Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL): A Trial To Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly In Patients With Type 2 Diabetes Mellitus
3 other identifiers
interventional
14,752
34 countries
620
Brief Summary
This study will compare the impact of including exenatide once weekly in addition to usual care vs. usual care without exenatide on major cardiovascular outcomes as measured by the primary composite endpoint of cardiovascular-related death, nonfatal myocardial infarction (MI), or nonfatal stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes-mellitus
Started Jun 2010
Longer than P75 for phase_3 type-2-diabetes-mellitus
620 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
June 10, 2010
CompletedFirst Posted
Study publicly available on registry
June 15, 2010
CompletedStudy Start
First participant enrolled
June 18, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 21, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 24, 2017
CompletedResults Posted
Study results publicly available
August 8, 2018
CompletedAugust 8, 2018
July 1, 2018
6.8 years
June 10, 2010
April 13, 2018
July 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Primary Efficacy Outcome MACE Events
The primary efficacy outcome variable is defined as the composite endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke. The number of participants who had an event is reported in the results. The primary efficacy endpoint is the same as the primary safety endpoint, and the statistical analysis tests the superiority of exenatide against the placebo.
Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Primary Safety Outcome MACE Events
The primary safety outcome variable is defined as the composite endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke. The number of participants who had an event is reported in the results. The primary safety endpoint is the same as the primary efficacy endpoints, and the statistical analysis tests the non-inferiority of exenatide against placebo.
Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary Outcomes (6)
Secondary Efficacy Outcome All-Cause Mortality
Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary Efficacy Outcome CV Death
Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary Efficacy Outcome MI
Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary Efficacy Outcome Stroke
Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
Secondary Efficacy Outcome Hospitalization for ACS
Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
- +1 more secondary outcomes
Study Arms (2)
Exenatide Once Weekly
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Subcutaneous injection, 2 mg, administered once weekly.
Eligibility Criteria
You may qualify if:
- Patient has type 2 diabetes mellitus
- Patient has an HbA1c of ≥ 6.5 % and ≤ 10.0% and is currently using one of the following treatment regimens: A) Treatment with 0-3 oral antihyperglycemic agents B) Insulin therapy, either alone or in combination with up to two oral agents
- Female patients must not be breast feeding and agree to use an effective method of contraception or must not otherwise be at risk of becoming pregnant.
You may not qualify if:
- Patient has a diagnosis of type 1 diabetes mellitus, or a history of ketoacidosis.
- Patient has ever been treated with an approved or investigational GLP-1 receptor agonist.
- Patient is enrolled in another experimental protocol which involves the use of an investigational drug or device, or an intervention that would interfere with the conduct of the trial.
- Patient has a planned or anticipated revascularization procedure.
- Pregnancy or planned pregnancy during the trial period.
- Patient has end-stage renal disease or an estimated glomerular filtration rate (eGFR) of \<30 mL/min/1.73m2.
- Patient has a history of gastroparesis or pancreatitis.
