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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06297083
Registration number
NCT06297083
Ethics application status
Date submitted
29/02/2024
Date registered
6/03/2024
Titles & IDs
Public title
Analysing HIgh Dose Probiotic Peanut Oral Immunotherapy (PPOIT) and High Dose Peanut Oral Immunotherapy (OIT) Versus LOw Dose Peanut OIT for Peanut Allergy
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Scientific title
Analysing HIgh Dose Probiotic Peanut Oral Immunotherapy (PPOIT) and High Dose Peanut Oral Immunotherapy (OIT) Versus LOw Dose Peanut OIT for Peanut Allergy
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Secondary ID [1]
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100992 HILO
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Universal Trial Number (UTN)
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Trial acronym
HILO
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Peanut Allergy
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Condition category
Condition code
Inflammatory and Immune System
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Allergies
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Peanut Oral Powder [PEANUT POWDER]
Treatment: Other - Probiotic (LGG®, Lactobacillus Rhamnosus) or placebo probiotic (maltodextrin)
Experimental: High-dose peanut OIT combined with probiotic (HD PPOIT) - High-dose rapid escalation peanut OIT combined with probiotic (HD PPOIT) taken daily for 18 months.
Experimental: High-dose peanut OIT combined with probiotic placebo (HD OIT) - High-dose rapid escalation peanut OIT combined with probiotic placebo (HD OIT) taken daily for 18 months
Active comparator: Low-dose peanut OIT combined with probiotic placebo (LD OIT) - Low-dose slow escalation peanut OIT combined with probiotic placebo (LD OIT) taken daily for 18 months.
Treatment: Drugs: Peanut Oral Powder [PEANUT POWDER]
Peanut oral immunotherapy at varying doses and build-up regimes given daily for 18 months
Treatment: Other: Probiotic (LGG®, Lactobacillus Rhamnosus) or placebo probiotic (maltodextrin)
Probiotic or placebo-probiotic given daily for 18 months
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Difference between the treatment arms in the proportion of participants who achieve remission of peanut allergy at 8 weeks post treatment.
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Assessment method [1]
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Remission will be assessed 8 weeks after the end of treatment timepoint and is defined as passing (completing without reaction) the double-blind placebo controlled food challenge (DBPCFC) at the end of treatment and at 8 weeks post treatment
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Timepoint [1]
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22 months
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Secondary outcome [1]
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Difference between the treatment arms in the proportion of participants who achieve full desensitisation of peanut allergy at end of treatment
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Assessment method [1]
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Full desensitisation will be defined by participants passing (completing without reaction) the double-blind placebo controlled food challenge (DBPCFC) undertaken at the end of treatment
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Timepoint [1]
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20 months
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Secondary outcome [2]
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Difference between the treatment arms in the exposure-adjusted event rate of adverse events (AE)
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Assessment method [2]
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The total number of treatment-related AE the participant reports during the course of treatment adjusted for the time the participant is on treatment (in years)
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Timepoint [2]
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20 months
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Secondary outcome [3]
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Difference between treatment arms in changes in Quality of Life Scores using the Food Allergy Quality of Life Questionnaires (FAQLQ).
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Assessment method [3]
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FAQLQ total score, as well as three sub-scores (food anxiety, general emotional impact, and social and dietary limitations) will be calculated as per the instrument scoring manual
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Timepoint [3]
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Baseline, 22weeks, 76 weeks, 84 weeks, 128 weeks
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Secondary outcome [4]
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Difference between treatment arms in changes in the peanut skin prick test (SPT) wheal size.
