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Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00809965
Registration number
NCT00809965
Ethics application status
Date submitted
16/12/2008
Date registered
17/12/2008
Date last updated
17/09/2014
Titles & IDs
Public title
An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome
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Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Event-Driven Multicenter Study to Evaluate the Efficacy and Safety of Rivaroxaban in Subjects With a Recent Acute Coronary Syndrome
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Secondary ID [1]
0
0
RIVAROXACS3001
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Secondary ID [2]
0
0
CR014710
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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 Coronary Syndrome
0
0
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Myocardial Infarction
0
0
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Myocardial Ischemia
0
0
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Unstable Angina
0
0
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Condition category
Condition code
Cardiovascular
0
0
0
0
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Coronary heart disease
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Cardiovascular
0
0
0
0
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Other cardiovascular diseases
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Other
0
0
0
0
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Rivaroxaban 2.5 mg
Treatment: Drugs - Rivaroxaban 5 mg
Treatment: Drugs - Placebo
Experimental: Rivaroxaban 2.5 mg bid - One 2.5 mg rivaroxaban tablet twice daily for up to 6 months
Experimental: Rivaroxaban 5 mg bid - One 5 mg rivaroxaban tablet twice daily for up to 6 months
Placebo comparator: Placebo - One placebo tablet twice daily for up to 6 months
Treatment: Drugs: Rivaroxaban 2.5 mg
One tablet twice daily
Treatment: Drugs: Rivaroxaban 5 mg
One tablet twice daily
Treatment: Drugs: Placebo
One placebo tablet twice daily
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Intervention code [1]
0
0
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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0
The Percentage of Patients With the Composite Endpoint of Cardiovascular Death, Myocardial Infarction, or Stroke
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Assessment method [1]
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0
The percentage of patients with the first occurrence of the composite of death, myocardial infarction, or stroke. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.
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Timepoint [1]
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0
From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
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Secondary outcome [1]
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0
The Percentage of Patients With the Composite of All Cause Death, Myocardial Infarction, or Stroke
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Assessment method [1]
0
0
The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.
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Timepoint [1]
0
0
From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
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Secondary outcome [2]
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0
The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Ischemic Stroke, or TIMI Major Bleeding Event Not Associated With Coronary Artery Bypass Graft Surgery
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Assessment method [2]
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0
The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.
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Timepoint [2]
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0
From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
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Secondary outcome [3]
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0
The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Requiring Revascularization
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Assessment method [3]
0
0
The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.
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Timepoint [3]
0
0
From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
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Secondary outcome [4]
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0
The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Leading to Hospitalization
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Assessment method [4]
0
0
The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.
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Timepoint [4]
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0
From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
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Eligibility
Key inclusion criteria
* Patients must be currently receiving aspirin therapy alone or in combination with a thienopyridine per national or local dosing recommendation
* Have been hospitalized for symptoms suggestive of acute coronary syndrome that lasted at least 10 minutes at rest and occurred 48 hours or less before going to the hospital
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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
* Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding
* Need for continued anticoagulant therapy
* Significant renal impairment or known significant liver disease
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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
1/11/2008
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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
1/09/2011
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Sample size
Target
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Accrual to date
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Final
15526
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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0
- Bedford Park
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Recruitment hospital [2]
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0
- Chermside N/A
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Recruitment hospital [3]
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0
- Coffs Harbour South
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Recruitment hospital [4]
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0
- Douglas
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Recruitment hospital [5]
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0
- Epping
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Recruitment hospital [6]
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- Fremantle
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Recruitment hospital [7]
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- Heidelberg
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Recruitment hospital [8]
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- Herston
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Recruitment hospital [9]
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0
- Launceston
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Recruitment hospital [10]
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- Milton
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Recruitment hospital [11]
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- Newcastle
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Recruitment hospital [12]
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- Parkville
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Recruitment hospital [13]
0
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- Perth
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Recruitment hospital [14]
0
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- Southport
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Recruitment hospital [15]
0
0
- Woolloongabba N/A
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Recruitment postcode(s) [1]
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- Bedford Park
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Recruitment postcode(s) [2]
0
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- Chermside N/A
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Recruitment postcode(s) [3]
0
0
- Coffs Harbour South
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Recruitment postcode(s) [4]
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- Douglas
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Recruitment postcode(s) [5]
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- Epping
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Recruitment postcode(s) [6]
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- Fremantle
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Recruitment postcode(s) [7]
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- Heidelberg
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Recruitment postcode(s) [8]
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- Herston
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Recruitment postcode(s) [9]
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- Launceston
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Recruitment postcode(s) [10]
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- Milton
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Recruitment postcode(s) [11]
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- Newcastle
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Recruitment postcode(s) [12]
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- Parkville
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Recruitment postcode(s) [13]
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- Perth
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Recruitment postcode(s) [14]
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- Southport
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Recruitment postcode(s) [15]
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- Woolloongabba N/A
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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California
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Colorado
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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State/province [7]
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Indiana
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United States of America
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Kansas
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United States of America
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Louisiana
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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State/province [12]
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Michigan
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United States of America
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Mississippi
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United States of America
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Missouri
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Montana
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New Jersey
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New York
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United States of America
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North Carolina
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Ohio
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Oklahoma
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Tennessee
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Washington
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United States of America
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Argentina
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Corrientes
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Argentina
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Junin
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Argentina
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Moron
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Argentina
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Morón
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Argentina
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Resistencia
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Argentina
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Rosario
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Argentina
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Salta
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Argentina
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San Luis
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Argentina
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Santa Fe
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Argentina
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Tucuman
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Belgium
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Bonheiden
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Belgium
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Eupen
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Belgium
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Genk
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Belgium
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Huy
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Mol
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Tienen
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Brazil
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Belo Horizonte
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Brazil
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Blumenau
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Brazil
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Campina Grande Do Sul
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Brazil
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Campinas
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Brazil
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Curitiba
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Brazil
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Porto Alegre
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Brazil
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Recife
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Brazil
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Brazil
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Rio De Janeiro
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Brazil
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Brazil
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Brazil
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Brazil
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São Paulo
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Bulgaria
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Bourgas
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Bulgaria
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Dimitrovgrad
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Bulgaria
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Rousse
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Sevlievo
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Bulgaria
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Canada
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Canada
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Ontario
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Canada
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Canada
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Canada
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Laval
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China
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Daqing
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Croatia
Query!
