Cardiovascular Outcomes Study of Alogliptin in Patients With Type 2 Diabetes and Acute Coronary Syndrome
EXAMINE
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment With Alogliptin in Addition to Standard of Care in Subjects With Type 2 Diabetes and Acute Coronary Syndrome
8 other identifiers
interventional
5,380
48 countries
896
Brief Summary
The purpose of this study is to evaluate the cardiovascular outcomes of alogliptin, once daily (QD), compared with placebo, in addition to standard of care, in patients with type 2 diabetes mellitus and acute coronary syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 diabetes-mellitus-type-2
Started Sep 2009
Longer than P75 for phase_3 diabetes-mellitus-type-2
896 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
First Submitted
Initial submission to the registry
August 28, 2009
CompletedFirst Posted
Study publicly available on registry
August 31, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
April 15, 2014
CompletedMay 2, 2014
April 1, 2014
3.6 years
August 28, 2009
March 8, 2014
April 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Primary Major Adverse Cardiac Events (MACE)
Primary Major Adverse Cardiac Events were defined as a composite of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke; these events were adjudicated by an independent cardiovascular endpoints committee.
From randomization until the adjudication cut-off date of May 31 2013 (maximum time on study was 41 months).
Secondary Outcomes (1)
Percentage of Participants With Secondary Major Adverse Cardiac Events (MACE)
From randomization until the adjudication cut-of date of May 31 2013 (maximum time on study was 41 months).
Study Arms (2)
Placebo
EXPERIMENTALAlogliptin placebo matching tablets, orally, once daily. Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines.
Alogliptin
EXPERIMENTALAlogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and \<60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR \<30 mL/min). Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of type 2 diabetes mellitus
- Is receiving monotherapy or combination antidiabetic therapy with a glycosylated hemoglobin level between 6.5% and 11.0%, inclusive, at Screening (between 7.0 and 11.0%, inclusive, if the participant's antidiabetic regimen includes insulin)
- Diagnosis of acute coronary syndrome within 15 to 90 days prior to randomization.
You may not qualify if:
- Signs of type 1 diabetes mellitus
- Currently receiving a glucagon-like peptide-1 analogue for glycemic control of type 2 diabetes mellitus at Screening
- Received a dipeptidyl peptidase-4 inhibitor for either more than 14 days total or within the 3 months prior to Screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (908)
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Birmingham, Alabama, United States
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Dothan, Alabama, United States
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Mobile, Alabama, United States
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Muscle Shoals, Alabama, United States
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Cottonwood, Arizona, United States
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Goodyear, Arizona, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Malvern, Arkansas, United States
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Searcy, Arkansas, United States
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White Hall, Arkansas, United States
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Alameda, California, United States
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Aliso Viejo, California, United States
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Anaheim, California, United States
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Bell Gardens, California, United States
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Beverly Hills, California, United States
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Chula Vista, California, United States
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Corona, California, United States
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Downey, California, United States
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Escondido, California, United States
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Fullerton, California, United States
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Huntington Beach, California, United States
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Huntington Park, California, United States
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Inglewood, California, United States
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La Mirada, California, United States
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Lakewood, California, United States
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Lancaster, California, United States
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Lomita, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Los Gatos, California, United States
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Merced, California, United States
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Newport Beach, California, United States
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Northridge, California, United States
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Oakland, California, United States
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Palm Springs, California, United States
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Pomona, California, United States
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San Diego, California, United States
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San Dimas, California, United States
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Santa Ana, California, United States
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Santa Clarita, California, United States
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Stockton, California, United States
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Tarzana, California, United States
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Torrence, California, United States
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Van Nuys, California, United States
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Ventura, California, United States
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Aurora, Colorado, United States
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Colorado Springs, Colorado, United States
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Bridgeport, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Boca Raton, Florida, United States
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Brandon, Florida, United States
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Davie, Florida, United States
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Daytona Beach, Florida, United States
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Delray Beach, Florida, United States
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Doral, Florida, United States
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Fleming Island, Florida, United States
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Fort Lauderdale, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Kissimmee, Florida, United States
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Lake Mary, Florida, United States
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Largo, Florida, United States
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Melbourne, Florida, United States
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Miami, Florida, United States
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Miami Lakes, Florida, United States
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Naples, Florida, United States
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New Smyrna Beach, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Palm Harbor, Florida, United States
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Panama City, Florida, United States
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Pembroke Pines, Florida, United States
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Pensacola, Florida, United States
