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Trial registered on ANZCTR
Registration number
ACTRN12614000774628
Ethics application status
Approved
Date submitted
2/07/2014
Date registered
21/07/2014
Date last updated
23/11/2018
Date data sharing statement initially provided
23/11/2018
Date results provided
23/11/2018
Type of registration
Retrospectively registered
Titles & IDs
Public title
Evaluation of a self-help manual for supporting family carers of clients with depression in Thailand: a randomised controlled trial.
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Scientific title
Effect of a self-help manual for supporting family carers of clients with depression in Thailand, on resilience, expressed emotion and experience of caregiving: a randomised controlled trial.
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Secondary ID [1]
284903
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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
This trial (ACTRN: 12614000774628) is the sub-study of another trial entitled 'A randomised controlled trial on the effect of a cognitive behavioural bibliotherapy self-help intervention program on increasing resilience in individuals with depression' (ACTRN: 12611000905965). ACTRN: 12611000905965 is the trial of people diagnosed with depression, while ACTRN 12614000774628 is the trial of their family caregivers.
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Health condition
Health condition(s) or problem(s) studied:
Experience of caregiving in carers of individuals with depression
292364
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Resilience in carers of individuals with depression
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Expressed emotion in caregivers of depression care recipients
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Condition category
Condition code
Mental Health
292686
292686
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0
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Depression
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This involves the intervention group of primary carers of individuals with depression reading a cognitive behaviour therapy based bibliotherapy manual; 'The Good Mood Guide: A Self-Help Manual for Depression,' plus a short weekly telephone contact, for 8 weeks, of approximately five minutes’ duration with one of the researchers. Adherence was also assessed through the weekly telephone calls, whereby the researcher asked a standardised set of questions about the content of the specific module. Answers to these questions enabled the research to ascertain complicance with the readings.
The manual contains eight modules, each module containing reading, writing and activities to be completed over a one-week time-frame. Each module takes approximately 1-2 hours per week to complete. The entire program was designed to be completed in eight weeks. By reading the manual, it is anticipated that participants will have an increase in their resilience. Data will be collected at three timepoints: Baseline (Week 0), end of program (Week 8), and 4 weeks follow-up (Week 12).
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Intervention code [1]
289722
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Behaviour
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Intervention code [2]
289723
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Treatment: Other
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Comparator / control treatment
The control group of primary caregivers will not be given the self-help manual but will continue to receive standard family support (standard outpatient support group) as well as a short weekly telephone call of approximately five minutes’ duration from a researcher. The duration of control group intervention is eight weeks. Data will be collected at three timepoints: Baseline (Week 0), completion of the intervention (Week 8), and 4 weeks after completing the intervention (Week 12).
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Control group
Active
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Outcomes
Primary outcome [1]
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To assess if there is any difference in the level of resilience of carers who complete the guided-help manual, at 12-week follow-up, compared to a control group who continue to receive only the standard care approach to caregivers of individuals with depression.
Resilience assessed using the following psychometric instrument: Resilience Scale measures the degree of individual resilience (Wagnild & Young, 1993). It contains 25 items rated on a 7-point Likert scale, with scores ranging from 25 to 175; higher scores reflecting greater resilience.
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Assessment method [1]
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Timepoint [1]
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Data will be collected at three timepoints: Baseline (Week 0), end of program (Week 8), and 4 weeks follow-up (Week 12).
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Primary outcome [2]
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To assess if there is any difference in the experience of caring of carers who complete the guided self-help manual, at 12-week follow-up, compared to a control group who continue to receive only the standard care approach to caregivers of individuals with depression.
Caregiving experience assessed using the following psychometric instrument: Experience of Caregiving Inventory (ECI) (Szmukler et al. 1996), a 66-item instrument which measures caregivers' appraisal of their caregiving experience.
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Assessment method [2]
292609
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Timepoint [2]
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Data will be collected at three timepoints: Baseline (Week 0), end of program (Week 8), follow-up (Week 12)
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Primary outcome [3]
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To assess if there is any difference in the level of expressed emotion of carers who complete the guided self-help manual, at 12-week follow-up, compared to a control group who continue to receive only the standard care approach to caregivers of individuals with depression.
Level of expressed emotion assessed using the following psychometric instrument: Family Questionnaire (Wiedemann et al. 2002), a 20-item self-report instrument, which assesses the level of expressed emotion in a family. Expressed emotion is a type of negative communication involving excessive criticism and emotional over-involvement directed at a patient by family members.
