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Trial registered on ANZCTR
Registration number
ACTRN12625000907448p
Ethics application status
Not yet submitted
Date submitted
25/07/2025
Date registered
20/08/2025
Date last updated
20/08/2025
Date data sharing statement initially provided
20/08/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Impact of premenopausal risk-reducing bilateral salpingo-oophorectomy on non-cancer outcomes in BRCA1/2: 10-year follow up of a multicentre prospective controlled study.
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Scientific title
A follow up at 10 years of the impact of premenopausal risk-reducing bilateral salpingo-oophorectomy on non-cancer outcomes in women who were at risk of developing ovarian cancer and who had undergone risk-reducing bilateral salpingo-oophorectomy (RRBSO). Outcomes include sexual function, menopause related quality of life and cognitive function.
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Secondary ID [1]
314997
0
nil known
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Universal Trial Number (UTN)
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Trial acronym
WHAM-10
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Linked study record
This is the 10 year follow up of participants previously enrolled in the Women's Health After Surgical Menopause study (ACTRN12615000082505).
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Health condition
Health condition(s) or problem(s) studied:
Ovarian cancer
338322
0
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Menopause
338430
0
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Osteoporosis
338431
0
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BRCA variants
338434
0
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Cardiovascular disease
338435
0
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Condition category
Condition code
Cancer
334615
334615
0
0
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Ovarian and primary peritoneal
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Reproductive Health and Childbirth
334616
334616
0
0
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Menstruation and menopause
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Cardiovascular
334617
334617
0
0
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Other cardiovascular diseases
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Musculoskeletal
334618
334618
0
0
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Osteoporosis
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Human Genetics and Inherited Disorders
334732
334732
0
0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Women at risk of developing ovarian and/or breast cancer who have undergone RRBSO. Non-cancer outcomes including sexual function, menopause symptoms and quality of life issues, bone health, cardiovascular health, sleep quality, depression/anxiety symptoms and cognitive function will be assessed at the 10 year follow up using the following:
Blood tests
Bone mineral density scanning
Completion of questionnaires
cognitive function (online and face-to-face) testing
Total time commitment no greater than 6hours includes a single in person visit and short online questionnaires over 5 days.
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Intervention code [1]
331586
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Not applicable
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Comparator / control treatment
The age matched control group participants from WHAM that were not at increased risk of ovarian cancer nor undergoing RRSO at that time will undergo the same processes as the identified high-risk group.
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Control group
Active
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Outcomes
Primary outcome [1]
342296
0
To determine the composite differences in nature, severity and trajectory of menopausal symptoms and menopause related quality of life between surgical menopause compared natural menopause - to include menopausal symptoms, sleep quality, sexual function, depression and anxiety,
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Assessment method [1]
342296
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Independent measures of menopause symptoms: Menopause related quality of life (intervention) scale MENQOL-I; Hot Flash Related Daily Interference Scale Measurement of sleep: Pittsburgh Sleep Quality Index (PSQI), a widely used and validated measure of sleep quality Measurement of anxiety and depression: Center for Epidemiologic Studies Depression (CES-D) and the Generalised Anxiety Disorder (GAD-7)(29) scales. Measurement of sexual function: Sexual Activity Questionnaire (SAQ); the Female Sexual Function Index (FSFI) and the revised Female Sexual Distress Scale (FSDS-R)
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Timepoint [1]
342296
0
10-year follow up
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Secondary outcome [1]
450267
0
The effect of surgical menopause compared to natural menopause on cardiometabolic health.
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Assessment method [1]
450267
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Measurement of cardiometabolic risk: Resting blood pressure, weight, height and waist/hip ratio will be measured. Fasting blood samples will be analysed for serum insulin, glucose, triglycerides, cholesterol, high-density lipoprotein (HDL-C), low-density lipoprotein (LDL-C) and high-sensitivity C reactive protein, In the Victorian cohort only, vascular health will be assessed using retinal photography and carotid ultrasound for pulse wave velocity, carotid distensibility and carotid intima media thickness. These will be measured according to a previously validated protocol and provide information about vascular markers that are predictive of future vascular health. Retinal imaging will be performed using a retinal camera. Photos will be reviewed by an ophthalmologist.
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Timepoint [1]
450267
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10-year follow up
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Secondary outcome [2]
450621
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The effect of surgical menopause compared to natural menopause on bone density and strength will be assessed independently.
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Assessment method [2]
450621
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Assessment measures include: circulating markers of bone turnover (beta C terminal telopeptide of type I collagen (beta CTX) and N terminal pro-peptide of type 1 collagen) will be measured as well as 25-OH vitamin D2 and D3 using LC-MS/MS and intact parathyroid hormone immunoassay. Regional BMD (at the lumbar spine and hip) will be measured using dual-energy X-ray absorptiometry (DXA). Fracture risk assessment using a FRAX tool will be used to calculate fracture risk. In the Victorian cohort Peripheral quantitative computed tomography (pQCT) will be used to assess assessment of bone structure, composition and geometry, while finite element analysis (FEA) will be used to assess bone strength. Standard clinical whole body DXA scans will be performed using Hologic fan-beam densitometers.
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Timepoint [2]
450621
0
10-year follow up
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Secondary outcome [3]
450622
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The effect of surgical menopause on cognition.
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Assessment method [3]
450622
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Standardised neurocognitive tests measured at 1 and 2 years will be repeated including the Hopkins Verbal Learning Test-Revised (HVLT-R) which measures verbal learning and memory, and the Symbol Digit Modalities Test (SDMT) which measures psychomotor speed, and the Verbal Fluency Test (VFT) to assess verbal fluency of letters and animals will be used to assess cognition. In addition subjective cognition will be measured using the Everyday Memory Questionnaire Revised EMQ-R) and, the Boston Remote Assessment for NeuroCognitive Health (BRANCH) (www.bostonbranch.org).
