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Trial registered on ANZCTR
Registration number
ACTRN12619001742167
Ethics application status
Approved
Date submitted
29/11/2019
Date registered
9/12/2019
Date last updated
9/12/2019
Date data sharing statement initially provided
9/12/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Is Spontaneous Swallowing Reduced in Parkinson's Compared to Healthy Controls?
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Scientific title
Is Spontaneous Swallowing Reduced in Parkinson's Compared to Healthy Controls?
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Secondary ID [1]
299296
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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
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Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease
314424
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Condition category
Condition code
Neurological
312766
312766
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0
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Parkinson's disease
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
A matched case design will be used for this study. Thirty people with Parkinson's and thirty controls will be recruited.
The primary independent variable will be PD diagnosis (y/n) and the primary dependent variable will be frequency of spontaneous salivary swallowing (swallows/minute).
Spontaneous swallowing is measured in a single session using audio recordings of swallowing via an electret microphone secured to the participant's neck. Participants are set up to use a tablet-based distraction task and left alone in a quiet, temperature-controlled room for 30 minutes.
The assessor is blinded to participant group. They use waveform and spectrogram information and unrestricted playback in Audacity to count the number of swallows. The first five minutes of the sample is not analysed, in order to ensure participants were sufficiently distracted.
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Intervention code [1]
315570
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Not applicable
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Comparator / control treatment
The same spontaneous swallowing measures will be taken from controls.
Controls will be selected from rehabilitation patients, age and gender matched to each case. The literature on age differences in swallowing rates is contradictory but a few papers indicate a difference between young adults (college students) and older adults; therefore, a control who is ± 2 years from the case’s age will be assumed to be sufficiently matched. Rehabilitation patients are sought for convenience of recruitment, but will provide suitable controls because:
• Inpatients at rehabilitation are medically stable and preparing for discharge
• Cases and controls are both rehabilitation patients, and therefore will be similarly matched across health and function
• The exclusion criteria for medical history below should eliminate possible alternative causes of swallowing rate differences
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Control group
Active
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Outcomes
Primary outcome [1]
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Difference in frequency of spontaneous swallowing (swallows/min) between groups.
Frequency of spontaneous swallowing is assessed using audio recordings of swallows via electret microphone attached to the neck and analysed manually using computer software for playback.
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Assessment method [1]
321392
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Timepoint [1]
321392
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Time of observation
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Secondary outcome [1]
374850
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Mean number of salvo swallows (>3 consecutive swallows) in Parkinson's Disease group.
Salvo swallows are defined as 3 or more consecutive swallows and will be manually identified from the audio recordings of spontaneous swallowing, using computer software for playback.
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Assessment method [1]
374850
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Timepoint [1]
374850
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Time of observation
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Secondary outcome [2]
374851
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Facial Masking severity - assessed using Movement Disoder Society Unified Parkinson's Disease Rating Scale (item 3.2) rated by the assessor.
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Assessment method [2]
374851
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Timepoint [2]
374851
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Time of observation
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Secondary outcome [3]
377671
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Dysphagia - assessed using the Clinical Assessment of Dysphagia in Neurodegeneration (CADN).
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Assessment method [3]
377671
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Timepoint [3]
377671
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Time of observation
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Secondary outcome [4]
377672
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Dysarthria - assessed from recordings of several speech tasks including reading 'The Rainbow Passage', stating the days of the week, maximum phonation of the vowel /a/, and producing alternating and sequential motion rates (/p/, /t/, /k/, /pataka/). The assessor conducts recordings during the single assessment visit using professional speech recording equipment.
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Assessment method [4]
377672
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Timepoint [4]
377672
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Time of observation
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Secondary outcome [5]
377673
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Disease severity - assessed using the Modified Hoehn and Yahr Scale, rated by staff conducting screening and consent.
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Assessment method [5]
377673
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Timepoint [5]
377673
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Time of observation
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Secondary outcome [6]
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Postural changes - assessed using the Movement Disoder Society Unified Parkinson's Disease Rating Scale (item 3.13) rated by the assessor.
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Assessment method [6]
377674
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Timepoint [6]
377674
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Time of observation
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Secondary outcome [7]
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Drooling severity - assessed using the Radboud Oral Motor Inventory for PD – saliva subset, completed by the participant
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Assessment method [7]
377675
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Timepoint [7]
377675
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Time of observation
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Eligibility
Key inclusion criteria
• Aged over 18 years [All participants]
• Diagnosis of Idiopathic PD as per neurologist [Parkinson's participants only]
• Hoehn & Yahr Parkinson’s severity >1 [Parkinson's participants only]
• If taking saliva management medication, cognitively able to consent to cease for three days prior [Parkinson's participants only]
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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?
