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Trial registered on ANZCTR
Registration number
ACTRN12616000786493
Ethics application status
Approved
Date submitted
6/06/2016
Date registered
16/06/2016
Date last updated
16/06/2016
Type of registration
Retrospectively registered
Titles & IDs
Public title
Phase II study of Paclitaxel and Epirubicin as Neoadjuvant Treatment for locally advanced Breast Cancer.
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Scientific title
Phase II study of Paclitaxel and Epirubicin as Neoadjuvant Treatment for locally advanced Breast Cancer.
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Secondary ID [1]
289361
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TAX1471I-2-1
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Universal Trial Number (UTN)
None
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Trial acronym
NAB
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
298994
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Condition category
Condition code
Cancer
299058
299058
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0
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Neoadjuvant therapy on day 1 of each cycle for 4 cycles (cycle duration is 3 weeks)
Epirubicin 90mg/m2 intravenously
Paclitaxel 175 mg/ m2 intravenously
Surgery
Surgical review 2-3 weeks after completion of neoadjuvant chemotherapy, if operable surgery planned for within the next week. Timing based on surgeon availability.
Surgery performed by specialist Breast Endocrine Surgical Unit. With larger tumours I.e. >5 cm original size, mastectomy recommended. Axillary dissection recommended for all patients. The duration of the surgical procedure is dependent on the tumour size, complexity of presentation and the procedure used.
Adjuvant chemotherapy will commence when patient is deemed by their treating Medical Oncologist to have fully recovered from surgery. Usual time frame anticipated to be 4-6 weeks post-operatively.
Adjuvant therapy (CMF) on days 1 and 8 of each cycle for 4 cycles (cycle duration is 4 weeks)
Cyclophosphamide 600 mg/m2 intravenously
Methotrexate 40 mg/ intravenously
Fluorouracil 600mg/m2 intravenously
Radiotherapy
Radiotherapy to chest wall/breast including supraclavicular node. Can begin any time after completion of the 1st cycle of CMF. Radiotherapy is planned for all patients and anticipated to commence no earlier than 2nd cycle of CMF chemotherapy, at the discretion of the treating Radiation Oncologist. Radiotherapy administered, including the dose, frequency and duration and any other relevant parameters at the discretion of the treating Radiation Oncologist.
Hormonal therapy
Tamoxifen 20mg orally per day administered to patients with ER +ve cancers to commence following the completion of all chemotherapy and radiotherapy. Planned duration of Tamoxifen therapy is 5 years. Patient compliance is monitored by patient self-report of dosing to treating Medical Oncologist.
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Intervention code [1]
294948
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Treatment: Drugs
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Intervention code [2]
294949
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Treatment: Surgery
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Intervention code [3]
295021
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Treatment: Other
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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]
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Primary Outcome:
Clinical response rate of the combination of Paclitaxel and Epirubicin as neoadjuvant treatment with locally advanced carcinoma of the breast.
Outcome Measure: Clinical response assessed by physical examination of the breast by the Medical Oncologist.
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Assessment method [1]
298542
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Timepoint [1]
298542
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Assessed at completion of neo-adjuvant chemotherapy with paclitaxel and epirubicin.
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Primary outcome [2]
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Pathological response rate of the combination of Paclitaxel and Epirubicin as neoadjuvant treatment with locally advanced carcinoma of the breast.
Outcome Measure: Histopathological assessment of breast tissue biopsied during surgery.
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Assessment method [2]
298637
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Timepoint [2]
298637
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At time of surgery
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Secondary outcome [1]
324523
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*Safety profile of the combination of Paclitaxel and Epirubicin in a neoadjuvant setting for locally advanced breast cancer.
Outcome Measure: All adverse events of any grade as defined by NCI CTCAE v 2.0. Adverse events may be self-reported or abnormal results of physical examinations, laboratory results or diagnostic imaging.
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Assessment method [1]
324523
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Timepoint [1]
324523
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30 days post completion of Paclitaxel and Epirubicin
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Secondary outcome [2]
324823
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*Disease free survival
Outcome Measure:
CT scan of the chest, abdomen and pelvis, Mammogram and MRI as per usual clinical practice
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Assessment method [2]
324823
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Timepoint [2]
324823
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At 10 years post completion of radiotherapy, with scans performed at the usual clinical practice frequency.
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Secondary outcome [3]
324824
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*Overall survival
Outcome Measure:
Patient survival status
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Assessment method [3]
324824
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Timepoint [3]
324824
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At 10 years post completion of radiotherapy or until death.
