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Trial registered on ANZCTR
Registration number
ACTRN12621001186842
Ethics application status
Approved
Date submitted
9/08/2021
Date registered
3/09/2021
Date last updated
17/09/2023
Date data sharing statement initially provided
3/09/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Transcranial Magnetic Stimulation (TMS) as a Treatment/Intervention for Depression in Adolescents and Young adults
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Scientific title
Acceptability and Tolerability of Transcranial Magnetic Stimulation for Depression in Adolescents and Young Adults.
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Secondary ID [1]
304864
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Orygen Protocol Number : Orygen 58852
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Universal Trial Number (UTN)
U1111-1268-2889
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Trial acronym
TDAY
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Linked study record
NA
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Health condition
Health condition(s) or problem(s) studied:
Depression
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Condition category
Condition code
Mental Health
320545
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0
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Depression
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Repetitive Transcranial Stimulation (rTMS) is a technique known to modulate brain cortical activity and has demonstrated efficacy in the treatment of treatment resistant depression. Participants in this rTMS based study will be randomised to one of two active treatment groups with one of the groups (1) receiving "standard" treatment while the other group (2) will receive intermittent Theta Burst Stimulation (iTBS) treatment (the intervention). Participants in the iTBS groups will receive treatment at the left side dorsolateral prefrontal cortex, a site approximately 7 cm above the left eyebrow. The treatment schedule for the iTBS group is outlined below:
Group 2 (iTBS) – Participants will receive 2 iTBS treatments per day, on three weekdays (Mondays, Wednesdays, Fridays) for the first two weeks and on two weekdays per week (Tuesdays and Thursdays) for the last two weeks. They will receive the same total number of treatments (20) as Group 1. Each treatment lasts for just over 3 minutes and is comprised of 20 trains of stimulation. Each train contains a 50 Hz burst of 3 pulses delivered every 200msec (i.e. 5 Hz) for 2 seconds followed by an 8 second intertrain interval. There will be a minimum of 30 minutes between treatments on each treatment day. The total duration of each session will be approximately 45 minutes.
Treatments will be administered by a Division 1 nurse with specialist rTMS training and experience.
Treatment attendance will be recorded in a paper copy treatment record form.
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Intervention code [1]
321254
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Treatment: Devices
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Comparator / control treatment
The control treatment is given to Group 1 as described above in Description of intervention(s)/Exposure section.
Participants in Group 1 will receive treatment at the left side dorsolateral prefrontal cortex, a site approximately 7 cm above the left eyebrow.
The treatment schedule for the control group is outlined below:
Group 1 (Standard)– Participants will receive 1 treatment per day on 5 weekdays (Monday to Friday) over the 4 weeks. Each treatment will last 30 minutes and is comprised of 75 trains of stimulation each with a 4 second pulse duration at 10 Hz and a 20 second inter-train interval. These parameters are typical of what is considered a “standard” rTMS treatment course for depression.
The total duration of each session will be approximately 45 minutes.
Treatments will be administered by a Division 1 nurse with specialist rTMS training and experience.
Treatment attendance will be recorded in a paper copy treatment record form.
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Control group
Active
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Outcomes
Primary outcome [1]
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To determine the acceptability of two TMS protocols in the treatment of depression in adolescents and young adults. Acceptability will be determined by assessing the number of planned treatments received by the participants as recorded in the patient's paper copy treatment record. For the purposes of measuring acceptability receiving 80% of the prescribed dose, which is 16 treatments for both treatment groups, will be considered the minimum therapeutic dose.
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Assessment method [1]
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Timepoint [1]
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Acceptability will be determined by assessing the number of planned treatments received by the participants. For the purposes of measuring acceptability receiving 80% of the prescribed dose, which is 16 treatments for both treatment groups, will be considered the minimum therapeutic dose. This will be measured at the end of Week 4.
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Primary outcome [2]
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To determine the safety/tolerability of two TMS protocols in the treatment of depression in adolescents and young adults. To explore safety/tolerability participants will be continually monitored throughout treatment days and any adverse events will be entered into a floating AE form. Before receiving a treatment participants will be asked about any residual side effects experienced after their last treatment and they will be asked about any side effects they are experiencing during a treatment.