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Assessment method [4]
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Skin prick test to whole peanut extract
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Timepoint [4]
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Baseline, 76 weeks, 84 weeks,128 weeks
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Secondary outcome [5]
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Difference between treatment arms in change from baseline peanut specific immunoglobulin E (sIgE) levels
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Assessment method [5]
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Blood samples will be collected and levels of sIgE against peanut will be measured by ImmunoCAP (Phadia AB, Uppsala, Sweden)
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Timepoint [5]
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Baseline, 76 weeks, 84 weeks,128 weeks
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Secondary outcome [6]
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Difference between treatment arms in adherence to treatment regime as measured by daily treatment doses taken by the participant
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Assessment method [6]
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Adherence to treatment will be monitored by reviewing the participant diary
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Timepoint [6]
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20 months
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Secondary outcome [7]
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Difference between treatment arms in participant experience as assessed from qualitative interviews
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Assessment method [7]
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Interview guide developed and conducted, recorded, transcribed verbatim, and responses explored using framework analysis
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Timepoint [7]
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20 months
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Secondary outcome [8]
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Difference between clinical outcome groups in cost using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS)
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Assessment method [8]
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Captured per number of hospitalizations, Emergency room (ER) visits, General Practitioner (GP) visits and medications / number of prescriptions required. Data acquired using participant questionnaires, participant study diaries and supplemented by administrative hospital data linkage
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Timepoint [8]
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Baseline through to 32 months
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Secondary outcome [9]
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Difference between clinical outcome groups in quality adjusted life year (QALY) will be estimated at 32 months using the Food Allergy Quality of Life Form (FAQLQ) mapped to the generic health utility instrument Assessment of Quality of Life-6D (AQoL-6D)
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Assessment method [9]
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Timepoint [9]
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32 months
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Secondary outcome [10]
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Difference between clinical outcome groups in peanut ingestion from end of treatment to 12 months post treatment
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Assessment method [10]
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Peanut ingestion data will be captured from the participant's study diary
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Timepoint [10]
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20 months to 32 months
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Secondary outcome [11]
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Difference between clinical outcome groups in reactions to peanut from end of treatment to 12 months post treatment
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Assessment method [11]
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Number of reactions, symptoms experienced, and treatment administered will be captured from the participant's study diary
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Timepoint [11]
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20 months to 32 months
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Eligibility
Key inclusion criteria
* Aged 1-10 years.
* >7kg (the weight considered safe for the administration of an adrenaline injector);
* Confirmed diagnosis of peanut allergy as defined by a failed DBPCFC with peanut and a positive SPT or sIgE to peanut at screening;
* Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf
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Minimum age
1
Year
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Maximum age
10
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* History of severe anaphylaxis (as defined by persistent hypotension, collapse, loss of consciousness, persistent hypoxia or ever needing more than three (3) doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction)
* Severe anaphylaxis during the study entry DBPCFC (defined as persistent hypotension, collapse, loss of consciousness, persistent hypoxia, or requiring more than 3 doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction)
* Ongoing chronic persistent asthma (as per Australian Asthma Foundation guidelines)
* Underlying medical conditions (e.g. cardiac disease) that increase the risks associated with anaphylaxis
* Use of beta-blockers, and angiotensin converting enzyme (ACE) inhibitors
* Reacting to the placebo component during the study entry DBPCFC
* Have received other food immunotherapy treatment in the preceding 12 months
* Currently taking immunomodulatory therapy (including allergen immunotherapy)
* Past or current major illness that in the opinion of the Site Investigator may affect the subject's ability to participate in the study e.g. increased risk to the participant
* History of suspected or biopsy-confirmed eosinophilic oesophagitis (EoE)
* Subjects who in the opinion of the Site Investigator are unable to follow the protocol
* Another family member already enrolled in the trial (to maintain blinding, safety and equity of access) or in any other clinical trial from the same study 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)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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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
Withdrawn
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/05/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/05/2027
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Primary sponsor type
Other
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Name
Murdoch Childrens Research Institute
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will compare the effectiveness of three different treatments to treat peanut allergy
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Trial website
https://clinicaltrials.gov/study/NCT06297083
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Trial related presentations / publications
Loke P, Orsini F, Lozinsky AC, Gold M, O'Sullivan MD, Quinn P, Lloyd M, Ashley SE, Pitkin S, Axelrad C, Metcalfe JR, Su EL, Tey D, Robinson MN, Allen KJ, Prescott SL, Galvin AD, Tang MLK; PPOIT-003 study group. Probiotic peanut oral immunotherapy versus oral immunotherapy and placebo in children with peanut allergy in Australia (PPOIT-003): a multicentre, randomised, phase 2b trial. Lancet Child Adolesc Health. 2022 Mar;6(3):171-184. doi: 10.1016/S2352-4642(22)00006-2. Epub 2022 Feb 4. Erratum In: Lancet Child Adolesc Health. 2022 May;6(5):e19. doi: 10.1016/S2352-4642(22)00097-9.
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Paxton Loke
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Address
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Murdoch Children's Research Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Julie Burns, Study Coordinator
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Address
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Country
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Phone
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+61399366184
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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
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?
Beginning 24 months after article publication, the following will be made available long-term for use by future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI's conditions for access (including any conditions relating to MCRI's intellectual property):
* Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures and appendices)
* Trial protocol, Statistical Analysis Plan, Informed Consent Form (ICF)
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
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When will data be available (start and end dates)?
Beginning 24 months following article publication
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Available to whom?
These will be made available long-term for use by future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI's conditions for access (including any conditions relating to MCRI's intellectual property)
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.melbournechildrens.com/mctc/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06297083