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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02145468
Registration number
NCT02145468
Ethics application status
Date submitted
15/05/2014
Date registered
23/05/2014
Titles & IDs
Public title
A Phase 3 Clinical Outcomes Study to Compare the Incidence of Major Adverse Cardiovascular Events in Subjects Presenting With Acute Coronary Syndrome Treated With Losmapimod Compared to Placebo (LATITUDE-TIMI 60)
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Scientific title
A Clinical Outcomes Study to Compare the Incidence of Major Adverse Cardiovascular Events in Subjects Presenting With Acute Coronary Syndrome Treated With Losmapimod Compared to Placebo (PM1116197) LosmApimod To Inhibit p38 MAP Kinase as a TherapeUtic Target and moDify Outcomes After an Acute Coronary syndromE (LATITUDE)-TIMI 60.
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Secondary ID [1]
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116197
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Universal Trial Number (UTN)
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Trial acronym
LATITUDE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Other
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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 - Losmapimod 7.5 mg twice daily
Treatment: Drugs - Placebo twice daily
Treatment: Drugs - Standard therapy
Experimental: Losmapimod - Losmapimod 7.5 mg twice daily oral tablet
Placebo comparator: Placebo - Placebo twice daily oral tablet
Treatment: Drugs: Losmapimod 7.5 mg twice daily
Subjects will receive Losmapimod 7.5 mg as film-coated, round, plain faced tablets.
Treatment: Drugs: Placebo twice daily
Subjects will receive placebo as film-coated, round, plain faced tablets.
Treatment: Drugs: Standard therapy
Subjects will receive standard therapy consistent with the appropriate guidelines from professional societies. The standard therapy includes nitrates, morphine sulfate, beta adrenergic blockers, renin-angiotensin aldosterone inhibitors, other anti-ischemic therapies, and analgesic therapy.
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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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Number of Participants With First Occurrence of Major Adverse Cardiovascular Events (MACE) Through Week 12
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Assessment method [1]
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The primary efficacy endpoint is the composite measure of adjudicated MACE that includes the time to first occurrence of CV death (death due to a cardiovascular cause), MI or SRI-UR (Severe Recurrent Ischemia requiring Urgent coronary artery Revascularization). Death for which the Clinical Events Committee (CEC) or investigator were unable to establish cause were analyzed as CV deaths.
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Timepoint [1]
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Up to 12 weeks
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Secondary outcome [1]
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Number of Participants With First Occurrence of MACE Through Week 24
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Assessment method [1]
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Number of participants with first occurrence of MACE through Week 24 including CV death, MI or SRI-UR are presented. Death for which the CEC or investigator were unable to establish cause were analyzed as CV deaths.
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Timepoint [1]
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Up to Week 24
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Secondary outcome [2]
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Number of Participants With First Occurrence of the Composite of CV Death or MI up to Week 12 and Week 24
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Assessment method [2]
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Week 12 results are considered the principal secondary endpoint. Number of participants with first occurrence of the composite of CV death or MI up to Week 12 and Week 24 are summarized.
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Timepoint [2]
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Week 12 and Week 24
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Secondary outcome [3]
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Number of Participants With First Occurrence of the Composite of CV Death, MI or Hospitalization for Heart Failure (HF) up to Week 12 and Week 24.
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Assessment method [3]
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Number of participants with first occurrence of the composite of CV death, MI or hospitalization for HF up to Week 12 and Week 24 are presented.
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Timepoint [3]
0
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Week 12 and Week 24
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Secondary outcome [4]
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Number of Participants With First Occurrence of the Expanded Composite of Arterial CV Events Defined as CV Death, MI, SRI-UR or Stroke Through to Week 12 and Week 24
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Assessment method [4]
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Number of participants with first occurrence of the expanded composite of arterial CV events defined as CV death, MI, SRI-UR or stroke through to Week 12 and Week 24 are presented.
