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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01998919
Registration number
NCT01998919
Ethics application status
Date submitted
25/11/2013
Date registered
2/12/2013
Date last updated
13/01/2015
Titles & IDs
Public title
A Study of Tarceva (Erlotinib) in Combination With Platinum Based Chemotherapy in Patients With Non-Small Cell Lung Cancer.
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Scientific title
A Randomised, Placebo-controlled, Double-blind Phase II of Sequential Administration of Tarceva (Erlotinib) or Placebo in Combination With Gemcitabine/Platinum as First-line Treatment in Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC).
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Secondary ID [1]
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MO18633
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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:
Non-Small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - erlotinib [Tarceva]
Treatment: Drugs - placebo
Treatment: Drugs - gemcitabine
Treatment: Drugs - cisplatin
Treatment: Drugs - carboplatin
Experimental: Tarceva + gemcitabine/platinum -
Placebo comparator: Placebo + gemcitabine/platinum -
Treatment: Drugs: erlotinib [Tarceva]
150 mg orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by 150 mg orally daily
Treatment: Drugs: placebo
orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by daily oral application
Treatment: Drugs: gemcitabine
1250 mg/m2 iv Days 1 and 8 of each 4-week cycle, 6 cycles
Treatment: Drugs: cisplatin
75 mg/m2 iv Day 1 of each 4.wek cycle, 6 cycles; or carboplatin
Treatment: Drugs: carboplatin
5 x AUC iv Day 1 of each 4.week cycle, 6 cycles; or cisplatin
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Intervention code [1]
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Treatment: Drugs
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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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Percentage of Participants With Non-Progression at Week 8 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
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Assessment method [1]
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Non-progression defined as documented best overall tumor response of complete response (CR), partial response (PR), or stable disease (SD; where SD was maintained for greater than \[\>\]8 weeks) per RECIST. Investigator's assessment of response used in all analyses. CR equals (=)disappearance of all target lesions; PR=at least a 30 percent (%) decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference smallest sum LD since treatment started.
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Timepoint [1]
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Week 8
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Secondary outcome [1]
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Percentage of Participants With Non-Progression at Week 16 as Assessed by RECIST
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Assessment method [1]
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Non-progression defined as documented best overall tumor response of CR, PR, or SD (where SD was maintained for \>16 weeks) per RECIST.
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Timepoint [1]
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Week 16
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Secondary outcome [2]
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Percentage of Participants With Confirmed CR or PR as Assessed by RECIST
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Assessment method [2]
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CR=disappearance of all target lesions; PR=at least a 30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD.
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Timepoint [2]
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Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases
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Secondary outcome [3]
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Duration of Response
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Assessment method [3]
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Duration of Response was defined similarly for complete responders and partial responders. CR was defined as the date CR was first recorded to the date on which PD was first noted or date of death. PR was defined as the date the first PR was recorded to the date of the first observation of PD or date of death.
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Timepoint [3]
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Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-study Phases
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Secondary outcome [4]
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Time to Progression
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Assessment method [4]
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Time to progression was defined as the interval between the day of randomization and the first documentation of PD. Participants who were withdrawn from the study without documented progression and for whom there exists CRF evidence that evaluations have been made, were censored at 1) the date of the last tumor assessment, 2) last date in the drug log, or 3) last date of follow-up when the participant was known to be progression free, whichever was last. Participants without post-baseline tumor assessments but known to be alive were censored at the time of randomization.
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Timepoint [4]
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Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases
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Secondary outcome [5]
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Progression-Free Survival (PFS)
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Assessment method [5]
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PFS was defined as the interval between the day of randomization and the date of first documentation of progressive disease or date of death, whichever came first.
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Timepoint [5]
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Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases
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Secondary outcome [6]
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Overall Survival
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Assessment method [6]
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Overall Survival (OS) was defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment.
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Timepoint [6]
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Date of randomization until date of death or date of last follow-up assessment
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Eligibility
Key inclusion criteria
* adult patients, >=18 years of age;
* histologically documented advanced or recurrent stage IIIB or IV non-small cell lung cancer;
* measurable disease;
* no previous chemotherapy for non-small cell lung cancer.
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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
* unstable systemic disease;
* any other malignancies in the last 5 years.
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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
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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
1/08/2006
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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
1/11/2011
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Sample size
Target
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Accrual to date
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Final
154
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Campbelltown
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Recruitment hospital [2]
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- Camperdown
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Recruitment hospital [3]
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- Liverpool
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Recruitment postcode(s) [1]
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2560 - Campbelltown
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Recruitment postcode(s) [2]
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2050 - Camperdown
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Recruitment postcode(s) [3]
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2170 - Liverpool
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Recruitment outside Australia
Country [1]
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China
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State/province [1]
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Guangzhou
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Country [2]
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China
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State/province [2]
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Shanghai
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Country [3]
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Hong Kong
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State/province [3]
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Hong Kong
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Country [4]
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Indonesia
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State/province [4]
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Jakarta
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Country [5]
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Indonesia
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State/province [5]
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Jogjakarta
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Country [6]
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Indonesia
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State/province [6]
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Semarang
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Country [7]
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Korea, Republic of
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State/province [7]
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Kyunggi-do
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Country [8]
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Philippines
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State/province [8]
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Manila
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Country [9]
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Philippines
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State/province [9]
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Metro Manila
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Country [10]
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Taiwan
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State/province [10]
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Taipei
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Country [11]
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Thailand
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State/province [11]
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Bangkok
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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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
This study will evaluate the efficacy and safety of sequential administration of Tarceva and gemcitabine/platinum chemotherapy in patients with stage IIIb/IV non-small cell lung cancer. Patients will be randomized to receive Tarceva (150 mg po) or placebo on days 15-28 of a 4 week cycle of intravenous platinum-based chemotherapy, for a total of 6 cycles. The anticipated time on study treatment is until disease progression or unacceptable toxicity.
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Trial website
https://clinicaltrials.gov/study/NCT01998919
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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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Clinical Trials
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Address
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Hoffmann-La Roche
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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
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
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01998919
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