State/province [117]
0
0
Rijeka
Query!
Country [118]
0
0
Croatia
Query!
State/province [118]
0
0
Slavonski Brod
Query!
Country [119]
0
0
Croatia
Query!
State/province [119]
0
0
Suska 6
Query!
Country [120]
0
0
Czech Republic
Query!
State/province [120]
0
0
Benesov Nad Cernou
Query!
Country [121]
0
0
Czech Republic
Query!
State/province [121]
0
0
Brno
Query!
Country [122]
0
0
Czech Republic
Query!
State/province [122]
0
0
Ceske Budejovice
Query!
Country [123]
0
0
Czech Republic
Query!
State/province [123]
0
0
Cesky Krumlov N/A
Query!
Country [124]
0
0
Czech Republic
Query!
State/province [124]
0
0
Hradec Kralove
Query!
Country [125]
0
0
Czech Republic
Query!
State/province [125]
0
0
Kolin N/A
Query!
Country [126]
0
0
Czech Republic
Query!
State/province [126]
0
0
Kromeriz
Query!
Country [127]
0
0
Czech Republic
Query!
State/province [127]
0
0
Litomysl
Query!
Country [128]
0
0
Czech Republic
Query!
State/province [128]
0
0
Nachod N/A
Query!
Country [129]
0
0
Czech Republic
Query!
State/province [129]
0
0
Pardubice N/A
Query!
Country [130]
0
0
Czech Republic
Query!
State/province [130]
0
0
Plzeò 1
Query!
Country [131]
0
0
Czech Republic
Query!
State/province [131]
0
0
Poruba
Query!
Country [132]
0
0
Czech Republic
Query!
State/province [132]
0
0
Praha 10 N/A
Query!
Country [133]
0
0
Czech Republic
Query!
State/province [133]
0
0
Praha 2
Query!
Country [134]
0
0
Czech Republic
Query!
State/province [134]
0
0
Praha 8
Query!
Country [135]
0
0
Czech Republic
Query!
State/province [135]
0
0
Praha
Query!
Country [136]
0
0
Czech Republic
Query!
State/province [136]
0
0
Slany
Query!
Country [137]
0
0
Czech Republic
Query!
State/province [137]
0
0
Teplice
Query!
Country [138]
0
0
Czech Republic
Query!
State/province [138]
0
0
Usti Nad Labem
Query!
Country [139]
0
0
Czech Republic
Query!
State/province [139]
0
0
Znojmo N/A
Query!
Country [140]
0
0
Denmark
Query!
State/province [140]
0
0
Aalborg
Query!
Country [141]
0
0
Denmark
Query!
State/province [141]
0
0
Esbjerg
Query!
Country [142]
0
0
Denmark
Query!
State/province [142]
0
0
Holbæk
Query!
Country [143]
0
0
Denmark
Query!
State/province [143]
0
0
Horsens N/A
Query!
Country [144]
0
0
Denmark
Query!
State/province [144]
0
0
Kolding
Query!
Country [145]
0
0
Denmark
Query!
State/province [145]
0
0
København
Query!
Country [146]
0
0
Denmark
Query!
State/province [146]
0
0
Odense
Query!
Country [147]
0
0
Egypt
Query!
State/province [147]
0
0
Alexandria
Query!
Country [148]
0
0
Egypt
Query!
State/province [148]
0
0
Cairo
Query!
Country [149]
0
0
Egypt
Query!
State/province [149]
0
0
Ismailia
Query!
Country [150]
0
0
Egypt
Query!
State/province [150]
0
0
Menofeya
Query!
Country [151]
0
0
France
Query!
State/province [151]
0
0
Besancon
Query!
Country [152]
0
0
France
Query!
State/province [152]
0
0
Cannes
Query!
Country [153]
0
0
France
Query!
State/province [153]
0
0
Chambray-Les-Tours
Query!
Country [154]
0
0
France
Query!
State/province [154]
0
0
Chartres
Query!
Country [155]
0
0
France
Query!
State/province [155]
0
0
Creteil N/A
Query!
Country [156]
0
0
France
Query!
State/province [156]
0
0
Dijon
Query!
Country [157]
0
0
France
Query!
State/province [157]
0
0
Haguenau
Query!
Country [158]
0
0
France
Query!
State/province [158]
0
0
Lagny
Query!
Country [159]
0
0
France
Query!
State/province [159]
0
0
Marseille
Query!
Country [160]
0
0
France
Query!
State/province [160]
0
0
Montfermeil
Query!
Country [161]
0
0
France
Query!
State/province [161]
0
0
Paris
Query!
Country [162]
0
0
France
Query!
State/province [162]
0
0
Poitiers
Query!
Country [163]
0
0
Germany
Query!
State/province [163]
0
0
Bad Friedrichshall
Query!
Country [164]
0
0
Germany
Query!
State/province [164]
0
0
Berlin
Query!
Country [165]
0
0
Germany
Query!
State/province [165]
0
0
Bonn
Query!
Country [166]
0
0
Germany
Query!
State/province [166]
0
0
Dresden
Query!
Country [167]
0
0
Germany
Query!
State/province [167]
0
0
Essen
Query!
Country [168]
0
0
Germany
Query!
State/province [168]
0
0
Esslingen
Query!
Country [169]
0
0
Germany
Query!
State/province [169]
0
0
Frankfurt / Main
Query!
Country [170]
0
0
Germany
Query!
State/province [170]
0
0
Freiburg
Query!
Country [171]
0
0
Germany
Query!