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Saint Cloud, Florida, United States
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Sarasota, Florida, United States
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St. Petersburg, Florida, United States
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Stuart, Florida, United States
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Tampa, Florida, United States
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Vero Beach, Florida, United States
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Atlanta, Georgia, United States
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Cartersville, Georgia, United States
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Conyers, Georgia, United States
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Dunwoody, Georgia, United States
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Marietta, Georgia, United States
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Savannah, Georgia, United States
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Tucker, Georgia, United States
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Waycross, Georgia, United States
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Nampa, Idaho, United States
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Aurora, Illinois, United States
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Boilingbrook, Illinois, United States
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Bolingbrook, Illinois, United States
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Burr Ridge, Illinois, United States
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Chicago, Illinois, United States
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Jerseyville, Illinois, United States
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Melrose Park, Illinois, United States
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Moline, Illinois, United States
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Peoria, Illinois, United States
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Quincy, Illinois, United States
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Springfield, Illinois, United States
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Elkhart, Indiana, United States
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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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Muncie, Indiana, United States
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Munster, Indiana, United States
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New Albany, Indiana, United States
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Valparaiso, Indiana, United States
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Council Bluffs, Iowa, United States
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Shawnee Mission, Kansas, United States
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Elizabethtown, Kentucky, United States
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Lexington, Kentucky, United States
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Madisonville, Kentucky, United States
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Owensboro, Kentucky, United States
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Alexandria, Louisiana, United States
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Houma, Louisiana, United States
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Lafayette, Louisiana, United States
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Natchitoches, Louisiana, United States
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New Orleans, Louisiana, United States
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Slidell, Louisiana, United States
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Biddeford, Maine, United States
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Rockport, Maine, United States
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Annapolis, Maryland, United States
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Baltimore, Maryland, United States
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Oxon Hill, Maryland, United States
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Rockville, Maryland, United States
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Boston, Massachusetts, United States
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Brockton, Massachusetts, United States
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Fall River, Massachusetts, United States
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Alpena, Michigan, United States
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Bridgman, Michigan, United States
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Dearborn, Michigan, United States
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Detroit, Michigan, United States
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Kalamazoo, Michigan, United States
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Lapeer, Michigan, United States
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Livonia, Michigan, United States
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Midland, Michigan, United States
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Muskegon, Michigan, United States
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Saginaw, Michigan, United States
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Troy, Michigan, United States
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Warren, Michigan, United States
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Waterford, Michigan, United States
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Ypsilanti, Michigan, United States
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Duluth, Minnesota, United States
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Minneapolis, Minnesota, United States
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Rochester, Minnesota, United States
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Chesterfield, Missouri, United States
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Jefferson City, Missouri, United States
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Kansas City, Missouri, United States
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Saint Joseph, Missouri, United States
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St Louis, Missouri, United States
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Great Falls, Montana, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Pahrump, Nevada, United States
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Brick, New Jersey, United States
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Bridgewater, New Jersey, United States
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Camden, New Jersey, United States
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Fort Lee, New Jersey, United States
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Haddon Heights, New Jersey, United States
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Linden, New Jersey, United States
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New Brunswick, New Jersey, United States
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Newark, New Jersey, United States
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Ridgewood, New Jersey, United States
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Sewell, New Jersey, United States
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Sicklerville, New Jersey, United States
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South Plainfield, New Jersey, United States
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Albuquerque, New Mexico, United States
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Cortlandt Manor, New York, United States
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Freeport, New York, United States
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Huntington, New York, United States
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Johnson City, New York, United States
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Kingston, New York, United States
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New Hartford, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Saratoga Springs, New York, United States
