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Trial registered on ANZCTR
Registration number
ACTRN12616001333404
Ethics application status
Approved
Date submitted
29/06/2016
Date registered
26/09/2016
Date last updated
2/10/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
PAIR of Hearts Study (Palliative care Approach, Investigating Real outcomes in Heart failure)
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Scientific title
The effects of early initiation of discussions regarding a palliative care approach with adults with moderate to severe non-valvular heart failure on quality of life and depressive symptoms.
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Secondary ID [1]
289501
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
PAIR of Hearts Study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart failure
299199
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Condition category
Condition code
Cardiovascular
299207
299207
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Intervention = Early initiation of discussions regarding a palliative approach to care.
Intervention Procedures = The early initiation of a palliative approach to care will involve the addition of sensitive discussions with participants and their nominated close associates on themes of prognosis, disease trajectory, palliative care, doctor-patient relationships and advanced care directives, in addition to standard care. This intervention will occur immediately post study randomisation into the intervention arm of the study independent of time since diagnosis.
Intervention Materials = Discussions will be guided using Intervention Checklists and written patient information booklets will be provided to participants.
Mode of delivery and location of intervention = 1x face-to-face session at Sir Charles Gairdner Hospital which will require attendance at the clinic for approximately 1 hour and 30 minutes (this will include time for the completion of paperwork and questionnaires and for the interventional discussion of duration = 45 minutes) and 1x follow-up phone call at 1 month after initial face-to-face session of duration no greater than 15 minutes.
Who will deliver intervention = The intervention will be delivered by a member of the study team. This will be a medical student who has completed palliative care on-line training modules, a doctor or a nurse.
How intervention is personalised or adapted = As occurs in real-life settings participants will be first asked for consent before discussing any topics.
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Intervention code [1]
295107
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Treatment: Other
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Comparator / control treatment
Standard care alone.
In this study standard care is defined as the usual standard of care being offered to patients with heart failure at Sir Charles Gairdner Hospital. This involves being under the care of a treating cardiologist, attending clinic appointments booked at the discretion of the treating cardiologist, hospital admissions when required, usual access to allied health services, management by the Cardiac Rehabilitation and Heart Failure service and usual utilisation of General Practice care. Standard care does not exclude involvement in formalised palliative care if requested by patients or their usual treating team. However, involvement in such a service will be recorded for study results discussion.
Participants receiving standard care alone will not be offered the intervention discussion as part of the study, but will not be discouraged from having discussions on similar topics with their usual health care team.
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Control group
Active
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Outcomes
Primary outcome [1]
298781
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To identify if there is an association between early initiation of discussions regarding a palliative care approach in patients suffering from non-valvular heart failure and improved quality of life as shown by % of patients with a 10 point decrease in the FACIT-Pal (version 4) questionnaire score.
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Assessment method [1]
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Timepoint [1]
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2 months post initial intervention.
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Primary outcome [2]
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To identify if there is an association between early initiation of discussions regarding a palliative care approach in patients suffering from non-valvular heart failure and increase in depressive symptoms as shown by % of patients with a 2 point increase in the Patient Health Questionnaire 9 (PHQ-9) score.
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Assessment method [2]
298782
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Timepoint [2]
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2 months post initial intervention.
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Secondary outcome [1]
325183
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To identify if there is an association between early initiation of discussions regarding a palliative care approach in patients suffering from non-valvular heart failure and improved overall wellness rating as reported by the patient on a Visual Analogue Scale from 0 to 10.
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Assessment method [1]
325183
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Timepoint [1]
325183
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2 months post initial intervention.
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Secondary outcome [2]
325184
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To determine if there is any statistically significant difference between patient self-reported overall wellness rating and overall wellness rating by the patient’s close associate at initial assessment as reported on a Visual Analogue Scale from 0 to 10.
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Assessment method [2]
325184
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Timepoint [2]
325184
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Measured on the day of randomisation prior to initial intervention,
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Secondary outcome [3]
325185
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To identify if there is an association between early initiation of discussions regarding a palliative care approach in patients suffering from non-valvular heart failure and a reduction in any difference between patient self-reported overall wellness rating and overall wellness rating by the patient’s close associate on a Visual Analogue Scale from 0 to 10.
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Assessment method [3]
325185
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Timepoint [3]
325185
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2 months post initial intervention.
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Secondary outcome [4]
327812
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To identify if there is an association between early initiation of discussions regarding a palliative care approach in patients suffering from non-valvular heart failure and improved quality of life as shown by % of patients with a 10 point decrease in the FACIT-Pal (version 4) questionnaire score.
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Assessment method [4]
327812
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Timepoint [4]
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4 months post initial intervention
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Secondary outcome [5]
327813
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To identify if there is an association between early initiation of discussions regarding a palliative care approach in patients suffering from non-valvular heart failure and increase in depressive symptoms as shown by % of patients with a 2 point increase in the Patient Health Questionnaire 9 (PHQ-9) score.
