A Study to Assess the Efficacy and Safety of Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease
ARRIVE
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group Study to Assess the Efficacy (Reduction of Cardiovascular Disease Events) and Safety of 100 mg Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease
2 other identifiers
interventional
12,546
8 countries
466
Brief Summary
The use of acetylsalicylic acid in the primary prevention of cardiovascular events has been extensively studied but to a lesser extent in patients with moderate levels of cardiovascular risk. The current study is designed to prove the efficacy and tolerability of 100 mg enteric-coated Aspirin versus placebo in the prevention of cardiovascular disease (CVD) events, which include fatal and nonfatal myocardial infarction, fatal and nonfatal stroke and CV death, in a population with no history of known CVD who are at moderate risk of major CHD events (approximately 10-20% 10 year CHD risk). This corresponds to a patient population mean 10-year CVD risk of approximately 30%. Subjects are treated in a standard care setting and may receive treatment for the underlying risk factors as defined by the treating physician. Outcome events will be adjudicated by an Endpoint Adjudication Committee and the study will be monitored by an independent Data Safety Monitoring Board.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2007
Longer than P75 for phase_3
466 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 5, 2007
CompletedFirst Submitted
Initial submission to the registry
July 12, 2007
CompletedFirst Posted
Study publicly available on registry
July 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2016
CompletedResults Posted
Study results publicly available
January 8, 2018
CompletedOctober 26, 2018
September 1, 2018
9.4 years
July 12, 2007
November 15, 2017
September 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to the First Occurrence of the Composite Outcome of MI (Myocardial Infarction), Stroke, Cardiovascular Death, UA (Unstable Angina) or TIA (Transient Ischemic Attack)
The primary efficacy endpoint was a composite outcome consisting of the first occurrence of confirmed MI, stroke, cardiovascular death, UA, TIA. The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.
Until follow-up (approximate 6 years)
Secondary Outcomes (5)
Time to the First Occurrence of the Composite Outcome of Cardiovascular Death, MI, or Stroke (Ischemic, Hemorrhagic, or Unknown)
Until follow-up (approximate 6 years)
Time to the First Occurrence of the Individual Components of the Primary: Non-fatal MI, Total MI, Non-fatal Stroke, Total Stroke, Cardiovascular Death, UA and TIA
Until follow-up (approximately 6 years)
Time to All-cause Mortality, the First Occurrence of All Cancers Excluding Non-melanoma Skin Cancer (NMSC) and the First Occurrence of Colon Cancer
Until follow-up (approximately 6 years)
Incidence of All-cause Mortality, All Cancers Excluding Non-melanoma Skin Cancer and Colon Cancer
Until follow-up (approximately 6 years)
Incidence of Confirmed MI, Stroke, Cardiovascular Death, UA, and TIA Separately
Until follow-up (approximately 6 years)
Other Outcomes (3)
Number of Subjects With Adjudicated GI Bleeding by Severity
Until follow-up (approximate 6 years)
Incidence of Composite Outcomes and Non-fatal MI
Until follow-up (approximate 6 years)
Incidence of Composite Outcomes and Individual Outcomes in Per-protocol Population
Until follow-up (approximate 6 years)
Study Arms (2)
Acetylsalicylic acid (Aspirin, BAYE4465)
EXPERIMENTALParticipants received 1 tablet of enteric-coated acetylsalicylic acid \[100 milligram (mg)\] orally once daily.
Placebo
PLACEBO COMPARATORParticipants received 1 tablets of matching placebo orally once daily.