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Springfield Gardens, New York, United States
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The Bronx, New York, United States
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Valhalla, New York, United States
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Williamsville, New York, United States
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Asheville, North Carolina, United States
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Burlington, North Carolina, United States
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Charlotte, North Carolina, United States
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Elizabeth City, North Carolina, United States
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Forsyth, North Carolina, United States
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Greensboro, North Carolina, United States
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Hickory, North Carolina, United States
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Lenoir, North Carolina, United States
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Smithfield, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Bismarck, North Dakota, United States
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Fargo, North Dakota, United States
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Minot, North Dakota, United States
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Akron, Ohio, United States
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Athens, Ohio, United States
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Berea, Ohio, United States
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Boardman, Ohio, United States
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Carlisle, Ohio, United States
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Centerville, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Franklin, Ohio, United States
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Lorain, Ohio, United States
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Marion, Ohio, United States
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Maumee, Ohio, United States
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Middleburg Heights, Ohio, United States
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Springfield, Ohio, United States
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Toledo, Ohio, United States
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Westlake, Ohio, United States
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Zanesville, Ohio, United States
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Bartlesville, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Yukon, Oklahoma, United States
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Bend, Oregon, United States
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Corvallis, Oregon, United States
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Hillsboro, Oregon, United States
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Portland, Oregon, United States
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Altoona, Pennsylvania, United States
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Bethlehem, Pennsylvania, United States
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Clymer, Pennsylvania, United States
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Fleetwood, Pennsylvania, United States
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Langhorne, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Schwenksville, Pennsylvania, United States
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Scotland, Pennsylvania, United States
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Sellersville, Pennsylvania, United States
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Yardley, Pennsylvania, United States
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East Providence, Rhode Island, United States
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Beaufort, South Carolina, United States
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Easley, South Carolina, United States
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Florence, South Carolina, United States
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Spartanburg, South Carolina, United States
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Taylors, South Carolina, United States
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Sioux Falls, South Dakota, United States
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Bartlett, Tennessee, United States
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Bristol, Tennessee, United States
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Cleveland, Tennessee, United States
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Franklin, Tennessee, United States
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Germantown, Tennessee, United States
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Jackson, Tennessee, United States
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Johnson City, Tennessee, United States
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Kingsport, Tennessee, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Murfreesboro, Tennessee, United States
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Nashville, Tennessee, United States
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Oak Ridge, Tennessee, United States
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Austin, Texas, United States
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Beaumont, Texas, United States
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Carrollton, Texas, United States
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Dallas, Texas, United States
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Denton, Texas, United States
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Edinburg, Texas, United States
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Fort Worth, Texas, United States
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Grapevine, Texas, United States
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Houston, Texas, United States
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McKinney, Texas, United States
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North Richland Hills, Texas, United States
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Plano, Texas, United States
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Saginaw, Texas, United States
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San Antonio, Texas, United States
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Southlake, Texas, United States
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Temple, Texas, United States
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Tomball, Texas, United States
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Bountiful, Utah, United States
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Ogden, Utah, United States
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Salt Lake City, Utah, United States
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Bennington, Vermont, United States
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South Burlington, Vermont, United States
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Burke, Virginia, United States
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Charlottesville, Virginia, United States
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Galax, Virginia, United States
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Lakeridge, Virginia, United States
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Manassas, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Roanoke, Virginia, United States
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Suffolk, Virginia, United States
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Virginia Beach, Virginia, United States
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Everett, Washington, United States
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Tacoma, Washington, United States
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Beloit, Wisconsin, United States
