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DEFINITIONS
Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12625000031460p
Ethics application status
Submitted, not yet approved
Date submitted
3/12/2024
Date registered
16/01/2025
Date last updated
16/01/2025
Date data sharing statement initially provided
16/01/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Subcutaneous injections of benzathine penicillin G (SCIP) for rheumatic heart disease in Kununurra
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Scientific title
Subcutaneous injections of benzathine penicillin G (SCIP) for rheumatic heart disease in Kununurra
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Secondary ID [1]
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Nil
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Universal Trial Number (UTN)
U1111-1316-4224
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Trial acronym
SCIP - Kununurra
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Linked study record
This study does not relate to ACTRN12624001383550 "SCIP - Maningrida" or to ACTRN12624000333516 "SCIP RHD"
While the aims and methods for these studies are similar, they are separate clinical trials.
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Health condition
Health condition(s) or problem(s) studied:
Rheumatic fever
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Rheumatic heart disease
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Condition category
Condition code
Cardiovascular
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0
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Other cardiovascular diseases
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Infection
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0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Subcutaneous injections of benzathine penicillin G (termed 'SCIP') will be offered as an alternative to the current standard of care for secondary prophylaxis, which involves regular deep intramuscular injections of benzathine penicillin G (BPG).
SCIP will be offered to participants at 10-week intervals. SCIP will be administered by healthcare workers at Ord Valley Aboriginal Health Service (OVAHS). The study period is 48-weeks. Each participant will have a minimum follow-up period of 12-weeks. Consequently participants will be offered a maximum of 5 SCIP doses and a minimum of 2 doses, depending on what point they were recruited at.
The drug administered is BPG: Bicillin® L-A (Pfizer).
Each vial contains 1.2MU BPG.
The dose depends on the participant body weight.
Participants <20kgs will receive 4 vials of Bicillin® L-A (9.2mL), those 20-<30kg receive 5 vials (11.5mL), those 30-<60kg receive 7 vials (13.8mL), and those weighing 60+ kg receive 9 vials (20.7mL).
BPG uptake via IM/SCIP will be monitored through reviewing participants' clinic records.
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Intervention code [1]
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Prevention
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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The acceptability of SCIP implementation
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Assessment method [1]
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Qualitative (thematic) analysis of stakeholder interviews. Purposive sampling of stakeholders will ensure that broad perspectives are represented across people living with RHD, their caregivers, community members, healthcare workers and public health stakeholders. The interviewer will follow a semi-structured interview guide. The interviewer will be a OVAHS community worker who is trained in qualitative data collection. Interviews are anticipated to be approximately 1 hours in duration. Audio recording will take place with the participant's permission, otherwise the interviewer will take notes for analysis.
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Timepoint [1]
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Qualitative data collection will occur at pre-SCIP eligibility screening, post-SCIP eligibility screening, post-consent for SCIP but pre SCIP administration, in the week after the first SCIP administration and at 10-12 weeks post-SCIP administration. This sampling schedule enables possible improvements to SCIP implementation to be identified at each stage of the SCIP participant journey. Purposive sampling will result in some participants being interviewed at multiple time points.
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Primary outcome [2]
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The self-reported tolerability of SCIP administration
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Assessment method [2]
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Survey data assessed using the Faces Pain Scale
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Timepoint [2]
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Immediately post SCIP administration
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Primary outcome [3]
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Intention to continue receiving SCIP as rheumatic heart disease (RHD) prophylaxis once the study period ends.
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Assessment method [3]
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The number and proportion of participants who, in their final post-SCIP survey, report an intention to continue using SCIP as secondary prophylaxis once the study period ends.
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Timepoint [3]
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Immediately after the participant's final SCIP administration in the study period.