Interventions
100mg enteric coated Aspirin, taken daily
Eligibility Criteria
You may qualify if:
- Males aged 55 years and above with 2 to 4 risk factors. Male Risk Factors:
- Elevated cholesterol (Tchol\>200 mg/dL or LDL\>130 mg/dL; as measured at screening) irrespective of current treatment
- Current smoking: defined as any cigarette smoking in the past 12 months
- Low HDL cholesterol (HDL\<40 mg/dL; as measured at screening)
- Elevated blood pressure (SBP\>140 mmHg; as measured at screening)
- Currently on any medication to treat high blood pressure
- Positive family history of early CHD (a first-degree relative \[father, mother, brother, sister, son, daughter\] suffered a heart attack \[myocardial infarction\] before the age of 60 years)
- Females aged 60 and above with 3 or more risk factors. Female Risk Factors:
- Elevated cholesterol (Tchol\>240 mg/dL or LDL\>160 mg/dL; as measured at screening) irrespective of current treatment
- Current smoking: defined as any cigarette smoking in the past 12 months
- Low HDL cholesterol (HDL\<40 mg/dL; as measured at screening)
- Elevated blood pressure (SBP\>140 mmHg; as measured at screening)
- Currently on any medication to treat high blood pressure
- Positive family history of early CHD (a first-degree relative \[father, mother, brother, sister, son, daughter\] suffered a heart attack \[myocardial infarction\] before the age of 60 years)
- An understanding and willingness to comply with trial procedures and has given written informed consent to participate in the trial
You may not qualify if:
- History of a documented vascular event, such as MI, stroke, coronary artery angioplasty or stenting, coronary artery bypass graft, relevant arrhythmias, or congestive heart failure or vascular intervention
- Patients who are at higher than moderate risk on the basis of their diabetes status, other factors known to the investigator, or the currently used national risk score
- Known contraindications to the study drug, e.g. hypersensitivity to acetylsalicylic acid
- Recent (in the past year) history of gastrointestinal or genitourinary bleeding or other bleeding disorders
- Active diagnosed and documented reflux esophagitis
- Patients presenting with any medical condition, or psychiatric or substance abuse disorder, that, in the opinion of the investigator, is likely to affect the patient's ability to complete the study or precludes the patient's participation in the study
- Lactating women or women of childbearing potential
- Severe liver disease or damage based on the clinical judgment of the investigator
- Severe renal disease or damage based on the clinical judgement of the investigator
- A definite indication for acetylsalicylic acid therapy, other antiplatelet drug, or anticoagulant in the opinion of the physician
- A history of asthma induced by administration of salicylates or substances with a similar action, notably NSAIDS
- Chronic, frequent (\> 5 days/month) use of NSAIDs (including aspirin, or aspirin containing products), COX-2 inhibitors or metamizole
- Current participation in any other trials involving investigational products within 30 days prior to the Screening Visit
- Current use of an anticoagulant medication
- Sitting systolic blood pressure greater than 170 mmHg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (466)
Unknown Facility
Birmingham, Alabama, 39294, United States
Unknown Facility
Graysville, Alabama, 35073, United States
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Pell City, Alabama, 35125, United States
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Phoenix, Arizona, 85051, United States
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Scottsdale, Arizona, 85260, United States
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Tucson, Arizona, 85712, United States
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Hot Springs, Arkansas, 71913-4457, United States
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Fremont, California, 94536-3702, United States
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Huntington Park, California, 90255, United States
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Los Angeles, California, 90025, United States
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Rancho Cucamonga, California, 91730, United States
Unknown Facility
Rolling Hills Estates, California, 90274, United States
Helping Hands Clinical Trials
Santa Ana, California, 92704, United States
Unknown Facility
Newark, Delaware, 19702, United States
Medical Research Trust
Boynton Beach, Florida, 33426, United States
Unknown Facility
Gainesville, Florida, 32601, United States
Unknown Facility
Hialeah, Florida, 33016, United States
Medical Research Centers of South Florida, Inc.
Hollywood, Florida, 33021, United States
Office of Dr.Larry Levinson, DO
Hollywood, Florida, 33021, United States
Unknown Facility
Kissimmee, Florida, 34741, United States
Unknown Facility
Largo, Florida, 33770, United States
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Marianna, Florida, 32446-2120, United States
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Panama City, Florida, 32401, United States
Tallahassee Memorial Family
Quincy, Florida, 32351, United States
Unknown Facility
Tampa, Florida, 33614, United States
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Atlanta, Georgia, 30318, United States
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Chicago, Illinois, 60628, United States
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Chicago, Illinois, 60631-1958, United States
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Lockport, Illinois, 60491, United States
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Vernon Hills, Illinois, 60061, United States
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Evansville, Indiana, 47713, United States
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Fort Wayne, Indiana, 46804, United States
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Lebanon, Kentucky, 40033, United States
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Prince Frederick, Maryland, 20678, United States
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Bridgman, Michigan, 49106, United States
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Cadillac, Michigan, 49601, United States
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Interlochen, Michigan, 49643-9264, United States
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Troy, Michigan, 48085, United States
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Port Gibson, Mississippi, 39150, United States
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Florissant, Missouri, 63031, United States
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Broken Bow, Nebraska, 68822, United States
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Omaha, Nebraska, 68114, United States
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Omaha, Nebraska, 68116-2004, United States
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Belvidere, New Jersey, 07823, United States
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Cherry Hill, New Jersey, 08084, United States
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Clifton, New Jersey, 07013, United States
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Hainesport, New Jersey, 08036, United States
Unknown Facility
Jersey City, New Jersey, 07306, United States
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Lawrenceville, New Jersey, 08648, United States
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Linden, New Jersey, 07036, United States
PharmaTrials, Inc.