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Assessment method [5]
327813
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Timepoint [5]
327813
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4 months post initial intervention
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Eligibility
Key inclusion criteria
The study will enrol men and women greater than or equal to 18 years old who are under the care of the Cardiovascular Medicine Department, at Sir Charles Gairdner Hospital, Perth WA, with a diagnosis or past diagnosis of chronic non-valvular heart failure of NYHA classification III or IV.
Close associates nominated by patients will also be invited to be involved in the study (these close associates may be healthy volunteers and must be greater than or equal to 18 years old).
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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 with heart failure that is known to be highly likely to be reversible (e.g. valvulopathy with planned correction via valvular surgery in an appropriate surgical candidate)
* Patients with current diagnosis of psychiatric illness
* Patients with other major illnesses that may require palliative care such as cancer
* Patients or close associates who have insufficient verbal, reading and written English language capability to provide full informed consent for study participation
* Patients or close associates with possible cognitive impairment likely to interfere with comprehension and the informed consent procedure
* Patients or close associates without telephone access or means to be contacted via phone
* Patients already receiving specialised palliative care services prior to study enrolment
* Close associates of the patient who are not nominated to be involved by the patient themselves
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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)
Randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Minimisation
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
N/A
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
A sample size of 90 patients is required to have an 80% chance of detecting an increase in the primary outcome measure of 10 points of difference in the FACIT-Pal questionnaire for quality of life with statistical significance at the 5% level. This is a pilot study in patients with heart failure so sample size has been approximated from a study in patients with cancer. This calculation of sample size was based on a standard deviation of 16.74 which was the mean standard deviation of the two groups in a study by Bakitas and colleagues 10 which used the FACIT-Pal questionnaire to evaluate quality of life in oncology patients. The calculation was made using the Power (Sample Size) Calculator for Continuous outcome superiority trials provided online by Sealed Envelope Ltd (https://www.sealedenvelope.com/power/continuous-superiority/).
Analyses will be conducted using IBM SPSS Statistics version 22. Baseline variables will be analysed to assess adequacy of randomisation. Continuous variables will be assessed by ANOVA. Categorical variables will be compared by Chi-square for proportions and logistic regression. Non-parametric analyses will be used where appropriate for small samples or non-normally distributed data. Subject data will be assessed on an as randomised basis.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
28/09/2016
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Actual
28/11/2016
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Date of last participant enrolment
Anticipated
2/02/2021
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Actual
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Date of last data collection
Anticipated
2/09/2021
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Actual
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Sample size
Target
90
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Accrual to date
55
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
6034
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
13483
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6009 - Nedlands
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Funding & Sponsors
Funding source category [1]
293941
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Hospital
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Name [1]
293941
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QEII
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Address [1]
293941
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QEII
Hospital Avenue
Nedlands WA 6009
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Country [1]
293941
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Australia
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Primary sponsor type
Individual
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Name
A/Prof Brendan McQuillan
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Address
L2 Harry Perkins Building
QQ Block
QEII Medical Centre
6 Verdun St
NEDLANDS WA 6009
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
292764
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Address [1]
292764
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Country [1]
292764
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
295354
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Sir Charles Gairdner Hospital HREC
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Ethics committee address [1]
295354
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Chairman or Executive Officer
HREC Office
Department of Research
2nd Floor A block
Sir Charles Gairdner Hospital
Nedlands WA 6009
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Ethics committee country [1]
295354
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Australia
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Date submitted for ethics approval [1]
295354
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23/05/2016
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Approval date [1]
295354
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07/10/2016
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Ethics approval number [1]
295354
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2016-032
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Summary
Brief summary
The purpose of this pilot study is to determine how different information discussed with, or given to, people suffering with heart failure might affect their quality of life, mood and overall well-being. Studies in this area of research may improve our understanding of how best to provide information and a palliative approach to care patients for with heart failure.
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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
66794
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A/Prof Brendan McQuillan
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Address
66794
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L2 Harry Perkins Building
QQ Block
QEII Medical Centre
6 Verdun St
NEDLANDS WA 6009
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Country
66794
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Australia
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Phone
66794
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+61 (08) 93463333
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Fax
66794
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Email
66794
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[email protected]
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Contact person for public queries
Name
66795
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A/Prof Brendan McQuillan
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Address
66795
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L2 Harry Perkins Building
QQ Block
QEII Medical Centre
6 Verdun St
NEDLANDS WA 6009
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Country
66795
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Australia
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Phone
66795
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+61 (08) 93463333
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Fax
66795
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Email
66795
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[email protected]
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Contact person for scientific queries
Name
66796
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A/Prof Brendan McQuillan
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Address
66796
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L2 Harry Perkins Building
QQ Block
QEII Medical Centre
6 Verdun St
NEDLANDS WA 6009
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Country
66796
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Australia
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Phone
66796
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+61 (08) 93463333
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Fax
66796
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Email
66796
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[email protected]
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No information has been provided regarding IPD availability
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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