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Trial registered on ANZCTR
Registration number
ACTRN12617000033347
Ethics application status
Approved
Date submitted
21/12/2016
Date registered
9/01/2017
Date last updated
14/12/2018
Date data sharing statement initially provided
14/12/2018
Date results information initially provided
14/12/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Evaluation of a mental health literacy program on community leaders’ knowledge about and attitudes towards people with mental disorder in the Brong-Ahafo region in Ghana: Cluster randomised controlled trial
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Scientific title
Effectiveness of a mental health literacy program on community leaders’ knowledge about and attitudes towards people with mental disorder in the Brong Ahafo region in Ghana: Cluster randomised controlled trial
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Secondary ID [1]
290725
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Nil known
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Universal Trial Number (UTN)
Nil known
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Trial acronym
Nil Known
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Linked study record
Nil known
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Health condition
Health condition(s) or problem(s) studied:
Community leaders' knowledge about mental disorders.
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Community leaders' attitudes toward persons with mental disorders.
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Condition category
Condition code
Mental Health
301052
301052
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0
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Depression
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Mental Health
301053
301053
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0
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Schizophrenia
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
A mental health literacy training program on depression and schizophrenia, which revolves around the “Story bridge” (Lubman et al 2014) will be conducted for the intervention cluster. The program will be an interactive 3-hour session for each intervention cluster group. The training program will be delivered face to face, using a combination of Power-Point presentations, video-recordings and large- and small-group discussions, about people with depression and schizophrenia. Participants will also be given printed material about people with depression and schizophrenia: “Guidelines for Carers of Someone with a Mental Disorder” (www.mhfa.com). The training program will take place at participants' routine meeting place in their district, and will be delivered by Yaw Amankwa Arthur, a PhD Candidate.
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Intervention code [1]
296625
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Behaviour
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Intervention code [2]
296709
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Treatment: Other
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Comparator / control treatment
The control cluster will be provided with a brochure containing basic information about mental health issues. The brochure is designed specifically for this project.
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in attitudes and beliefs about mental health problems. This will be assessed using the Attitudes and Beliefs about Mental Health Problems: Professional and Public Views questionnaire (Jorm et al., 1999).
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Assessment method [1]
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Timepoint [1]
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Data will be collected at two time points. Baseline (Week 0) and follow-up (Week 12)
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Primary outcome [2]
300692
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Change in attitudes about people with a mental disorder. This will be assessed using the Community Attitudes to Mental Disorder (CAMI) scale (Taylor & Dear, 1981).
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Assessment method [2]
300692
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Timepoint [2]
300692
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Data will be collected at two time points. Baseline (week 0) and follow up (week 12)
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Secondary outcome [1]
330348
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None
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Assessment method [1]
330348
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Timepoint [1]
330348
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None
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Eligibility
Key inclusion criteria
All districts assemblies and current assembly members within the Brong Ahafo region of Ghana are potential clusters and participants.
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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?
Yes
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Key exclusion criteria
1. A district assembly unit and / or an assembly member who has received prior training about mental disorders.
2. An assembly member with current or previous work experience as a mental health professional.
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Study design
Purpose of the study
Educational / counselling / training
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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)
Cluster allocation will be concealed. Allocation, which will be off-site, will be carried out by a researcher who is not directly involved in the recruitment process for the study. Randomisation will be then emailed to the researcher allocating participants to intervention and control groups in Ghana.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation generated by a computer.
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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
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
In Brong Ahafo region there are 27 districts and a total of 766 elected assembly members. The study is planned with equally-sized control and treatment groups, with individuals clustered within districts, with each district comprising an average of 29 assembly members (approximately). For the control group, we anticipate a difference of 5 points in mental health literacy scores (as assessed by the Attitudes and Beliefs about Mental Health Problems: Public Views questionnaire (Jorm, Korten, Jacomb, Christensen, & Henderson, 1999) from baseline to 12 weeks. For the intervention group, we anticipate a change in 10 points in the intervention group cluster scores from baseline to 12 weeks. We anticipate data variability across both groups to be 10 points. We anticipate the intra-class correlation coefficient to be 0.03; of approximately medium magnitude. Hence, about 3% of total data variability is anticipated to occur between clusters; corresponding to a clustering design effect of 1.56.
At a 5% level of significance and a power of 80%, we would need to recruit a total of 128 participants (64 intervention group participants and 64 control group participants) to be able to reject the null hypothesis that the population means of the intervention and control group clusters are equal without clustering. Hence, we aim to recruit and cluster 2-3 intervention and 2- 3 control group clusters. To allow for some attrition, an additional 10% of the estimated sample size will be recruited, making a total of 140 participants.
