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Trial registered on ANZCTR
Registration number
ACTRN12624001402538
Ethics application status
Approved
Date submitted
11/11/2024
Date registered
26/11/2024
Date last updated
26/11/2024
Date data sharing statement initially provided
26/11/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
Endo Gut Study - Understanding the prevalence, type and frequency of gastrointestinal symptoms in women with and without endometriosis.
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Scientific title
Prevalence, type and frequency of gastrointestinal symptoms in women with and without endometriosis - Role of psychological distress and comparison of stool and vaginal microbiota in these women
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Secondary ID [1]
312604
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Nil known
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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:
Endometriosis
335703
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Irritable bowel syndrome
335704
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Condition category
Condition code
Reproductive Health and Childbirth
332271
332271
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0
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Other reproductive health and childbirth 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
There is a high prevalence of gut symptoms in the endometriosis population where a concurrent diagnosis of irritable bowel syndrome (IBS) is common. As symptoms in women with or without endometriosis are similar it is often difficult distinguishing between endometriosis and IBS. We want to know if IBS in this setting is a true co-morbidity or a misdiagnosis. To do this we will examine differences in the stool and vaginal microbiota, psychological distress and clinical phenotypes of women with endometriosis compared to those with endometriosis excluded via laparoscopy and healthy controls.
For participants, this involves collecting one-off stool and vaginal swab samples at home on the same day completing several one-off questionnaires (e.g. Bristol stool chart, ENDOMETRIOSIS HEALTH PROFILE QUESTIONNIRE, NIH PROMIS GI symptom scale, gastrointestinal quality of life (GIQLI) questionnaire, Depression and Anxiety Symptom Score (DASS21).
These data collection tools will provide information about the gastrointestinal symptoms, psychological status and faecal + vaginal microbiota of study participants.
Completing the questionnaires will take participants approximately 30 mins and collecting the stool and vaginal swab will take approximately 10 mins.
Participants will complete the study once they collect the samples and completed the questionnaires on one day.
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Intervention code [1]
329933
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Not applicable
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Comparator / control treatment
People with gastrointestinal symptoms who have had endometriosis ruled out via laparoscopy and heathy controls. The reference control group will be people with gastrointestinal symptoms who have had endometriosis ruled out via laparoscopy.
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Control group
Active
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Outcomes
Primary outcome [1]
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Differences in microbiota profile
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Assessment method [1]
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Metagenomic sequencing and bioinformatics
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Timepoint [1]
339842
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One-off assessment - cross-sectional data
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Secondary outcome [1]
441936
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Constipation
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Assessment method [1]
441936
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NIH PROMIS Gastrointestinal Symptom Scales
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Timepoint [1]
441936
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one off assessment
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Secondary outcome [2]
441621
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Quality of life
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Assessment method [2]
441621
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ENDOMETRIOSIS HEALTH PROFILE QUESTIONNIRE, Gastrointestinal quality of life (GIQLI) questionnaire
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Timepoint [2]
441621
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One-off assessment - cross-sectional data
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Secondary outcome [3]
441938
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Abdominal pain
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Assessment method [3]
441938
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NIH PROMIS Gastrointestinal Symptom Scales
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Timepoint [3]
441938
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one-off assessment
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Secondary outcome [4]
441935
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Diarrhoea
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Assessment method [4]
441935
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NIH PROMIS Gastrointestinal Symptom Scales
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Timepoint [4]
441935
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one-off assessment - cross-sectional data
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Secondary outcome [5]
441934
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Bloating
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Assessment method [5]
441934
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NIH Promis GI symptom scales
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Timepoint [5]
441934
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One-off assessment - cross-sectional data
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Secondary outcome [6]
441622
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Psychological distress
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Assessment method [6]
441622
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Depression and Anxiety Symptom Score (DASS21)
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Timepoint [6]
441622
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One-off assessment - cross-sectional data
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Secondary outcome [7]
441619
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Stool characteristics - this will be assessed as a composite outcome
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Assessment method [7]
441619
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Bristol stool form scale
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Timepoint [7]
441619
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One-off assessment - cross-sectional data
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Secondary outcome [8]
441939
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disrupted swallowing
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Assessment method [8]
441939
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NIH PROMIS Gastrointestinal Symptom Scales
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Timepoint [8]
441939
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one-off assessment
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Secondary outcome [9]
441618
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Prevalence of IBS
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Assessment method [9]
441618
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Rome IV questionnaire
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Timepoint [9]
441618
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One-off assessment - cross-sectional data
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Secondary outcome [10]
441940
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nausea
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Assessment method [10]
441940
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NIH PROMIS Gastrointestinal Symptom Scales
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Timepoint [10]
441940
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one-off assessment
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Secondary outcome [11]
441937
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Bloating
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Assessment method [11]
441937
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NIH PROMIS Gastrointestinal Symptom Scales
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Timepoint [11]
441937
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one-off assessment
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Eligibility
Key inclusion criteria
Group 1 - People diagnosed with endometriosis either by laparoscopy or imaging studies, and experiencing gut symptoms, e.g. IBS
Group 2 - People who have been investigated via laparoscopy but no endometriosis found, and are experiencing gut symptoms e.g. IBS
Group 3 - healthy controls, no endometriosis and no gut symptoms
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Minimum age
19
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
Anitbiotics or probiotics within the month before participating.
Known inflammatory bowel disease / symptoms
GI malignancy
Past bowel resection
Pregnancy or breast feeding
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Random sample
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
8/03/2022
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Date of last participant enrolment
Anticipated
31/05/2025
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Actual
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Date of last data collection
Anticipated
30/06/2025
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Actual
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Sample size
Target
124
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Accrual to date
114
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Final
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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]
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Government body
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Name [1]
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Australian Government Department of Health and Aged Care: Medical Research Future Fund
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Address [1]
317033
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Country [1]
317033
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Australia
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Primary sponsor type
University
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Name
Monash University
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Address
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Country
Australia
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Secondary sponsor category [1]
319280
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None
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Name [1]
319280
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Address [1]
319280
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Country [1]
319280
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315789
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Monash University Human Research Ethics Committee
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Ethics committee address [1]
315789
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https://www.monash.edu/researchoffice/ethics
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Ethics committee country [1]
315789
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Australia
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Date submitted for ethics approval [1]
315789
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26/10/2020
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Approval date [1]
315789
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10/11/2020
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Ethics approval number [1]
315789
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26636
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Summary
Brief summary
The purpose of this study is to understand the prevalence, type and frequency of gastrointestinal symptoms in women with and without endometriosis, and to understand the role of psychological distress and stool and vaginal microbiota in influencing these symptoms. It is hypothesised that gastrointestinal symptoms will be more severe in women with endometriosis than those without.
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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 Jane Muir
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Address
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Monash University, 99 Commercial Rd, Melbourne, VIC 3004
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Country
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Australia
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Phone
135798
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+61 03 9903 0274
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Fax
135798
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Email
135798
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[email protected]
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Contact person for public queries
Name
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Jane Varney
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Address
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Monash University, 99 Commercial Rd, Melbourne, VIC 3004
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Country
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Australia
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Phone
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+61 03 9903 3615
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Fax
135799
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Email
135799
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[email protected]
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Contact person for scientific queries
Name
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Jane Muir
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Address
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Monash University, 99 Commercial Rd, Melbourne, VIC 3004
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Country
135800
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Australia
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Phone
135800
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+61 9903 3615
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Fax
135800
0
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Email
135800
0
[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment:
Not agreed to do this
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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