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Timepoint [4]
0
0
Week 12, Week 24
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Secondary outcome [5]
0
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Number of Participants With First Occurrence of the Composite of Coronary Events Defined as CHD Death, MI, SRI-UR or Any Unplanned Coronary Artery Revascularization Through to Week 12 and Week 24
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Assessment method [5]
0
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Number of participants with first occurrence of the composite of coronary events defined as coronary heart disease (CHD) death, MI, SRI-UR or any unplanned coronary artery revascularization through to Week 12 and Week 24 are presented.
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Timepoint [5]
0
0
Week 12, Week 24
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Secondary outcome [6]
0
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Number of Participants With First Occurrence of the Composite of CV Death or Hospitalization for HF Through to Week 12 and Week 24
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Assessment method [6]
0
0
Number of participants with first occurrence of the composite of CV death or hospitalization for HF through to Week 12 and Week 24 are presented.
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Timepoint [6]
0
0
Week 12, Week 24
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Secondary outcome [7]
0
0
Number of Participants With First Occurrence of the Composite of CV Death, MI or Stroke Through to Week 12 and Week 24
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Assessment method [7]
0
0
Number of participants with first occurrence of the composite of CV death, MI or stroke through to Week 12 and Week 24 are presented.
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Timepoint [7]
0
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Week 12, Week 24
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Secondary outcome [8]
0
0
Number of Participants With First Occurrence of the Expanded Composite of CV Death, MI, SRI-UR, Stroke or Hospitalization for HF Through to Week 12 and Week 24
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Assessment method [8]
0
0
Number of participants with first occurrence of the expanded composite of CV death, MI, SRI-UR, stroke or hospitalization for HF through to Week 12 and Week 24 are presented.
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Timepoint [8]
0
0
Week 12, Week 24
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Secondary outcome [9]
0
0
Number of Participants With First Occurrence of the Composite of CHD Death, MI or SRI-UR Through to Week 12 and Week 24
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Assessment method [9]
0
0
Number of participants with first occurrence of the composite of CHD death, MI or SRI-UR through to Week 12 and Week 24 are presented.
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Timepoint [9]
0
0
Week 12, Week 24
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Secondary outcome [10]
0
0
Number of Participants With First Occurrence of the Composite of CHD Death or MI Through to Week 12 and Week 24
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Assessment method [10]
0
0
Number of participants with first occurrence of the composite of CHD death or MI through to Week 12 and Week 24 are presented.
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Timepoint [10]
0
0
Week 12, Week 24
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Secondary outcome [11]
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Number of Participants With First Occurrence of the Composite of All-cause Death, MI or SRI-UR Through to Week 12 and Week 24
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Assessment method [11]
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Number of participants with first occurrence of the composite of all-cause death, MI or SRI-UR through to Week 12 and Week 24 are presented.
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Timepoint [11]
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Week 12, Week 24
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Secondary outcome [12]
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Number of Participants With First Occurrence of the Composite of All-cause Death or MI Through to Week 12 and Week 24
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Assessment method [12]
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Number of participants with first occurrence of the composite of all-cause death or MI through to Week 12 and Week 24 are presented.
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Timepoint [12]
0
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Week 12, Week 24
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Secondary outcome [13]
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Number of Participants With First Occurrence of the Composite of CV Death, Type I (Spontaneous) MI or SRI-UR Through to Week 12 and Week 24
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Assessment method [13]
0
0
Number of participants with first occurrence of the composite of CV death, type I (spontaneous) MI or SRI-UR through to Week 12 and Week 24 are presented.
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Timepoint [13]
0
0
Week 12, Week 24
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Secondary outcome [14]
0
0
Number of Participants With First Occurrence of the Composite of CV Death or Type I (Spontaneous) MI Through to Week 12 and Week 24
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Assessment method [14]
0
0
Number of participants with first occurrence of the composite of CV death or type I (spontaneous) MI through to Week 12 and Week 24 are presented.
