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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00259064
Registration number
NCT00259064
Ethics application status
Date submitted
25/11/2005
Date registered
29/11/2005
Date last updated
2/06/2016
Titles & IDs
Public title
Iressa v BSC (Best Supportive Care) in First Line NSCLC
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Scientific title
A Phase II Multicentre Randomised, Parallel Group, Double-Blind, Placebo-Controlled Study of ZD1839 (IRESSATM) (250MG Tablet) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Chemotherapy-Naive Patients With Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) and Poor Performance Status
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Secondary ID [1]
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D7913C00711
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Secondary ID [2]
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1839IL/0711
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Universal Trial Number (UTN)
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Trial acronym
INSTEP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
NSCLC
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Condition category
Condition code
Cancer
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Lung - Non small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Gefitinib
Other interventions - Placebo
Experimental: Gefitinib - ZD1839 + BSC (best supportive care)
Placebo Comparator: Placebo - Placebo + BSC (best supportive care)
Treatment: Drugs: Gefitinib
Other interventions: Placebo
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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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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To compare Iressa v best supportive care in terms of progression free survival
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Assessment method [1]
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Timepoint [1]
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Progression-free survival
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Secondary outcome [1]
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To compare Iressa v best supportive care in terms of objective tumour response rate
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Assessment method [1]
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Timepoint [1]
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Overall objective tumour response rate (CR and PR) according to the RECIST criteria
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Secondary outcome [2]
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To compare Iressa v best supportive care in terms of overall survival
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Assessment method [2]
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Timepoint [2]
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Time to death
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Secondary outcome [3]
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To compare Iressa v best supportive care in terms of quality of life
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Assessment method [3]
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Timepoint [3]
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Improvement in patient-reported functionality as measured by trial outcome index, comprised of the physical and functional well being sections and LCS of FACT-L and quality of life measured by the FACT-L total score
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Secondary outcome [4]
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To compare Iressa v best supportive care in terms of tolerability
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Assessment method [4]
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Timepoint [4]
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Adverse event profile (type, frequency and severity of adverse events); laboratory parameters and vital signs
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Eligibility
Key inclusion criteria
- Histologically or cytologically confirmed NSCLC
- NSCLC - locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable
to curative surgery or radiotherapy
- Not suitable for chemotherapy
- WHO Performance status 2 or 3
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Minimum age
18
Years
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Maximum age
130
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
- Newly diagnosed CNS mets
- Less than 4 weeks since completion of radiotherapy or persistence of any radiotherapy
related toxicity
- Other co-existing malignancies
- ALT/AST greater than 5 x upper limit of normal
- ANC less than 1.0 x 109/L or platelets less than 100 x 109/L
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2/Phase 3
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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
1/09/2004
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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
1/04/2016
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Sample size
Target
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Accrual to date
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Final
216
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Bedford Park
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Recruitment hospital [2]
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Research Site - Chermside
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Recruitment hospital [3]
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Research Site - Concord
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Recruitment hospital [4]
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Research Site - Melbourne
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Recruitment hospital [5]
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Research Site - Newcastle
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Recruitment hospital [6]
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Research Site - Prahran
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Recruitment hospital [7]
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Research Site - Randwick
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Recruitment postcode(s) [1]
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- Bedford Park
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Recruitment postcode(s) [2]
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- Chermside
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Recruitment postcode(s) [3]
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- Concord
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Recruitment postcode(s) [4]
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- Melbourne
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Recruitment postcode(s) [5]
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- Newcastle
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Recruitment postcode(s) [6]
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- Prahran
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Recruitment postcode(s) [7]
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- Randwick
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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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Alberta
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Country [2]
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Canada
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State/province [2]
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British Columbia
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Canada
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State/province [3]
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Manitoba
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Country [4]
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Canada
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State/province [4]
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New Brunswick
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Country [5]
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Canada
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Nova Scotia
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Country [6]
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Canada
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State/province [6]
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Ontario
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Country [7]
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Czech Republic
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State/province [7]
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Nova Ves pod Plesi
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Country [8]
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Netherlands
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State/province [8]
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Amsterdam
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Country [9]
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Netherlands
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State/province [9]
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Den Bosch
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Netherlands
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State/province [10]
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Den Haag
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Country [11]
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Netherlands
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State/province [11]
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Eindhoven
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Country [12]
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Netherlands
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State/province [12]
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Zutphen
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Country [13]
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United Kingdom
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State/province [13]
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Abergavenny
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Country [14]
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United Kingdom
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State/province [14]
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Birmingham
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Country [15]
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United Kingdom
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State/province [15]
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Cardiff
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Country [16]
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United Kingdom
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State/province [16]
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Leeds
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Country [17]
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United Kingdom
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State/province [17]
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of the study is to determine if the addition of Iressa to Best Supportive Care
treatment will increase the progression free survival of chemo-naïve, poor performance status
patients, with stage IIIB or IV NSCLC.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00259064
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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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AstraZeneca Iressa Medical Science Director, MD
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Address
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AstraZeneca
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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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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00259064
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