- Personal or family history of medullary thyroid cancer or MEN2 (Multiple EndocrineNeoplasia Type 2) or calcitonin level of \>40 ng/L at baseline.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (629)
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Birmingham, Alabama, 35294, United States
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Glendale, Arizona, 85306, United States
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Phoenix, Arizona, 85012, United States
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Jonesboro, Arkansas, 72401, United States
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Little Rock, Arkansas, 72204, United States
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Chula Vista, California, 91911-1350, United States
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Concord, California, 94520, United States
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Escondido, California, 92029, United States
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Fullerton, California, 92835, United States
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Greenbrae, California, 94904, United States
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La Mesa, California, 91942, United States
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Laguna Hills, California, 92653, United States
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Long Beach, California, 90822, United States
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Los Angeles, California, 90033, United States
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Northridge, California, 91325, United States
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Oceanside, California, 92056, United States
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Orange, California, 92868, United States
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Redondo Beach, California, 90277, United States
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San Diego, California, 92120, United States
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San Diego, California, 92161, United States
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Sylmar, California, 91342, United States
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Torrance, California, 90505, United States
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Tustin, California, 92780, United States
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Victorville, California, 92392, United States
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Aurora, Colorado, 80045, United States
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Colorado Springs, Colorado, 80920, United States
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Littleton, Colorado, 80120, United States
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Thomaston, Connecticut, 06787, United States
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Washington D.C., District of Columbia, 20037, United States
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Cape Coral, Florida, 33904, United States
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Fort Lauderdale, Florida, 33308, United States
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Jacksonville, Florida, 32216, United States
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Sarasota, Florida, 34239, United States
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Atlanta, Georgia, 30339, United States
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Atlanta, Georgia, 30342, United States
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Decatur, Georgia, 30033, United States
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Marietta, Georgia, 30067, United States
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Roswell, Georgia, 30076, United States
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Pocatello, Idaho, 83201, United States
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Chicago, Illinois, 60607, United States
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Hines, Illinois, 60141, United States
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Rock Island, Illinois, 61201, United States
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Springfield, Illinois, 62704, United States
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Avon, Indiana, 46123, United States
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Gary, Indiana, 46403, United States
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Indianapolis, Indiana, 46260, United States
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Des Moines, Iowa, 50263, United States
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Kansas City, Kansas, 66160, United States
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Covington, Kentucky, 41011, United States
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Evansville, Kentucky, 47713, United States
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Lexington, Kentucky, 40502, United States
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Alexandria, Louisiana, 71301, United States
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Auburn, Maine, 04210, United States
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Baltimore, Maryland, 21215, United States
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Randallstown, Maryland, 21133, United States
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Rockville, Maryland, 20874, United States
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Alpena, Michigan, 49707, United States
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Ann Arbor, Michigan, 48109, United States
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Bloomfield Hills, Michigan, 48302, United States
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Detroit, Michigan, 48201, United States
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Detroit, Michigan, 48202, United States
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Duluth, Minnesota, 55805, United States
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Minneapolis, Minnesota, 55416, United States
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Minneapolis, Minnesota, 55454, United States
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Saint Cloud, Minnesota, 56303, United States
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Bridgeton, Missouri, 63044, United States
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Chesterfield, Missouri, 63017, United States
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Billings, Montana, 59101, United States
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Butte, Montana, 59701, United States
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Omaha, Nebraska, 68154, United States
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Las Vegas, Nevada, 89121, United States
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Reno, Nevada, 89511, United States
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Hamilton, New Jersey, 08690, United States
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Lyons, New Jersey, 07939, United States
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Margate City, New Jersey, 08402, United States
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South Plainfield, New Jersey, 07080, United States
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Albany, New York, 12203, United States
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Manhasset, New York, 11030, United States
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New York, New York, 10001, United States
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New York, New York, 10032, United States
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North Massapequa, New York, 11758, United States