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Assessment method [2]
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Timepoint [2]
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To explore safety/tolerability participants will be continually monitored throughout treatment days and any adverse events will be entered into a floating AE form.
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Secondary outcome [1]
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To explore the efficacy of the intensive iTBS compared to the standard rTMS in the treatment of depression in adolescents and young adults as assessed by changes in 16 item Quick Inventory of Depressive Symptomatology (Clinician Rated) (QIDS-C).
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Assessment method [1]
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Timepoint [1]
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• Trajectory of 16 item Quick Inventory of Depressive Symptomatology (Clinician Rated) (QIDS-C) measured at baseline, weeks 2, 4 and 8.
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Secondary outcome [2]
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To explore the effect of the TMS treatment on changes in symptoms of suicidal ideation as measured by the QIDS-C, sub item 12
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Assessment method [2]
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Timepoint [2]
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QIDS-C subitem 12 Suicidal Ideation is measured at baseline, weeks 2,4 and 8.
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Secondary outcome [3]
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Pattern of remission (QIDS-C of 5 or less) in depression for the two groups
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Assessment method [3]
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Timepoint [3]
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Pattern of remission (defined as QIDS-C of 5 or less) measured at baseline, weeks 2,4 and 8.
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Secondary outcome [4]
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To explore the effect of the TMS treatment on changes in symptoms of anxiety as measured by the self rated GAD7 scale.
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Assessment method [4]
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Timepoint [4]
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Pattern of self rated GAD7 is measured at baseline, weeks 2,4 and 8.
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Secondary outcome [5]
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To explore the efficacy of the intensive iTBS compared to the standard rTMS in the treatment of depression in adolescents and young adults as assessed by changes in Hamilton Depression Rating Scale 6 – Self Report, .
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Assessment method [5]
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Timepoint [5]
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Trajectory of Hamilton Depression Rating Scale 6 – Self Report measured at baseline, weeks 1-4, and week 8.
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Eligibility
Key inclusion criteria
A participant will be considered eligible for inclusion in this study only if ALL of the following criteria apply:
• Aged 15 – 25years old
• Capacity to consent
• Current major depressive episode as determined by psychiatrist/ psychiatry trainee (persons with BPAD in a depressive phase can be included)
• A QIDS-C of > 10 (moderate to severe depression)
• Treatment resistance defined as a failure to respond to first-line treatment with structured psychotherapy or antidepressant medication
• If taking psychotropic medication regime, on a stable dose in the four weeks prior to screening
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Minimum age
15
Years
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Maximum age
25
Years
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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
Participants who meet ANY of the following criteria will not be eligible for participation in this study.
• History of seizure disorder or any condition leading to an increased risk of seizure
• Significant neurological disorder or brain trauma
• Presence of internal metal objects in the head, either implanted or result of shrapnel injury, that would be considered unsafe for MRI (dental work is not an exclusion)
• Any implanted medical devices with electronic components (e.g.: pacemaker, neural stimulator)
• Current severe or uncontrolled substance use as assessed by study psychiatrist interview at screening
• Any unstable or poorly managed significant medical condition
• Females who are pregnant or currently breastfeeding, or who are not using effective contraception.
• Participation in any other clinical intervention trial from baseline to the Week 8 follow-up
• Comorbid psychotic/delusional disorders or any psychiatric disorder that would prevent patient from attending treatment schedule
• Severe behavioural disturbances such that they would be unable to comply with the requirements of informed consent or comply with the study protocol
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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)
The allocation sequence will be concealed using the online Research Project Management System (RPMS) that has been developed at Orygen.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be developed by a statistician independent of the trial. Random permutated blocks will be used.
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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
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
The primary outcomes are acceptability and safety/tolerability. The former will be assessed by the proportion of participants receiving 80% of the prescribed dose (i.e. 16 treatment sessions). The latter will be measured by the proportion of participants belonging to various frequency categories for side effects (such as 0, 1-5, >5) and the proportion of drop-outs. Comparison between the two trial treatments will be performed using Fisher’s exact test.
