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Trial registered on ANZCTR
Registration number
ACTRN12624000880549
Ethics application status
Approved
Date submitted
4/07/2024
Date registered
19/07/2024
Date last updated
4/08/2024
Date data sharing statement initially provided
19/07/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
What are the perceptions and attitudes of adults with ulcerative colitis toward protein supplements and are they consuming them?
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Scientific title
Understanding the perceptions, attitudes and use of protein supplements amongst adults with ulcerative colitis
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Secondary ID [1]
312320
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None
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Universal Trial Number (UTN)
U1111-1309-1335
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Trial acronym
USE-PROTEIN
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
ulcerative colitis
334074
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Condition category
Condition code
Oral and Gastrointestinal
330748
330748
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0
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Inflammatory bowel 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
An online survey will be used via a secure platform to collect data at a single time point. A study advertisement will contain a QR code that links to the survey website. The survey will take 10-20 minutes to complete. The study aims to understand the perceptions and attitudes of people with ulcerative colitis toward protein supplements. The survey will also obtain data on whether participants have consumed protein supplements within the last six months. For those indicating consumption, further data to characterise and describe their intake of protein supplements will be obtained.
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Intervention code [1]
328794
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
338510
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Proportion (% of cohort) of adults with ulcerative colitis who have consumed any protein supplements within the last 6-months.
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Assessment method [1]
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Self-completed survey question with binary outcome (yes, no, unsure)
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Timepoint [1]
338510
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Single time point at survey completion.
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Secondary outcome [1]
436210
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Proportion (% of cohort) who have concurrently aimed to increase dietary protein intake from table foods/ fluids when taking protein supplements.
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Assessment method [1]
436210
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Self-completed survey question using a binary outcome (yes, no, unsure) followed by textbox for those selecting 'yes' to obtain details on the types of foods/ fluids increased in the diet.
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Timepoint [1]
436210
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Single time point at survey completion.
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Secondary outcome [2]
436211
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Proportion (% of cohort) who consume animal-based protein supplements compared to plant-based protein supplements
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Assessment method [2]
436211
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Self-completed survey question with nominal outcome (animal-based, plant-based, combination, unsure)
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Timepoint [2]
436211
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Single time point at survey completion.
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Secondary outcome [3]
436212
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Proportion (% of cohort) who consume doses of protein supplements in line with manufacturer recommendations
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Assessment method [3]
436212
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Self-completed survey question using a binary outcome (yes, no, unsure) followed by a text box for those indicating 'no' to determine quantity consumed
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Timepoint [3]
436212
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Single time point at survey completion.
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Secondary outcome [4]
436213
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The diversity in protein type and source of protein supplements consumed in the cohort
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Assessment method [4]
436213
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Self-completed survey question with nominal outcome (powders and shakes, food-items, other/ protein concentrate, isolate, hydrolysate, other)
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Timepoint [4]
436213
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Single time point at survey completion.
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Secondary outcome [5]
436214
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The frequency of consumption of protein supplements within the cohort
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Assessment method [5]
436214
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self-completed survey question using a nominal outcome (daily, 4-6 days a week, 2-3 days a week, weekly, monthly, infrequently)
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Timepoint [5]
436214
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Single time point at survey completion.
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Secondary outcome [6]
436215
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The diversity in source of information regarding recommendations to commence protein supplementation
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Assessment method [6]
436215
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Self-completed survey question using a nominal outcome (social media, websites, health professionals, trainers, family/ friends, other) and text option for those indicating other or health professional to obtain further details on information source
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Timepoint [6]
436215
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Single time point at survey completion.
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Secondary outcome [7]
436216
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Proportion (% of cohort) who perceive protein supplements to be beneficial for overall health
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Assessment method [7]
436216
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self-completed survey questions using a 5-point Likert scale where 'strongly agree' and 'agree' indicate perceived benefit
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Timepoint [7]
436216
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Single time point at survey completion.