State/province [171]
0
0
Greifswald
Query!
Country [172]
0
0
Germany
Query!
State/province [172]
0
0
Göttingen
Query!
Country [173]
0
0
Germany
Query!
State/province [173]
0
0
Halle
Query!
Country [174]
0
0
Germany
Query!
State/province [174]
0
0
Hamburg
Query!
Country [175]
0
0
Germany
Query!
State/province [175]
0
0
Hannover
Query!
Country [176]
0
0
Germany
Query!
State/province [176]
0
0
Heidelberg
Query!
Country [177]
0
0
Germany
Query!
State/province [177]
0
0
Kiel
Query!
Country [178]
0
0
Germany
Query!
State/province [178]
0
0
Leipzig
Query!
Country [179]
0
0
Germany
Query!
State/province [179]
0
0
Limburg
Query!
Country [180]
0
0
Germany
Query!
State/province [180]
0
0
Lübeck
Query!
Country [181]
0
0
Germany
Query!
State/province [181]
0
0
Magdeburg
Query!
Country [182]
0
0
Germany
Query!
State/province [182]
0
0
Mannheim
Query!
Country [183]
0
0
Germany
Query!
State/province [183]
0
0
Weiden
Query!
Country [184]
0
0
Germany
Query!
State/province [184]
0
0
Wermsdorf
Query!
Country [185]
0
0
Germany
Query!
State/province [185]
0
0
Witten
Query!
Country [186]
0
0
Greece
Query!
State/province [186]
0
0
Athens
Query!
Country [187]
0
0
Greece
Query!
State/province [187]
0
0
Larisa
Query!
Country [188]
0
0
Greece
Query!
State/province [188]
0
0
Rhodes
Query!
Country [189]
0
0
Greece
Query!
State/province [189]
0
0
Thessalonikis
Query!
Country [190]
0
0
Hungary
Query!
State/province [190]
0
0
Budapest N/A
Query!
Country [191]
0
0
Hungary
Query!
State/province [191]
0
0
Budapest
Query!
Country [192]
0
0
Hungary
Query!
State/province [192]
0
0
Debrecen
Query!
Country [193]
0
0
Hungary
Query!
State/province [193]
0
0
Gyor
Query!
Country [194]
0
0
Hungary
Query!
State/province [194]
0
0
Kecskemet
Query!
Country [195]
0
0
Hungary
Query!
State/province [195]
0
0
Komarom
Query!
Country [196]
0
0
Hungary
Query!
State/province [196]
0
0
Miskolc
Query!
Country [197]
0
0
Hungary
Query!
State/province [197]
0
0
Szolnok
Query!
Country [198]
0
0
Hungary
Query!
State/province [198]
0
0
Szombathely
Query!
Country [199]
0
0
Hungary
Query!
State/province [199]
0
0
Zalaegerszeg
Query!
Country [200]
0
0
India
Query!
State/province [200]
0
0
Ahmedabad
Query!
Country [201]
0
0
India
Query!
State/province [201]
0
0
Allahabad
Query!
Country [202]
0
0
India
Query!
State/province [202]
0
0
Bangalore
Query!
Country [203]
0
0
India
Query!
State/province [203]
0
0
Chandigarh
Query!
Country [204]
0
0
India
Query!
State/province [204]
0
0
Chennai
Query!
Country [205]
0
0
India
Query!
State/province [205]
0
0
Cochin
Query!
Country [206]
0
0
India
Query!
State/province [206]
0
0
Coimbatore
Query!
Country [207]
0
0
India
Query!
State/province [207]
0
0
Ernakulam
Query!
Country [208]
0
0
India
Query!
State/province [208]
0
0
Gandhinagar Guiarat
Query!
Country [209]
0
0
India
Query!
State/province [209]
0
0
Gurgaon
Query!
Country [210]
0
0
India
Query!
State/province [210]
0
0
Hyderabad
Query!
Country [211]
0
0
India
Query!
State/province [211]
0
0
Jaipur
Query!
Country [212]
0
0
India
Query!
State/province [212]
0
0
Karamsad
Query!
Country [213]
0
0
India
Query!
State/province [213]
0
0
Kochi
Query!
Country [214]
0
0
India
Query!
State/province [214]
0
0
Kolkata
Query!
Country [215]
0
0
India
Query!
State/province [215]
0
0
Lucknow Gpo
Query!
Country [216]
0
0
India
Query!
State/province [216]
0
0
Ludhiana
Query!
Country [217]
0
0
India
Query!
State/province [217]
0
0
Madurai
Query!
Country [218]
0
0
India
Query!
State/province [218]
0
0
Mangalore
Query!
Country [219]
0
0
India
Query!
State/province [219]
0
0
Mumbai
Query!
Country [220]
0
0
India
Query!
State/province [220]
0
0
Mysore
Query!
Country [221]
0
0
India
Query!
State/province [221]
0
0
Nagpur
Query!
Country [222]
0
0
India
Query!
State/province [222]
0
0
Nasik
Query!
Country [223]
0
0
India
Query!
State/province [223]
0
0
New Delhi
Query!
Country [224]
0
0
India
Query!
State/province [224]
0
0
Pune
Query!
Country [225]
0
0
India
Query!
State/province [225]
0
0
Surat
Query!
Country [226]
0
0
India
Query!
State/province [226]
0
0
Trissur
Query!
Country [227]
0
0
India
Query!
State/province [227]
0
0
Trivandrum
Query!
Country [228]
0
0
India
Query!
State/province [228]
0
0
Vadodara
Query!
Country [229]
0
0
India
Query!
State/province [229]
0
0
Vijayawada
Query!
Country [230]
0
0
Israel
Query!
State/province [230]
0
0
Afula
Query!
Country [231]
0
0
Israel
Query!
State/province [231]
0
0
Hadera
Query!
Country [232]
0
0
Israel
Query!
State/province [232]
0
0
Haifa
Query!
Country [233]
0
0
Israel
Query!
