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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05184478
Registration number
NCT05184478
Ethics application status
Date submitted
2/12/2021
Date registered
11/01/2022
Date last updated
27/11/2024
Titles & IDs
Public title
Is Medicinal Cannabis an Effective Treatment for Tourette Syndrome in Adolescents? a Pilot Study
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Scientific title
A Pilot Randomized Placebo-controlled Crossover Trial of Medicinal Cannabis (MC) in Adolescents with Tourette Syndrome (TS)
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Secondary ID [1]
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RCH HREC 69238
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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:
Tourette Syndrome in Adolescence
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Condition category
Condition code
Mental Health
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Other mental health disorders
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Neurological
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Other neurological disorders
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Medicinal cannabis (MC): THC 10mg/mL : CBD 15mg/mL, manufactured by Cann Group Ltd.
Treatment: Drugs - Placebo
Experimental: Group A (MC then placebo) - Group A will receive medicinal cannabis during Treatment Period 1 (70 days), followed by a 7 day dose reduction and 21 day wash-out period, then will receive placebo during Treatment Period 2 (70 days).
Experimental: Group B (placebo then MC) - Group B will receive placebo during Treatment Period 1 (70 days), followed by a 7 day dose reduction and 21 day wash-out period, then will receive medicinal cannabis during Treatment Period 2 (70 days).
Treatment: Drugs: Medicinal cannabis (MC): THC 10mg/mL : CBD 15mg/mL, manufactured by Cann Group Ltd.
Each 1mL contains 10mg tetrahydrocannabinol (THC),15 mg cannabidiol (CBD), and 0.004mL peppermint oil in medium chain triglyceride (MCT) oil.
All participants will start at 0.1 mL per day, and will gradually increase in 0.1mL increments until day 21 when a dose of 0.5mL (participants weighing \<50kg) or 1mL (participants weighing =50kg) is reached. At day 29, an assessment of treatment response will be conducted. Participants who meet criteria for a treatment response will remain on the same dose for the remainder of the treatment period. Participants who do not meet criteria for a treatment response will gradually increase the dose in 0.1mL increments until day 49 when a daily dose of 1mL (participants weighing \<50kg) or 2mL (participants =50kg) is reached.
Treatment: Drugs: Placebo
The placebo contains MCT oil and peppermint flavoring solution, which is indistinguishable from the active medication in appearance, smell and taste.
The dose will be matched for volume to the medicinal cannabis, and will follow the same dosing schedule as the medicinal cannabis treatment phase.
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Intervention code [1]
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Treatment: Drugs
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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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Rate of study participant recruitment, calculated as the time required to reach a sample size of 10.
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Assessment method [1]
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The rate of recruitment will be calculated as the number of months from the date of commencing recruitment to the date of randomizing the tenth participant.
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Timepoint [1]
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From the date of pre-screening the first participant until the tenth participant is randomized, up to 2 years.
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Primary outcome [2]
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Participant withdrawal rate, calculated as the number of participants who withdraw from the trial as a proportion of the total number of participants randomized.
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Assessment method [2]
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The number of participants who withdraw from the trial will be calculated as a proportion of the total number of participants randomized.
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Timepoint [2]
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Day 1 to day 176 (end of treatment period 2)
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Primary outcome [3]
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Study medication tolerability, as indicated by the proportion of participants who tolerate the protocol dosing schedule.
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Assessment method [3]
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The number of participants who adhere to the protocol dosing schedule without medication related protocol deviations, treatment discontinuations or dose modifications will be calculated as a proportion of the total sample for each treatment condition (medicinal cannabis or placebo).
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Timepoint [3]
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Day 1 to day 176 (end of treatment period 2)
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Primary outcome [4]
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Participant adherence to the study medication dosing schedule, calculated as the proportion of participants who demonstrate acceptable medication compliance.
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Assessment method [4]
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Medication compliance will be assessed through pharmacy calculations from returned bottle volumes. Acceptable compliance will fall within the range of 80-120%. The number of participants with acceptable medication compliance will be reported as a proportion of the total sample randomized.
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Timepoint [4]
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Day 78 (end of treatment period 1) and day 176 (end of treatment period 2)
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Primary outcome [5]
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Study visit attendance, calculated as the proportion of visits completed across the study sample.
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Assessment method [5]
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The number of study visits attended by all participants will be calculated as a proportion of the total possible visits in accordance with the study protocol.
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Timepoint [5]
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Screening to day 169 (final study visit)
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Primary outcome [6]
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Blood test completion, calculated as the proportion of blood tests completed across the study sample.
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Assessment method [6]
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The number of study blood tests completed by all participants will be calculated as a proportion of the total possible blood tests in accordance with the study protocol.
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Timepoint [6]
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Screening to day 169 (final study visit)
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Primary outcome [7]
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Parent questionnaire completion, calculated as the proportion of parent-report questionnaires completed across the study sample.
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Assessment method [7]
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The number of study questionnaires completed by all parents will be calculated as a proportion of the total possible questionnaires requiring completion in accordance with the study protocol.