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Timepoint [14]
0
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Week 12, Week 24
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Secondary outcome [15]
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Number of Participants With First Occurrence of Definite or Probable Stent Thrombosis Through to Week 12 and Week 24
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Assessment method [15]
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Number of participants with first occurrence of definite or probable stent thrombosis through to Week 12 and Week 24 are presented. Participants receiving stent prior to randomization or during the study prior to Week 12 were included.
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Timepoint [15]
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Week 12, Week 24
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Secondary outcome [16]
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Number of Participants Re-hospitalized Within 30 Days of Discharge
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Assessment method [16]
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Participants who had a death or re-hospitalization within 30 days of discharge, plus participants who were never discharged from the initial hospitalization were included.
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Timepoint [16]
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Within up to 30 days of post discharge
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Secondary outcome [17]
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Number of Participants With All-cause Mortality Through to Week 12 and Week 24
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Assessment method [17]
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Number of participants with all-cause mortality through to Week 12 and Week 24 are presented.
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Timepoint [17]
0
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Week 12, Week 24
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Secondary outcome [18]
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Number of Participants With CV Death Events Through to Week 12 and Week 24
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Assessment method [18]
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0
Number of participants with CV death events through to Week 12 and Week 24 are presented.
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Timepoint [18]
0
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Week 12, Week 24
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Secondary outcome [19]
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Number of Participants With CHD Death Events Through to Week 12 and Week 24
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Assessment method [19]
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0
Number of participants with CHD death events through to Week 12 and Week 24 are presented.
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Timepoint [19]
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Week 12, Week 24
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Secondary outcome [20]
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Number of Participants With First Occurrence of Myocardial Infarction (Fatal and Non-fatal) Events Through to Week 12 and Week 24
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Assessment method [20]
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Number of participants with first occurrence of myocardial infarction (fatal and non-fatal) events through to Week 12 and Week 24 are presented.
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Timepoint [20]
0
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Week 12, Week 24
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Secondary outcome [21]
0
0
Number of Participants With First Occurrence of Type I (Spontaneous) MI Events Through to Week 12 and Week 24
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Assessment method [21]
0
0
Number of participants with first occurrence of type I (spontaneous) MI events through to Week 12 and Week 24 are presented.
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Timepoint [21]
0
0
Week 12, Week 24
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Secondary outcome [22]
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Number of Participants With First Occurrence of SRI-UR Events Through to Week 12 and Week 24
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Assessment method [22]
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Number of participants with first occurrence of SRI-UR events through to Week 12 and Week 24 are presented.
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Timepoint [22]
0
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Week 12, Week 24
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Secondary outcome [23]
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Number of Participants With First Occurrence of Stroke (Fatal and Non-fatal) Events Through to Week 12 and Week 24
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Assessment method [23]
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Number of participants with first occurrence of stroke (fatal and non-fatal) events through to Week 12 and Week 24 are presented.
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Timepoint [23]
0
0
Week 12, Week 24
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Secondary outcome [24]
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Number of Participants With First Occurrence of Hospitalization for HF Through to Week 12 and Week 24
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Assessment method [24]
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0
Number of participants with first occurrence of hospitalization for HF through to Week 12 and Week 24 are presented.
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Timepoint [24]
0
0
Week 12, Week 24
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Secondary outcome [25]
0
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Number of Participants With First Occurrence of Any Unplanned Coronary Revascularization Through to Week 12 and Week 24
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Assessment method [25]
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Number of participants with first occurrence of any unplanned coronary revascularization through to Week 12 and Week 24 are presented.
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Timepoint [25]
0
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Week 12, Week 24
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Eligibility
Key inclusion criteria
* Signed written informed consent
* Men or women at least 35 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy
* Hospitalization for NSTEMI or STEMI (Universal Definition Type 1 MI)
* With the following timing of symptoms: NSTEMI: Presence of ischemic symptoms (>=5 minutes) at rest within 24 hours prior to randomization (may include qualifying episode). STEMI: Onset of qualifying ischemic symptoms within 12 hours of randomization.