State/province [233]
0
0
Jerusalem
Query!
Country [234]
0
0
Israel
Query!
State/province [234]
0
0
Nahariya
Query!
Country [235]
0
0
Israel
Query!
State/province [235]
0
0
Petah Tikva
Query!
Country [236]
0
0
Israel
Query!
State/province [236]
0
0
Rehovot
Query!
Country [237]
0
0
Israel
Query!
State/province [237]
0
0
Safed
Query!
Country [238]
0
0
Israel
Query!
State/province [238]
0
0
Tel Aviv
Query!
Country [239]
0
0
Israel
Query!
State/province [239]
0
0
Tiberias
Query!
Country [240]
0
0
Japan
Query!
State/province [240]
0
0
Anan
Query!
Country [241]
0
0
Japan
Query!
State/province [241]
0
0
Fukui
Query!
Country [242]
0
0
Japan
Query!
State/province [242]
0
0
Fukuoka-Shi,
Query!
Country [243]
0
0
Japan
Query!
State/province [243]
0
0
Fukuyama-City,
Query!
Country [244]
0
0
Japan
Query!
State/province [244]
0
0
Gifu-City
Query!
Country [245]
0
0
Japan
Query!
State/province [245]
0
0
Higashiosaka-City
Query!
Country [246]
0
0
Japan
Query!
State/province [246]
0
0
Kagoshima-City
Query!
Country [247]
0
0
Japan
Query!
State/province [247]
0
0
Kanazawa-City
Query!
Country [248]
0
0
Japan
Query!
State/province [248]
0
0
Kasuga
Query!
Country [249]
0
0
Japan
Query!
State/province [249]
0
0
Kawachinagano-City
Query!
Country [250]
0
0
Japan
Query!
State/province [250]
0
0
Kawasaki-City
Query!
Country [251]
0
0
Japan
Query!
State/province [251]
0
0
Kisarazu-City
Query!
Country [252]
0
0
Japan
Query!
State/province [252]
0
0
Kobe-City
Query!
Country [253]
0
0
Japan
Query!
State/province [253]
0
0
Kobe-Shi
Query!
Country [254]
0
0
Japan
Query!
State/province [254]
0
0
Kumamoto-City
Query!
Country [255]
0
0
Japan
Query!
State/province [255]
0
0
Kumamoto
Query!
Country [256]
0
0
Japan
Query!
State/province [256]
0
0
Kuwana-City
Query!
Country [257]
0
0
Japan
Query!
State/province [257]
0
0
Maebashi-City Gunma
Query!
Country [258]
0
0
Japan
Query!
State/province [258]
0
0
Matsudo-City
Query!
Country [259]
0
0
Japan
Query!
State/province [259]
0
0
Matsumoto
Query!
Country [260]
0
0
Japan
Query!
State/province [260]
0
0
Matsuyama-City Ehime
Query!
Country [261]
0
0
Japan
Query!
State/province [261]
0
0
Miyazaki-Gun
Query!
Country [262]
0
0
Japan
Query!
State/province [262]
0
0
Nagano-City
Query!
Country [263]
0
0
Japan
Query!
State/province [263]
0
0
Nagasaki
Query!
Country [264]
0
0
Japan
Query!
State/province [264]
0
0
Nagoya-City
Query!
Country [265]
0
0
Japan
Query!
State/province [265]
0
0
Nagoya
Query!
Country [266]
0
0
Japan
Query!
State/province [266]
0
0
Namegata-City
Query!
Country [267]
0
0
Japan
Query!
State/province [267]
0
0
Nankoku-City
Query!
Country [268]
0
0
Japan
Query!
State/province [268]
0
0
Nishinomiya
Query!
Country [269]
0
0
Japan
Query!
State/province [269]
0
0
Okayama-City
Query!
Country [270]
0
0
Japan
Query!
State/province [270]
0
0
Osaka-City
Query!
Country [271]
0
0
Japan
Query!
State/province [271]
0
0
Osaka
Query!
Country [272]
0
0
Japan
Query!
State/province [272]
0
0
Sakaide-City
Query!
Country [273]
0
0
Japan
Query!
State/province [273]
0
0
Sakura-Shi
Query!
Country [274]
0
0
Japan
Query!
State/province [274]
0
0
Suwa-City
Query!
Country [275]
0
0
Japan
Query!
State/province [275]
0
0
Tokushima-City
Query!
Country [276]
0
0
Japan
Query!
State/province [276]
0
0
Tokushima
Query!
Country [277]
0
0
Japan
Query!
State/province [277]
0
0
Tokyo,
Query!
Country [278]
0
0
Japan
Query!
State/province [278]
0
0
Tokyo
Query!
Country [279]
0
0
Japan
Query!
State/province [279]
0
0
Toyama-City
Query!
Country [280]
0
0
Japan
Query!
State/province [280]
0
0
Urasoe-City
Query!
Country [281]
0
0
Japan
Query!
State/province [281]
0
0
Yamaguchi
Query!
Country [282]
0
0
Japan
Query!
State/province [282]
0
0
Yokohama N/A
Query!
Country [283]
0
0
Japan
Query!
State/province [283]
0
0
Yokohama-City
Query!
Country [284]
0
0
Japan
Query!
State/province [284]
0
0
Yokohama-Shi
Query!
Country [285]
0
0
Japan
Query!
State/province [285]
0
0
Yokohama
Query!
Country [286]
0
0
Japan
Query!
State/province [286]
0
0
Yonago-Shi
Query!
Country [287]
0
0
Korea, Republic of
Query!
State/province [287]
0
0
Daejeon
Query!
Country [288]
0
0
Korea, Republic of
Query!
State/province [288]
0
0
Gwangju
Query!
Country [289]
0
0
Korea, Republic of
Query!
State/province [289]
0
0
Seognam-Si, Kyungki-Do
Query!
Country [290]
0
0
Korea, Republic of
Query!
