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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00342316
Registration number
NCT00342316
Ethics application status
Date submitted
20/06/2006
Date registered
21/06/2006
Titles & IDs
Public title
Reduced Intensity Conditioning Transplantation Versus Standard of Care in Acute Myeloid Leukemia
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Scientific title
Prospective Controlled Clinical Study of Allogeneic Stem Cell Transplantation With Reduced Conditioning (RICT) Versus Best Standard of Care in Acute Myeloid Leukemia (AML)in First Complete Remission (CR)
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Secondary ID [1]
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TRALG1/02
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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:
Acute Myeloid Leukemia
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Reduced Intensity Conditioning Stem Cell Transplantation
Experimental: Stem cell transplant (RICT) - Receiving intervention consisting of Reduced Intensity Conditioning Stem Cell Transplantation
No intervention: Control arm - Treatment according to standard of care, i.e. not undergoing RICT
Treatment: Surgery: Reduced Intensity Conditioning Stem Cell Transplantation
One of the following conditioning regimens:
1. Busulphan (orally or IV), fludarabine
2. Fludarabine, carmustine, melfalan
3. Cyclophosphamide, fludarabine
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall survival (OS)
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Assessment method [1]
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OS is the time from Inclusion to death, lost to follow-up, refusal, or study termination.
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Timepoint [1]
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From Inclusion until one of the above events (=2yrs in all surviving pts).
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Secondary outcome [1]
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Disease-free survival
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Assessment method [1]
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DFS is the time from Inclusion until date of first documented relapse, death from any cause whichever came first, assessed until study termination.
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Timepoint [1]
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From Inclusion to relapse, death or study termination. Follow-up =24 mo in all surviving pts.
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Secondary outcome [2]
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Quality of Life for pts in the RICT and Control Groups.
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Assessment method [2]
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European Organization for Research and Treatment of Cancer (EORTC). Quality of Life Questionnaire (QLQ), Cancer C) #30. An instrument commonly used for the evaluation of QoL after under and after cancer treatment
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Timepoint [2]
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All pts were asked to fill out the instrument at 12 and 24 months after inclusion
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Secondary outcome [3]
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Non-relapse mortality (NRM). Numbers and causes of death in non-relapsed pts
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Assessment method [3]
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NRM is death without preceding relapse, from Inclusion to study termination.
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Timepoint [3]
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From Inclusion to relapse or death until study termination.
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Secondary outcome [4]
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Acute and Chronic Graft-versus-Host Disease (GvHD)
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Assessment method [4]
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In transplanted pts only. Acute GvHD appears from transplant to 100 days. Chronic GvHD occurs later, and often remains for years. Both are clinical diagnoses and cGvHD grading were performed annually until death or study termination.
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Timepoint [4]
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Acute GvHD: From transplant to 3 months. Chronic From transplantation to relapse, death or study termination
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Eligibility
Key inclusion criteria
* Newly diagnosed patients with de novo or secondary AML
* Intermediate or poor risk
* In first complete remission
* Age 51-70 years
* Fit for the procedure
* Fit for further consolidation chemotherapy
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Minimum age
51
Years
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Maximum age
70
Years
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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
* Planned for a full-dose allogeneic transplant
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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)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/12/2003
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
20/07/2018
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Sample size
Target
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Accrual to date
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Final
340
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [3]
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Austalasian Leukaemia &Lymphoma Group Limited - East Melbourne
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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5000 - Adelaide
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Recruitment postcode(s) [3]
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3002 - East Melbourne
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Manitoba
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Country [2]
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Canada
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State/province [2]
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Ontario
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Country [3]
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Canada
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State/province [3]
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Quebec
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Country [4]
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Canada
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State/province [4]
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Saskatchewan
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Country [5]
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Estonia
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State/province [5]
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Tartu
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Country [6]
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Finland
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State/province [6]
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Turku
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Country [7]
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Germany
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State/province [7]
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Freiburg
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Country [8]
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Greece
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State/province [8]
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Patras
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Country [9]
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New Zealand
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State/province [9]
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Christchurch
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Country [10]
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New Zealand
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State/province [10]
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Wellington
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Country [11]
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Norway
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State/province [11]
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Oslo
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Country [12]
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Sweden
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State/province [12]
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Goteborg
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Country [13]
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Sweden
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State/province [13]
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Luleå
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Country [14]
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Sweden
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State/province [14]
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Lund
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Country [15]
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Sweden
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State/province [15]
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Stockholm
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Country [16]
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Sweden
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State/province [16]
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Uppsala
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Country [17]
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Sweden
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State/province [17]
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Örebro
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Funding & Sponsors
Primary sponsor type
Government body
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Name
Vastra Gotaland Region
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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The Canadian Blood and Marrow Transplant Group
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Australasian Leukaemia and Lymphoma Group
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
This study compares overall survival between patients with acute myeloid leukemia, who are in complete remission following initial treatment with chemotherapy and whose remission is maintained either with a transplantation of stem cells obtained from a sibling or unrelated donor or with standard treatment, which is additional chemotherapy. The study hypothesis is that the group transplanted with stem cells from a donor will have a superior survival compared with patients treated with standard of care.
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Trial website
https://clinicaltrials.gov/study/NCT00342316
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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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Mats Brune, MD, PhD
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Address
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Göteborg University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
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
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00342316