Perth Amboy, New Jersey, 08861, United States
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Stratford, New Jersey, 08084, United States
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Burlington, North Carolina, 27215, United States
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Columbus, North Carolina, 28722, United States
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Greensboro, North Carolina, 27401, United States
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Raleigh, North Carolina, 27609, United States
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Carlisle, Ohio, 45005-3320, United States
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Marion, Ohio, 43302, United States
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Montgomery, Ohio, 45242, United States
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Perrysburg, Ohio, 43551, United States
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Doylestown, Pennsylvania, 18901, United States
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Duncansville, Pennsylvania, 16635, United States
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Sellersville, Pennsylvania, 18960, United States
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Taylors, South Carolina, 29687, United States
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Daingerfield, Texas, 75638, United States
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McKinney, Texas, 75069, United States
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Rockwall, Texas, 75032, United States
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San Antonio, Texas, 78205-1116, United States
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San Marcos, Texas, 78666, United States
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Stephenville, Texas, 76401, United States
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Sugar Land, Texas, 77478, United States
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Honaker, Virginia, 24260, United States
Merit Medical Group, Inc.
Richlands, Virginia, 24641-2067, United States
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Benningen am Neckar, Baden-Wurttemberg, 71726, Germany
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Deggingen, Baden-Wurttemberg, 73326, Germany
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Dossenheim, Baden-Wurttemberg, 69221, Germany
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Ettlingen, Baden-Wurttemberg, 78275, Germany
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Graben-Neudorf, Baden-Wurttemberg, 76676, Germany
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Heilbronn, Baden-Wurttemberg, 74080, Germany
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Hockenheim, Baden-Wurttemberg, 68766, Germany
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Ludwigsburg, Baden-Wurttemberg, 71640, Germany
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Schwetzingen, Baden-Wurttemberg, 68723, Germany
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Sinzheim, Baden-Wurttemberg, 76547, Germany
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Stockach, Baden-Wurttemberg, 78333, Germany
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Stuttgart, Baden-Wurttemberg, 70378, Germany
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Trossingen, Baden-Wurttemberg, 78647, Germany
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Weinheim, Baden-Wurttemberg, 69469, Germany
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Arzberg, Bavaria, 95659, Germany
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Bergrheinfeld, Bavaria, 97493, Germany
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Dinkelsbühl, Bavaria, 91550, Germany
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Gars, Bavaria, 83536, Germany
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Hohenau, Bavaria, 94545, Germany
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Künzing, Bavaria, 94550, Germany
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München, Bavaria, 80336, Germany
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Oberaurach, Bavaria, 97514, Germany
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Sand Am Main, Bavaria, 97522, Germany
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Schrobenhausen, Bavaria, 86529, Germany
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Spalt, Bavaria, 91174, Germany
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Straßkirchen, Bavaria, 94342, Germany
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Sulzbach-Rosenberg, Bavaria, 92237, Germany
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Ursensollen, Bavaria, 92289, Germany
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Cottbus, Brandenburg, 03046, Germany
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Elsterwerda, Brandenburg, 04910, Germany
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Gransee, Brandenburg, 16775, Germany
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Ketzin, Brandenburg, 14669, Germany
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Potsdam, Brandenburg, 14778, Germany
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Frankfurt am Main, Hesse, 60599, Germany
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Frankfurt am Main, Hesse, 65929, Germany
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Hanau, Hesse, 63450, Germany
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Kelkheim, Hesse, 65779, Germany
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Rotenburg an der Fulda, Hesse, 36199, Germany