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Green Bay, Wisconsin, United States
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Madison, Wisconsin, United States
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Manitowoc, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Waukesha, Wisconsin, United States
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Bahía Blanca, Argentina
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Buenos Aires, Argentina
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C0rdoba, Argentina
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Capital Federal, Buenos Aires, Argentina
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Capital Federal, Argentina
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Carlos Paz, C0rdoba, Argentina
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Ciudad Aut0noma de Buenos Aires, Argentina
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Ciudad de C0rdoba, Argentina
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Cordoba - Cordoba, Argentina
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Corrientes, Argentina
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Córdoba, Argentina
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Derqui Pilar, Buenos Aires, Argentina
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Formosa, Argentina
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Haedo, Buenos Aires, Argentina
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La Plata, Argentina
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La Plata, Buenos Aires, Argentina
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Mar del Plata, Argentina
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Mar Del Plata, Provincia de Buenos Aires, Argentina
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Mendoza, Argentina
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Moron, Buenos Aires, Argentina
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Olivos, Argentina
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Quilmes, Argentina
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Ramos Mejia, Buenos Aries, Argentina
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Ramos Mejía, Argentina
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Rosario, Argentina
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Rosario - Santa Fe, Argentina
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Rosario, Provincia de Santa Fe, Argentina
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Salta, Argentina
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San Isidro, Argentina
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San Juan, San Juan, Argentina
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San Justo, Argentina
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San Luis, Argentina
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San Miguel de Tucumán, Argentina
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San Salvador de Jujuy, Argentina
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Santa Fe, Argentina
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Trelew, Chubut, Argentina
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Villa María, Argentina
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Broken Hill, New South Wales, Australia
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Kogarah, New South Wales, Australia
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Milton, Queensland, Australia
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Nambour, Queensland, Australia
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Hobart, Tasmania, Australia
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Fitzroy, Victoria, Australia
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Frankston, Victoria, Australia
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Heidelberg, Victoria, Australia
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Prahran, Victoria, Australia
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Adelaide, SA, Australia
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Bruce, Australia
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Feldkirch, Austria
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Graz, Austria
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Salzburg, Austria
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Vienna, Austria
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Antwerp, Belgium
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Bonheiden, Belgium
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Brasschaat, Belgium
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Brussels, Belgium
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Ghent, Belgium
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La Louvière, Belgium
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Curitiba, Paraná, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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São Paulo, São Paulo, Brazil
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Tatuí, São Paulo, Brazil
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Aracaju, Sergipe, Brazil
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Belem - PA, Brazil
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Belo Horizonte - MG, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Blumenau, Brazil
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Brasilia - DF, Brazil
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Brasilia, Distrito Federal, Brazil
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Campina Grande do Sul, Brazil
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Campinas, Sao Paulo, Brazil
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Campo Grande, Mato Grosso Do Sul, Brazil
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Curitiba, Parana, Brazil
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Fortaleza - CE, Brazil
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Fortaleza, Ceara, Brazil
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Goiania, Goias, Brazil
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Goiânia, Brazil
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Joinville, Brazil
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Londrina/PR, Brazil
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Macei0, Brazil
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Marilia, Sao Paulo, Brazil
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Marília, Brazil
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Mogi das Cruzes, Brazil
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Natal, Brazil
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Natal, RN, Brazil
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Passo Fundo, Rio Grande Do Sul, Brazil
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Porto Alegre, Brazil
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Porto Alegre - RS, Brazil
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Porto Alegre, Rio Grande Do Sul, Brazil
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Recife, Brazil
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Recife, PE, Brazil
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Recife, Pernambuco, Brazil
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Rio de Janeiro, Brazil
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Rio de Janeiro - RJ, Brazil
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Salvador - BA, Brazil
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Salvador, Bahia, Brazil
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Santo André, Brazil
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Sao Jose Do Rio Preto, Sao Paulo, Brazil
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Sao Jose Do Rio Preto- SP, Brazil
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Sao Jose, Santa Catarina, Brazil
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Sao Paulo, Sao Paulo, Brazil
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Sao Paulo, SP, Brazil
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São José do Rio Preto, Brazil
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São Paulo, Brazil
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Sobral, CE, Brazil