Demographic characteristics of the participants will be summarised using frequencies and percentages. Analysis of Variance (ANOVA) will be conducted on the groups’ mean of the measures. Cronbach’s alpha will be used to assess the reliability of each scale at baseline. Pairwise comparisons will be undertaken to compare the different combinations between the three time points of the intervention and the control group clusters. The Chi-square will also be used to analyse the differences in knowledge, stigmatizing and discriminatory scores at baseline and follow-up time points.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/02/2017
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Actual
20/03/2017
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Date of last participant enrolment
Anticipated
31/03/2017
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Actual
11/04/2017
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Date of last data collection
Anticipated
30/06/2017
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Actual
14/07/2017
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Sample size
Target
128
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Accrual to date
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Final
140
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Recruitment outside Australia
Country [1]
8474
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Ghana
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State/province [1]
8474
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Brong-Ahafo region
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Funding & Sponsors
Funding source category [1]
295154
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University
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Name [1]
295154
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Victoria University, Institute for Health and Sport
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Address [1]
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Victoria University
P. O. Box 14428
Melbourne
Victoria 8001
Australia
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Country [1]
295154
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Australia
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Primary sponsor type
Individual
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Name
Professor Terence McCann
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Address
Institute of Health and Sport
Victoria University
P. O. Box 14428
Melbourne
Victoria 8001
Australia
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Country
Australia
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Secondary sponsor category [1]
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University
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Name [1]
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Victoria University, Institute of Health and Sport
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Address [1]
293976
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Victoria University
P. O. Box 14428
Melbourne
Victoria 8001
Australia
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Country [1]
293976
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
296506
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Ghana Health Service Ethics Review Committee
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Ethics committee address [1]
296506
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Research and Development Division
Ghana Health Service
P. O. Box MB 190
Accra.
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Ethics committee country [1]
296506
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Ghana
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Date submitted for ethics approval [1]
296506
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09/05/2016
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Approval date [1]
296506
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22/07/2016
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Ethics approval number [1]
296506
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GHS-ERC 09/05/16
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Ethics committee name [2]
296507
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Victoria University Human Research Ethics Committee
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Ethics committee address [2]
296507
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Victoria University
PO Box 14428
Melbourne
Victoria 8001
Australia.
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Ethics committee country [2]
296507
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Australia
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Date submitted for ethics approval [2]
296507
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27/05/2016
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Approval date [2]
296507
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12/09/2016
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Ethics approval number [2]
296507
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HRE16-140
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Summary
Brief summary
The aim of this study is to evaluate the effectiveness of a mental health literacy program on Ghanaian assembly members’ knowledge about and attitudes towards people with mental disorders. Based on a power analysis, 128 participants in six districts will be recruited. Districts will be clustered and randomised into intervention and control group clusters. Participants in the intervention cluster will be exposed to a mental health literacy program, while the control cluster will be given a brochure with basic information about mental health. Outcomes will be evaluated using standardized instruments about mental disorders. A quantitative process evaluation will be conducted on participants who took part in the training program. A randomised sample of the intervention cluster will also be interviewed to qualitatively evaluate the program. It is hypothesised that assembly members who participate in the mental health literacy training program will have higher mental health literacy and less stigmatizing attitudes than those who receive a brochure about mental health. The results of this study may contribute to Ghana’s mental health literacy programs because its effectiveness may assist participants who are local legislators to appreciate the need to commit resources for programs.
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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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Prof Terence McCann
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Address
71090
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Institute for Health and Sport, Victoria University P. O. Box 14428 Melbourne Victoria 8001 Australia
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Country
71090
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Australia
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Phone
71090
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+ 61399192325
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Fax
71090
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+61399192325
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Email
71090
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[email protected]
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Contact person for public queries
Name
71091
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Prof Terence McCann
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Address
71091
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Institute for Health and Sport, Victoria University P. O. Box 14428 Melbourne Victoria 8001 Australia
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Country
71091
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Australia
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Phone
71091
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+ 61399192325
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Fax
71091
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+ 61399192325
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Email
71091
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[email protected]
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Contact person for scientific queries
Name
71092
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Prof Terence McCann
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Address
71092
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Institute for Health and Sport, Victoria University P. O. Box 14428 Melbourne Victoria 8001 Australia
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Country
71092
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Australia
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Phone
71092
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+ 61399192325
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Fax
71092
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+ 61399192325
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Email
71092
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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
Ethics approval was not obtained to make IPD available
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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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