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Trial registered on ANZCTR
Registration number
ACTRN12625000200482
Ethics application status
Approved
Date submitted
23/12/2024
Date registered
20/02/2025
Date last updated
20/02/2025
Date data sharing statement initially provided
20/02/2025
Type of registration
Retrospectively registered
Titles & IDs
Public title
Assessing the effectiveness of Hospital-Based Manufactured Medical Device Restorabite for treatment of Trismus in adults after head and neck cancer surgery (Cohort 2)
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Scientific title
Efficacy of Hospital-Based Manufactured Medical Device Restorabite for treatment of Trismus in adults after head and neck cancer surgery (Cohort 2).
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Secondary ID [1]
313588
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Nil Known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
This record is a sub-study of ACTRN12621000585820
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Health condition
Health condition(s) or problem(s) studied:
Trismus
336117
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Head and Neck Cancer
336118
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Condition category
Condition code
Cancer
332669
332669
0
0
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Head and neck
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Oral and Gastrointestinal
332671
332671
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Musculoskeletal
332670
332670
0
0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The primary objective is to determine optimal exercise duration and force to treat Trismus.
Description of Interventions:
• Passive jaw range of motion exercises using Restorabite as per randomised Arm
• Active jaw range of motion exercises using Restorabite as per randomised Arm
• 10 x 1hr weekly sessions face to face or over telehealth with speech pathology. Gradual progression through the force hierarchy as clinically indicated.
• Home practice: daily for 20 minutes for duration of study (10 weeks)
Passive and active jaw range of motion exercises is a continuous exercise performed with Restorabite. It involves inserting the pressed down Restorabite between the front teeth and letting the device stretch the jaw (passive motion exercise) then bite down on the mouth guards (active motion exercise). Then repeat the letting go of the bite (passive motion exercise) and biting down on the device (active motion exercise).
Participants will be given a Restorabite device and randomised to one of seven daily exercise programs (20 minutes daily).
Arm 1. Low force for maximum of 30 seconds of 4 repetitions x 5 times with Restorabite
Arm 2. Low force for maximum of 60 seconds of 2 repetitions x 5 times with Restorabite
Arm 3. Low force for maximum of 120 seconds of 1 repetition x 5 times with Restorabite
Arm 4. High force for maximum of 30 seconds of 4 repetitions x 5 times with Restorabite
Arm 5. High force for maximum of 60 seconds of 2 repetitions x 5 times with Restorabite
Arm 6. High force for maximum of 120 seconds of 1 repetition x 5 times with Restorabite
Control. Stacked tongue depressor for maximum of 30 seconds of 5 repetitions x 5 times
Low force is defined as maximum intensity of up to 30N (insert position 4 on Restorabite device)
High force is defined as maximum intensity of up to 50N (insert position 8 on Restorabite device)
Participants will be given a device, and the treatment will last for 10 weeks. Participants will be asked to attend 10 sessions of 1-hour weekly appointments with the speech pathologist. These appointments can be conducted either in person or via Telehealth.
Follow up appointments will be required at 6 months and 12 months after the study treatment finishes.
At the first and last appointments and 6 months and 12 months follow up appointments, participants will be asked to answer Quality of Life (QoL) questionnaires.
Optional semi-structured interviews, using an interview guide, will be conducted with patients to evaluate their experiences using a device for trismus at the end of the intervention. These 30-60minute interviews will be conducted via video conferencing (Zoom) once during the course of the trial.
To monitor adherence to the intervention speech pathologists will closely follow up participants. To increase the adherence to the intervention, speech pathologists will set up a 10-week appointment plan at the beginning of the trial and also offer tele-health appointments.
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Intervention code [1]
330183
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Treatment: Devices
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Comparator / control treatment
Standard care as control. Standard of care of trismus includes other common devices such as Ark-J (wooden tongue depressor) Theraband or Therabite.
Note: This intervention does not differ from the standard of care of trismus, the novel part of this intervention is the use of Restorabite (with defined duration and force) instead of other devices such as Ark-J.
Home practice: daily for 20 minutes for duration of study (10 weeks)
10 x sessions of 1-hour weekly appointments with the speech pathologist. These appointments can be conducted either in person or via Telehealth.
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in interincisal distance (IID)
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Assessment method [1]
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Measurement of IID using TheraBite Range of Motion Scale (disposable paper measuring scales, specifically designed to allow patients and providers to measure the opening, movement and function of the mouth and jaw).
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Timepoint [1]
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Baseline, end of 10 X weekly sessions, 6 and 12 months follow up.
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Secondary outcome [1]
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Change in patient quality of life
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Assessment method [1]
443227
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Eating assessment tool - 10: patient reported outcome measures that enquires as to the effects of eating on their lives.