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Taguatinga, Brazil
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Uberlandia, Minas Gerais, Brazil
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Votuporanga, Brazil
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Blagoevgrad, Bulgaria
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Dimitrovgrad, Bulgaria
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Kazanlak, Bulgaria
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Lovech, Bulgaria
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Sevlievo, Bulgaria
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Smolyan, Bulgaria
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Sofia, Bulgaria
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Stara Zagora, Bulgaria
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Varna, Bulgaria
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Abbotsford, British Columbia, Canada
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Kelowna, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Grand Falls-Windsor, Newfoundland and Labrador, Canada
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St. John's, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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Ajax, Ontario, Canada
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Cambridge, Ontario, Canada
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Greater Sudbury, Ontario, Canada
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Hamilton, Ontario, Canada
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Newmarket, Ontario, Canada
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Niagara Falls, Ontario, Canada
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Ontario, Ontario, Canada
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Oshawa, Ontario, Canada
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Pickering, Ontario, Canada
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Smiths Falls, Ontario, Canada
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Toronto, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Greenfield, Quebec, Canada
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Lachine, Quebec, Canada
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Mount Royal, Quebec, Canada
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Pointe-Claire, Quebec, Canada
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Québec, Quebec, Canada
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Saint-Jérôme, Quebec, Canada
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Sainte-Foy, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Terrebonne, Quebec, Canada
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Antofagasta, Chile
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Antofagasta, Region II, Chile
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Iquique, Region I, Chile
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Osorno, Chile
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Rancagua, Chile
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Santiago, Chile
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Talcahuano, Chile
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Temuco, Chile
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Temuco, Region de La Araucania, Chile
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Viña del Mar, Chile
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Barranquilla, Colombia
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Bogotá, Colombia
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Bucaramanga, Colombia
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Medellín, Colombia
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Čakovec, Croatia
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Krapinske Toplice, Croatia
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Osijek, Croatia
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Rijeka, Croatia
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Sisak, Croatia
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Split, Croatia
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Virovitica, Croatia
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Zadar, Croatia
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Zagreb, Croatia
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Čáslav, Czechia
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Hradec Králové, Czechia
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Olomouc, Czechia
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Ostrava - Vitkovice, Czechia
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Zlín, Czechia
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Znojmo, Czechia
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Herlev, Denmark
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Herning, Denmark
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København NV, Denmark
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Alexandria, Egypt
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Giza, Egypt
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Monofia, Egypt
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Helsinki, Finland
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Jyväskylä, Finland
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Kokkola, Finland
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Kuopio, Finland
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Tampere, Finland
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Turku, Finland
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Bordeaux, France
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Corbeil-Essonnes, France
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Créteil, France
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Dijon, France
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La Rochelle, France
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Lille, France
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Montpellier, France
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Narbonne, France
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Paris, France
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Pau, France
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Pessac, France
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Rennes, France
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Toulouse, France
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Bad Nauheim, Germany
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Bensheim, Germany
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Berlin, Germany
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Cologne, Germany
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Dortmund, Germany
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Dresden, Germany
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Essen, Germany
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Halle, Germany
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Jena, Germany
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Kassel, Germany
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Leipzig, Germany
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Mainz, Germany
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Mannheim, Germany
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München, Germany
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Münster, Germany
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Neumünster, Germany
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Neuwied, Germany
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Sankt Ingbert, Germany
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Siegen, Germany
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Wangen, Germany
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Marousi, Greece
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Guatemala City, Guatemala
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Quetzaltenango, Guatemala
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Hong Kong, Hong Kong
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Kowloon, Hong Kong
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Shatin, Hong Kong
