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Trial registered on ANZCTR
Registration number
ACTRN12623000397617
Ethics application status
Approved
Date submitted
24/01/2023
Date registered
19/04/2023
Date last updated
21/06/2024
Date data sharing statement initially provided
19/04/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Temporary Withholding of Immunosuppressant in Rheumatic diseases and Lupus (TWIRL) Study
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Scientific title
Change in Anti-Influenza Antibody Level following Temporary Withholding of Immunosuppressant in Rheumatic diseases and Lupus (TWIRL) Study
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Secondary ID [1]
308823
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None
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Universal Trial Number (UTN)
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Trial acronym
TWIRL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Systemic lupus erythematosus
328781
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Condition category
Condition code
Inflammatory and Immune System
325788
325788
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0
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Autoimmune diseases
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Inflammatory and Immune System
325789
325789
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0
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Connective tissue diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Temporary withholding of mycophenolate for 2 weeks after vaccination. The dose will depend on the usual dose that patient is currently receiving, which can vary usually between 500mg twice daily to 1.5g twice daily orally. We will be relying on text messages and emails to remind participants to resume to taking their medications.
We will be offering participants the standard influenza vaccine as eligible for patients who have impaired immunity as part of the National Immunisation Program. For those who participated in 2023, we offered the Afluria Quad (CSL Sequirus) influenza vaccination. In 2024, we will offer an equally appropriate influenza vaccine of those available as part of the National Immunisation Program - the Flucelvax Quad (CSL Sequirus) influenza vaccination.
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Intervention code [1]
325271
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Treatment: Drugs
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Comparator / control treatment
Control arm is usual care which is to continue immunosuppressant as per usual
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Control group
Active
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Outcomes
Primary outcome [1]
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Proportion of patients achieving greater than 4-fold increase in antibody titre of Anti-influenza antibody in plasma by haemagglutination inhibition assay (HIA) in 2 of 4 influenza vaccine antigens compared to baseline
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Assessment method [1]
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Timepoint [1]
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Bloods collected at baseline (week 0) and 4 weeks following vaccination will be analysed to measure change in HIA
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Secondary outcome [1]
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Patient flares will be assessed via both physician-reported and patient-reported measures. A patient-reported outcome measure in the form of RAPID3 (score 0-30) will be captured, with a flare defined as a RAPID3 score of greater than or equal to 13.
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Assessment method [1]
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Timepoint [1]
417812
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Participants will be asked to complete the RAPID3 questionnaire at five timepoints: at baseline (week 0), week 2, 4, 8, and 12 following influenza vaccine.
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Secondary outcome [2]
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Flares will also be captured by SFI (SLE Flare Index), a physician-reported measurment
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Assessment method [2]
420436
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Timepoint [2]
420436
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SFI will be assessed at baseline (week 0) and at a lupus clinic visit 5 weeks following influenza vaccine.
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Secondary outcome [3]
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Flare assessment by physician using the Physicians' Global Assessment (PGA), where a flare is defined as a change of 1 or greater from baseline.
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Assessment method [3]
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Timepoint [3]
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PGA will be assessed at baseline (week 0) and at a lupus clinic visit 5 weeks following influenza vaccine.
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Eligibility
Key inclusion criteria
• Patients with systemic lupus erythematosus, who are currently enrolled in the Australian Lupus Registry & Biobank.
• Receiving stable doses of mycophenolate and have not experienced a flare in the last 3 months.
• Combination with hydroxychloroquine will be permitted
• Prednisolone must be at a dose equal or lower than 7.5mg/day.
