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Trial registered on ANZCTR
Registration number
ACTRN12624001037594
Ethics application status
Approved
Date submitted
13/08/2024
Date registered
28/08/2024
Date last updated
28/08/2024
Date data sharing statement initially provided
28/08/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
Qigong Plus: Feasibility of delivering Qigong online to address social connection and wellbeing for the vulnerable in our community
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Scientific title
Qigong Plus: Feasibility of delivering Qigong online to address social connection and wellbeing for older adults aged 60 years and over living in the community
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Secondary ID [1]
312699
0
None
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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:
Healthy Ageing in Older Adults
334766
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Condition category
Condition code
Public Health
331327
331327
0
0
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Other public health
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Physical Medicine / Rehabilitation
331328
331328
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0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Qigong Plus (QGP) is a 6-week digital Qigong program for older adults living within the community. The program consisted of delivering an online group Qigong session once per week for one-hour guided in realtime by a qualified Qigong instructor. The weekly live sessions were delivered online via ZOOM videoconferencing platform to participants utilising their personal devices (e.g mobile phones, tablets, computers, etc.). After each week, participants were also given access to the ZOOM recordings of the Qigong practice for self-practice.
Program attendance tracking:
The target attendance for program completion was 5 out of 6 online Qigong Plus sessions. Online session attendance was manually recorded by the QGP instructor. Participants were also encouraged to journal their self-practice frequency outside of the online Qigong Plus sessions.
QGP Session structure:
The physical activity component of QGP was primarily in the form of Qigong exercises, which are generally considered to be low-intensity and well-tolerated amongst older adults. Thus, the exercise intensity for the QGP program was considered low - moderate for older adults. In addition, the QGP program was designed to allow participants to practice in sitting or standing positions - allowing for participants to opt for sitting practice if they perceived the training intensity to be too difficult. Participants were also encouraged to provide feedback regarding the training intensity for the QGP instructor to adjust the program accordingly.
Please refer to the following example of a 60min QGP online session structure:
Arrivals & Greetings - 5mins
Warm-up exercises (i.e dynamic stretching exercises such as neck and shoulder rotations, etc.)- 15mins
Breath and Chi regulation exercises (e.g exercises include "Lotus Flower Opening", "Two hands hold up the heaven", "Cloud hands", "The Archer Draws the Bow", "Circling the Moon", "Parting the Wild Horse's Mane".) - 15-20mins
Cool Down exercises -5-10mins
Mindfulness exercises - 10mins
Procedures: Participants were recruited within Australia. The QGP program took place primarily online. The QGP sessions were led by a Qualified Qigong master instructor experienced in the delivery of online and in-person Qigong programs. Once a week, for 6 weeks, participants attended an online group Qigong session led by the Qigong instructor. Participants also attended a 30-minute online orientation session one week before QGP program commencement via ZOOM, where they met with the Qigong instructor. The orientation session introduced participants to the program and helped them familirise themselves with the procedures for participating in the QGP program. Subsequently, each QGP online session was 60-minutes, consisting of 45-minutes Qigong practice, followed by 15-minutes of meditation for self-awareness and reflection. Examples of Qigong exercises included were “Lotus Flower Opening", "Two hands hold up the heaven", "Cloud hands", "The Archer Draws the Bow", "Circling the Moon", "Parting the Wild Horse's Mane". Qigong exercises were also adapted to better suit older adults (e.g minimising Qigong stances that require balancing on a single foot, etc.) In addition, participants were given access to ZOOM recordings of the Qigong sessions. The Qigong recordings were edited to focus on the program delivery of the Qigong instructor and removed the screens of the participants. Access to each session recording was only provided after completion of the respective weekly session.
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Intervention code [1]
329277
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Lifestyle
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Intervention code [2]
329278
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Behaviour
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Comparator / control treatment
No control group.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
339102
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Engagement Facilitators and Barriers
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Assessment method [1]
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Facilitators and Barriers were assessed through questionnaires (Self-developed based on previous research findings), interviews, and focus groups)
Questionnaires were designed specifically for this study and were focused on enquiring if the participants perceived any intrapersonal, interpersonal, or environmental factors as a facilitator / barrier to their participation in the program.
Interviews and focus groups were conducted online, led by a member of the research tine. A semi-structured script was developed for use in these interviews. Topics discussed during the interviews and focus groups were focused on examining the participants' experiences and feedback of the QGP program. Interviews were one-to-one, while focus groups had up to 6 participants at a time. All participants were invited to participate in the online focus groups, one-to-one interviews were offered to participants who preferred not to be interviewed in group settings. There were no limits to the number of participants to be selected for focus groups or interviews.
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Timepoint [1]
339102
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Baseline, end of program (Week 6, primary timepoint)
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Primary outcome [2]
339103
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Safety
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Assessment method [2]
339103
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Program safety assessed through [1] number of adverse events reported by QGP instructor and participants, and [2] Reported by participants through questionnaires (self-developed), interviews, and focus groups.
There were minimal adverse events predicted to occur during the course of thr 6-week Qigong program, however some examples of possible adverse events may include falls, overexertion, and musculoskeletal injuries.