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Tsuen Wan, Hong Kong
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Budaörs, Hungary
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Budapest, Hungary
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Debrecen, Hungary
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Dunaújváros, Hungary
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Gyula, Hungary
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H0dmezovasarhely, Hungary
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Kaposvár, Hungary
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Kecskemét, Hungary
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Nagykanizsa, Hungary
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Pécs, Hungary
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Sopron, Hungary
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Szentes, Hungary
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Székesfehérvár, Hungary
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Szombathely, Hungary
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Zalaegerszeg, Hungary
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Hyderabad, Andhra Pradesh, India
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Nellore, Andhra Pradesh, India
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Vijayawada, Andhra Pradesh, India
Unknown Facility
Visakhapatnam, Andhra Pradesh, India
Unknown Facility
Perumbākkam, Chennai, India
Unknown Facility
Ahmedabad, Gujarat, India
Unknown Facility
Anand, Gujarat, India
Unknown Facility
Surat, Gujarat, India
Unknown Facility
Vadodara, Gujarat, India
Unknown Facility
Bangalore, Karnataka, India
Unknown Facility
Belagavi, Karnataka, India
Unknown Facility
Mangalore, Karnataka, India
Unknown Facility
Manipal, Karnataka, India
Unknown Facility
Mysore, Karnataka, India
Unknown Facility
Kochi, Kerala, India
Unknown Facility
Thiruvananthapuram, Kerala, India
Unknown Facility
Thrissur, Kerala, India
Unknown Facility
Trivandrum, Kerala, India
Unknown Facility
Aurangabad, Maharashtra, India
Unknown Facility
Mumbai, Maharashtra, India
Unknown Facility
Nagpur, Maharashtra, India
Unknown Facility
Nashik, Maharashtra, India
Unknown Facility
Pune, Maharashtra, India
Unknown Facility
Delhi, National Capital Territory of Delhi, India
Unknown Facility
New Delhi, National Capital Territory of Delhi, India
Unknown Facility
Jalandhar, Punjab, India
Unknown Facility
Ludhiana, Punjab, India
Unknown Facility
Jaipur, Rajasthan, India
Unknown Facility
Chennai, Tamil Nadu, India
Unknown Facility
Coimbatore, Tamil Nadu, India
Unknown Facility
Madurai, Tamil Nadu, India
Unknown Facility
Kolkata, West Bengal, India
Unknown Facility
Ashkelon, Israel
Unknown Facility
Beersheba, Israel
Unknown Facility
Haifa, Israel
Unknown Facility
Holon, Israel
Unknown Facility
Jerusalem, Israel
Unknown Facility
Kfar Saba, Israel
Unknown Facility
Nahariya, Israel
Unknown Facility
Nazareth, Israel
Unknown Facility
Petah Tikva, Israel
Unknown Facility
Rehovot, Israel
Unknown Facility
Rishon LeZiyyon, Israel
Unknown Facility
Safed, Israel
Unknown Facility
Tel Aviv, Israel
Unknown Facility
Tiberias, Israel
Unknown Facility
Cosenza, Italy
Unknown Facility
Isernia, Italy
Unknown Facility
Milan, Italy
Unknown Facility
Napoli, Italy
Unknown Facility
Palermo, Italy
Unknown Facility
Pavia, Italy
Unknown Facility
Ravenna, Italy
Unknown Facility
Roma, Italy
Unknown Facility
Sesto San Giovanni, Italy
Unknown Facility
Aichi-gun, Aichi-ken, Japan
Unknown Facility
Nagoya, Aichi-ken, Japan
Unknown Facility
Seto, Aichi-ken, Japan
Unknown Facility
Funabashi, Chiba, Japan
Unknown Facility
Kashiwa, Chiba, Japan
Unknown Facility
Imabari, Ehime, Japan
Unknown Facility
Fukuoka, Fukuoka, Japan
Unknown Facility
Kasuga, Fukuoka, Japan
Unknown Facility
Kitakyushu, Fukuoka, Japan
Unknown Facility
Ohkawa-city, Fukuoka, Japan
Unknown Facility
Fukushima, Fukushima, Japan
Unknown Facility
Gifu, Gifu, Japan
Unknown Facility
Shibukawa, Gunma, Japan
Unknown Facility
Takasaki, Gunma, Japan
Unknown Facility
Higashihiroshima, Hiroshima, Japan
Unknown Facility
Tomakomai, Hokkaido, Japan
Unknown Facility
Amagasaki, Hyōgo, Japan
Unknown Facility
Kanazawa, Ishikawa-ken, Japan
Unknown Facility
Sakaidechō, Kagawa-ken, Japan
Unknown Facility
Kawasaki, Kanagawa, Japan
Unknown Facility
Sagamihara-shi, Kanagawa, Japan
Unknown Facility
Nankoku, Kochi, Japan
Unknown Facility
Kumamoto, Kumamoto, Japan
Unknown Facility
Uji-shi, Kyoto, Japan
Unknown Facility
Matsusaka, Mie-ken, Japan
Unknown Facility
Nagasaki, Nagasaki, Japan
Unknown Facility
Niigata, Niigata, Japan
Unknown Facility
Ōita, Oita Prefecture, Japan
Unknown Facility
Okayama, Okayama-ken, Japan
Unknown Facility
Shimajiri-gun, Okinawa, Japan
Unknown Facility
Tomigusuku, Okinawa, Japan
Unknown Facility
Kishiwada, Osaka, Japan
Unknown Facility
Matsubara, Osaka, Japan
Unknown Facility
Yao-shi, Osaka, Japan
Unknown Facility
Saga, Saga-ken, Japan
Unknown Facility
Ageo, Saitama, Japan
Unknown Facility
Wako, Saitama, Japan
Unknown Facility
Hamada, Shimane, Japan
Unknown Facility
Suntou-gun, Shizuoka, Japan
Unknown Facility
Komatsushimachō, Tokushima, Japan
Unknown Facility
Tokushima, Tokushima, Japan
Unknown Facility
Hino, Tokyo, Japan
Unknown Facility
Tachikawa, Tokyo, Japan
Unknown Facility
Tokyo, Tokyo, Japan
Unknown Facility
Iwakuni-shi, Yamaguchi, Japan
Unknown Facility
Dasman, Kuwait
Unknown Facility
Daugavpils, Latvia
Unknown Facility
Ogre, Latvia
Unknown Facility
Riga, Latvia
Unknown Facility
Tukums, Latvia
Unknown Facility
Valmiera, Latvia
Unknown Facility
Kaunas, Lithuania
Unknown Facility
Kėdainiai, Lithuania
Unknown Facility
Klaipėda, Lithuania
Unknown Facility
Palanga, Lithuania
Unknown Facility
Panevezys, Lithuania
Unknown Facility
Vilnius, Lithuania
Unknown Facility
Alor Star, Malaysia
Unknown Facility
Batu Caves, Malaysia
Unknown Facility
George Town, Malaysia
Unknown Facility
Kuala Lumpur, Malaysia
Unknown Facility
Kuala Selangor, Malaysia
Unknown Facility
Kuantan, Malaysia
Unknown Facility
Kubang Kerian, Malaysia
Unknown Facility
Pulau Pinang, Malaysia
Unknown Facility
Acapulco, Guerrero, Mexico
Unknown Facility
Aguascalientes, Mexico
Unknown Facility
Chihuahua City, Mexico
Unknown Facility
Chihuhua, Chihuhua, Mexico
Unknown Facility
Ciudad Obregon, Sonora, Mexico
Unknown Facility
Cuernavaca, Mexico
Unknown Facility
Cuernavaca, Morelos, Mexico
Unknown Facility
Culiacán, Mexico
Unknown Facility
Durango, Mexico
Unknown Facility
Guadalajara, Mexico
Unknown Facility
Guadalajara, Jalisco, Mexico
Unknown Facility
Merida, Yucatan, Mexico
Unknown Facility
Metepec, Mexico
Unknown Facility
Mexicali, Baja California, Mexico
Unknown Facility
Mexico City, Mexico
Unknown Facility
Mexico City, Mexico, Mexico
Unknown Facility
México, Mexico
Unknown Facility
Monclova, Coahuila, Mexico
Unknown Facility
Monterrey, Mexico
Unknown Facility
Monterrey, NL, Mexico
Unknown Facility
Monterrey, Nuevo Le0n, Mexico
Unknown Facility
Monterrey, Nuevo Leon, Mexico
Unknown Facility
Morelia, Michoacan, Mexico
Unknown Facility
Pachuca, Mexico
Unknown Facility
Saltillo, Mexico
Unknown Facility
Saltillo, Coahuila, Mexico
Unknown Facility
San Luis Potosi.SLP, Mexico
Unknown Facility
San Luis Potosí City, Mexico
Unknown Facility
Tijuana, Baja California Norte, Mexico
Unknown Facility
Tlalnepantla, Mexico
Unknown Facility
Tlalnepantla, Edo de Mexico, Mexico
Unknown Facility
Xalapa, Veracruz, Mexico
Unknown Facility
Zapopan, Mexico
Unknown Facility
Auckland, New Zealand
Unknown Facility
Christchurch, New Zealand
Unknown Facility
Otahuhu, New Zealand
Unknown Facility
Palmerston North, New Zealand
Unknown Facility
Takapuna, New Zealand
Unknown Facility
Tauranga, New Zealand
Unknown Facility
Arequipa, Peru
Unknown Facility
Bellavista, Peru
Unknown Facility
Callao, Peru
Unknown Facility
Cusco, Peru
Unknown Facility
Huacho, Peru
Unknown Facility
Ica, Peru
Unknown Facility
La Victoria, Lima, Peru
Unknown Facility
Lima, Peru
Unknown Facility
Lima San Isidro, Peru
Unknown Facility
Los Olivos, Peru
Unknown Facility
Miraflores, Lima, Peru
Unknown Facility
Piura, Peru
Unknown Facility
San Isidro, Lima, Peru
Unknown Facility
San Miguel, Lima, Peru
Unknown Facility
Trujillo, Peru
Unknown Facility
Trujillo, La Libertad, Peru
Unknown Facility
Baguio City, Philippines
Unknown Facility
Dasmariñas, Philippines
Unknown Facility
Davao City, Philippines