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Secondary outcome [1]
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Changes in cardiac status
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Assessment method [1]
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Detected using routinely collected clinic data and RHD patient register data
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Timepoint [1]
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At the end of the study period (48 weeks post initial dose)
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Secondary outcome [2]
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Acute rheumatic fever recurrence
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Assessment method [2]
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Detected using routinely collected clinic data and RHD patient register data
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Timepoint [2]
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At baseline and daily until the end of the study period (48 weeks post initial dose)
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Secondary outcome [3]
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BPG adherence
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Assessment method [3]
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Comparison of the proportion of recommended BPG doses received pre-SCIP and during SCIP implementation identified by auditing patient medical records
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Timepoint [3]
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At the end of the study period (48 weeks post initial dose)
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Secondary outcome [4]
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Plasma penicillin concentration
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Assessment method [4]
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Dried blood spot assays using fingerprick sampling
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Timepoint [4]
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4-8 weeks post-SCIP dose and immediately before the next BPG dose
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Secondary outcome [5]
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The frequency of adverse events that are causally related to SCIP administration
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Assessment method [5]
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Adverse events will be detected on clinical examination and from participant self-reporting identified by auditing patient medical records. Root cause analysis of reported adverse events will determine causality.
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Timepoint [5]
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Baseline and daily until the end of the study period (48 weeks post initial dose)
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Secondary outcome [6]
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The proportion of participants who receive >80% of the recommended SCIP administrations during the study period
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Assessment method [6]
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Descriptive analyses of SCIP uptake data from patient medical records
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Timepoint [6]
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At the Initial Progress Review (predicted in April 2025), and at the end of the study period (48-weeks following the first SCIP administration)
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Eligibility
Key inclusion criteria
Provide informed consent to participate (or informed assent to receive SCIP with a caregiver's informed consent if aged <15 years)
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Minimum age
No limit
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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
Excluded from receiving SCIP are those who have:
• Never had IM BPG through OVAHS to prevent acute rheumatic fever recurrence.
• Anticipated to be unavailable for one or more of the recommended SCIP administrations during the follow-up period
• Unwilling to undergo height, weight, and vital sign assessments prior to receiving SCIP
• History of adverse drug reaction/hypersensitivity/allergy to penicillin.
• Pregnancy (self-reported)
• Extensive scarring or dermatological conditions affecting skin integrity at the intended site of SCIP administration
• Are unable to contact clinic staff following SCIP administration if they have safety concerns.
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Study design
Purpose of the study
Treatment
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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
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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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
17/02/2025
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Actual
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Date of last participant enrolment
Anticipated
27/10/2025
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Actual
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Date of last data collection
Anticipated
19/01/2026
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Wesfarmers Centre of Vaccines & Infectious Diseases
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Address [1]
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Country [1]
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Australia
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Funding source category [2]
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Government body
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Name [2]
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Australian Government Department of Health and Aged Care - Medical Research Future Fund
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Address [2]
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Country [2]
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Australia
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Funding source category [3]
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Government body
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Name [3]
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WA Child Research Fund
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Address [3]
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Country [3]
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Australia
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Primary sponsor type
Charities/Societies/Foundations
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Name
The Kids Research Institute Australia
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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]
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Address [1]
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Country [1]
320307
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
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Western Australian Aboriginal Health Ethics Committee
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Ethics committee address [1]
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https://www.ahcwa.org.au/ethics
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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30/10/2024
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Approval date [1]
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Ethics approval number [1]
316638
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Summary
Brief summary
People living with rheumatic fever and rheumatic heart disease are often recommended to have antibiotic injections at least every 28-days over five years to reduce their risk of permanent heart damage. Our team has developed a new, less painful, way to deliver the antibiotic, called ‘SCIP’, which provides 10-weeks of protection. By partnering with the Ord Valley Aboriginal Health Service, we will offer SCIP to people in need of regular BPG in Kununurra, Western Australia, and evaluate how well it works for them, with the ultimate goal of using SCIP to reduce rheumatic heart disease morbidity. We hypothesize that SCIP will provide an acceptable alternative way for people to get their regular BPG.
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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 Laurens Manning
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Address
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The Kids Research Institute Australia, Northern Entrance, Perth Children's Hospital, 15 Hospital Avenue, NEDLANDS Western Australia 6009
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Country
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Australia
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Phone
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+61 8 6319 1456
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Jane Oliver
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Address
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The Kids Research Institute Australia, Northern Entrance, Perth Children's Hospital, 15 Hospital Avenue, NEDLANDS Western Australia 6009
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Country
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Australia
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Phone
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+61 8 6319 1000
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Jane Oliver
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Address
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The Kids Research Institute Australia, Northern Entrance, Perth Children's Hospital, 15 Hospital Avenue, NEDLANDS Western Australia 6009
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Country
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Australia
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Phone
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+61 8 6319 1000
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Fax
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment:
Participant privacy is paramount
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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