State/province [290]
0
0
Seoul
Query!
Country [291]
0
0
Korea, Republic of
Query!
State/province [291]
0
0
Suwon
Query!
Country [292]
0
0
Latvia
Query!
State/province [292]
0
0
Daugavpils
Query!
Country [293]
0
0
Latvia
Query!
State/province [293]
0
0
Liepaja
Query!
Country [294]
0
0
Latvia
Query!
State/province [294]
0
0
Riga
Query!
Country [295]
0
0
Lithuania
Query!
State/province [295]
0
0
Kaunas
Query!
Country [296]
0
0
Lithuania
Query!
State/province [296]
0
0
Klaipeda
Query!
Country [297]
0
0
Lithuania
Query!
State/province [297]
0
0
Siauliai
Query!
Country [298]
0
0
Lithuania
Query!
State/province [298]
0
0
Vilnius Lt
Query!
Country [299]
0
0
Lithuania
Query!
State/province [299]
0
0
Vilnius
Query!
Country [300]
0
0
Malaysia
Query!
State/province [300]
0
0
Johor Bahru
Query!
Country [301]
0
0
Malaysia
Query!
State/province [301]
0
0
Kelantan
Query!
Country [302]
0
0
Malaysia
Query!
State/province [302]
0
0
Kota Samarahan
Query!
Country [303]
0
0
Malaysia
Query!
State/province [303]
0
0
Kuala Lumpur
Query!
Country [304]
0
0
Malaysia
Query!
State/province [304]
0
0
Selayang N/A
Query!
Country [305]
0
0
Mexico
Query!
State/province [305]
0
0
Aguascalientes
Query!
Country [306]
0
0
Mexico
Query!
State/province [306]
0
0
Cd. Juarez
Query!
Country [307]
0
0
Mexico
Query!
State/province [307]
0
0
Ciudad De Mexico
Query!
Country [308]
0
0
Mexico
Query!
State/province [308]
0
0
Culiacan
Query!
Country [309]
0
0
Mexico
Query!
State/province [309]
0
0
Guadalajara
Query!
Country [310]
0
0
Mexico
Query!
State/province [310]
0
0
Leon
Query!
Country [311]
0
0
Mexico
Query!
State/province [311]
0
0
Mexico
Query!
Country [312]
0
0
Mexico
Query!
State/province [312]
0
0
Monterrey
Query!
Country [313]
0
0
Mexico
Query!
State/province [313]
0
0
Queretaro
Query!
Country [314]
0
0
Mexico
Query!
State/province [314]
0
0
San Luis Potosi
Query!
Country [315]
0
0
Mexico
Query!
State/province [315]
0
0
Sinaloa
Query!
Country [316]
0
0
Mexico
Query!
State/province [316]
0
0
Veracruz
Query!
Country [317]
0
0
Mexico
Query!
State/province [317]
0
0
Zapopan
Query!
Country [318]
0
0
Morocco
Query!
State/province [318]
0
0
Marrakech
Query!
Country [319]
0
0
Morocco
Query!
State/province [319]
0
0
Meknès
Query!
Country [320]
0
0
Morocco
Query!
State/province [320]
0
0
Rabat
Query!
Country [321]
0
0
Netherlands
Query!
State/province [321]
0
0
Amsterdam
Query!
Country [322]
0
0
Netherlands
Query!
State/province [322]
0
0
Arnhem
Query!
Country [323]
0
0
Netherlands
Query!
State/province [323]
0
0
Delft
Query!
Country [324]
0
0
Netherlands
Query!
State/province [324]
0
0
Den Haag
Query!
Country [325]
0
0
Netherlands
Query!
State/province [325]
0
0
Eindhoven
Query!
Country [326]
0
0
Netherlands
Query!
State/province [326]
0
0
Gorinchem
Query!
Country [327]
0
0
Netherlands
Query!
State/province [327]
0
0
Gouda
Query!
Country [328]
0
0
Netherlands
Query!
State/province [328]
0
0
Haarlem
Query!
Country [329]
0
0
Netherlands
Query!
State/province [329]
0
0
Harderwijk
Query!
Country [330]
0
0
Netherlands
Query!
State/province [330]
0
0
Hengelo Ov
Query!
Country [331]
0
0
Netherlands
Query!
State/province [331]
0
0
Nieuwegein
Query!
Country [332]
0
0
Netherlands
Query!
State/province [332]
0
0
Nijmegen
Query!
Country [333]
0
0
Netherlands
Query!
State/province [333]
0
0
Sittard
Query!
Country [334]
0
0
Netherlands
Query!
State/province [334]
0
0
Vlaardingen
Query!
Country [335]
0
0
New Zealand
Query!
State/province [335]
0
0
Auckland
Query!
Country [336]
0
0
New Zealand
Query!
State/province [336]
0
0
Dunedin
Query!
Country [337]
0
0
New Zealand
Query!
State/province [337]
0
0
Hamilton
Query!
Country [338]
0
0
New Zealand
Query!
State/province [338]
0
0
Lower Hutt
Query!
Country [339]
0
0
New Zealand
Query!
State/province [339]
0
0
Nelson
Query!
Country [340]
0
0
New Zealand
Query!
State/province [340]
0
0
New Plymouth
Query!
Country [341]
0
0
Philippines
Query!
State/province [341]
0
0
Iloilo City
Query!
Country [342]
0
0
Philippines
Query!
State/province [342]
0
0
Marikina City
Query!
Country [343]
0
0
Philippines
Query!
State/province [343]
0
0
Quezon City
Query!
Country [344]
0
0
Poland
Query!
State/province [344]
0
0
Bedzin
Query!
Country [345]
0
0
Poland
Query!
State/province [345]
0
0
Bialystok
Query!
Country [346]
0
0
Poland
Query!
State/province [346]
0
0
Bielsko-Biala
Query!
Country [347]
0
0
Poland
Query!
State/province [347]
0
0
Bydgoszcz
Query!
