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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01285609
Registration number
NCT01285609
Ethics application status
Date submitted
24/01/2011
Date registered
28/01/2011
Date last updated
18/06/2020
Titles & IDs
Public title
Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin
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Scientific title
Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab in Addition to Paclitaxel and Carboplatin Versus Placebo in Addition to Paclitaxel and Carboplatin in Subjects With Stage IV/Recurrent Non Small Cell Lung Cancer (NSCLC)
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Secondary ID [1]
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2009-017396-19
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Secondary ID [2]
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CA184-104
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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:
Lung Cancer - Non Small Cell Squamous
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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
Experimental: Ipilimumab + Paclitaxel and Carboplatin - Ipilimumab + Active Chemo Backbone
Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)
Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses
Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
Placebo comparator: Placebo + Paclitaxel and Carboplatin - Placebo + Active Chemo Backbone
Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)
Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses
Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
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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) in Participants Who Received at Least One Dose of Blinded Study Therapy at Primary Endpoint
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Assessment method [1]
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Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.
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Timepoint [1]
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Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
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Secondary outcome [1]
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Overall Survival (OS) in All Randomized Participants at Primary Endpoint
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Assessment method [1]
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Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.
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Timepoint [1]
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Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
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Secondary outcome [2]
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Median Number of Months With Progression Free Survival (PFS) Per mWHO in Participants Who Have Received at Least One Dose of Blinded Study Therapy at Primary Endpoint
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Assessment method [2]
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Progression-free survival (PFS) is defined as the time between the date of randomization and the date of tumor progression per Modified World Health Organization (mWHO) criteria or death, whichever occurs first. A participant who died without reported progression per mWHO criteria were considered to have progressed on the date of death. For participants who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment. For participants who remain alive and have no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.
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Timepoint [2]
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Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
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Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
* Non small cell lung cancer (NSCLC) - squamous cell
* Stage IV or recurrent NSCLC
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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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
* Brain Metastases
* Autoimmune diseases
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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 administering the treatment/s
The people assessing the outcomes
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 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
16/01/2011
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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
22/08/2017
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Sample size
Target
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Accrual to date
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Final
1289
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Recruitment hospital [1]
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Local Institution - Bedford Park
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Local Institution - Heidelberg
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Local Institution - Wodonga
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5042 - Bedford Park
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3128 - Box Hill
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3199 - Frankston
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3084 - Heidelberg
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3690 - Wodonga
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Recruitment outside Australia
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State/province [129]
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Sondrio
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Country [130]
0
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Italy
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Terni
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Italy
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Treviglio
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Country [132]
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Japan
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State/province [132]
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Aichi
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Japan
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Chiba
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Japan
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Ishikawa
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Japan
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Kanagawa
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Japan
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Miyagi
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Country [137]
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Japan
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State/province [137]
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Okayama
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Japan
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Osaka
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Japan
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State/province [139]
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Shizuoka
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Japan
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State/province [140]
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Tokyo
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Japan
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State/province [141]
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Yamaguchi
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Japan
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State/province [142]
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Akashi, Hyogo
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Country [143]
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Japan
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State/province [143]
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Fukuoka
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Country [144]
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Japan
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State/province [144]
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Matsuyama, Ehime
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Japan
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State/province [145]
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Osakasayama-city
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Country [146]
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Japan
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State/province [146]
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Sapporo Hokkaido
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Country [147]
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Japan
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State/province [147]
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Sapporo, Hokkaido
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Country [148]
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Japan
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State/province [148]
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Sendai, Miyagi
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Country [149]
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Japan
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State/province [149]
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Takatsuki
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Country [150]
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Korea, Republic of
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State/province [150]
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Chungcheongbuk-do
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Country [151]
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Korea, Republic of
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State/province [151]
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Gyeonggi-do
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Country [152]
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Korea, Republic of
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State/province [152]
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Kangnam-gu
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Korea, Republic of
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Seodaemungu
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Country [154]
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Korea, Republic of
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State/province [154]
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Busan
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Country [155]
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Korea, Republic of
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State/province [155]
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Daegu
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon
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0
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Mexico
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Distrito Federal
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Mexico
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State/province [159]
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Jalisco
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Country [160]
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Mexico
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State/province [160]
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Nuevo LEON
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Netherlands
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Breda
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Netherlands
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State/province [162]
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Harderwijk
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Netherlands
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State/province [163]
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Hertogenbosch
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Netherlands
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State/province [164]
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Nieuwegein