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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
• Concomitant use of other biologics such as rituximab or belimumab in the last 6 months
• Other targeted synthetic disease modifying anti-rheumatic drugs such as JAK inhibitors
• Age >65 as a different, adjuvated vaccine is clinically recommended for this age group
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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)
Allocation will be carried out through randomisation
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised 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
Parallel
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Other design features
No new medication is being trialled. This study aims to investigate the effect of withholding mycophenolate in SLE patients for two weeks after patients receive an influenza vaccine. Patients will be randomised to either Group 1: withholding mycophenolate for two weeks or Group 2: continuing mycophenolate use per normal
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Phase
Phase 2
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Satisfactory vaccine response to seasonal influenza vaccination will be defined by greater than or equal to a four-fold increase in antibody titre in two of four influenza vaccine antigens compared to baseline responses prior to immunization. The proportion of participants who achieve a satisfactory vaccine response from each group will be reported and compared, using Fisher’s exact test. Other continuous variables are analysed by using a t-test or Mann Whitney U test as appropriate. Binary secondary efficacy variables (such as frequency of disease flare and incidence of infection) will be compared using Fisher’s exact test. Logistic regression will be used to assess the association of clinical variables such as absolute B-cell and/or T-cells numbers at baseline, study group assignment (temporary interruption vs continuation), and other disease-related parameters with adequate vaccine response. P<0.05 is considered to indicate statistical significance.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
24/04/2023
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Actual
16/05/2023
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Date of last participant enrolment
Anticipated
31/08/2024
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Actual
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Date of last data collection
Anticipated
31/10/2024
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Actual
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Sample size
Target
80
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Accrual to date
19
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
24473
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Monash Medical Centre - Clayton campus - Clayton
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Recruitment postcode(s) [1]
39340
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3168 - Clayton
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Monash University
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Address [1]
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School of Clinical Sciences
246 Clayton Road
Clayton Victoria 3168
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Country [1]
313046
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Australia
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Funding source category [2]
313582
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Charities/Societies/Foundations
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Name [2]
313582
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Arthritis Australia
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Address [2]
313582
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Arthritis Australia
Level 2/255 Broadway
GLEBE NSW 2037
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Country [2]
313582
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Australia
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Primary sponsor type
Hospital
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Name
Monash Health
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Address
Monash Health
246 Clayton Road
Clayton 3168
Victoria
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Country
Australia
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Secondary sponsor category [1]
314733
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University
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Name [1]
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Monash University
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Address [1]
314733
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School of Clinical Science
246 Clayton Road
Clayton 3168
Victoria
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Country [1]
314733
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
312299
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Monash Health HREC
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Ethics committee address [1]
312299
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Research Support Services Level 2, i Block, Monash Medical Centre 246 Clayton Road Clayton VIC 3168
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Ethics committee country [1]
312299
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Australia
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Date submitted for ethics approval [1]
312299
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15/11/2022
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Approval date [1]
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10/02/2023
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Ethics approval number [1]
312299
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Summary
Brief summary
Mycophenolate is an immunosuppressant that is widely used as a treatment for systemic lupus erythematosus (SLE). Its biological effects involve a reduction in immune cell functions, which in turn reduce systemic or organ related inflammation and damage. The benefits of using mycophenolate in SLE need to be carefully balanced against unintended side effects such as increased risk of infection or blunting of vaccine responses. One strategy to counteract these effects is the temporary withdrawal of the immunosuppressant, which allows for the immune system to recover and effectively respond to a vaccine or infection. Our study will examine the effects of withdrawing mycophenolate for a short period in SLE patients. Our hypothesis is that this temporary withdrawal will result in an improvement in the immune responses to the influenza vaccination while maintaining disease control.
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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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A/Prof Alberta Hoi
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Address
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School of Clinical Sciences, Monash Health, 246 Clayton Road, Clayton 3168, Victoria
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Country
124162
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Australia
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Phone
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+61 411145282
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Fax
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Email
124162
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[email protected]
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Contact person for public queries
Name
124163
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Alberta Hoi
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Address
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School of Clinical Sciences
246 Clayton Road
Clayton 3168
Victoria
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Country
124163
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Australia
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Phone
124163
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+61 03 9594 4899
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Fax
124163
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Email
124163
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[email protected]
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Contact person for scientific queries
Name
124164
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Alberta Hoi
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Address
124164
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School of Clinical Sciences, Monash Health, 246 Clayton Road, Clayton 3168, Victoria
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Country
124164
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Australia
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Phone
124164
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+61411145282
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Fax
124164
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Email
124164
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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?
Upon request, deidentified, pooled data may be shared.
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When will data be available (start and end dates)?
For up to 7 years after publication date
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Available to whom?
For academic researchers
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Available for what types of analyses?
For researchers interested in meta-analyses
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How or where can data be obtained?
In writing by email principal investigator
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
18113
Study protocol
[email protected]
385276-(Uploaded-05-04-2024-11-47-01)-Study-related document.docx
18115
Informed consent form
[email protected]
385276-(Uploaded-05-04-2024-11-47-29)-Study-related document.pdf
18116
Clinical study report
[email protected]
18117
Ethical approval
[email protected]
385276-(Uploaded-05-04-2024-11-49-34)-Study-related document.pdf
18118
Analytic code
[email protected]
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.
Download to PDF