Country [348]
0
0
Poland
Query!
State/province [348]
0
0
Bytom
Query!
Country [349]
0
0
Poland
Query!
State/province [349]
0
0
Dabrowa Górnicza
Query!
Country [350]
0
0
Poland
Query!
State/province [350]
0
0
Gdynia
Query!
Country [351]
0
0
Poland
Query!
State/province [351]
0
0
Gorlice
Query!
Country [352]
0
0
Poland
Query!
State/province [352]
0
0
Katowice N/A
Query!
Country [353]
0
0
Poland
Query!
State/province [353]
0
0
Katowice-Ochojec
Query!
Country [354]
0
0
Poland
Query!
State/province [354]
0
0
Katowice
Query!
Country [355]
0
0
Poland
Query!
State/province [355]
0
0
Koszalin
Query!
Country [356]
0
0
Poland
Query!
State/province [356]
0
0
Krakow N/A
Query!
Country [357]
0
0
Poland
Query!
State/province [357]
0
0
Krakow
Query!
Country [358]
0
0
Poland
Query!
State/province [358]
0
0
Kutno
Query!
Country [359]
0
0
Poland
Query!
State/province [359]
0
0
Lodz
Query!
Country [360]
0
0
Poland
Query!
State/province [360]
0
0
Nowy Targ
Query!
Country [361]
0
0
Poland
Query!
State/province [361]
0
0
Opole
Query!
Country [362]
0
0
Poland
Query!
State/province [362]
0
0
Plock
Query!
Country [363]
0
0
Poland
Query!
State/province [363]
0
0
Poznan N/A
Query!
Country [364]
0
0
Poland
Query!
State/province [364]
0
0
Poznan
Query!
Country [365]
0
0
Poland
Query!
State/province [365]
0
0
Ruda Slaska
Query!
Country [366]
0
0
Poland
Query!
State/province [366]
0
0
Starogard Gdanski Nap
Query!
Country [367]
0
0
Poland
Query!
State/province [367]
0
0
Szczecin N/A
Query!
Country [368]
0
0
Poland
Query!
State/province [368]
0
0
Szczecin
Query!
Country [369]
0
0
Poland
Query!
State/province [369]
0
0
Torun
Query!
Country [370]
0
0
Poland
Query!
State/province [370]
0
0
Warszawa N/A
Query!
Country [371]
0
0
Poland
Query!
State/province [371]
0
0
Warszawa
Query!
Country [372]
0
0
Poland
Query!
State/province [372]
0
0
Wloclawek
Query!
Country [373]
0
0
Poland
Query!
State/province [373]
0
0
Wroclaw
Query!
Country [374]
0
0
Poland
Query!
State/province [374]
0
0
Zamosc
Query!
Country [375]
0
0
Portugal
Query!
State/province [375]
0
0
Aveiro
Query!
Country [376]
0
0
Portugal
Query!
State/province [376]
0
0
Braga
Query!
Country [377]
0
0
Portugal
Query!
State/province [377]
0
0
Coimbra
Query!
Country [378]
0
0
Portugal
Query!
State/province [378]
0
0
Faro
Query!
Country [379]
0
0
Portugal
Query!
State/province [379]
0
0
Leiria
Query!
Country [380]
0
0
Portugal
Query!
State/province [380]
0
0
Lisboa
Query!
Country [381]
0
0
Portugal
Query!
State/province [381]
0
0
Penafiel
Query!
Country [382]
0
0
Portugal
Query!
State/province [382]
0
0
Porto
Query!
Country [383]
0
0
Portugal
Query!
State/province [383]
0
0
Vila Nova De Gaia
Query!
Country [384]
0
0
Romania
Query!
State/province [384]
0
0
Bucuresti
Query!
Country [385]
0
0
Romania
Query!
State/province [385]
0
0
Craiova
Query!
Country [386]
0
0
Romania
Query!
State/province [386]
0
0
Focsani
Query!
Country [387]
0
0
Romania
Query!
State/province [387]
0
0
Oradea
Query!
Country [388]
0
0
Romania
Query!
State/province [388]
0
0
Pitesti
Query!
Country [389]
0
0
Romania
Query!
State/province [389]
0
0
Tg Mures
Query!
Country [390]
0
0
Romania
Query!
State/province [390]
0
0
Timisoara
Query!
Country [391]
0
0
Russian Federation
Query!
State/province [391]
0
0
Arkhangelsk
Query!
Country [392]
0
0
Russian Federation
Query!
State/province [392]
0
0
Barnaul
Query!
Country [393]
0
0
Russian Federation
Query!
State/province [393]
0
0
Chelyabinsk
Query!
Country [394]
0
0
Russian Federation
Query!
State/province [394]
0
0
Ekaterinburg
Query!
Country [395]
0
0
Russian Federation
Query!
State/province [395]
0
0
Ivanovo
Query!
Country [396]
0
0
Russian Federation
Query!
State/province [396]
0
0
Kaliningrad
Query!
Country [397]
0
0
Russian Federation
Query!
State/province [397]
0
0
Kemerovo
Query!
Country [398]
0
0
Russian Federation
Query!
State/province [398]
0
0
Kirov
Query!
Country [399]
0
0
Russian Federation
Query!
State/province [399]
0
0
Krasnodar
Query!
Country [400]
0
0
Russian Federation
Query!
State/province [400]
0
0
Krasnoyarsk
Query!
Country [401]
0
0
Russian Federation
Query!
State/province [401]
0
0
Kursk
Query!
Country [402]
0
0
Russian Federation
Query!
State/province [402]
0
0
Lyubertsy
Query!
Country [403]
0
0
Russian Federation
Query!
State/province [403]
0
0
Moscow N/A
Query!
Country [404]
0
0
Russian Federation
Query!
State/province [404]
0
0
Moscow
Query!
Country [405]
0
0
Russian Federation
Query!
State/province [405]
0
0
Nizhny Novgorod
Query!
Country [406]
0
0
Russian Federation
Query!