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Timepoint [3]
450622
0
10-year follow up
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Secondary outcome [4]
450873
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The effect of surgical menopause compared to natural menopause on body composition.
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Assessment method [4]
450873
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Measurement of cardiometabolic risk: weight, height and waist/hip ratio will be measured. Whole body DXA will be used to assess body composition. In the Victorian cohort only, strength, balance and endurance will be tested using hand dynamometer, 6-minute walk test and the gait mat. The 6-minute walk test will be performed according to the Queensland Cardiorespiratory Physiotherapy guideline. Grip strength will be measured by a hand dynamometer. Balance will be tested using a gait mat (GaitRite ®). In the Victorian cohort only, vascular health will be assessed using retinal photography and carotid ultrasound for pulse wave velocity, carotid distensibility and carotid intima media thickness. These will be measured according to a previously validated protocol and provide information about vascular markers that are predictive of future vascular health. Retinal imaging will be performed using a retinal camera. Photos will be reviewed by an ophthalmologist. T Each total body composition scan, inclusive of the head, trunk and limbs, was performed in array mode and data were analyzed using the manufacturer's commercial body composition software.
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Timepoint [4]
450873
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10-year follow up
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Secondary outcome [5]
450874
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The effect of surgical menopause on the presence of vascular-inflammatory mediators.
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Assessment method [5]
450874
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Vascular and inflammatory mediators will be measured in plasma (p-tau217, NfL, GFAP) using the S-PLEX ® assay platform from Meso Scale Discovery from the 10-year visit and from samples stored from Baseline, 12-month and 24-month visits. A proteomic panel using Nucleic acid Linked Immuno-Sandwich Assay (NULISA) will also be measured in plasma at the same time intervals.
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Timepoint [5]
450874
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10-year follow up
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Eligibility
Key inclusion criteria
This is a 10-year follow-up study of a prospective cohort study that compared high-risk premenopausal women who underwent risk reduction salpingo-oophorectomy (RRSO) (n=104) with age-matched, premenopausal women (n=102). Only women who were enrolled in WHAM will be invited to participate in WHAM-10.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Not previously enrolled in the WHAM study.
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Case control
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Timing
Both
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
5/01/2026
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Actual
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Date of last participant enrolment
Anticipated
5/01/2027
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Actual
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Date of last data collection
Anticipated
31/01/2027
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Funding & Sponsors
Funding source category [1]
319548
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Charities/Societies/Foundations
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Name [1]
319548
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Wellcome Leap
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Address [1]
319548
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Country [1]
319548
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United States of America
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Funding source category [2]
319549
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University
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Name [2]
319549
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University of Melbourne
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Address [2]
319549
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Country [2]
319549
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Australia
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Primary sponsor type
University
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Name
University of Melbourne
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Address
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Country
Australia
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Secondary sponsor category [1]
322053
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None
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Name [1]
322053
0
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Address [1]
322053
0
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Country [1]
322053
0
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
318123
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The Royal Melbourne Hospital Human Research Ethics Committee
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Ethics committee address [1]
318123
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https://www.thermh.org.au/research/researchers/ethics
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Ethics committee country [1]
318123
0
Australia
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Date submitted for ethics approval [1]
318123
0
27/08/2025
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Approval date [1]
318123
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Ethics approval number [1]
318123
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Summary
Brief summary
This is a follow up study evaluating the impact of risk-reducing bilateral salpingo-oophorectomy (RRBSO) on sexual function, menopause symptoms and quality of life issues, bone health, cardiovascular health, sleep quality, depression/anxiety symptoms and cognitive function in high-risk, pre-menopausal women who participated in the WHAM study 10 years ago. Who is it for? You may be eligible if you participated in the WHAM study 10 years ago. Study details Participants will be assessed for non-cancer outcomes including sexual function, menopause symptoms and quality of life issues, bone health, cardiovascular health, sleep quality, depression/anxiety symptoms and cognitive function will be assessed at the 10 year follow up using the following: Blood tests, Bone mineral density scanning, Completion of questionnaires, cognitive function (online and face-to-face) testing Total time commitment no greater than 6hours. It is hoped that the result from this study will contribute to understanding the long-term effects of RRBSO to better inform future management.
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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
143190
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Prof Martha Hickey
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Address
143190
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University of Melbourne Department of Obstetrics and Gynaecology Level 7, Research Precinct Royal Women's Hospital (RWH) Cnr Grattan St & Flemington Rd Parkville 3052 Victoria
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Country
143190
0
Australia
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Phone
143190
0
+61414916734
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Fax
143190
0
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Email
143190
0
[email protected]
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Contact person for public queries
Name
143191
0
Martha Hickey
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Address
143191
0
University of Melbourne Department of Obstetrics and Gynaecology Level 7, Research Precinct Royal Women's Hospital (RWH) Cnr Grattan St & Flemington Rd Parkville 3052 Victoria
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Country
143191
0
Australia
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Phone
143191
0
+61 3 8345 2000
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Fax
143191
0
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Email
143191
0
[email protected]
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Contact person for scientific queries
Name
143192
0
Martha Hickey
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Address
143192
0
University of Melbourne Department of Obstetrics and Gynaecology Level 7, Research Precinct Royal Women's Hospital (RWH) Cnr Grattan St & Flemington Rd Parkville 3052 Victoria
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Country
143192
0
Australia
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Phone
143192
0
+61 3 8345 2000
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Fax
143192
0
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Email
143192
0
[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
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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