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Rosedale, New York, 11422, United States
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Smithtown, New York, 11787, United States
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The Bronx, New York, 10461, United States
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Charlotte, North Carolina, 28207, United States
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Durham, North Carolina, 27705, United States
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Greensboro, North Carolina, 27401, United States
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Hickory, North Carolina, 28602, United States
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Mooresville, North Carolina, 28117, United States
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Morehead City, North Carolina, 28557, United States
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Raleigh, North Carolina, 27609, United States
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Salisbury, North Carolina, 28144, United States
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Statesville, North Carolina, 28625, United States
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Wilmington, North Carolina, 28401, United States
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Winston-Salem, North Carolina, 27103, United States
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Fargo, North Dakota, 58103, United States
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Barberton, Ohio, 44203, United States
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Canal Fulton, Ohio, 44614, United States
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Cleveland, Ohio, 44121, United States
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Cleveland, Ohio, 44122, United States
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Cleveland, Ohio, 44195, United States
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Columbus, Ohio, 43210, United States
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Kettering, Ohio, 45429, United States
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Mentor, Ohio, 44060, United States
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Toledo, Ohio, 43614, United States
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Oklahoma City, Oklahoma, 73103, United States
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Bethlehem, Pennsylvania, 18015, United States
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Feasterville, Pennsylvania, 19053, United States
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Lansdale, Pennsylvania, 19446, United States
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Newport, Pennsylvania, 17011, United States
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Newport, Pennsylvania, 17074, United States
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Penndel, Pennsylvania, 19047, United States
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Philadelphia, Pennsylvania, 19114, United States
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Philadelphia, Pennsylvania, 19134, United States
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Tipton, Pennsylvania, 16684, United States
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Pawtucket, Rhode Island, 02860, United States
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Charleston, South Carolina, 29401, United States
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Mt. Pleasant, South Carolina, 29464, United States
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Murrells Inlet, South Carolina, 29576, United States
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Rapid City, South Dakota, 57701, United States
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Bristol, Tennessee, 37620, United States
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Chattanooga, Tennessee, 37403, United States
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Jackson, Tennessee, 38305, United States
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Johnson City, Tennessee, 37601, United States
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Kingsport, Tennessee, 37660, United States
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Knoxville, Tennessee, 37912, United States
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McKenzie, Tennessee, 38201, United States
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Nashville, Tennessee, 37203, United States
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Arlington, Texas, 76012, United States
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Dallas, Texas, 75218, United States
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Dallas, Texas, 75231, United States
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Dallas, Texas, 75251, United States
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Dallas, Texas, 75390, United States
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El Paso, Texas, 79925, United States
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Friendswood, Texas, 77546, United States
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Houston, Texas, 77030, United States
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San Antonio, Texas, 78229, United States
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Webster, Texas, 77598, United States
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Layton, Utah, 84041, United States
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Buenos Aires, C1425AGC, Argentina
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Buenos Aires, C1437BZL, Argentina
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CABA, 1426, Argentina
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CABA, C1119ACN, Argentina
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CABA, C1120AAC, Argentina
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Capital Federal, C1425DES, Argentina
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CiudadAutonoma de Buenos Aires, C1419AHL, Argentina
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Córdoba, 5000, Argentina
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Córdoba, X5003DCE, Argentina
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Córdoba, X5004FHP, Argentina
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Córdoba, X5008HHW, Argentina
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Godoy Cruz, M5501ARP, Argentina
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Mar Del Plata Buenos Aires, B7600DIA, Argentina
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Rosario, S2000CVD, Argentina
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Salta, A4400ANG, Argentina
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San Miguel de Tucumán, 4000, Argentina
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San Salvador de Jujuy, Argentina
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Santa Rosa, Argentina
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Adelaide, 5000, Australia
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Camperdown, 2050, Australia
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Clayton, 3168, Australia
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East Gosford, 2250, Australia
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Elizabeth Vale, 5112, Australia
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Fitzroy, 3065, Australia
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Garran, 2605, Australia
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Geelong, 3220, Australia
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Heidelberg West, 3081, Australia
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Meadobank, 4131, Australia
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Milton, 4064, Australia