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Wetter, Hesse, 35083, Germany
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Aurich, Lower Saxony, 26603, Germany
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Bockenem, Lower Saxony, 31167, Germany
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Braunschweig, Lower Saxony, 38100, Germany
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Horneburg, Lower Saxony, 21640, Germany
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Jühnde, Lower Saxony, 37127, Germany
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Loxstedt, Lower Saxony, 27612, Germany
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Nienburg, Lower Saxony, 31582, Germany
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Northeim, Lower Saxony, 37154, Germany
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Papenburg, Lower Saxony, 26871, Germany
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Stuhr, Lower Saxony, 28816, Germany
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Wardenburg, Lower Saxony, 26203, Germany
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Weyhe, Lower Saxony, 28844, Germany
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Winsen, Lower Saxony, 21423, Germany
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Aachen, North Rhine-Westphalia, 52074, Germany
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Aachen, North Rhine-Westphalia, 52080, Germany
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Arnsberg, North Rhine-Westphalia, 59757, Germany
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Bad Lippspringe, North Rhine-Westphalia, 33175, Germany
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Bad Salzuflen, North Rhine-Westphalia, 32105, Germany
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Bad Salzuflen, North Rhine-Westphalia, 32108, Germany
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Bad Sassendorf, North Rhine-Westphalia, 59505, Germany
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Bergkamen, North Rhine-Westphalia, 59192, Germany
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Bochum, North Rhine-Westphalia, 44797, Germany
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Cologne, North Rhine-Westphalia, 51069, Germany
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Dortmund, North Rhine-Westphalia, 44139, Germany
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Dortmund, North Rhine-Westphalia, 44328, Germany
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Dortmund, North Rhine-Westphalia, 44339, Germany
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Duisburg, North Rhine-Westphalia, 47199, Germany
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Essen, North Rhine-Westphalia, 45130, Germany
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Essen, North Rhine-Westphalia, 45136, Germany
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Essen, North Rhine-Westphalia, 45276, Germany
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Essen, North Rhine-Westphalia, 45355, Germany
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Essen, North Rhine-Westphalia, 45359, Germany
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Freudenberg, North Rhine-Westphalia, 57258, Germany
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Greven, North Rhine-Westphalia, 48268, Germany
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Hamm, North Rhine-Westphalia, 59069, Germany
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Hünxe, North Rhine-Westphalia, 46569, Germany
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Kamp-Lintfort, North Rhine-Westphalia, 47475, Germany
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Krefeld, North Rhine-Westphalia, 47798, Germany
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Langenfeld, North Rhine-Westphalia, 40764, Germany
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Lienen, North Rhine-Westphalia, 49536, Germany
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Lippetal, North Rhine-Westphalia, 59510, Germany
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Löhne, North Rhine-Westphalia, 32584, Germany
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Marl, North Rhine-Westphalia, 45770, Germany
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Münster, North Rhine-Westphalia, 48167, Germany
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Netphen, North Rhine-Westphalia, 57250, Germany
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Porta Westfalica, North Rhine-Westphalia, 32457, Germany
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Remscheid, North Rhine-Westphalia, 42897, Germany
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Siegen, North Rhine-Westphalia, 57072, Germany
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Viersen, North Rhine-Westphalia, 41751, Germany
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Welver, North Rhine-Westphalia, 59514, Germany
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Wetter, North Rhine-Westphalia, 58300, Germany
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Witten, North Rhine-Westphalia, 58455, Germany
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Kallstadt, Rhineland-Palatinate, 67169, Germany
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Ludwigshafen am Rhein, Rhineland-Palatinate, 67063, Germany
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Mainz, Rhineland-Palatinate, 55116, Germany
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Mainz, Rhineland-Palatinate, 55127, Germany
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Nassau, Rhineland-Palatinate, 56377, Germany