State/province [406]
0
0
Novosibirsk
Query!
Country [407]
0
0
Russian Federation
Query!
State/province [407]
0
0
Omsk
Query!
Country [408]
0
0
Russian Federation
Query!
State/province [408]
0
0
Orenburg
Query!
Country [409]
0
0
Russian Federation
Query!
State/province [409]
0
0
Penza
Query!
Country [410]
0
0
Russian Federation
Query!
State/province [410]
0
0
Perm
Query!
Country [411]
0
0
Russian Federation
Query!
State/province [411]
0
0
Pskov
Query!
Country [412]
0
0
Russian Federation
Query!
State/province [412]
0
0
Pushkin, Saint-Petersburg
Query!
Country [413]
0
0
Russian Federation
Query!
State/province [413]
0
0
Ryazan
Query!
Country [414]
0
0
Russian Federation
Query!
State/province [414]
0
0
Saint-Petersbrug
Query!
Country [415]
0
0
Russian Federation
Query!
State/province [415]
0
0
Saint-Petersburg
Query!
Country [416]
0
0
Russian Federation
Query!
State/province [416]
0
0
Sestroretsk, Saint-Petersburg
Query!
Country [417]
0
0
Russian Federation
Query!
State/province [417]
0
0
St Petersburg N/A
Query!
Country [418]
0
0
Russian Federation
Query!
State/province [418]
0
0
St Petersburg
Query!
Country [419]
0
0
Russian Federation
Query!
State/province [419]
0
0
St. Petersburg
Query!
Country [420]
0
0
Russian Federation
Query!
State/province [420]
0
0
Syktyvkar
Query!
Country [421]
0
0
Russian Federation
Query!
State/province [421]
0
0
Tomsk
Query!
Country [422]
0
0
Russian Federation
Query!
State/province [422]
0
0
Tula
Query!
Country [423]
0
0
Russian Federation
Query!
State/province [423]
0
0
Tumen Region
Query!
Country [424]
0
0
Russian Federation
Query!
State/province [424]
0
0
Vladimir
Query!
Country [425]
0
0
Russian Federation
Query!
State/province [425]
0
0
Voronezh
Query!
Country [426]
0
0
Russian Federation
Query!
State/province [426]
0
0
Yaroslavl Nap
Query!
Country [427]
0
0
Serbia
Query!
State/province [427]
0
0
Belgrade
Query!
Country [428]
0
0
Serbia
Query!
State/province [428]
0
0
Beograd
Query!
Country [429]
0
0
Serbia
Query!
State/province [429]
0
0
Kragujevac
Query!
Country [430]
0
0
Serbia
Query!
State/province [430]
0
0
Niska Banja
Query!
Country [431]
0
0
Serbia
Query!
State/province [431]
0
0
Nis
Query!
Country [432]
0
0
Slovakia
Query!
State/province [432]
0
0
Bratislava
Query!
Country [433]
0
0
Slovakia
Query!
State/province [433]
0
0
Nové Zámky
Query!
Country [434]
0
0
Slovakia
Query!
State/province [434]
0
0
Zilina
Query!
Country [435]
0
0
Spain
Query!
State/province [435]
0
0
Alicante N/A
Query!
Country [436]
0
0
Spain
Query!
State/province [436]
0
0
Aviles Asturias
Query!
Country [437]
0
0
Spain
Query!
State/province [437]
0
0
Barcelona
Query!
Country [438]
0
0
Spain
Query!
State/province [438]
0
0
Burgos
Query!
Country [439]
0
0
Spain
Query!
State/province [439]
0
0
Elche
Query!
Country [440]
0
0
Spain
Query!
State/province [440]
0
0
Figueres
Query!
Country [441]
0
0
Spain
Query!
State/province [441]
0
0
Guadalajara
Query!
Country [442]
0
0
Spain
Query!
State/province [442]
0
0
Huelva N/A
Query!
Country [443]
0
0
Spain
Query!
State/province [443]
0
0
Madrid
Query!
Country [444]
0
0
Spain
Query!
State/province [444]
0
0
Malaga
Query!
Country [445]
0
0
Spain
Query!
State/province [445]
0
0
Málaga
Query!
Country [446]
0
0
Spain
Query!
State/province [446]
0
0
Salamanca
Query!
Country [447]
0
0
Spain
Query!
State/province [447]
0
0
Santander
Query!
Country [448]
0
0
Spain
Query!
State/province [448]
0
0
Sevilla
Query!
Country [449]
0
0
Spain
Query!
State/province [449]
0
0
Tarragona
Query!
Country [450]
0
0
Spain
Query!
State/province [450]
0
0
Valencia
Query!
Country [451]
0
0
Spain
Query!
State/province [451]
0
0
Vigo
Query!
Country [452]
0
0
Sweden
Query!
State/province [452]
0
0
Danderyd
Query!
Country [453]
0
0
Sweden
Query!
State/province [453]
0
0
Göteborg
Query!
Country [454]
0
0
Sweden
Query!
State/province [454]
0
0
Jönköping
Query!
Country [455]
0
0
Sweden
Query!
State/province [455]
0
0
Linköping
Query!
Country [456]
0
0
Sweden
Query!
State/province [456]
0
0
Lund
Query!
Country [457]
0
0
Sweden
Query!
State/province [457]
0
0
Malmö
Query!
Country [458]
0
0
Sweden
Query!
State/province [458]
0
0
Umeå
Query!
Country [459]
0
0
Sweden
Query!
State/province [459]
0
0
Örebro
Query!
Country [460]
0
0
Sweden
Query!
State/province [460]
0
0
Östersund
Query!
Country [461]
0
0
Thailand
Query!
State/province [461]
0
0
Bangkok
Query!
Country [462]
0
0
Thailand
Query!
State/province [462]
0
0
Chiang Mai
Query!
Country [463]
0
0
Thailand
Query!
State/province [463]
0
0
Pathumthani
Query!