Yes
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Key exclusion criteria
• History of stroke
• History of head and neck cancer
• History of neurological conditions (other than PD)
• History of surgery or trauma impacting the upper aerodigestive tract
• Pathological oral condition as observed on examination by Speech Pathologist
• Allergy to adhesives
• Deep Brain Stimulator
• Botox to salivary glands past 6 months
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Study design
Purpose
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Duration
Cross-sectional
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Selection
Case control
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Timing
Prospective
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Statistical methods / analysis
Based on a population mean swallowing frequency of 1.18 (SD 0.47) (Pehlivan et al, 1996), to find a difference in spontaneous swallowing frequency of 0.38 with an alpha of 0.05 and a power of 0.80, a minimum of 26 participants in each group is necessary.
The assessor will re-assess a random 10% sample at least two weeks after the initial assessment to examine intra-rater reliability. A second assessor will analyse a random 10% sample to examine inter-rater reliability.
A biostatistician will be employed to complete statistical analysis.
Inter-rater reliability will be analysed using ICC (2, 1), in which the same raters assess the same subjects, each rating is considered individually, and both rathers and subjects are assumed to be representative of their respective populations. Intra-rater reliability will be assessed with ICC (3,1) which also considers each rating individually but does not assume that a rater is representative of other raters.
Data for H1-H3 will each be checked for normality visually using histograms and confirmed with Shapiro-Wilks tests. If data are not normally distributed, logarithmic or square root transformations may be used as advised by the statistician to meet the parametric testing requirements.
For H1 and H2, the two groups will be compared using a two-sample t-test (p = .05).
H3 will be examined using a 2-sample equivalence test with p = 0.05.
For H4, the relationships between each factor and the drooling severity will be assessed using Spearman’s correlation analysis (p = .05).
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
13/12/2019
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Actual
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Date of last participant enrolment
Anticipated
20/12/2020
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Actual
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Date of last data collection
Anticipated
31/12/2020
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
14792
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Cabrini Hopetoun Rehabilitation Hospital - Elsternwick
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Recruitment postcode(s) [1]
28034
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3185 - Elsternwick
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Funding & Sponsors
Funding source category [1]
303820
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Charities/Societies/Foundations
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Name [1]
303820
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Cabrini Foundation
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Address [1]
303820
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181/183 Wattletree Rd
Malvern VIC 3144
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Country [1]
303820
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Australia
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Primary sponsor type
Individual
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Name
John E. Pierce
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Address
Cabrini Rehabilitation - Hopetoun
2-6 Hopetoun Street
Elsternwick VIC3185
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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Adam Vogel
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Address [1]
303945
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University of Melbourne
550 Swanston St, Carlton VIC 3053
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Country [1]
303945
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
304334
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Monash Health
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Ethics committee address [1]
304334
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Research Support Services
Monash Health
Level 2, I Block
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168
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Ethics committee country [1]
304334
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Australia
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Date submitted for ethics approval [1]
304334
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16/07/2019
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Approval date [1]
304334
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17/10/2019
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Ethics approval number [1]
304334
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RES-19-0000-552A
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Summary
Brief summary
Parkinson’s Disease (PD) is a progressive condition that affects at least 1% of people over 65 with 10% of PD cases younger than 50. Drooling occurs in up to 74% of people with PD and leads to debilitating effects on social interaction, confidence, speech and eating.
Despite its high prevalence, treatments for drooling are limited because the cause is unclear. It is assumed that people with PD swallow their saliva less frequently than the general population, and that this leads to an accumulation of saliva in the mouth. However, a reduction in swallowing rates has not been definitively established in research.
This study aims to measure the rate of spontaneous saliva swallowing in people with and without PD. A non-invasive, validated method will be used to count swallows in participants recruited from the Parkinson’s Program at Cabrini rehabilitation. Swallowing rates will be compared between groups and results will show whether swallowing rates differ in PD. This information is vital for developing treatments for this degrading symptom of Parkinson’s. Lower swallowing rates in Parkinson’s will support treatments to encourage swallowing more regularly, whereas no difference in rates will call these approaches into question.
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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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Mr John E. Pierce
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Address
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Cabrini Rehabilitation - Hopetoun
2-6 Hopetoun St
Elsternwick VIC3185
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Country
96582
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Australia
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Phone
96582
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+61 3 9508 5132
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Fax
96582
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Email
96582
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[email protected]
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Contact person for public queries
Name
96583
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Mr John E. Pierce
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Address
96583
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Cabrini Rehabilitation - Hopetoun
2-6 Hopetoun St
Elsternwick VIC3185
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Country
96583
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Australia
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Phone
96583
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+61 3 9508 5132
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Fax
96583
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Email
96583
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[email protected]
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Contact person for scientific queries
Name
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Mr John E. Pierce
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Address
96584
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Cabrini Rehabilitation - Hopetoun
2-6 Hopetoun St
Elsternwick VIC3185
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Country
96584
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Australia
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Phone
96584
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+61 3 9508 5132
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Fax
96584
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Email
96584
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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
Only aggregate group data will be available
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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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