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Timepoint [7]
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Screening to day 169 (final study visit)
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Primary outcome [8]
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Self-report questionnaire completion, calculated as the proportion of adolescent self-report questionnaires completed across the study sample.
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Assessment method [8]
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The number of study self-report questionnaires completed by all participants will be calculated as a proportion of the total possible questionnaires requiring completion in accordance with the study protocol.
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Timepoint [8]
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Screening to day 169 (final study visit)
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Primary outcome [9]
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Study design acceptability will be evaluated through a parent-completed study specific evaluation questionnaire completed at the end of the study.
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Assessment method [9]
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Study design acceptability will be assessed using an evaluation questionnaire developed specifically for this study, which uses Likert scales to assess satisfaction with recruitment, medication tolerability, frequency of study visits, burden of completing questionnaires, and overall study quality. Parents will complete this questionnaire at the end of their study participation (day 197). Data will be reported for each item individually, as the proportion of parents who responded positively on the Likert scale, where higher scores indicate more favorable responses.
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Timepoint [9]
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Day 197
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Secondary outcome [1]
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The frequency of adverse events as reported on the modified version of the Liverpool Adverse Event Profile (LAEP) at day 71 and day 169 will be summarized across the medicinal cannabis and placebo treatment phases.
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Assessment method [1]
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Completed by the parent or guardian, the LAEP was designed to capture known side-effects of anti-epileptic medication. The modified version includes additional items to ascertain other known side-effects of medicinal cannabis. This measure includes 34 items. Adverse Events (AEs) reported on the LAEP will be considered significant if a 2-point increase in severity is reported from baseline to end of the maintenance dosing period (day 71 and day 176). The frequency of AEs meeting this criteria will be presented for the medicinal cannabis and placebo treatment phases respectively.
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Timepoint [1]
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Day 71 and 176
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Secondary outcome [2]
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The frequency of adverse events as reported throughout the study will be summarized across the medicinal cannabis and placebo treatment phases.
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Assessment method [2]
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All possible adverse events will be recorded, as reported at study visits, during safety check phone calls and in between scheduled appointments. All Serious Adverse Events will be published, as well as all non-serious adverse events deemed by the investigators to be at least possibly related to the study drug. The frequency of these adverse events will be presented for the medicinal cannabis and placebo treatment phases respectively.
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Timepoint [2]
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Day 1 to day 197
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Eligibility
Key inclusion criteria
* Males and females aged 12 - 18 years of age;
* DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) diagnosis of TS as assessed by the study clinician;
* TS severity defined as a score of 20 or higher on the Total Tic Severity section of the Yale Global Tic Severity Scale;
* No changes in either medication or other interventions in the 4 weeks prior to randomization, and intention to remain on same dose for the duration of the study;
* Participant and family have the ability to comply with the protocol requirements, in the opinion of the investigator;
* Agrees not to drive for the duration of the study.
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Minimum age
12
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Maximum age
18
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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
* Non-English speaking parents;
* Participant history of psychosis, schizophrenia, bipolar disorder, or major depressive disorder, or a family history of psychosis;
* Taking anti-epileptic medications which interact with medicinal cannabis: clobazam, mTOR (mammalian target of rapamycin) inhibitors (e.g sirolimus, tacrolimus), anti-cancer agents, citalopram >20mg/day, escitalopram >10mg/day;
* Abnormal liver function tests defined as ALT (alanine transaminase) > twice ULN (upper limit of normal);
* Current use of illicit drugs or medicinal cannabis, or use in the 4 weeks prior to screening;
* Pregnant or intending to become pregnant during the study, or breastfeeding;
* History of clinically significant suicidal thoughts in the prior 12 months.
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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 assessing the outcomes
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
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Actual
16/05/2022
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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
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Actual
4/01/2024
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Sample size
Target
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Accrual to date
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Final
10
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Royal Children's Hospital / Murdoch Children's Research Institute - Parkville
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Recruitment postcode(s) [1]
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3052 - Parkville
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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 is a single site, pilot double-blind, randomized, placebo-controlled, cross-over study of 10 participants comparing medicinal cannabis (THC:CBD 10:15 oil) with placebo in reducing tics in adolescents aged 12 - 18 years with severe Tourette Syndrome (TS). The primary objective of this pilot study is to evaluate all elements of the study design (recruitment strategy, study duration, study procedures, study medication tolerance and outcome measures) to assess if they are acceptable and feasible for the conduct of a full-scale randomized controlled trial of THC:CBD 10:15 oil to reduce tic severity in adolescents with TS. The secondary objective of this study is to collect preliminary data on the safety of oral THC:CBD 10:15 oil in adolescents aged 12 to 18 years with TS. As an exploratory aim data from clinician- and parent-rated measures will be compared across the phases to explore for a signal of efficacy on primary (tic reduction) and secondary (premonitory urges, obsessive compulsive behaviors, Attention Deficit Hyperactivity Disorder \[ADHD\] symptoms) outcome measures.
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Trial website
https://clinicaltrials.gov/study/NCT05184478
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Fax
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Contact person for scientific queries
Data sharing statement
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/NCT05184478
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