing the "worst pain imaginable".
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Timepoint [4]
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Month 12
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Secondary outcome [1]
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Change in the self-reported disability level - Questionnaire A
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Assessment method [1]
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The change in the self-reported disability between the baseline and 6-week follow-up will be evaluated using the Oswestry Disability Index \[0-100 scale\].
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Timepoint [1]
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Week 6
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Secondary outcome [2]
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Change in the self-reported disability level - Questionnaire A
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Assessment method [2]
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The change in the self-reported disability between the baseline and 4-month follow-up will be evaluated using the Oswestry Disability Index \[0-100 scale\].
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Timepoint [2]
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Month 4
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Secondary outcome [3]
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Change in the self-reported disability level - Questionnaire A
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Assessment method [3]
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The change in the self-reported disability between the baseline and 8-month follow-up will be evaluated using the Oswestry Disability Index \[0-100 scale\].
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Timepoint [3]
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Month 8
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Secondary outcome [4]
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Change in the self-reported disability level - Questionnaire A
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Assessment method [4]
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The change in the self-reported disability between the baseline and 12-month follow-up will be evaluated using the Oswestry Disability Index \[0-100 scale\].
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Timepoint [4]
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Month 12
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Secondary outcome [5]
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Change in the self-reported disability level - Questionnaire B
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Assessment method [5]
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The change in the self-reported disability between the baseline and 6-week follow-up will be evaluated using the Roland-Morris Low Back Pain and Disability Questionnaire Index \[0-24 scale\].
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Timepoint [5]
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Week 6
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Secondary outcome [6]
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Change in the self-reported disability level - Questionnaire B
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Assessment method [6]
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The change in the self-reported disability between the baseline and 4-month follow-up will be evaluated using the Roland-Morris Low Back Pain and Disability Questionnaire Index \[0-24 scale\].
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Timepoint [6]
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Month 4
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Secondary outcome [7]
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Change in the self-reported disability level - Questionnaire B
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Assessment method [7]
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The change in the self-reported disability between the baseline and 8-month follow-up will be evaluated using the Roland-Morris Low Back Pain and Disability Questionnaire Index \[0-24 scale\].
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Timepoint [7]
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Month 8
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Secondary outcome [8]
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Change in the self-reported disability level - Questionnaire B
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Assessment method [8]
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The change in the self-reported disability between the baseline and 12-month follow-up will be evaluated using the Roland-Morris Low Back Pain and Disability Questionnaire Index \[0-24 scale\].
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Timepoint [8]
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Month 12
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Eligibility
Key inclusion criteria
* Aged between 18 and 65 years
* Ambulatory
* Able to read and understand English
* Living in Edmonton
* Presenting to an emergency department
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Minimum age
18
Years
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Maximum age
65
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
* Back pain due to systemic or specific disease such as known cancer, spinal infection, fracture, or ankylosing spondylitis
* Pregnancy
* Significant compression of the spinal cord/nerves
* Previous back surgery
* On-going workers' compensation or litigation cases
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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 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
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/06/2019
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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
31/12/2025
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Actual
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Sample size
Target
152
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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- Perth
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Alberta
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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American Orthotic and Prosthetic Association
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Curtin University
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
Low back pain accounts for billions of dollars in health care expenditures. Most cases of back pain do not have a clear cause. Thus, low back pain management methods usually rely on targeting people' pain and discomfort. Painkillers, including opioids, are usually prescribed in the emergency departments for people with low back pain. But, like all medications, painkillers can have side effects, and some of those can be serious. There are also serious concerns about the overuse of painkillers. Thus, newer pain management methods are needed to reduce the use of painkillers in people with low back pain. Lumbar braces are one of the underutilized low back pain management methods in the emergency departments. Like crutches for leg and ankle injuries, they can minimise movements of the spine. This may decrease people pain and improve their function. This may also reduce the use of painkillers. In support of this approach, two recent studies conducted in a primary-care setting observed a reduction in the use of painkillers in people with low back pain who wore lumbar braces. The investigators are conducting this study to determine if wearing a lumbar brace for 4 weeks following emergency department presentation will reduce people's pain and discomfort and increase spine function. This may decrease the use of painkiller and future use of healthcare resources. This research study may also assist emergency-department staff with offering new recommendations to improve the quality of clinical decisions.
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Trial website
https://clinicaltrials.gov/study/NCT03829631
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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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Greg Kawchuk, PhD
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Address
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University of Alberta
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Greg Kawchuk, PhD
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Address
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Country
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Phone
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17802939486
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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
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03829631
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