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Rhaunen, Rhineland-Palatinate, 55624, Germany
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Speyer, Rhineland-Palatinate, 67346, Germany
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Beucha, Saxony, 04824, Germany
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Borna, Saxony, 04552, Germany
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Delitzsch, Saxony, 04509, Germany
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Dresden, Saxony, 01069, Germany
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Dresden, Saxony, 01127, Germany
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Dresden, Saxony, 01277, Germany
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Leipzig, Saxony, 04103, Germany
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Leipzig, Saxony, 04249, Germany
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Markkleeberg, Saxony, 04416, Germany
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Meissen, Saxony, 01662, Germany
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Oberwiesenthal, Saxony, 09484, Germany
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Riesa, Saxony, 01587, Germany
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Wermsdorf, Saxony, 04779, Germany
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Bitterfeld-Wolfen, Saxony-Anhalt, 06749, Germany
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Halle, Saxony-Anhalt, 06124, Germany
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Magdeburg, Saxony-Anhalt, 39104, Germany
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Bad Bramstedt, Schleswig-Holstein, 24576, Germany
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Reinfeld, Schleswig-Holstein, 23858, Germany
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Apolda, Thuringia, 99510, Germany
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Blankenhain, Thuringia, 99444, Germany
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Grimma, Thuringia, 04668, Germany
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Berlin, 10249, Germany
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Berlin, 10407, Germany
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Berlin, 12099, Germany
Unknown Facility
Berlin, 13055, Germany
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Berlin, 13057, Germany
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Berlin, 13405, Germany
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Berlin, 13467, Germany
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Berlin, 14050, Germany
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Daaden, 57567, Germany
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Hamburg, 22041, Germany
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Hamburg, 22143, Germany
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Hamburg, 22177, Germany
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Hamburg, 22299, Germany
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Hamburg, 22335, Germany
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Rehburg-Loccum, 31547, Germany
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Riede, 27339, Germany
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Thedinghausen, 27321, Germany
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Bishopstown, Cork, Ireland
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Kilmallock, Limerick, Ireland
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Rathkeale, Limerick, Ireland
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Tallow, Waterford, Ireland
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Enniscorthy, Wexford, Ireland
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Gorey, Wexford, Ireland
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Bray, Wicklow, Ireland
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Cork, Ireland
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Dublin, 2, Ireland
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Chieti, Abruzzo, 66100, Italy
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Foggia, Apulia, 71100, Italy
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Amandola, Ascoli Piceno, 63021, Italy
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Napoli, Campania, 80131, Italy
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Reggio Emilia, Emilia-Romagna, 42019, Italy
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Chiavari, Genova, 16043, Italy
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Rome, Lazio, 00157, Italy
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Rome, Lazio, 00161, Italy
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Como, Lombardy, 22066, Italy
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Varese, Lombardy, 21100, Italy
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Legnano, Milano, 20025, Italy
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Novara, Piedmont, 28100, Italy
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Turin, Piedmont, 10023, Italy
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Catania, Sicily, 95124, Italy
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Chieri, Torino, 10023, Italy
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Moncalieri, Torino, 10024, Italy
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Grosseto, Tuscany, 58100, Italy
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Asti, 14100, Italy
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Bergamo, 24128, Italy
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Reggio Emilia, 42123, Italy