Unknown Facility
Iloilo City, Philippines
Unknown Facility
Laoag, Philippines
Unknown Facility
Makati City, Philippines
Unknown Facility
Manila, Philippines
Unknown Facility
Marikina City, Philippines
Unknown Facility
Pasig, Philippines
Unknown Facility
Quezon City, Philippines
Unknown Facility
Bialystok, Poland
Unknown Facility
Bydgoszcz, Poland
Unknown Facility
Częstochowa, Poland
Unknown Facility
Dąbrowa Górnicza, Poland
Unknown Facility
Elblag, Poland
Unknown Facility
Gdansk, Poland
Unknown Facility
Gdynia, Poland
Unknown Facility
Grodzisk Mazowiecki, Poland
Unknown Facility
Inowrocław, Poland
Unknown Facility
Katowice, Poland
Unknown Facility
Kielce, Poland
Unknown Facility
Krakow, Poland
Unknown Facility
Legnica, Poland
Unknown Facility
Lodz, Poland
Unknown Facility
Lubartów, Poland
Unknown Facility
Lublin, Poland
Unknown Facility
Puławy, Poland
Unknown Facility
Płock, Poland
Unknown Facility
Radom, Poland
Unknown Facility
Ruda Śląska, Poland
Unknown Facility
Skierniewice, Poland
Unknown Facility
Szczecin, Poland
Unknown Facility
Słupsk, Poland
Unknown Facility
Torun, Poland
Unknown Facility
Warsaw, Poland
Unknown Facility
Wroclaw, Poland
Unknown Facility
Zabrze, Poland
Unknown Facility
Zgierz, Poland
Unknown Facility
Coimbra, Portugal
Unknown Facility
Faro, Portugal
Unknown Facility
Lisbon, Portugal
Unknown Facility
Vila Real, Portugal
Unknown Facility
Aibonito, PR, Puerto Rico
Unknown Facility
Halo Rey, PR, Puerto Rico
Unknown Facility
Ponce, PR, Puerto Rico
Unknown Facility
Salinas, PR, Puerto Rico
Unknown Facility
Santurce, PR, Puerto Rico
Unknown Facility
Carolina, Puerto Rico
Unknown Facility
Cidra, Puerto Rico
Unknown Facility
Levittown, Puerto Rico
Unknown Facility
Manatí, Puerto Rico
Unknown Facility
Mayagüez, Puerto Rico
Unknown Facility
San Juan, Puerto Rico
Unknown Facility
Bacau, Romania
Unknown Facility
Baia Mare, Romania
Unknown Facility
Brasov, Romania
Unknown Facility
Brăila, Romania
Unknown Facility
Bucharest, Romania
Unknown Facility
Buzău, Romania
Unknown Facility
Galati, Romania
Unknown Facility
Iași, Romania
Unknown Facility
Oradea, Romania
Unknown Facility
Ploieşti, Romania
Unknown Facility
Satu Mare, Romania
Unknown Facility
Târgu Mureş, Romania
Unknown Facility
Timișoara, Romania
Unknown Facility
Arkhangelsk, Russia
Unknown Facility
Barnaul, Russia
Unknown Facility
Ivanovo, Russia
Unknown Facility
Kazan', Russia
Unknown Facility
Kemerovo, Russia
Unknown Facility
Krasnodar, Russia
Unknown Facility
Krasnoyarsk, Russia
Unknown Facility
Kursk, Russia
Unknown Facility
Moscow, Russia
Unknown Facility
Nizhny Novgorod, Russia
Unknown Facility
Novosibirsk, Russia
Unknown Facility
Rostov-on-Don, Russia
Unknown Facility
Saint Petersburg, Russia
Unknown Facility
Saratov, Russia
Unknown Facility
Ufa, Russia
Unknown Facility
Volgograd, Russia
Unknown Facility
Vsevolozhsk, Russia
Unknown Facility
Belgrade, Serbia
Unknown Facility
Niš, Serbia
Unknown Facility
Bardejov, Slovakia
Unknown Facility
Bratislava, Slovakia
Unknown Facility
Dolný Kubín, Slovakia
Unknown Facility
Komárno, Slovakia
Unknown Facility
Kosice - Saca, Slovakia
Unknown Facility
Košice, Slovakia
Unknown Facility
Levice, Slovakia
Unknown Facility
Liptovský Hrádok, Slovakia
Unknown Facility
Nové Mesto nad Váhom, Slovakia
Unknown Facility
Nové Zámky, Slovakia
Unknown Facility
Považská Bystrica, Slovakia
Unknown Facility
Rimavská Sobota, Slovakia
Unknown Facility
Ružomberok, Slovakia
Unknown Facility
Svidník, Slovakia
Unknown Facility
Žilina, Slovakia
Unknown Facility
Port Elizabeth, Eastern Cape, South Africa
Unknown Facility
Johannesburg, Gauteng, South Africa
Unknown Facility
Pretoria, Gauteng, South Africa
Unknown Facility
Durban, KwaZulu-Natal, South Africa
Unknown Facility
Cape Town, Western Cape, South Africa
Unknown Facility
Paarl, Western Cape, South Africa
Unknown Facility
Somerset West, Western Cape, South Africa
Unknown Facility
Tygerberg, Western Cape, South Africa
Unknown Facility
Worcester, Western Cape, South Africa
Unknown Facility
Durban, South Africa
Unknown Facility
Pretoria, South Africa
Unknown Facility
Anyang, South Korea
Unknown Facility
Busan, South Korea
Unknown Facility
Daegu, South Korea
Unknown Facility
Goyang-si, South Korea
Unknown Facility
Guri-si, South Korea
Unknown Facility
Gyeonggi-do, South Korea
Unknown Facility
Jeonju, South Korea
Unknown Facility
Kangwon-do, South Korea
Unknown Facility
Pusan, South Korea
Unknown Facility
Seoul, South Korea
Unknown Facility
Suwon, South Korea
Unknown Facility
Yangsan, South Korea
Unknown Facility
Zaragoza, Arag0n, Spain
Unknown Facility
Cuenca, Castille-La Mancha, Spain
Unknown Facility
Barcelona, Catalonia, Spain
Unknown Facility
Figueres, Catalonia, Spain
Unknown Facility
A Coruña, Galicia, Spain
Unknown Facility
Santiago de Compostela, Galicia, Spain
Unknown Facility
Oviedo, Principality of Asturias, Spain
Unknown Facility
Torrevieja, Valencia, Spain
Unknown Facility
Bacarot, Spain
Unknown Facility
Mérida, Spain
Unknown Facility
Palma de Mallorca, Spain
Unknown Facility
Dalby, Sweden
Unknown Facility
Falköping, Sweden
Unknown Facility
Gothenburg, Sweden
Unknown Facility
Härnösand, Sweden
Unknown Facility
Kristianstad, Sweden
Unknown Facility
Malmo, Sweden
Unknown Facility
Motala, Sweden
Unknown Facility
Stockholm, Sweden
Unknown Facility
Kaohsiung City, Taiwan
Unknown Facility
Taipei County, Taiwan
Unknown Facility
Taoyuan District, Taiwan
Unknown Facility
Amphure Muang, Thailand
Unknown Facility
Bangkojk, Thailand
Unknown Facility
Bangkok, Thailand
Unknown Facility
Chiang Mai, Thailand
Unknown Facility
Chiang Rai, Thailand
Unknown Facility
Muang, Thailand
Unknown Facility
Nakhon Ratchasima, Thailand
Unknown Facility
Pathumwan, Thailand
Unknown Facility
Patumthani, Thailand
Unknown Facility
Phitsanulok, Thailand
Unknown Facility
Phrae, Thailand
Unknown Facility
Ankara, Balgat, Turkey (Türkiye)
Unknown Facility
Antalya, Turkey (Türkiye)
Unknown Facility
Istanbul, Turkey (Türkiye)
Unknown Facility
Kayseri, Turkey (Türkiye)
Unknown Facility
Konya, Turkey (Türkiye)
Unknown Facility
Donetsk, Ukraine
Unknown Facility
Ivano-Frankivsk, Ukraine
Unknown Facility
Kharkiv, Ukraine
Unknown Facility
Kyiv, Ukraine
Unknown Facility
Lviv, Ukraine
Unknown Facility
Odesa, Ukraine
Unknown Facility
Poltava, Ukraine
Unknown Facility
Simferopol, Ukraine
Unknown Facility
Vinnytsia, Ukraine
Unknown Facility
Zaporizhzhya, Ukraine
Unknown Facility
Abu Dhabi, United Arab Emirates
Unknown Facility
Barnsley, United Kingdom
Unknown Facility
Bath, United Kingdom
Unknown Facility
Birmingham, United Kingdom
Unknown Facility
Bournemouth, United Kingdom
Unknown Facility
Carshalton, United Kingdom
Unknown Facility
Chertsey, United Kingdom
Unknown Facility
Chichester, United Kingdom
Unknown Facility
Colchester, United Kingdom
Unknown Facility
Coventry, United Kingdom
Unknown Facility
Croydon, United Kingdom
Unknown Facility
Doncaster, United Kingdom
Unknown Facility
Glasgow, United Kingdom
Unknown Facility
Hull, United Kingdom
Unknown Facility
Inverness, United Kingdom
Unknown Facility
Kirkcaldy, United Kingdom
Unknown Facility
Liverpool, United Kingdom
Unknown Facility
Livingston, United Kingdom
Unknown Facility
London, United Kingdom
Unknown Facility
Nuneaton, United Kingdom
Unknown Facility
Stevenage, United Kingdom
Unknown Facility
Sunderland, United Kingdom
Unknown Facility
Torquay, United Kingdom
Unknown Facility
Wakefield, United Kingdom
Unknown Facility
West Midlands, United Kingdom
Related Publications (14)
Ferreira JP, Rossignol P, Bakris G, Mehta C, White WB, Zannad F. Blood and Urine Biomarkers Predicting Worsening Kidney Function in Patients with Type 2 Diabetes Post-Acute Coronary Syndrome: An Analysis from the EXAMINE Trial. Am J Nephrol. 2021;52(12):969-976. doi: 10.1159/000519436. Epub 2021 Dec 6.
PMID: 34872085DERIVEDFerreira JP, Mehta C, Sharma A, Nissen SE, Rossignol P, Zannad F. Alogliptin after acute coronary syndrome in patients with type 2 diabetes: a renal function stratified analysis of the EXAMINE trial. BMC Med. 2020 Jun 4;18(1):165. doi: 10.1186/s12916-020-01616-8.
PMID: 32493335DERIVEDSharma A, Vaduganathan M, Ferreira JP, Liu Y, Bakris GL, Cannon CP, White WB, Zannad F. Clinical and Biomarker Predictors of Expanded Heart Failure Outcomes in Patients With Type 2 Diabetes Mellitus After a Recent Acute Coronary Syndrome: Insights From the EXAMINE Trial. J Am Heart Assoc. 2020 Jan 7;9(1):e012797. doi: 10.1161/JAHA.119.012797. Epub 2020 Jan 4.