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Parkville, 3050, Australia
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Sydney, 2006, Australia
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Feldkirch, 6807, Austria
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Salzburg, 5020, Austria
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Vienna, 1030, Austria
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Vienna, 1090, Austria
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Vienna, 1130, Austria
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Vienna, 1160, Austria
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Zams, 6511, Austria
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Brussels, 1200, Belgium
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Leuven, 3000, Belgium
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Merksem, 2170, Belgium
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Ronse, 9600, Belgium
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Aparecida de Goiânia, 74905-350, Brazil
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Belém, 66073-000, Brazil
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Brasília, 71625-175, Brazil
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Campinas, 13010-001, Brazil
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Campinas, 13060-904, Brazil
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Curitiba, 80060-900, Brazil
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Curitiba, 80730-150, Brazil
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Fortaleza, 60115282, Brazil
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Fortaleza, 60430-350, Brazil
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Goiânia, 74125-170, Brazil
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Marília, 17515-460, Brazil
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Passo Fundo, 99010-080, Brazil
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Recife, 52020010, Brazil
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São Paulo, 01244-030, Brazil
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São Paulo, 04022001, Brazil
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Blagoevgrad, 2700, Bulgaria
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Gabrovo, 5300, Bulgaria
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Golenci, 5960, Bulgaria
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Plovdiv, 4000, Bulgaria
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Plovdiv, 4002, Bulgaria
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Sevlievo, 5400, Bulgaria
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Sliven, 8800, Bulgaria
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Sofia, 1233, Bulgaria
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Sofia, 1431, Bulgaria
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Sofia, 1606, Bulgaria
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Sofia, 1632, Bulgaria
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Sofia, Bulgaria
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Stara Zagora, 6000, Bulgaria
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Calgary, Alberta, T2T 5C7, Canada
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Delta, British Columbia, V4K 2K5, Canada
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New Westminster, British Columbia, V3L 3W4, Canada
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Surrey, British Columbia, V3V 0C6, Canada
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Vancouver, British Columbia, V5Z 1M9, Canada
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Winnipeg, Manitoba, R2H 0R8, Canada
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Winnipeg, Manitoba, R3E 3P4, Canada
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Moncton, New Brunswick, E1G 1A7, Canada
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Bridgewater, Nova Scotia, B4V 3N2, Canada
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Liverpool, Nova Scotia, B0T 1K0, Canada
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Cambridge, Ontario, N1R 6V6, Canada
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Guelph, Ontario, N1H 1B1, Canada
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Hamilton, Ontario, L8L 5G8, Canada
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Hamilton, Ontario, L8M 1K7, Canada
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Hamilton, Ontario, L8N 3Z5, Canada
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Kitchener, Ontario, N2M 5N6, Canada
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London, Ontario, N6B 2E5, Canada
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North York, Ontario, M3M 3E5, Canada
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Ottawa, Ontario, K1H 1A2, Canada
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Scarborough Village, Ontario, M1E 5E9, Canada
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Smiths Falls, Ontario, K7A 4W8, Canada
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Toronto, Ontario, M5C 2T2, Canada
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Toronto, Ontario, M5T 3L9, Canada
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Laval, Quebec, H7T 2P5, Canada
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Montreal, Quebec, H1M 1B1, Canada
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Montreal, Quebec, H3A 1A1, Canada
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Sainte-Foy, Quebec, G1V 4G5, Canada
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Terrebonne, Quebec, J6V 1S8, Canada
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Osorno, 5290000, Chile
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Puerto Varas, Chile
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Santiago, 7500710, Chile
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Santiago, 8053095, Chile
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Temuco, 4781173, Chile
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Viña del Mar, 2570017, Chile
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Beijing, 100029, China
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Beijing, 100034, China
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Beijing, 100044, China
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Beijing, 100853, China
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Chongqing, 400010, China
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Chongqing, 400016, China
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Chuangchun, 130012, China
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Guangzhou, 510080, China
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Guangzhou, 510120, China
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Hangzhou, 310009, China
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Hong Kong, China
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Nanjing, 210012, China
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Nanjing, 210029, China
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Nanning, 530021, China
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Shanghai, 200072, China
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Shijiazhuang, 050000, China
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Siping, 136000, China
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Suzhou, 215004, China
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Wenzhou, China
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Wuhan, 430000, China
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Xi'an, 710061, China
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Yinchuan, 750004, China
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Barranquilla, 80020, Colombia
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Barranquilla, Colombia