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Bialystok, 15-183, Poland
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Bydgoszcz, 85-863, Poland
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Bydgoszcz, Poland
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Chrzanów, Poland
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Czechowice-Dziedzice, Poland
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Elblag, 82-300, Poland
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Gdansk, 80-286, Poland
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Gdansk, 80-461, Poland
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Gdansk, 80-822, Poland
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Gdynia, 81-317, Poland
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Gliwice, 44-109, Poland
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Grodzisk Mazowiecki, 05-825, Poland
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Katowice, 40-226, Poland
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Katowice, 40-752, Poland
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Krakow, 30-424, Poland
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Krakow, 31-011, Poland
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Krakow, 31-156, Poland
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Krakow, 31-567, Poland
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Krakow, 31-637, Poland
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Krakow, Poland
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Kutno, 99-300, Poland
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Linia, 84-223, Poland
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Lodz, Poland
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Lublin, 20-044, Poland
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Lublin, 20-258, Poland
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Lublin, Poland
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Malbork, 82-200, Poland
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Małaszewicze, Poland
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Nakło nad Notecią, 98-100, Poland
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Olkusz, Poland
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Ostrów Wielkopolski, 63-400, Poland
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Poznan, 60-539, Poland
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Przeworsk, 37-200, Poland
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Radom, 26-600, Poland
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Skierniewice, 96-100, Poland
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Skierniewice, Poland
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Sobótka, Poland
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Sopot, 81-746, Poland
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Szczyrk, 43-370, Poland
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Warsaw, 01-192, Poland
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Warsaw, 02-507, Poland
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Warsaw, 02-796, Poland
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Wąbrzeźno, Poland
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Wejherowo, Poland
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Wola, Poland
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Wroclaw, 50-127, Poland
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Wroclaw, 51-112, Poland
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Włocławek, Poland
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Zabrze, Poland
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Łańcut, Poland
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Guaynabo, 00968, Puerto Rico
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Manatí, 00674, Puerto Rico
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Orocovis, 00720, Puerto Rico
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San Juan, 00918, Puerto Rico
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Trujilo Alto, 00976, Puerto Rico
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Sobrado Dos Monxes, A Coruña, 15813, Spain
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La Roda, Albacete, 06230, Spain
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Benidorm, Alicante, 03503, Spain
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Elche, Alicante, Spain
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Petrel, Alicante, 03610, Spain
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Xixona, Alicante, 03100, Spain
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Vic (Barcelona), Catalonia, 08500, Spain
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Begonte, Lugo, 27373, Spain
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Viveiro, Lugo, 27850, Spain
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Espinardo, Murcia, 30100, Spain
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Ourense, Ourense, 32003, Spain
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Oviedo, Principality of Asturias, 33009, Spain
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Oviedo, Principality of Asturias, 33013, Spain
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Posada de Llanes, Principality of Asturias, 33594, Spain
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Gümar, Santa Cruz De Tenerife, 38591, Spain
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La Victoria, Santa Cruz De Tenerife, 38380, Spain
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Alcover, Tarragona, 43460, Spain