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Secondary outcome [8]
436217
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Proportion (% of cohort) who perceive there to be any risks associated with protein supplements
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Assessment method [8]
436217
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self-completed survey questions using 5-point Likert scales where 'strongly disagree' and 'disagree' indicate perceived risk
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Timepoint [8]
436217
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Single time point at survey completion.
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Secondary outcome [9]
436218
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Proportion (% of cohort) who perceive consumption of protein supplements to produce gastrointestinal symptoms
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Assessment method [9]
436218
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self-completed survey question using a 5-point Likert scale where 'strongly agree' and 'agree' indicate perceived associated gastrointestinal symptoms
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Timepoint [9]
436218
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Single time point at survey completion.
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Eligibility
Key inclusion criteria
Adults aged 18 years and older with a self-confirmed diagnosis of ulcerative colitis via colonoscopy and biopsy
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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
Aged less than 18 years old, people who do not have a diagnosis of ulcerative colitis. People who are unable to read and interpret English.
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Study design
Purpose
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Descriptive statistics will be used to analyse data. Categorical data will be expressed as frequency and percentage. Any qualitative data where text responses have been collected will be quantitatively grouped into categories for analysis and expressed as frequency and percentage. Tables and graphs will be used to display data.
No power calculation has been performed for this descriptive study as no data exists on the intake of protein supplements amongst adults with ulcerative colitis.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
2/09/2024
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Actual
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Date of last participant enrolment
Anticipated
29/08/2025
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Actual
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Date of last data collection
Anticipated
29/08/2025
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Actual
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Sample size
Target
500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Recruitment outside Australia
Country [1]
26371
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New Zealand
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State/province [1]
26371
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Country [2]
26372
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United Kingdom
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State/province [2]
26372
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Funding & Sponsors
Funding source category [1]
316715
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Hospital
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Name [1]
316715
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The Queen Elizabeth Hospital
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Address [1]
316715
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Country [1]
316715
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Australia
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Funding source category [2]
316936
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University
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Name [2]
316936
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The University of Adelaide
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Address [2]
316936
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Country [2]
316936
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Australia
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Primary sponsor type
Hospital
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Name
The Queen Elizabeth Hospital
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Address
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Country
Australia
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Secondary sponsor category [1]
319117
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None
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Name [1]
319117
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Address [1]
319117
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Country [1]
319117
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315491
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Central Adelaide Local Health Network HREC
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Ethics committee address [1]
315491
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https://www.rah.sa.gov.au/research/for-researchers/central-adelaide-local-health-network-human-research-ethics-committee
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Ethics committee country [1]
315491
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Australia
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Date submitted for ethics approval [1]
315491
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04/07/2024
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Approval date [1]
315491
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19/07/2024
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Ethics approval number [1]
315491
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19770
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Summary
Brief summary
Diet has been identified as a risk factor in ulcerative colitis. Understanding the habitual diet of people with ulcerative colitis is therefore important. Protein supplementation has become increasingly popular to optimise dietary protein intakes across the general population however data on protein supplement use in ulcerative colitis has not been examined. It is hypothesised that people with ulcerative colitis are consuming protein supplements for perceived health benefits.
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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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Miss Rachel Davis
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Address
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The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South, 5011, South Australia
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Country
134862
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Australia
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Phone
134862
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+61478267780
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Fax
134862
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Email
134862
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[email protected]
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Contact person for public queries
Name
134863
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Rachel Davis
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Address
134863
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The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South, 5011, South Australia
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Country
134863
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Australia
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Phone
134863
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+61478267780
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Fax
134863
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Email
134863
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[email protected]
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Contact person for scientific queries
Name
134864
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Rachel Davis
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Address
134864
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The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South, 5011, South Australia
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Country
134864
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Australia
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Phone
134864
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+61478267780
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Fax
134864
0
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Email
134864
0
[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
No - IPD will not be publically 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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