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Trial registered on ANZCTR
Registration number
ACTRN12624001485527p
Ethics application status
Submitted, not yet approved
Date submitted
2/11/2024
Date registered
19/12/2024
Date last updated
19/12/2024
Date data sharing statement initially provided
19/12/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Self-Collection or Practitioner-collection Evaluation 3 to compare the clinical performance of detecting HPV associated with cervical disease
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Scientific title
Self-Collection or Practitioner-collection Evaluation 3 to compare the clinical performance of detecting HPV associated with cervical disease in a HPV-based cervical screening referral population
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Secondary ID [1]
313297
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None
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Universal Trial Number (UTN)
U1111-1315-2723
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Trial acronym
SCoPE3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HPV infection
335635
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Cervical screening
335636
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Cervical Intraepithelial Neoplasia
335637
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cervical cancer
335634
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Condition category
Condition code
Cancer
332194
332194
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0
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Cervical (cervix)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The study will ask participants to take two self-collected samples, one using a swab to collect a vaginal sample, and the other being a urine sample, and compare them against the standard of care clinician-collected specimen from the cervix for the detection of Human Papillomavirus (HPV) using any colposcopy biopsy findings as the reference for sensitivity and specificity for cervical disease. Participants who have been referred to colposcopy would not be routinely tested for HPV as this is a risk stratification rather than diagnostic test. The two devices are the Abbott simpli-COLLECT kit and the Novosanis Colli-pee device. The simpli-COLLECT swab is identical to swabs used for self-collection of vaginal samples for testing for sexually transmitted infections. The Colli-pee is a device which allows the collection of a specific volume of the first pass urine and has been validated for self-collection of urine for HPV testing in other studies. Both self-collection samples will be collected at the same time in a private space while waiting for the patient's colposcopy appointment, Collection with both devices would be completed is less than five minutes total time . Adherence to correct use of either the Colli-pee or simpli-COLLLECT devices will be determined by the presence of clinical material. The collection of urine into the Colli-pee will be visible by the increase in volume in the device. The Abbott Alinity m HPV assay will also detected whether sufficient human cellular material is present to determine if a valid clincal sample has been collected. Valid sample rates for both devices will be assessed and reported.
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Intervention code [1]
329870
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Early detection / Screening
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Comparator / control treatment
The standard of care for detection of HPV as part of the Australian National Cervical Screening program was clinician-collected cervical liquid-based cytology specimens. All participants will have the clinician-collected specimen collected during the same visit (for colposcopy based on clinical referral) as the self-collected specimens.
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Control group
Active
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Outcomes
Primary outcome [1]
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Relative Clinical Sensitivity for HPV of self-collection specimens for the detection of cervical intraepithlial neoplasia grade 2 or above (CIN2+).
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Assessment method [1]
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Relative Clinical Sensitivity (CIN2+) for HPV of self-collection specimens will be assessed by comparison with clinician-collected cervical specimens in liquid-based cytology media. Participants who give informed consent consent to their colposcopy findings, including biopsy results, to be accessed by researchers (through the RWH EPIC patient management system). Clinician-collected and self-collected specimens from participants with biopsy proven CIN2+ will be used for the calculation of Relative Clinical Sensitivity.
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Timepoint [1]
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Single timepoint for collection for self- and clinician-collected specimens
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Primary outcome [2]
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Relative Clinical Specificity for HPV of self-collection specimens for the detection of CIN2+
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Assessment method [2]
339778
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Relative Clinical Specificity (CIN2+) for HPV of self-collection specimens will be assessed by comparison with clinician-collected cervical specimens in liquid-based cytology media. Participants who give informed consent consent to their colposcopy findings, including biopsy results, to be accessed by researchers (through the RWH EPIC patient management system). Clinician-collected and self-collected specimens from participants with no evidence (biopsy result) of CIN2+ will be used for the calculation of Relative Clinical Specificity.
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Timepoint [2]
339778
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Single sample collection timepoint
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Secondary outcome [1]
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Absolute Clinical Specificity for HPV of self-collection specimens for the detection of CIN2+ (the outcome from colposcopic asssessment) will be assessed.
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Assessment method [1]
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Participants who give informed consent consent to their colposcopy findings, including biopsy results, to be accessed by researchers (through the RWH EPIC patient management system). Self-collected specimens from participants with no evidence (biopsy result) of CIN2+ will be used for the calculation of Absolute Clinical Specificity. Absolute Clinical Specificity(CIN2+) is calculated as; HPV Negative
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Timepoint [1]
441273
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Single sample collection timepoint
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Secondary outcome [2]
441270
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Positive Predictive Agreement (PPA)
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Assessment method [2]
441270
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Calculated for each self-collection method with the practitioner-collected sample as the reference result. PPA can be calculated from the HPV results undertaken as part of this research without any further input. True positives /True Positives + False Negatives
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Timepoint [2]
441270
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Single sample collection timepoint
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Secondary outcome [3]
441271
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HPV positivity
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Assessment method [3]
441271
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Number of HPV positive results for each method/ Number of total valid results for each method. HPV positivity can be calculated from the HPV results undertaken as part of this research without any further input. Number of specimens with HPV detected/ Total number of specimens with valid HPV results.