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Bogotá, Colombia
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Bogotá D.C., Colombia
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Cali, 760035, Colombia
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Manizales, 17001, Colombia
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Medellín, 5001000, Colombia
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Medellín, Colombia
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Olomouc-Lazce, 779 00, Czechia
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Prague, 140 00, Czechia
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Praha 10, Prague, 100 34, Czechia
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Svitavy, 568 25, Czechia
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Znojmo, 669 02, Czechia
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Aachen, 52074, Germany
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Aschaffenburg, 63739, Germany
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Bad Nauheim, 61231, Germany
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Bad Oeynhausen, 32545, Germany
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Berlin, 10787, Germany
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Berlin, 13125, Germany
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Berlin, 13353, Germany
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Bochum, 44791, Germany
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Burg, 03096, Germany
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Burghausen, 84489, Germany
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Chemnitz, 09111, Germany
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Dortmund, 44137, Germany
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Dresden, 01067, Germany
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Dresden, 01219, Germany
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Dresden, 01307, Germany
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Eschweiler, 52249, Germany
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Essen, 45355, Germany
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Giessen, 35392, Germany
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Herne, 44653, Germany
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Hohenmölsen, 06679, Germany
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Kassel, 34121, Germany
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Kiel-Kronshagen, 24119, Germany
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Köthen, 06366, Germany
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Lichtenfels, 96215, Germany
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Mainz, 55116, Germany
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Mayen, 56727, Germany
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München, 80336, Germany
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München, 81925, Germany
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Münster, 48145, Germany
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Obermichelbach, 90587, Germany
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Osnabrück, 49080, Germany
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Riesa, 01587, Germany
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Rotenburg (Wümme), 36199, Germany
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Stuttgart, 70376, Germany
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Würzburg, 97072, Germany
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Hong Kong, Hong Kong
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Shatin, Hong Kong
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Balatonfüred, 8230, Hungary
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Budapest, 1036, Hungary
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Budapest, 1045, Hungary
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Budapest, 1083, Hungary
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Budapest, 1085, Hungary
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Budapest, 1096, Hungary
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Budapest, 1145, Hungary
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Budapest, 1204, Hungary
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Budapest, 1213, Hungary
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Budapest, H-1096, Hungary
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Csongrád, 6640, Hungary
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Debrecen, 4032, Hungary
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Eger, 3300, Hungary
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Győr, 9023, Hungary
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Hódmezővásárhely, 6800, Hungary
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Jászberény, 5100, Hungary
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Kaposvár, 7400, Hungary
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Kecskemét, 6000, Hungary
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Komárom, 2921, Hungary
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Mosonmagyaróvár, H-9200, Hungary
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Nagykanizsa, 8800, Hungary
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Nyíregyháza, 4400, Hungary
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Pápa, 8500, Hungary
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Pécs, 7624, Hungary
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Sátoraljaújhely, 3980, Hungary
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Szekszárd, 7100, Hungary
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Szentes, 6600, Hungary
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Szentes, H-6600, Hungary
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Székesfehérvár, 8000, Hungary
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Szigetvár, 7900, Hungary
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Szikszó, 3800, Hungary
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Veszprém, 8200, Hungary
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Zalaegerszeg, 8900, Hungary
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Giv‘atayim, 53583, Israel
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Hadera, 38100, Israel
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Hadera, 3842207, Israel
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Haifa, 31048, Israel
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Haifa, 34362, Israel
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Holon, 58100, Israel
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Jerusalem, 9103102, Israel
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Jerusalem, 91120, Israel
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Kfar Saba, 49281, Israel
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Nahariya, 22100, Israel
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Nazareth, 16100, Israel
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Petah Tikva, 49100, Israel
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Safed, 13100, Israel
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Tel Aviv, 62038, Israel
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Tel Aviv, 64239, Israel
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Florence, 50134, Italy
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Foggia, 71100, Italy
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Milan, 20138, Italy
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Pisa, 56100, Italy
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Roma, 00128, Italy
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Sesto San Giovanni, 20099, Italy
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Terni, 05100, Italy