* At least one of the following
* Age >=60 years at randomization.
* Myocardial infarction prior to the qualifying ACS event
* CABG prior to qualifying ACS event.
* NSTEMI with new ischemic ST-segment depression >= 0.1 mV in >= 2 contiguous leads.
* Diabetes mellitus requiring pharmacotherapy.
* Coexistent clinically diagnosed arterial disease
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Minimum age
35
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
* Unable to be randomized prior to coronary revascularization or fibrinolysis for the qualifying MI.
* Current severe heart failure or shock
* Ongoing clinical instability
* History of chronic liver disease
* Known severe renal impairment
* Any condition, other than vascular disease, with life expectancy <1 year that might prevent the subject from completing the study.
* Known active tuberculosis, HIV, active opportunistic or life threatening infections.
* Vaccination with a live attenuated vaccine within 6 weeks of randomization.
* Concomitant use of cytotoxic chemotherapy for cancer or known ongoing or anticipated use of chronic severe immunosuppressive agents
* Positive pregnancy test or is known to be pregnant or lactating
* Known alcohol or drug abuse within the past 6 months
* Any current mental condition, which may affect study compliance or prevent understanding of the aims, investigational procedures or possible consequences of the study.
* Participation in a study of an investigational medication within the past 30 days.
* Anticipated inability to comply with any study procedures, including participation in study visits according to the visit schedule through 24 weeks.
* Use of another investigational product within 30 days or 5 half-lives (whichever is longer) or according to local regulations, or currently participating in a study of an investigational device. Subjects must be randomized only one time in this investigational study
* Any other reason the investigator deems the subject to be unsuitable for the study
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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
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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
3/06/2014
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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
14/12/2015
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Sample size
Target
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Accrual to date
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Final
3503
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Recruitment in Australia
Recruitment state(s)
QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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GSK Investigational Site - Brisbane
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Recruitment hospital [2]
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GSK Investigational Site - Cairns
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GSK Investigational Site - Herston
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GSK Investigational Site - Nambour
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GSK Investigational Site - Bedford Park
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GSK Investigational Site - Hobart
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GSK Investigational Site - Murdoch
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GSK Investigational Site - Nedlands
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Recruitment postcode(s) [1]
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4032 - Brisbane
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Recruitment postcode(s) [2]
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4870 - Cairns
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4029 - Herston
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4560 - Nambour
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5042 - Bedford Park
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7000 - Hobart
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Recruitment postcode(s) [7]
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3076 - Epping
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Recruitment postcode(s) [8]
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3220 - Geelong
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Recruitment postcode(s) [9]
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6150 - Murdoch
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Recruitment postcode(s) [10]
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6009 - Nedlands
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Recruitment outside Australia
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Alabama
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Yvoir
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Bulgaria
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Blagoevgrad
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Bulgaria
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Dimitrovgrad
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Bulgaria
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Bulgaria
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Sofia
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Región Metro De Santiago
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Chile
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Santiago
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Czechia
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0
Brno
Query!
Country [59]
0
0
Czechia
Query!
State/province [59]
0
0
Ceske Budejovice
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Country [60]
0
0
Czechia
Query!
State/province [60]
0
0
Hradec Kralove
Query!
Country [61]
0
0
Czechia
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State/province [61]
0
0
Liberec
Query!
Country [62]
0
0
Czechia
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State/province [62]
0
0
Ostrava.
Query!
Country [63]
0
0
Czechia
Query!
State/province [63]
0
0
Pardubice
Query!
Country [64]
0
0
Czechia
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State/province [64]
0
0
Praha 10
Query!
Country [65]
0
0
Czechia
Query!
State/province [65]
0
0
Praha 2
Query!