PMID: 31902327DERIVEDWhite WB, Jalil F, Cushman WC, Bakris GL, Bergenstal R, Heller SR, Liu Y, Mehta C, Zannad F, Cannon CP. Average Clinician-Measured Blood Pressures and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus and Ischemic Heart Disease in the EXAMINE Trial. J Am Heart Assoc. 2018 Oct 16;7(20):e009114. doi: 10.1161/JAHA.118.009114.
PMID: 30371278DERIVEDJarolim P, White WB, Cannon CP, Gao Q, Morrow DA. Serial Measurement of Natriuretic Peptides and Cardiovascular Outcomes in Patients With Type 2 Diabetes in the EXAMINE Trial. Diabetes Care. 2018 Jul;41(7):1510-1515. doi: 10.2337/dc18-0109. Epub 2018 May 30.
PMID: 29848776DERIVEDSharma A, Cannon CP, White WB, Liu Y, Bakris GL, Cushman WC, Zannad F. Early and Chronic Dipeptidyl-Peptidase-IV Inhibition and Cardiovascular Events in Patients With Type 2 Diabetes Mellitus After an Acute Coronary Syndrome: A Landmark Analysis of the EXAMINE Trial. J Am Heart Assoc. 2018 May 16;7(11):e007649. doi: 10.1161/JAHA.117.007649.
PMID: 29769203DERIVEDWhite WB, Heller SR, Cannon CP, Howitt H, Khunti K, Bergenstal RM; EXAMINE Investigators. Alogliptin in Patients with Type 2 Diabetes Receiving Metformin and Sulfonylurea Therapies in the EXAMINE Trial. Am J Med. 2018 Jul;131(7):813-819.e5. doi: 10.1016/j.amjmed.2018.02.023. Epub 2018 Mar 23.
PMID: 29581078DERIVEDHwang YC, Morrow DA, Cannon CP, Liu Y, Bergenstal R, Heller S, Mehta C, Cushman W, Bakris GL, Zannad F, White WB. High-sensitivity C-reactive protein, low-density lipoprotein cholesterol and cardiovascular outcomes in patients with type 2 diabetes in the EXAMINE (Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care) trial. Diabetes Obes Metab. 2018 Mar;20(3):654-659. doi: 10.1111/dom.13136. Epub 2017 Nov 21.
PMID: 29064626DERIVEDKay S, Strickson A, Puelles J, Selby R, Benson E, Tolley K. Comparative Effectiveness of Adding Alogliptin to Metformin Plus Sulfonylurea with Other DPP-4 Inhibitors in Type 2 Diabetes: A Systematic Review and Network Meta-Analysis. Diabetes Ther. 2017 Apr;8(2):251-273. doi: 10.1007/s13300-017-0245-8. Epub 2017 Mar 8.
PMID: 28275958DERIVEDCavender MA, White WB, Jarolim P, Bakris GL, Cushman WC, Kupfer S, Gao Q, Mehta CR, Zannad F, Cannon CP, Morrow DA. Serial Measurement of High-Sensitivity Troponin I and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus in the EXAMINE Trial (Examination of Cardiovascular Outcomes With Alogliptin Versus Standard of Care). Circulation. 2017 May 16;135(20):1911-1921. doi: 10.1161/CIRCULATIONAHA.116.024632. Epub 2017 Feb 28.
PMID: 28246236DERIVEDWhite WB, Kupfer S, Zannad F, Mehta CR, Wilson CA, Lei L, Bakris GL, Nissen SE, Cushman WC, Heller SR, Bergenstal RM, Fleck PR, Cannon CP; EXAMINE Investigators. Cardiovascular Mortality in Patients With Type 2 Diabetes and Recent Acute Coronary Syndromes From the EXAMINE Trial. Diabetes Care. 2016 Jul;39(7):1267-73. doi: 10.2337/dc16-0303. Epub 2016 Jun 11.
PMID: 27289121DERIVEDZannad F, Cannon CP, Cushman WC, Bakris GL, Menon V, Perez AT, Fleck PR, Mehta CR, Kupfer S, Wilson C, Lam H, White WB; EXAMINE Investigators. Heart failure and mortality outcomes in patients with type 2 diabetes taking alogliptin versus placebo in EXAMINE: a multicentre, randomised, double-blind trial. Lancet. 2015 May 23;385(9982):2067-76. doi: 10.1016/S0140-6736(14)62225-X. Epub 2015 Mar 10.
PMID: 25765696DERIVEDWhite WB, Cannon CP, Heller SR, Nissen SE, Bergenstal RM, Bakris GL, Perez AT, Fleck PR, Mehta CR, Kupfer S, Wilson C, Cushman WC, Zannad F; EXAMINE Investigators. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med. 2013 Oct 3;369(14):1327-35. doi: 10.1056/NEJMoa1305889. Epub 2013 Sep 2.
PMID: 23992602DERIVEDWhite WB, Bakris GL, Bergenstal RM, Cannon CP, Cushman WC, Fleck P, Heller S, Mehta C, Nissen SE, Perez A, Wilson C, Zannad F. EXamination of cArdiovascular outcoMes with alogliptIN versus standard of carE in patients with type 2 diabetes mellitus and acute coronary syndrome (EXAMINE): a cardiovascular safety study of the dipeptidyl peptidase 4 inhibitor alogliptin in patients with type 2 diabetes with acute coronary syndrome. Am Heart J. 2011 Oct;162(4):620-626.e1. doi: 10.1016/j.ahj.2011.08.004. Epub 2011 Sep 14.
PMID: 21982652DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Director Clinical Science
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2009
First Posted
August 31, 2009
Study Start
September 1, 2009
Primary Completion
April 1, 2013
Study Completion
June 1, 2013
Last Updated
May 2, 2014
Results First Posted
April 15, 2014
Record last verified: 2014-04