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Timepoint [1]
443227
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Baseline, end of 10 x weekly sessions, 6 and 12 months follow up
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Secondary outcome [2]
443226
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Change in patient quality of life
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Assessment method [2]
443226
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Gothenburg trismus questionnaire: patient reported outcome measure that measures the impact of trismus on the patient's daily life
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Timepoint [2]
443226
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Baseline, end of 10 x weekly sessions, 6 and 12 months follow up
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Secondary outcome [3]
443230
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Changes in patient quality of life
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Assessment method [3]
443230
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McGill questionnaire (short form): describes the sensory dimension of pain including an overall intensity measure
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Timepoint [3]
443230
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Baseline, end of 10 x weekly sessions, 6 and 12 months
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Secondary outcome [4]
443228
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Change in patient quality of life
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Assessment method [4]
443228
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Speech handicap index (SHI): patient report outcome measure that enquires as to the impact of speech problems on a patient's daily life
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Timepoint [4]
443228
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Baseline, end of 10 x weekly sessions, 6 and 12 months follow up
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Secondary outcome [5]
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Changes in patient quality of life
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Assessment method [5]
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MD Anderson Dysphagia Inventory (MDADI): patient reported outcome measures that enquires as to the impact of swallowing problems on a patient’s daily life
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Timepoint [5]
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Baseline, end of 10 x weekly sessions, 6 and 12 months follow up
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Eligibility
Key inclusion criteria
• 18 years and older
• Diagnosis of head and neck cancer (HNC)
• Patients with an interincisal distance (IID) of 35mm or less
• Willingness to give informed consent
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Minimum age
18
Years
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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
Patients where trismus therapy is contraindicated due to medical/surgical parameters, guided by their managing physician.
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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)
Simple randomisation using a randomisation table created by computer software (i.e. computerised 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
Parallel
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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
The maximum sample size of 280 (7 arms with 20 participants at stage 1 and 7 arms with 20 participants at stage 2) is based on a minimal detectable difference of 5 mm increase in IID, baseline mean IID of 20 mm, standard deviation 6 mm, Family-wide error rate (FWER) 0.05, power 80%, and 20% dropout rate. If futility is demonstrated at interim analysis with no dropouts, the sample size required is 112 participants.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
14/04/2023
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Date of last participant enrolment
Anticipated
8/06/2025
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Actual
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Date of last data collection
Anticipated
9/06/2026
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Actual
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Sample size
Target
280
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Accrual to date
146
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
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Recruitment hospital [1]
27434
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Chris O’Brien Lifehouse - Camperdown
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Recruitment hospital [2]
27437
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Westmead Private Hospital - Westmead
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Recruitment hospital [3]
27439
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The Canberra Hospital - Garran
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Recruitment hospital [4]
27435
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [5]
27438
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Wollongong Hospital - Wollongong
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Recruitment hospital [6]
27436
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Royal Melbourne Hospital - City campus - Parkville
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Recruitment postcode(s) [1]
43547
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3000 - Melbourne
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Recruitment postcode(s) [2]
43549
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2145 - Westmead
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Recruitment postcode(s) [3]
43548
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3050 - Parkville
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Recruitment postcode(s) [4]
43546
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2050 - Camperdown
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Recruitment postcode(s) [5]
43551
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2605 - Garran
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Recruitment postcode(s) [6]
43550
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2500 - Wollongong
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Funding & Sponsors
Funding source category [1]
318056
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Hospital
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Name [1]
318056
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Chris O'Brien Lifehouse
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Address [1]
318056
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Country [1]
318056
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Australia
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Primary sponsor type
Hospital
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Name
Chris O'Brien Lifehouse
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Address
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Country
Australia
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Secondary sponsor category [1]
320435
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None
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Name [1]
320435
0
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Address [1]
320435
0
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Country [1]
320435
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316707
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St Vincent’s Hospital Human Research Ethics Committee
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Ethics committee address [1]
316707
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https://svhs.org.au/home/research-education/research-office
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Ethics committee country [1]
316707
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Australia
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Date submitted for ethics approval [1]
316707
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23/04/2021
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Approval date [1]
316707
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09/06/2021
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Ethics approval number [1]
316707
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2021/ETH00758
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Summary
Brief summary
This study aims to assess the efficacy of a "Restorabite" device to treat a disorder called trismus in head and neck cancer patients. Who is it for? You may be eligible for this study if you are an adult with, or who has had in the past, head and neck cancer, and has trouble opening your jaw wider than 35mm. Study details Patients will attend 10 x 1 hour weekly sessions with a speech pathologist, where they will be taken through passive and active jaw range of motion exercises. They will also be instructed to complete 20 minutes of home practice daily over the 10-week study period. Data on changes in jaw opening distance and quality of life will be collected. It is hoped that findings in this study help researchers determine optimal stretching regime for trismus treatment. Participation in this clinical trial is voluntary.
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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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Prof Jonathan Clark
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Address
138738
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Chris O'Brien Lifehouse; 119-143 Missenden Rd, Camperdown, NSW, 2050
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Country
138738
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Australia
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Phone
138738
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+61 2 8514 0268
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Fax
138738
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Email
138738
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[email protected]
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Contact person for public queries
Name
138739
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Masako Dunn
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Address
138739
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Chris O'Brien Lifehouse; 119-143 Missenden Rd, Camperdown, NSW, 2050
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Country
138739
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Australia
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Phone
138739
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+61 2 8514 0411
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Fax
138739
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Email
138739
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[email protected]
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Contact person for scientific queries
Name
138740
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Jonathan Clark
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Address
138740
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Chris O'Brien Lifehouse; 119-143 Missenden Rd, Camperdown, NSW, 2050
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Country
138740
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Australia
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Phone
138740
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+61 2 8514 0268
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Fax
138740
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Email
138740
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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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