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Assessment method [3]
292610
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Timepoint [3]
292610
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Data will be collected at three timepoints: Baseline (Week 0), end of program (Week 8), follow-up (week 12)
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Secondary outcome [1]
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Nil
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Assessment method [1]
309161
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Timepoint [1]
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Nil
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Eligibility
Key inclusion criteria
a) main family support person to a Thai national diagnosed with moderate depression ((F32.1), ICD-10 classification) receiving outpatient treatment at Suan Prung Psychiatric Hospital, (b) aged 18–60 years, (c) able to read and write Thai, and (d) had a working telephone at home.
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Minimum age
18
Years
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Maximum age
60
Years
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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
Currently receiving treatment for mental illness.
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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)
Allocation was concealed. Allocation, which was off-site, was carried out by a researcher who was not directly involved in the recruitment process for the study. Randomisation was then emailed to the researcher allocating participants to intervention and control groups in Thailand.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants were randomly assigned to either the intervention or the control group by means of independent random allocation, using a computer generated randomisation list. This process was carried out by a researcher who was not directly involved in the recruitment process for the study.
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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
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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
20/10/2007
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Actual
20/10/2007
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Date of last participant enrolment
Anticipated
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Actual
8/02/2008
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Date of last data collection
Anticipated
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Actual
2/05/2008
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Sample size
Target
54
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Accrual to date
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Final
54
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Recruitment outside Australia
Country [1]
6189
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Thailand
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State/province [1]
6189
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Chiang Mai Province
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Terence McCann & Wallapa Songprakun
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Address [1]
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Victoria University
Institute of Health and Sport
McKechnie Street
St. Albans
Vic 3021
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Victoria University
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Address
Victoria University
Institute of Health and Sport
McKechnie Street
St. Albans
Vic 3021
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
288218
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
291269
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Victoria University Human Research Ethics Committee
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Ethics committee address [1]
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Victoria University PO Box 14428 Melbourne Victoria 8001
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Ethics committee country [1]
291269
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Australia
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Date submitted for ethics approval [1]
291269
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Approval date [1]
291269
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09/08/2007
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Ethics approval number [1]
291269
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HRETH 07/155
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Ethics committee name [2]
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Institutional Review Board, Department of Mental Health, Ministry of Public Health, Thailand
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Ethics committee address [2]
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Department of Mental Health, Ministry of Public Health, 88/20 Tivanond Road, Nonthaburi 11000, Bangkok, Thailand
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Ethics committee country [2]
291270
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Australia
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Date submitted for ethics approval [2]
291270
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Approval date [2]
291270
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17/10/2007
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Ethics approval number [2]
291270
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Summary
Brief summary
The aim of this study was to assess whether a self-help manual for caregivers of individuals with depression was effective in strengthening their resilience, reducing expressed emotion and improving their experience of caregiving. The study involved two groups: an 'intervention' group who studied the manual, and a 'control' group who did not study the manual.
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Trial website
Nil
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Trial related presentations / publications
Publications are pending.
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Public notes
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Contacts
Principal investigator
Name
49614
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Prof Terence McCann
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Address
49614
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Victoria University
Institute of Health and Sport
McKechnie Street
St. Albans
Vic 3021
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Country
49614
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Australia
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Phone
49614
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+61 3 9919 2325
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Fax
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Email
49614
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[email protected]
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Contact person for public queries
Name
49615
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Terence McCann
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Address
49615
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Victoria University
Institute of Health and Sport
McKechnie Street
St. Albans
Vic 3021
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Country
49615
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Australia
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Phone
49615
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+61 3 9919 2325
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Fax
49615
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Email
49615
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[email protected]
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Contact person for scientific queries
Name
49616
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Terence McCann
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Address
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Victoria University
Institute of Health and Sport
McKechnie Street
St. Albans
Vic 3021
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Country
49616
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Australia
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Phone
49616
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+61 3 9919 2325
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Fax
49616
0
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Email
49616
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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
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
McCann, T.V., Songprakun, W. & Stephenson, J. (201...
[
More Details
]
Study results article
Yes
McCann, T. V., Songprakun, W., & Stephenson, J. (2...
[
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Study results article
Yes
McCann, T. V., Songprakun, W., & Stephenson, J. (2...
[
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Study results article
Yes
McCann, T. V., Songprakun, W., & Stephenson, J. (2...
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Basic results
No
366639-(Uploaded-23-11-2018-11-07-40)-Basic results summary.docx
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
A randomized controlled trial of guided self-help for improving the experience of caring for carers of clients with depression.
2015
https://dx.doi.org/10.1111/jan.12624
N.B. These documents automatically identified may not have been verified by the study sponsor.
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