Questionnaires were designed specifically for this study and were focused on enquiring if the participants had encountered any adverse events during the course of the program, and if these events were directly related to their participation in the program
Interviews and focus groups were conducted online, led by a member of the research tine. A semi-structured script was developed for use in these interviews. Topics discussed during the interviews and focus groups were focused on examining the participants' experiences and feedback of the QGP program. Interviews were one-to-one, while focus groups had up to 6 participants at a time. All participants were invited to participate in the online focus groups, one-to-one interviews were offered to participants who preferred not to be interviewed in group settings. There were no limits to the number of participants to be selected for focus groups or interviews.
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Timepoint [2]
339103
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Baseline, end of program (Week 6, primary timepoint)
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Primary outcome [3]
339104
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Acceptability
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Assessment method [3]
339104
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Acceptability assessed through questionnaires (Self-developed based on previous research findings), interviews, and focus groups.
Interviews and focus groups were conducted online, led by a member of the research tine. A semi-structured script was developed for use in these interviews. Topics discussed during the interviews and focus groups were focused on examining the participants' experiences and feedback of the QGP program. Interviews were one-to-one, while focus groups had up to 6 participants at a time. All participants were invited to participate in the online focus groups, one-to-one interviews were offered to participants who preferred not to be interviewed in group settings. There were no limits to the number of participants to be selected for focus groups or interviews.
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Timepoint [3]
339104
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Baseline, end of program (Week 6, primary timepoint)
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Secondary outcome [1]
438562
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Barriers to Technology Usage (This is an additional primary outcome)
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Assessment method [1]
438562
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Issues with using the required technology for the program was reported by participants through questionnaires (self-developed), interviews, and focus groups.
Questionnaires were designed specifically for this study and were focused on enquiring if the participants had encountered any technology usage difficulty (e.g lack of digital literacy, unstable internet connection, etc.) during the course of the program.
Interviews and focus groups were conducted online, led by a member of the research tine. A semi-structured script was developed for use in these interviews. Topics discussed during the interviews and focus groups were focused on examining the participants' experiences and feedback of the QGP program. Interviews were one-to-one, while focus groups had up to 6 participants at a time. All participants were invited to participate in the online focus groups, one-to-one interviews were offered to participants who preferred not to be interviewed in group settings. There were no limits to the number of participants to be selected for focus groups or interviews.
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Timepoint [1]
438562
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Baseline, mid-program (3rd week), end of program (Week 6, primary timepoint)
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Eligibility
Key inclusion criteria
Older adults who fulfil the following criteria:
I. 60 years old and above
II. Living within the community
III. Had access to the internet.
IV. Had access to a device (mobile, tablet, laptop, etc.) to participate in program.
V. Must have been able to perform basic limb movements in either sitting or standing positions.
VI. Must not have had severe visual, hearing, and /or cognitive impairments.
VII. Able to communicate in basic English.
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Minimum age
60
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?
Yes
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Key exclusion criteria
Individuals who had undertaken Qigong practice within the past 1 year of their date of recruitment.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised 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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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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
Completed
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Date of first participant enrolment
Anticipated
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Actual
11/04/2022
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Date of last participant enrolment
Anticipated
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Actual
4/10/2022
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Date of last data collection
Anticipated
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Actual
7/12/2022
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Sample size
Target
20
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Accrual to date
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Final
10
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
317132
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University
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Name [1]
317132
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RMIT University - ECP COVID Restart: ReStart - A Healthier Start
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Address [1]
317132
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Country [1]
317132
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Australia
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Primary sponsor type
University
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Name
RMIT UNIVERSITY
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Address
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Country
Australia
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Secondary sponsor category [1]
319399
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None
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Name [1]
319399
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Address [1]
319399
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Country [1]
319399
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315884
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Royal Melbourne Institute of Technology Human Research Ethics Committee
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Ethics committee address [1]
315884
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https://www.rmit.edu.au/research/our-research/ethics-and-integrity/human-ethics
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Ethics committee country [1]
315884
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Australia
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Date submitted for ethics approval [1]
315884
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25/10/2021
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Approval date [1]
315884
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22/12/2021
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Ethics approval number [1]
315884
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2022-24895-18321
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Summary
Brief summary
The purpose of this project was to provide information for the development of online physical activity programs for older adults to improve well-being and reduce social isolation. This study assessed the feasibility, engagement, and acceptability of a 6-week online Qigong program delivered to community-dwelling older adults.
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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
136090
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Prof Zhen Zheng
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Address
136090
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RMIT University, School of Health & Biomedical Science, PO Box 71, Bundoora Victoria, 3083, Australia
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Country
136090
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Australia
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Phone
136090
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+61 3 9925 7167
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Fax
136090
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Email
136090
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[email protected]
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Contact person for public queries
Name
136091
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Zhen Zheng
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Address
136091
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RMIT University, School of Health & Biomedical Science, PO Box 71, Bundoora Victoria, 3083, Australia
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Country
136091
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Australia
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Phone
136091
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+61 3 9925 7167
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Fax
136091
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Email
136091
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[email protected]
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Contact person for scientific queries
Name
136092
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Zhen Zheng
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Address
136092
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RMIT University, School of Health & Biomedical Science, PO Box 71, Bundoora Victoria, 3083, Australia
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Country
136092
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Australia
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Phone
136092
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+61 3 9925 7167
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Fax
136092
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Email
136092
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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)?
No
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No/undecided IPD sharing reason/comment
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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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