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Trial registered on ANZCTR
Registration number
ACTRN12617001367336
Ethics application status
Approved
Date submitted
31/08/2017
Date registered
27/09/2017
Date last updated
31/08/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
In the intensive care setting immediately after Coronary Artery Bypass surgery, what is the glucose management range associated with the best outcomes?
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Scientific title
Determination of the optimal glucose management range during critical care management post Coronary Artery Bypass surgery.
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Secondary ID [1]
289736
0
Nil known
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Universal Trial Number (UTN)
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Trial acronym
OGRE-CABG (Optimal Glucose RangE for post-op CABG)
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Coronary artery bypass surgery
299582
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Post-operative glucose management
299583
0
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Stress hyperglycaemia
299664
0
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Condition category
Condition code
Metabolic and Endocrine
299548
299548
0
0
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Diabetes
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Surgery
299549
299549
0
0
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Other surgery
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Cardiovascular
303942
303942
0
0
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Coronary heart 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
Patients undergoing elective or semi-urgent Coronary Artery Bypass Graft surgery at Flinders Medical Centre will be identified using the ANZ Cardiac Surgery Registry. The glucose range associated with optimal post-operative outcomes in the 30 day post-op period will be determined.
Glucose ranges tested will be defined by both absolute glucose ranges, and the Stress Hyperglycaemia Ratio. SHR is defined by the time-weighted glucose during ICU stay divided by the estimated average glycaemia ( as calculated from the HbA1c using the formula developed by Nathan et al. Diab Care 2008;31:1473–14788. The study is retrospective - patients will have undergone routine post-op intensive care. Pathology results used in the analysis will be those already available through routine care.
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Intervention code [1]
295434
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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]
299080
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Combined endpoint for adverse outcomes - mortality, infection (deep and superficial sternal wound infection, bacteraemia, pneumonia), respiratory failure (need for ventilator assistance for longer than 48 h), acute kidney injury (increase in creatinine level 40% from baseline), new MI, new CCF, new arrhythmias, stroke,hospital readmissions within 30 days related to the procedure as determined by the ANZ Cardiac Surgery Registry.
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Assessment method [1]
299080
0
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Timepoint [1]
299080
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up to 30 days post discharge
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Secondary outcome [1]
326087
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Readmission
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Assessment method [1]
326087
0
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Timepoint [1]
326087
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up to 30 days post discharge as determined by the ANZ Cardiac Surgery Registry
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Secondary outcome [2]
338599
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infection
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Assessment method [2]
338599
0
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Timepoint [2]
338599
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up to 30 days post discharge as determined by the ANZ Cardiac Surgery Registry
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Secondary outcome [3]
338600
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Myocardial infarction
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Assessment method [3]
338600
0
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Timepoint [3]
338600
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the hospital admission period as determined by the ANZ Cardiac Surgery Registry
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Secondary outcome [4]
339015
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new arrythmias
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Assessment method [4]
339015
0
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Timepoint [4]
339015
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the hospital admission period as determined by the ANZ Cardiac Surgery Registry
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Secondary outcome [5]
339016
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stroke
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Assessment method [5]
339016
0
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Timepoint [5]
339016
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the hospital admission period as determined by the ANZ Cardiac Surgery Registry
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Secondary outcome [6]
339017
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Mortality
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Assessment method [6]
339017
0
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Timepoint [6]
339017
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the hospital admission period as determined by the ANZ Cardiac Surgery Registry
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Secondary outcome [7]
339018
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Respiratory failure (>48hours of ventilator assistance)
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Assessment method [7]
339018
0
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Timepoint [7]
339018
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the hospital admission period as determined by the ANZ Cardiac Surgery Registry
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Secondary outcome [8]
339019
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acute kidney injury (increase of 40% or more from baseline creatinine)
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Assessment method [8]
339019
0
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Timepoint [8]
339019
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the hospital admission period as determined by the ANZ Cardiac Surgery Registry
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Secondary outcome [9]
339020
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new onset exacerbation of heart failure
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Assessment method [9]
339020
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Timepoint [9]
339020
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the hospital admission period as determined by the ANZ Cardiac Surgery Registry
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Eligibility
Key inclusion criteria
Patients undergoing elective or semi-urgent Coronary Artery Bypass Graft surgery with or without other concurrent cardiac surgery.
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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
<18 years age, pregnant, emergency surgery, GFR<30ml/min/sq.m., hepatic failure, history of hyperglycaemic crisis.