Country [464]
0
0
Thailand
Query!
State/province [464]
0
0
Phathumwan
Query!
Country [465]
0
0
Tunisia
Query!
State/province [465]
0
0
Sfax
Query!
Country [466]
0
0
Tunisia
Query!
State/province [466]
0
0
Sousse
Query!
Country [467]
0
0
Tunisia
Query!
State/province [467]
0
0
Tunis
Query!
Country [468]
0
0
Turkey
Query!
State/province [468]
0
0
Ankara
Query!
Country [469]
0
0
Turkey
Query!
State/province [469]
0
0
Aydin
Query!
Country [470]
0
0
Turkey
Query!
State/province [470]
0
0
Bursa
Query!
Country [471]
0
0
Turkey
Query!
State/province [471]
0
0
Erzurum
Query!
Country [472]
0
0
Turkey
Query!
State/province [472]
0
0
Istanbul
Query!
Country [473]
0
0
Turkey
Query!
State/province [473]
0
0
Izmir
Query!
Country [474]
0
0
Turkey
Query!
State/province [474]
0
0
Kayseri
Query!
Country [475]
0
0
Turkey
Query!
State/province [475]
0
0
Samsun
Query!
Country [476]
0
0
Turkey
Query!
State/province [476]
0
0
Sivas
Query!
Country [477]
0
0
Ukraine
Query!
State/province [477]
0
0
Cherkassy
Query!
Country [478]
0
0
Ukraine
Query!
State/province [478]
0
0
Dnepropetrovsk
Query!
Country [479]
0
0
Ukraine
Query!
State/province [479]
0
0
Donetsk
Query!
Country [480]
0
0
Ukraine
Query!
State/province [480]
0
0
Ivano-Frankivsk
Query!
Country [481]
0
0
Ukraine
Query!
State/province [481]
0
0
Kharkov
Query!
Country [482]
0
0
Ukraine
Query!
State/province [482]
0
0
Khemelnitskiy
Query!
Country [483]
0
0
Ukraine
Query!
State/province [483]
0
0
Kiev
Query!
Country [484]
0
0
Ukraine
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Ternopol
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Exeter
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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Bayer
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Ethics approval
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Summary
Brief summary
The purpose of this study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke in patients with a recent acute coronary syndrome compared with placebo.
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Trial website
https://clinicaltrials.gov/study/NCT00809965
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Trial related presentations / publications
Gibson WJ, Nafee T, Travis R, Yee M, Kerneis M, Ohman M, Gibson CM. Machine learning versus traditional risk stratification methods in acute coronary syndrome: a pooled randomized clinical trial analysis. J Thromb Thrombolysis. 2020 Jan;49(1):1-9. doi: 10.1007/s11239-019-01940-8. Gibson CM, Levitan B, Gibson WJ, Yee MK, Murphy SA, Yuan Z, Chakrabarti AK, Lee M, Braunwald E. Fatal or Irreversible Bleeding and Ischemic Events With Rivaroxaban in Acute Coronary Syndrome. J Am Coll Cardiol. 2018 Jul 10;72(2):129-136. doi: 10.1016/j.jacc.2018.04.055. Cavender MA, Gibson CM, Braunwald E, Wiviott SD, Murphy SA, Toda Kato E, Plotnikov AN, Amuchastegui M, Oude Ophuis T, van Hessen M, Mega JL. The effect of rivaroxaban on myocardial infarction in the ATLAS ACS 2 - TIMI 51 trial. Eur Heart J Acute Cardiovasc Care. 2015 Oct;4(5):468-74. doi: 10.1177/2048872614554109. Epub 2014 Oct 15. Gibson CM, Chakrabarti AK, Mega J, Bode C, Bassand JP, Verheugt FW, Bhatt DL, Goto S, Cohen M, Mohanavelu S, Burton P, Stone G, Braunwald E; ATLAS-ACS 2 TIMI 51 Investigators. Reduction of stent thrombosis in patients with acute coronary syndromes treated with rivaroxaban in ATLAS-ACS 2 TIMI 51. J Am Coll Cardiol. 2013 Jul 23;62(4):286-90. doi: 10.1016/j.jacc.2013.03.041. Epub 2013 Apr 16. Mega JL, Braunwald E, Murphy SA, Plotnikov AN, Burton P, Kiss RG, Parkhomenko A, Tendera M, Widimsky P, Gibson CM. Rivaroxaban in patients stabilized after a ST-segment elevation myocardial infarction: results from the ATLAS ACS-2-TIMI-51 trial (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with Acute Coronary Syndrome-Thrombolysis In Myocardial Infarction-51). J Am Coll Cardiol. 2013 May 7;61(18):1853-9. doi: 10.1016/j.jacc.2013.01.066. Epub 2013 Mar 7. Mega JL, Braunwald E, Wiviott SD, Bassand JP, Bhatt DL, Bode C, Burton P, Cohen M, Cook-Bruns N, Fox KA, Goto S, Murphy SA, Plotnikov AN, Schneider D, Sun X, Verheugt FW, Gibson CM; ATLAS ACS 2-TIMI 51 Investigators. Rivaroxaban in patients with a recent acute coronary syndrome. N Engl J Med. 2012 Jan 5;366(1):9-19. doi: 10.1056/NEJMoa1112277. Epub 2011 Nov 13. Gibson CM, Mega JL, Burton P, Goto S, Verheugt F, Bode C, Plotnikov A, Sun X, Cook-Bruns N, Braunwald E. Rationale and design of the Anti-Xa therapy to lower cardiovascular events in addition to standard therapy in subjects with acute coronary syndrome-thrombolysis in myocardial infarction 51 (ATLAS-ACS 2 TIMI 51) trial: a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rivaroxaban in subjects with acute coronary syndrome. Am Heart J. 2011 May;161(5):815-821.e6. doi: 10.1016/j.ahj.2011.01.026.
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Public notes
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Contacts
Principal investigator
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Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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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/NCT00809965
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