Country [66]
0
0
Czechia
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State/province [66]
0
0
Praha 6
Query!
Country [67]
0
0
Czechia
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State/province [67]
0
0
Usti nad Labem
Query!
Country [68]
0
0
Czechia
Query!
State/province [68]
0
0
Zlin
Query!
Country [69]
0
0
Denmark
Query!
State/province [69]
0
0
Hellerup
Query!
Country [70]
0
0
Denmark
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State/province [70]
0
0
Hvidovre
Query!
Country [71]
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0
Denmark
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State/province [71]
0
0
København NV
Query!
Country [72]
0
0
Denmark
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State/province [72]
0
0
København S
Query!
Country [73]
0
0
Estonia
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State/province [73]
0
0
Tallinn
Query!
Country [74]
0
0
Estonia
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State/province [74]
0
0
Tartu
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Country [75]
0
0
France
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State/province [75]
0
0
Besançon Cedex
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Country [76]
0
0
France
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State/province [76]
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0
Dijon
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Country [77]
0
0
France
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State/province [77]
0
0
Montauban cedex
Query!
Country [78]
0
0
France
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State/province [78]
0
0
Nantes cedex 1
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Country [79]
0
0
France
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State/province [79]
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0
Paris Cedex 18
Query!
Country [80]
0
0
France
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State/province [80]
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0
Pau
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Country [81]
0
0
France
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State/province [81]
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0
Strasbourg cedex
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Country [82]
0
0
France
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State/province [82]
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0
Toulouse cedex 09
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Country [83]
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0
France
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State/province [83]
0
0
Tourcoing cedex
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Country [84]
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0
France
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State/province [84]
0
0
Valenciennes Cedex
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Country [85]
0
0
Germany
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State/province [85]
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0
Baden-Wuerttemberg
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Country [86]
0
0
Germany
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State/province [86]
0
0
Brandenburg
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Country [87]
0
0
Germany
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State/province [87]
0
0
Hessen
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Country [88]
0
0
Germany
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State/province [88]
0
0
Niedersachsen
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Country [89]
0
0
Germany
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State/province [89]
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0
Nordrhein-Westfalen
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Country [90]
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0
Germany
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State/province [90]
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0
Sachsen
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Country [91]
0
0
Germany
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State/province [91]
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0
Hamburg
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Country [92]
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0
Greece
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State/province [92]
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0
Alexandroupolis
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Country [93]
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0
Greece
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State/province [93]
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0
Athens
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Country [94]
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0
Greece
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State/province [94]
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0
Chalkida
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Country [95]
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0
Greece
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State/province [95]
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0
N. Efkarpia, Thessaloniki
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Country [96]
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0
Greece
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State/province [96]
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0
Thessaloniki
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Country [97]
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0
Hong Kong
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State/province [97]
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Chai Wan
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Country [98]
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0
Hong Kong
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State/province [98]
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0
Kowloon
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Country [99]
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0
Hong Kong
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State/province [99]
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0
Shatin, New Territories
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Country [100]
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0
Hungary
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State/province [100]
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0
Balatonfüred
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Country [101]
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Hungary
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State/province [101]
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Budapest
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Country [102]
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0
Hungary
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State/province [102]
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Szolnok
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Country [103]
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0
Hungary
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State/province [103]
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0
Zalaegerszeg
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Country [104]
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0
Israel
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State/province [104]
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0
Ashkelon
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Country [105]
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0
Israel
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State/province [105]
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0
Haddera
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Country [106]
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0
Israel
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State/province [106]
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0
Kfar Saba
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Country [107]
0
0
Israel
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State/province [107]
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0
Nahariya
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Country [108]
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0
Israel
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State/province [108]
0
0
Tel Aviv
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Country [109]
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0
Italy
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State/province [109]
0
0
Emilia-Romagna
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Country [110]
0
0
Italy
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State/province [110]
0
0
Friuli-Venezia-Giulia
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Country [111]
0
0
Italy
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State/province [111]
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0
Lombardia
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Country [112]
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0
Italy
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State/province [112]
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0
Umbria
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Country [113]