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Retrospective
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Statistical methods / analysis
ROC curves will be used to ascertain AUC, sensitivity, and specificity of pre-defined ranges, including ranges designated by both the relative and absolute changes in glucose during post-op critical care management. Best final model will be determined using AUC, specificity and sensitivity from ROC curves in consideration with the lowest OR for adverse outcomes associated with Time-In-Range using multivariable regression. Following variables to be used:
- Time In Range
- APACHE lllj
- lactate
- CABG, re-do CABG, CABG + other cardiac surgery
- other variables depending on results of univariable analysis and degree of co-linearity
The successful model will then be applied to a validation sample to determine reproducibility.
We will use a cohort of 2500 patients identified in the SHR-CABG study (also listed on ANZCTR)
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
10/10/2017
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Actual
22/12/2017
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Date of last participant enrolment
Anticipated
20/12/2017
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Actual
20/07/2018
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Date of last data collection
Anticipated
20/12/2017
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Actual
22/08/2018
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Sample size
Target
1500
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Accrual to date
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Final
1495
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
6301
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Flinders Medical Centre - Bedford Park
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Recruitment postcode(s) [1]
13835
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5042 - Bedford Park
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Funding & Sponsors
Funding source category [1]
294158
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Hospital
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Name [1]
294158
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Flinders Medical Centre
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Address [1]
294158
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Flinders Drive, Bedford Park 5042 SA
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Country [1]
294158
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Australia
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Primary sponsor type
Hospital
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Name
Flinders Medical Centre
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Address
Flinders Drive, Bedford Park SA 5042
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Country
Australia
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Secondary sponsor category [1]
292991
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None
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Name [1]
292991
0
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Address [1]
292991
0
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Country [1]
292991
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
295570
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Southern Adelaide Clinical Human Research Ethics Committee
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Ethics committee address [1]
295570
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The Flats G5 – Rooms 3 and 4 Flinders Drive Flinders Medical Centre, Bedford Park SA 5042
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Ethics committee country [1]
295570
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Australia
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Date submitted for ethics approval [1]
295570
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15/09/2016
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Approval date [1]
295570
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19/10/2016
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Ethics approval number [1]
295570
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OFR # 373.16 - HREC/16/SAC/346
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Summary
Brief summary
Hyperglycaemia in hospitalised patients is independently associated with increased morbidity and mortality in a wide range of patient groups, including post-operative outcomes. The association between hyperglycaemia and poor post-operative outcomes is strong in patients without diabetes, but a weaker predictor in patients with diabetes. This discrepancy is in part driven by the difficulty in distinguishing genuine stress hyperglycaemia from chronic high levels seen in diabetic patients. A high plasma glucose concentration in a hospitalised patient can occur because of chronic poor diabetes control and be “normal” for that patient, represent a transient physiologic response to an inter¬current illness (stress hyperglycaemia), or be a combination of the above. A metric for stress hyperglycaemia has been developed at FMC - the Stress Hyperglycaemia Ratio is defined as glucose concentration divided by the Estimated Average Glucose concentration, which is calculated from HbA1c. This enables quantification of the relative change in hyperglycaemia eg a patient with a SHR of 1.4 has an glucose concentration 40% higher than their average glucose over the prior 3 months. Our previous work indicated that the relative change in glucose was a better indicator of stress hyperglycaemia and more strongly associated with adverse patient outcomes than glucose. Patients undergoing CABG surgery require mandatory post-op observation in the ICU setting, and commonly require intervention for glucose management. There is some conjecture that the commonly used glucose control range is no appropriate for all patients. We aim to determine the glucose control range that is associated with the best post-op outcomes.
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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
67626
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Mr Greg Roberts
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Address
67626
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Pharmacy Department
Flinders Medical Centre
Flinders Drive, Bedford Park, SA 5042
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Country
67626
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Australia
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Phone
67626
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+61 8 82046936
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Fax
67626
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+61 8 82046245
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Email
67626
0
[email protected]
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Contact person for public queries
Name
67627
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Greg Roberts
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Address
67627
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Pharmacy Department
Flinders Medical Centre
Flinders Drive, Bedford Park, SA 5042
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Country
67627
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Australia
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Phone
67627
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+61 8 82046936
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Fax
67627
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+61 8 82046245
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Email
67627
0
[email protected]
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Contact person for scientific queries
Name
67628
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Greg Roberts
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Address
67628
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Pharmacy Department
Flinders Medical Centre
Flinders Drive, Bedford Park, SA 5042
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Country
67628
0
Australia
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Phone
67628
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+61 8 82046936
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Fax
67628
0
+61 8 82046936
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Email
67628
0
[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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