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Timepoint [3]
441271
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Single sample collection timepoint
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Secondary outcome [4]
441272
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Absolute Clinical Sensitivity for HPV of self-collection specimens for the detection of CIN2+
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Assessment method [4]
441272
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Participants who give informed consent consent to their colposcopy findings, including biopsy results, to be accessed by researchers (through the RWH EPIC patient management system). Self-collected specimens from participants with biopsy proven CIN2+ will be used for the calculation of Absolute Clinical Sensitivity. Absolute Clinical Sensitivity (CIN2+) is calculated as; HPV positive CIN2+ cases/ All CIN2+ cases with a valid HPV result
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Timepoint [4]
441272
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Single sample collection timepoint
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Eligibility
Key inclusion criteria
- have a cervix
- are willing and able to provide informed consent
- are willing and able to self-collect two samples, one vaginal swab, one urine sample
- Is willing and able to allow collection of a practitioner-collected (cervical) specimen
- Has had a colposcopy referral based on an abnormal result of routine cervical screening that included HPV testing (HPV primary screening or co-testing) performed within 24 weeks preceding the colposcopy visit (either abnormal cytology, or HPV positive test result, or both)
- is willing and able to undergo colposcopy and biopsy as needed
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Minimum age
25
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- are unable or unwilling to provide informed consent
- are unable to read and comprehend project study instructions
- unable or unwilling to provide self-collected samples
- have voided urine with one hour prior to urine specimen collection
- has had a complete or partial hysterectomy
- has a known history of excisional or ablative therapy (e.g., LEEP, cone biopsy, cervical laser surgery, or cryotherapy) to the cervix in the 12 months prior to the screening visit
- is currently participating, or recently (within 6 months) participated in any trial for cervical cancer or HPV diagnostics
- is currently participating or planning to participate in any clinical trial for HPV treatment
- Is already a participant in this research project
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (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
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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
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
13/01/2025
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Actual
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Date of last participant enrolment
Anticipated
13/10/2025
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Actual
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Date of last data collection
Anticipated
13/10/2025
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Actual
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Sample size
Target
450
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
317747
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Commercial sector/Industry
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Name [1]
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Abbott Molecular Inc.
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Address [1]
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Country [1]
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United States of America
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Primary sponsor type
Charities/Societies/Foundations
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Name
Australian Centre for the Prevention of Cervical Cancer
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Address
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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]
320064
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Address [1]
320064
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Country [1]
320064
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Other collaborator category [1]
283274
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Hospital
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Name [1]
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Royal Women's Hospital, Victoria
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Address [1]
283274
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Country [1]
283274
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Australia
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
316434
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Royal Melbourne Hospital HREC
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Ethics committee address [1]
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The RMH Parkville 300 Grattan St, Parkville, Victoria
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
316434
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27/11/2024
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Approval date [1]
316434
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Ethics approval number [1]
316434
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Summary
Brief summary
This study aims to assess whether vaginal swabs self-collected using the Abbott simpli-COLLECT kit and self-collected urine samples using the Novosanis Colli-pee device have similar clinical performance detecting HPV associated with cervical disease, compared with the reference practitioner-collected cervical samples. Who is it for? You may be eligible to participate in this study if you are a female aged 25 or above, and has colposcopy referral based on abnormal result of a test within the cervical screening program.. Study details All participants in this study will attend a single clinical appointment, during which time they will be asked to take two self-collected samples, one using a swab to collect a vaginal sample, and the other being a urine sample, and compare them against the standard of care clinician- collected specimen from the cervix for the detection of Human Papillomavirus (HPV) using any colposcopy biopsy findings as the reference for sensitivity and specificity for cervical disease. It is hoped that the results from this study will identify a new option for people wanting to participate in cervical screening.
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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 Dave Hawkes
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Address
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Australian Centre for the Prevention of Cervical Screening, 265 Faraday Street, Carlton, Victoria, 3053
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Country
137886
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Australia
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Phone
137886
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+61 400722202
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Fax
137886
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Email
137886
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[email protected]
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Contact person for public queries
Name
137887
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Dave Hawkes
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Address
137887
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Australian Centre for the Prevention of Cervical Cancer, 265 Faraday Street, Carlton, Victoria, 3053
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Country
137887
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Australia
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Phone
137887
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+61 400722202
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Fax
137887
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Email
137887
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[email protected]
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Contact person for scientific queries
Name
137888
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Dave Hawkes
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Address
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Australian Centre for the Prevention of Cervical Cancer, 265 Faraday Street, Carlton, Victoria, 3053
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Country
137888
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Australia
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Phone
137888
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+61 3400722202
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Fax
137888
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Email
137888
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[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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