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0
Korea, Republic of
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State/province [113]
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0
Daejeon
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Country [114]
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0
Korea, Republic of
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State/province [114]
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0
Ganwon-do
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Country [115]
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0
Korea, Republic of
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State/province [115]
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0
Gwangju
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Country [116]
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0
Korea, Republic of
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State/province [116]
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Seoul
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0
Mexico
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0
Jalisco
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Mexico
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Queretaro
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Country [119]
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0
Mexico
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San Luis Potosi
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Country [120]
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0
Netherlands
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State/province [120]
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Alkmaar
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Country [121]
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0
Netherlands
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State/province [121]
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0
Amersfoort
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0
Netherlands
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State/province [122]
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0
Amsterdam
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Country [123]
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0
Netherlands
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State/province [123]
0
0
Delft
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Country [124]
0
0
Netherlands
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State/province [124]
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0
Deventer
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Country [125]
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0
Netherlands
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State/province [125]
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0
Helmond
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Country [126]
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0
Netherlands
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State/province [126]
0
0
Nieuwegein
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Country [127]
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0
Netherlands
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State/province [127]
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0
Nijmegen
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Country [128]
0
0
Netherlands
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State/province [128]
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0
Rotterdam
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Country [129]
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0
Netherlands
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State/province [129]
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0
Schiedam
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Country [130]
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0
Netherlands
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Sittard-geleen
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Netherlands
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Tilburg
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Country [132]
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0
Netherlands
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Venlo
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0
Netherlands
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Zwolle
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Country [134]
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New Zealand
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State/province [134]
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Christchurch
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Country [135]
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New Zealand
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0
Grafton, Auckland
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Country [136]
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0
New Zealand
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State/province [136]
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Hamilton
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Country [137]
0
0
New Zealand
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State/province [137]
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0
New Plymouth
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Country [138]
0
0
New Zealand
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State/province [138]
0
0
Otahuhu, Auckland
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Country [139]
0
0
New Zealand
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State/province [139]
0
0
Wellington South
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Country [140]
0
0
Norway
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State/province [140]
0
0
Lillehammer
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Country [141]
0
0
Norway
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State/province [141]
0
0
Oslo
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Country [142]
0
0
Norway
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State/province [142]
0
0
Skien
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Country [143]
0
0
Norway
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State/province [143]
0
0
Stavanger
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Country [144]
0
0
Norway
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State/province [144]
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0
Tromsø
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Country [145]
0
0
Philippines
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State/province [145]
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0
Manila
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Country [146]
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0
Philippines
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State/province [146]
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0
Pasig City
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Country [147]
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0
Philippines
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State/province [147]
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Quezon City
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Country [148]
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0
Philippines
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State/province [148]
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San Juan
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Country [149]
0
0
Poland
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State/province [149]
0
0
Bydgoszcz
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Country [150]
0
0
Poland
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State/province [150]
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0
Gdansk
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Country [151]
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0
Poland
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State/province [151]
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0
Gdynia
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Country [152]
0
0
Poland
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State/province [152]
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0
Inowroclaw
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Country [153]
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0
Poland
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State/province [153]
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0
Krakow
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Country [154]
0
0
Poland
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State/province [154]
0
0
Lubin
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Country [155]
0
0
Poland
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State/province [155]
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Lublin
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Country [156]
0
0
Poland
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State/province [156]
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0
Olsztyn
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Country [157]
0
0
Poland
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State/province [157]
0
0
Torun
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Country [158]
0
0
Poland
Query!