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Albacete, 2260, Spain
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Alicante, 03007, Spain
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Badajoz, 06140, Spain
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Barcelona, 08017, Spain
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Barcelona, 08023, Spain
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Barcelona, 08025, Spain
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Huelva, 21003, Spain
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León, 24001, Spain
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León, Spain
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Lugo, 27770, Spain
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Madrid, 28003, Spain
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Madrid, 28030, Spain
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Madrid, 28032, Spain
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Murcia, 300005, Spain
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Murcia, 30007, Spain
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Murcia, 30008, Spain
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Salamanca, 27-31, Spain
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Santander, 39009, Spain
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Valladolid, 47007, Spain
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Ballymena, Antrim, BT42 4JP, United Kingdom
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Ballymena, Antrim, BT43 6JD, United Kingdom
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Crumlin, Antrim, BT29 4LP, United Kingdom
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Newtonabbey, Antrim, BT37 9QU, United Kingdom
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Craigavon, Armagh, BT67 0LQ, United Kingdom
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Bath, Avon, BA2 3HT, United Kingdom
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Bath, Avon, BA2 4BY, United Kingdom
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Radstock, Avon, BA3 2UH, United Kingdom
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Irvine, Ayrshire, KA12 0AY, United Kingdom
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Luton, Bedfordshire, LU2 9SB, United Kingdom
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Slough, Berkshire, SL1 1TT, United Kingdom
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Ely, Cambridgeshire, CB7 4HF, United Kingdom
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Ely, Cambridgeshire, CB7 5SQ, United Kingdom
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Peterborough, Cambridgeshire, PE2 5GP, United Kingdom
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Peterborough, Cambridgeshire, PE7 3JL, United Kingdom
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Sandbach, Cheshire, CW11 1EQ, United Kingdom
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Boscastle, Cornwall, PL35 0BG, United Kingdom
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Fowey, Cornwall, PL23 1DT, United Kingdom
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Penzance, Cornwall, TR18 4EL, United Kingdom
Unknown Facility
Penzance, Cornwall, TR18 4JH, United Kingdom
Unknown Facility
Penzance, Cornwall, TR19 7HX, United Kingdom
Unknown Facility
Saltash, Cornwall, PL12 6DL, United Kingdom
Unknown Facility
St Austell, Cornwall, PL26 7RL, United Kingdom
Unknown Facility
Chesterfield, Derbyshire, S40 4AA, United Kingdom
Unknown Facility
Dronfield, Derbyshire, S18 8QY, United Kingdom
Unknown Facility
Plymouth, Devon, PL6 7TH, United Kingdom
Unknown Facility
Carryduff, Down, BT8 8HR, United Kingdom
Unknown Facility
Annan, Dumfries And Galloway, DG12 6BG, United Kingdom
Unknown Facility
Bishop Auckland, Durham, DL14 6AB, United Kingdom
Unknown Facility
Darlington, Durham, DL2 1AA, United Kingdom
Unknown Facility
Darlington, Durham, DL3 7JR, United Kingdom
Unknown Facility
Darlington, Durham, DL3 8SQ, United Kingdom
Unknown Facility
Leigh-on-Sea, Essex, SS9 2SQ, United Kingdom
Unknown Facility
Tiptree, Essex, CO5 0HB, United Kingdom
Unknown Facility
High Valleyfield, Fife, KY12 8SJ, United Kingdom
Unknown Facility
Glasgow, Glasgow City, G20 0XA, United Kingdom
Unknown Facility
Bangor, Gwynedd, BT19 1PP, United Kingdom
Unknown Facility
Hitchin, Hertfordshire, SG4 9TH, United Kingdom
Unknown Facility
Letchworth Garden City, Hertfordshire, SG6 4TS, United Kingdom
Unknown Facility
Letchworth Garden City, Hertfordshire, SG6 4UB, United Kingdom
Unknown Facility
Canterbury, Kent, CT1 3HX, United Kingdom
Unknown Facility
Chestfield, Kent, CT5 3QU, United Kingdom
Unknown Facility
Whitstable, Kent, CT5 3SE, United Kingdom
Unknown Facility
Carstairs, Lanarkshire, ML11 8QD, United Kingdom
Unknown Facility
Coatbridge, Lanarkshire, ML5 3AP, United Kingdom
Unknown Facility
Forth, Lanarkshire, ML1 8AJ, United Kingdom
Unknown Facility
Blackpool, Lancashire, FY3 7EN, United Kingdom
Unknown Facility
Blackpool, Lancashire, FY4 3AD, United Kingdom
Unknown Facility
Bolton, Lancashire, BL3 6TL, United Kingdom
Unknown Facility
Bolton, Lancashire, BL5 3UB, United Kingdom
Unknown Facility
Hinckley, Leicestershire, LE10 2SE, United Kingdom
Unknown Facility
Wells-next-the-Sea, Norfolk, NR23 1JP, United Kingdom
Unknown Facility
Wymondham, Norfolk, NR18 0RF, United Kingdom
Unknown Facility
Antrim, North Ireland, BT36 4PP, United Kingdom
Unknown Facility
Antrim, North Ireland, BT37 9QN, United Kingdom
Unknown Facility
Antrim, North Ireland, BT41 3AE, United Kingdom
Unknown Facility
Tyrone, North Ireland, BT80 8BG, United Kingdom
Unknown Facility