As a pilot study, the sample size is not likely to be large enough to determine statistically significant differences on efficacy measures. We have determined a sample size that is large enough to obtain preliminary data on acceptability and tolerability.
The secondary outcomes of symptom trajectories will be analysed using linear mixed-effects modelling. Between-treatment comparison of suicidal ideation and remission at particular time points and the corresponding patterns over time will be performed using Fisher’s exact test.
For the exploratory aims, the relationship between demographic/clinical characteristics and outcome measures at end of treatment (week 4) and follow-up (week 8) will be analysed using analysis of variance or Fisher’s exact test as appropriate.
The intention-to-treat approach will be adopted in the analysis. If necessary, multiple imputation will be used to handle missing data.
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Recruitment
Recruitment status
Suspended
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Date of first participant enrolment
Anticipated
1/10/2021
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Actual
17/03/2022
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Date of last participant enrolment
Anticipated
31/03/2024
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Actual
30/06/2023
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Date of last data collection
Anticipated
31/05/2024
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Actual
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Sample size
Target
40
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Accrual to date
4
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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]
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Other
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Name [1]
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Orygen
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Address [1]
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35 Poplar Road
Parkville VIC 3052
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Country [1]
309238
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Australia
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Primary sponsor type
Other
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Name
Orygen
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Address
35 Poplar Road, Parkville VIC Australia 3052
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Country
Australia
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Secondary sponsor category [1]
310251
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None
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Name [1]
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Address [1]
310251
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Country [1]
310251
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
309086
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Melbourne Health Human Research Ethics Comittee
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Ethics committee address [1]
309086
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Office for Research
The Royal Melbourne Hospital
Level 2 South West
300 Grattan Street
Parkville, VIC 3050
Australia
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Ethics committee country [1]
309086
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Australia
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Date submitted for ethics approval [1]
309086
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26/08/2020
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Approval date [1]
309086
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24/11/2020
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Ethics approval number [1]
309086
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HREC/58852/MH-2020
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Summary
Brief summary
TDAY is a pilot open-label randomised control study comparing two different forms of repetitive Transcranial Magnetic Stimulation (rTMS) as a treatment for Major Depressive Disorder (MDD) in adolescents and young adults. Participants with MDD will be randomised to one of two rTMS treatment groups. In both groups a magnetic coil will be applied to L) side of the scalp, in which the coil generates an electrical impulse to the stimulate the underlying brain tissue, No anaesthetic is required. Group 1 will receive what is considered a standard 10Hz treatment protocol while Group 2 will receive a more novel, intensive intermittent thetaburst (iTBS) treatment protocol. Treatments will be administered Monday - Friday for 4 weeks. All participants will be engaged with their treating doctor for the duration of the trial, and will continue their current treatment regimen (i.e., either maintain a stable dose of antidepressant medication, or continue without antidepressant treatment). The primary outcome measures of safety and tolerability will be assessed continually across the study by monitoring adverse events and dropout rates. The secondary outcome measure (change in depression score) will be assessed at the end of week 2 and week 4, with a further assessment at week 8 to ascertain if any improvements have been maintained, and if some participants have a delayed response to treatment.
The study hypothesis is that the acceptability and safety/tolerability of the more novel intensive iTBS treatment protocol (Group 2) will similar or greater than that of the standard rTMS treatment protocol (Group 1).
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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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Dr Aswin Ratheesh
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Address
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Orygen
35 Poplar Road (Locked Bag 10)
Parkville, Victoria 3052
Australia
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Country
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Australia
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Phone
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+61 3 9966 9207
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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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Dr James Kean
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Address
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Orygen
35 Poplar Road (Locked Bag 10)
Parkville, Victoria 3052
Australia
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Country
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Australia
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Phone
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+61 3 9966 9258
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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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Dr Aswin Ratheesh
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Address
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Orygen
35 Poplar Road (Locked Bag 10)
Parkville, Victoria 3052
Australia
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Country
112924
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Australia
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Phone
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+61 399669100
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Fax
112924
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Email
112924
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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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