State/province [158]
0
0
Walbrzych
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Country [159]
0
0
Poland
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State/province [159]
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0
Warszawa
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Country [160]
0
0
Poland
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State/province [160]
0
0
Wroclaw
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Country [161]
0
0
Romania
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State/province [161]
0
0
Bucharest
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Country [162]
0
0
Romania
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State/province [162]
0
0
Craiova
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Country [163]
0
0
Russian Federation
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State/province [163]
0
0
Barnaul
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Country [164]
0
0
Russian Federation
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State/province [164]
0
0
Gatchina
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Country [165]
0
0
Russian Federation
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State/province [165]
0
0
Irkutsk
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Country [166]
0
0
Russian Federation
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State/province [166]
0
0
Kemerovo
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Country [167]
0
0
Russian Federation
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State/province [167]
0
0
Moscow
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Country [168]
0
0
Russian Federation
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State/province [168]
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0
Novosibirsk
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Country [169]
0
0
Russian Federation
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State/province [169]
0
0
Perm
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Country [170]
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0
Russian Federation
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State/province [170]
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0
Ryazan
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Country [171]
0
0
Russian Federation
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State/province [171]
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0
Samara
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Country [172]
0
0
Russian Federation
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State/province [172]
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0
Saratov
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Country [173]
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0
Russian Federation
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State/province [173]
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0
St-Petersburg
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Country [174]
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0
Russian Federation
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State/province [174]
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0
St. Petersburg
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Country [175]
0
0
Russian Federation
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State/province [175]
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0
Tomsk
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Country [176]
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0
Russian Federation
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State/province [176]
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0
Tyumen
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Country [177]
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0
Slovakia
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State/province [177]
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0
Bratislava
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Country [178]
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0
Slovakia
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State/province [178]
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0
Kosice
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Country [179]
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0
Slovakia
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State/province [179]
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0
Martin
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Country [180]
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0
Slovakia
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State/province [180]
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0
Nitra
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Country [181]
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0
South Africa
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State/province [181]
0
0
Bellville
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Country [182]
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0
South Africa
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State/province [182]
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0
Cape Town
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Country [183]
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0
South Africa
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State/province [183]
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0
Kuils River
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Country [184]
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0
South Africa
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State/province [184]
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Parktown West
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Country [185]
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0
South Africa
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State/province [185]
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0
Pinelands
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Country [186]
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0
South Africa
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State/province [186]
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0
Somerset West
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Country [187]
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0
Spain
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State/province [187]
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Barcelona
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Country [188]
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0
Spain
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State/province [188]
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0
Galdakano
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Country [189]
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0
Spain
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State/province [189]
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0
Madrid
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Country [190]
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0
Spain
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State/province [190]
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Majadahonda (Madrid)
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Country [191]
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Spain
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Malaga
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Country [192]
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0
Spain
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State/province [192]
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Marid
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Country [193]
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0
Spain
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0
Santiago De Compostela
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Country [194]
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Spain
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State/province [194]
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Sevilla
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Country [195]
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Sweden
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State/province [195]
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Göteborg
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Country [196]
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0
Sweden
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State/province [196]
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Helsingborg