Wellingborough, Northamptonshire, NN8 4RW, United Kingdom
Unknown Facility
Chipping Norton, Oxfordshire, OX75FA, United Kingdom
Unknown Facility
Eccles, Sheffield, S35 9XQ, United Kingdom
Unknown Facility
Bath, Somerset, BA1 2SR, United Kingdom
Unknown Facility
Barry, SOuth Glamorgan, CF63 4HP, United Kingdom
Unknown Facility
Doncaster, South Yorkshire, DN1 2ET, United Kingdom
Unknown Facility
Sheffield, South Yorkshire, S7 2DW, United Kingdom
Unknown Facility
Chapelhall, Stratchclyde, ML6 8SR, United Kingdom
Unknown Facility
Glasgow, Stratchclyde, G45 9AW, United Kingdom
Unknown Facility
Hamilton, Stratchclyde, ML3 ODR, United Kingdom
Unknown Facility
Johnstone, Stratchclyde, PA5 8EY, United Kingdom
Unknown Facility
Motherwell, Stratchclyde, ML1 3JX, United Kingdom
Unknown Facility
Bury Saint Edmonds, Suffolk, IP30 9QU, United Kingdom
Unknown Facility
Bury St Edmunds, Suffolk, IP31 2HD, United Kingdom
Unknown Facility
Bury St Edmunds, Suffolk, IP32 7EW, United Kingdom
Unknown Facility
Hadleigh, Suffolk, IP7 5DN, United Kingdom
Unknown Facility
Stowmarket, Suffolk, IP14 1NL, United Kingdom
Unknown Facility
Addlestone, Surrey, KT15 2BH, United Kingdom
Unknown Facility
East Horsley, Surrey, KT24 6QT, United Kingdom
Unknown Facility
Worcester Park, Surrey, KT4 7BX, United Kingdom
Unknown Facility
Newcastle upon Tyne, Tyne and Wear, NE15 6TQ, United Kingdom
Unknown Facility
Coventry, Warwickshire, CV6 4DD, United Kingdom
Unknown Facility
Coventry, Warwickshire, CV7 8LA, United Kingdom
Unknown Facility
Rugby, Warwickshire, CV21 3SP, United Kingdom
Unknown Facility
Coventry, West Midlands, CV9 1EU, United Kingdom
Unknown Facility
Brighton, West Sussex, BN2 1ES, United Kingdom
Unknown Facility
Crawley, West Sussex, RH10 1LL, United Kingdom
Unknown Facility
Crawley, West Sussex, RH10 7DX, United Kingdom
Unknown Facility
Leeds, West Yorkshire, LS10 3NB, United Kingdom
Unknown Facility
Leeds, West Yorkshire, LS118BS, United Kingdom
Unknown Facility
Leeds, West Yorkshire, LS15 9JH, United Kingdom
Unknown Facility
Leeds, West Yorkshire, LS25 1AN, United Kingdom
Unknown Facility
Leeds, West Yorkshire, LS25 1HB, United Kingdom
Unknown Facility
Leeds, West Yorkshire, LS25 7AB, United Kingdom
Unknown Facility
Leeds, West Yorkshire, LS26 8SZ, United Kingdom
Unknown Facility
Leeds, West Yorkshire, LS9 9EF, United Kingdom
Unknown Facility
Bradford-on-Avon, Wiltshire, BA15 1DQ, United Kingdom
Unknown Facility
Chippenham, Wiltshire, SN14 6GT, United Kingdom
Unknown Facility
Chippenham, Wiltshire, SN15 2SB, United Kingdom
Unknown Facility
Corsham, Wiltshire, SN3 9DL, United Kingdom
Unknown Facility
Trowbridge, Wiltshire, BA14 9AR, United Kingdom
Unknown Facility
Westbury, Wiltshire, BA13 3FQ, United Kingdom
Unknown Facility
Aberdeen, AB25 2ZD, United Kingdom
Unknown Facility
Airedire, ML66DB, United Kingdom
Unknown Facility
Antrim, BT38 9TG, United Kingdom
Unknown Facility
Bath, BA11 2FH, United Kingdom
Unknown Facility
Bath, BA2 4JT, United Kingdom
Unknown Facility
Belfast, BT1 2JR, United Kingdom
Unknown Facility
Belfast, BT12 5EY, United Kingdom
Unknown Facility
Belfast, BT12 5LT, United Kingdom
Unknown Facility
Belfast, BT13 3BW, United Kingdom
Unknown Facility
Belfast, BT15 2GE, United Kingdom
Unknown Facility
Belfast, BT5 7BP, United Kingdom
Unknown Facility
Belfast, BT8 6GR, United Kingdom
Unknown Facility
Belfast, United Kingdom
Unknown Facility
Bellshill, ML4 1PS, United Kingdom
Unknown Facility
Blantyre, G72 0BS, United Kingdom
Unknown Facility
Cardiff, CF5 4AD, United Kingdom
Unknown Facility
Coatrbridge, ML5 3BJ, United Kingdom
Unknown Facility
Crossgar, BT30 9JU, United Kingdom
Unknown Facility
Doncaster, DN1 2EU, United Kingdom
Unknown Facility
Dundee, DD19SY, United Kingdom
Unknown Facility
Glasgow, G21 1TR, United Kingdom
Unknown Facility
Glasgow, G5 0BQ, United Kingdom
Unknown Facility
Glasgow, G52 3QN, United Kingdom
Unknown Facility
Glasgow, G67 1BJ, United Kingdom
Unknown Facility
Hamilton, ML3 7EN, United Kingdom
Unknown Facility
Hamilton, ML3 8AA, United Kingdom
Unknown Facility
Inverness, IV2 4AG, United Kingdom
Unknown Facility
Ipswich, IP4 2PU, United Kingdom
Unknown Facility
Lockerbie, D11 2BJ, United Kingdom
Unknown Facility
London, SW12 8EU, United Kingdom
Unknown Facility
Manchester, M13 9WL, United Kingdom
Unknown Facility
New Stevenson, ML1 4LT, United Kingdom
Unknown Facility
Paisley, United Kingdom
Unknown Facility
Peterborough, PE8 6PL, United Kingdom
Unknown Facility
Thornhill, DG3 5AA, United Kingdom
Unknown Facility
Watford, WD25 7NL, United Kingdom
Unknown Facility
Wishaw, ML2 7BQ, United Kingdom
Unknown Facility
Witley Bay, NE26 1NA, United Kingdom
Related Publications (1)
Gaziano JM, Brotons C, Coppolecchia R, Cricelli C, Darius H, Gorelick PB, Howard G, Pearson TA, Rothwell PM, Ruilope LM, Tendera M, Tognoni G; ARRIVE Executive Committee. Use of aspirin to reduce risk of initial vascular events in patients at moderate risk of cardiovascular disease (ARRIVE): a randomised, double-blind, placebo-controlled trial. Lancet. 2018 Sep 22;392(10152):1036-1046. doi: 10.1016/S0140-6736(18)31924-X. Epub 2018 Aug 26.
PMID: 30158069RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The reported analyses are limited to endpoint events that met strict criteria. Further blinded review of events is ongoing to identify endpoints based on pragmatic criteria. Interpretations for clinical decision making should await future reporting.
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2007
First Posted
July 13, 2007
Study Start
July 5, 2007
Primary Completion
November 15, 2016
Study Completion
November 15, 2016
Last Updated
October 26, 2018
Results First Posted
January 8, 2018
Record last verified: 2018-09