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Country [165]
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Peru
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State/province [165]
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LA Libertad
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Country [166]
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Peru
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State/province [166]
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Arequipa
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Country [167]
0
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Peru
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State/province [167]
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Cercado
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Country [168]
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Peru
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State/province [168]
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Lima
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Country [169]
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Poland
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State/province [169]
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Elblag
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Country [170]
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Poland
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Gdansk- Zaspa
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Poland
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State/province [171]
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Gdansk
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Country [172]
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Poland
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Grudziadz
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Poland
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State/province [173]
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Olsztyn
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Poland
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Otwock
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Poland
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Poznan
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Poland
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State/province [176]
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Szczecin
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Country [177]
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Poland
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Torun
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Poland
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Warsaw
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Portugal
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Coimbra
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Portugal
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Lisboa
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Portugal
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Porto
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Portugal
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State/province [182]
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Santa Maria Da Feira
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Country [183]
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Portugal
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State/province [183]
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Vila Nova De Gaia
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Romania
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State/province [184]
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Bucharest
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Romania
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Bucuresti
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Romania
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Cluj Napoca
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Country [187]
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Romania
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State/province [187]
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Sibiu
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Country [188]
0
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Romania
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State/province [188]
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Suceava
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Country [189]
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Romania
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Timisoara
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Country [190]
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0
Russian Federation
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State/province [190]
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0
Chelyabinsk
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Country [191]
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Russian Federation
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Kazan
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Country [192]
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Russian Federation
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State/province [192]
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Moscow
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Country [193]
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Russian Federation
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State/province [193]
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Pyatigorsk
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Country [194]
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Russian Federation
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Saint Petersburg
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Russian Federation
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St-Peterburg
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Russian Federation
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St. Petersburg
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Country [197]
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Russian Federation
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Tula
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Country [198]
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Singapore
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Singapore
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Country [199]
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South Africa
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State/province [199]
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Gauteng
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Country [200]
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South Africa
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Western CAPE
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Country [201]
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0
South Africa
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Cape Town
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Country [202]
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0
South Africa
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Durban
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Country [203]
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Spain
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State/province [203]
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Vizcaya
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Country [204]
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Spain
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Avila
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Country [205]
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Spain
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Benidorm-alicante
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Spain
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Castellon
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Country [207]
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0
Spain
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Madrid
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Country [208]
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Spain
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Manresa
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Spain
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Ourense
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Spain
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Valencia
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Sweden
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Gothenburg
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Sweden
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Lund
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Country [213]
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Sweden
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Stockholm
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Sweden
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Umea
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Switzerland
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Basel
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Country [216]
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Switzerland
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Winterthur
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Taiwan
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Changhua City
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Taiwan
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Chiayi
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Taiwan
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Kaohsiung County
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Taiwan
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Taichung
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Taiwan
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Taipei City
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Taiwan
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Taipei
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Thailand
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Tungpayathai
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Country [226]
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Thailand
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Songkhla
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United Kingdom
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Angus/forfarshire
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United Kingdom
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Cornwall
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United Kingdom
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Hampshire
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United Kingdom
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Nottingham
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Country [231]
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0
United Kingdom
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State/province [231]
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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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 whether Ipilimumab plus Paclitaxel and Carboplatin will extend the lives of patients with squamous only non small cell lung cancer more than placebo plus Paclitaxel and Carboplatin.
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Trial website
https://clinicaltrials.gov/study/NCT01285609
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Bristol-Myers Squibb
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Address
0
0
Bristol-Myers Squibb
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Country
0
0
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Phone
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0
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Fax
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Email
0
0
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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/NCT01285609
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