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Country [197]
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Sweden
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State/province [197]
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Jönköping
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Country [198]
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0
Sweden
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State/province [198]
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Stockholm
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Country [199]
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Sweden
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Västerås
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Country [200]
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Sweden
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Örebro
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Country [201]
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Sweden
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Östersund
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Country [202]
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Taiwan
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Changhua
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Country [203]
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Taiwan
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Hualien
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Country [204]
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Taiwan
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Kaohsiung
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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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Country [207]
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Thailand
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Bangkok
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Country [208]
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Thailand
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Chiangmai
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Country [209]
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Ukraine
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State/province [209]
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Cherkassy
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Country [210]
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Ukraine
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Ivano-Frankivsk
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Country [211]
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Ukraine
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State/province [211]
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Kharkiv
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Country [212]
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Ukraine
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State/province [212]
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Kyiv
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Country [213]
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Ukraine
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State/province [213]
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Lviv
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Country [214]
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Ukraine
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State/province [214]
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Uzhhorod
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Country [215]
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Ukraine
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State/province [215]
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0
Zaporizhzhya
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Country [216]
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United Kingdom
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State/province [216]
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Basingstoke
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Country [217]
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United Kingdom
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State/province [217]
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Bournemouth
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Country [218]
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United Kingdom
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State/province [218]
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Dundee
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Country [219]
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United Kingdom
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Edinburgh
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Country [220]
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United Kingdom
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Newcastle-upon-Tyne
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Country [221]
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United Kingdom
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State/province [221]
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York
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
GlaxoSmithKline
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Address
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Country
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Other collaborator category [1]
0
0
Other
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Name [1]
0
0
The TIMI Study Group
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Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
Losmapimod is a new anti-inflammatory medication which potentially may benefit patients with Acute Coronary Syndrome, (ACS), a condition which includes heart attack. There is a growing understanding that the inflammatory response to ACS is integral to the subsequent evolution of plaque instability. Losmapimod inhibits p38 mitogen activated protein kinase (MAPK), an enzyme which may play a central role in inflammation in the setting of heart attack. Inhibition of p38 MAPK may stabilize atherosclerotic plaques, reduce the risk of subsequent plaque rupture, indirectly improve vascular function and prevent subsequent thrombosis, and thus reduce infarct size and the risk of subsequent cardiac events. This study will test whether losmapimod can safely reduce the risk of a subsequent cardiovascular event (such as death, heart attack, or near heart attack requiring urgent treatment ) when started immediately after ACS (specifically, heart attack). Patients who present with heart attack and qualify for the study will be randomly assigned to receive 3 months treatment with either losmapimod twice daily or placebo, which will be administered in addition to the usual standard of care therapies for heart attack. Following the in-hospital period, subjects will return for outpatient visits at 4 and 12 weeks, as well as a follow up visit at 24 weeks.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02145468
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Trial related presentations / publications
Cavender MA, O'Donoghue ML, Abbate A, Aylward P, Fox KA, Glaser RX, Park JG, Lopez-Sendon J, Steg PG, Sabatine MS, Morrow DA. Inhibition of p38 MAP kinase in patients with ST-elevation myocardial infarction - findings from the LATITUDE-TIMI 60 trial. Am Heart J. 2022 Jan;243:147-157. doi: 10.1016/j.ahj.2021.08.022. Epub 2021 Sep 8. O'Donoghue ML, Glaser R, Cavender MA, Aylward PE, Bonaca MP, Budaj A, Davies RY, Dellborg M, Fox KA, Gutierrez JA, Hamm C, Kiss RG, Kovar F, Kuder JF, Im KA, Lepore JJ, Lopez-Sendon JL, Ophuis TO, Parkhomenko A, Shannon JB, Spinar J, Tanguay JF, Ruda M, Steg PG, Theroux P, Wiviott SD, Laws I, Sabatine MS, Morrow DA; LATITUDE-TIMI 60 Investigators. Effect of Losmapimod on Cardiovascular Outcomes in Patients Hospitalized With Acute Myocardial Infarction: A Randomized Clinical Trial. JAMA. 2016 Apr 19;315(15):1591-9. doi: 10.1001/jama.2016.3609. O'Donoghue ML, Glaser R, Aylward PE, Cavender MA, Crisp A, Fox KA, Laws I, Lopez-Sendon JL, Steg PG, Theroux P, Sabatine MS, Morrow DA. Rationale and design of the LosmApimod To Inhibit p38 MAP kinase as a TherapeUtic target and moDify outcomes after an acute coronary syndromE trial. Am Heart J. 2015 May;169(5):622-630.e6. doi: 10.1016/j.ahj.2015.02.012. Epub 2015 Feb 23.
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Public notes
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Contacts
Principal investigator
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GSK Clinical Trials
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GlaxoSmithKline
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02145468