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Eligibility
Key inclusion criteria
1. Female aged 18 years or over with histological or cytologically confirmed locally advanced breast cancer. T3-4 Nx, Tx N2-3
2. No evidence of metastatic disease.
3. Normal cardiac function as determined by left ventricular injection fraction of greater that 50 % (gated heart pool scan or echocardiogram).
4. ECOG performance status of 0 or 1.
5. Must give written in form consent prior to commencement of any specific studies and any starting specific treatment.
6. Patients must be willing and able to comply with the protocol for the duration of the study.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Presence of metastatic disease.
2. Pregnant women or breast feeding mothers.
3. Women of child bearing potential who are unable or unwilling to use contraception.
4. Patients with a history of significant cardiac disease.
5. Patients with a history of significant neuropathy.
6. Patients with base line laboratory values with neutrophils less than 1.5 x 109/L, platelet count less than 100 x 109/L, serum creatinine greater than 1.5 x upper normal limit, serum bilirubin greater than 1.5 x upper normal limit, serum ALT or AST greater than 2.5 x upper normal limit, serum alkaline phosphatase greater than 2.5 x upper normal limit.
7. No patients with any prior malignancy other than completely excised basal cell carcinoma of the skin or completely resected cervical carcinoma in-situ.
8. Patients with any other uncontrolled medical condition or psychiatric condition deemed by the treating doctor to be unsuitable for treatment protocol.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
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Actual
16/08/2004
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Date of last participant enrolment
Anticipated
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Actual
13/10/2008
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
40
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Accrual to date
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Final
26
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
5914
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The Queen Elizabeth Hospital - Woodville
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Recruitment hospital [2]
5915
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Lyell McEwin Hospital - Elizabeth Vale
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Recruitment postcode(s) [1]
13361
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5011 - Woodville South
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Recruitment postcode(s) [2]
13362
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5112 - Elizabeth Vale
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Funding & Sponsors
Funding source category [1]
293754
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Commercial sector/Industry
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Name [1]
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Bristol-Myers Squibb Pty Ltd
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Address [1]
293754
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556 Princes Highway
Noble Park
Victoria 3174
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Country [1]
293754
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Australia
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Funding source category [2]
293755
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Hospital
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Name [2]
293755
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The Queen Elizabeth Hospital
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Address [2]
293755
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28 Woodville Road
Woodville South
South Australia
5011
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Country [2]
293755
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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
28 Woodville Road
Woodville South
South Australia
5011
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Country
Australia
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Secondary sponsor category [1]
292583
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None
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Name [1]
292583
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Address [1]
292583
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Country [1]
292583
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
295192
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North Western Adelaide Health Service Ethics of Human Research Committee
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Ethics committee address [1]
295192
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28 Woodville Road
Woodville South
South Australia
5011
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Ethics committee country [1]
295192
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Australia
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Date submitted for ethics approval [1]
295192
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05/05/2004
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Approval date [1]
295192
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26/05/2004
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Ethics approval number [1]
295192
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2004059
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Summary
Brief summary
This phase II study will determine whether the combination of Paclitaxel and Epirubicin can be used safely in the neoadjuvant setting in women with locally advanced breast cancer. The study will determine whether, in a multi-centre setting, the activity of this combination is maintained with acceptable toxicity. The study will also determine the disease free survival and overall survival in patients with locally advanced breast cancer, treated with neoadjuvant Paclitaxel and Epirubicin followed by definitive local surgery and radiotherapy and adjuvant Cyclophosphamide Methotrexate Fluorouracil.
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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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A/Prof Ken Pittman
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Address
66406
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Level 8C, The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
South Australia
5011
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Country
66406
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Australia
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Phone
66406
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+61 8 82228474
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Fax
66406
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+61 8 82227486
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Email
66406
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[email protected]
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Contact person for public queries
Name
66407
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Ms Sue Yeend
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Address
66407
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Level 8C, Clinical Trials, The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
South Australia
5011
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Country
66407
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Australia
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Phone
66407
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+61 8 82226148
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Fax
66407
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+61 8 82227486
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Email
66407
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[email protected]
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Contact person for scientific queries
Name
66408
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A/Prof Ken Pittman
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Address
66408
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Level 8C, The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
South Australia
5011
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Country
66408
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Australia
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Phone
66408
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+61 8 82228474
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Fax
66408
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+61 8 82227486
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Email
66408
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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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