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Udine, 33100, Italy
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Daugavpils, 5417, Latvia
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Jelgava, LV-3000, Latvia
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Kuldīga, LV-3301, Latvia
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Kuldīga, LV3301, Latvia
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Ogre, LV-5001, Latvia
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Riga, 1012, Latvia
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Riga, LV-1002, Latvia
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Riga, LV-1050, Latvia
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Riga, LV1002, Latvia
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Talsi, LV-3201, Latvia
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Tukums, LV3101, Latvia
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Kaunas, 48259, Lithuania
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Kaunas, 49449, Lithuania
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Kaunas, 50009, Lithuania
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Kaunas, LT-48426, Lithuania
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Kaunas, LT-49287, Lithuania
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Kaunas, LT-49427, Lithuania
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Kėdainiai, LT-57445, Lithuania
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Klaipėda, LT-92288, Lithuania
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Klaipėda, LT-94198, Lithuania
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Panevezys, LT-37355, Lithuania
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Ukmerge, LT-20184, Lithuania
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Utena, LT-28151, Lithuania
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Vilnius, 04318, Lithuania
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Vilnius, 08661, Lithuania
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Vilnius, 09112, Lithuania
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Alor Star, 5460, Malaysia
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Batu Caves, 68100, Malaysia
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Kota Samarahan, 94300, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Kuching, 93586, Malaysia
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Sungai Buloh, 47000, Malaysia
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Taiping, 34000, Malaysia
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Aguascalientes, 20127, Mexico
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Cuautla, 62746, Mexico
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Durango, 34080, Mexico
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Guadalajara, 44670, Mexico
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México, 06700, Mexico
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México, 10700, Mexico
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México, 52763, Mexico
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México, 6090, Mexico
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Monterrey, 64710, Mexico
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Puebla City, 72190, Mexico
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Querétaro, 76000, Mexico
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San Luis Potosí City, 78240, Mexico
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Amersfoort, 3813 TZ, Netherlands
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Amsterdam, 1081 HV, Netherlands
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Eindhoven, 5611 NV, Netherlands
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Groningen, 9711 SG, Netherlands
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Hardenberg, 7772 SE, Netherlands
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Hoogeveen, 7909 AA, Netherlands
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Meppel, 7943 KA, Netherlands
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Rotterdam, 3039 BD, Netherlands
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Sneek, 8601 ZK, Netherlands
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Utrecht, 3584 CX, Netherlands
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Christchurch, 08011, New Zealand
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Christchurch, 8024, New Zealand
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Christchurch, 8041, New Zealand
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Hamilton, 3240, New Zealand
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Nelson, 7010, New Zealand
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Newtown, 6242, New Zealand
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Palmerston North, 4410, New Zealand
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Takapuna, 0622, New Zealand
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Tauranga, 3112, New Zealand
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Tauranga, 3143, New Zealand
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Wellington, 6021, New Zealand
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Cebu, 6000, Philippines
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Iloilo City, 5000, Philippines
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Manila, 1000, Philippines
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Marikina City, 1810, Philippines
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Pasig, 1605, Philippines
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Quezon, 1000, Philippines
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Quezon, 1110, Philippines
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Quezon, 1113, Philippines
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Quezon City, 1101, Philippines
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San Juan City, Philippines
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Elblag, 82-300, Poland
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Gdynia, 81-472, Poland
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Grodzisk Mazowiecki, 05-825, Poland
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Grudziądz, 86-300, Poland
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Katowice, 40-752, Poland
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Lodz, 94-074, Poland
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Lublin, 20-090, Poland
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Ostrołęka, 07-400, Poland
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Poznan, 60-659, Poland
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Płock, 09-402, Poland
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Słupsk, 76-200, Poland
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Warsaw, 04-635, Poland
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Wroclaw, 50-127, Poland
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Wroclaw, 50-403, Poland
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Wroclaw, 51-124, Poland
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Łęczna, 21-010, Poland
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Bacau, 600164, Romania
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Bucharest, 010507, Romania
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Bucharest, 010627, Romania
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Bucharest, 020725, Romania
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Bucharest, 030306, Romania
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Bucharest, 042122, Romania
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Buzău, 120203, Romania
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Cluj-Napoca, 400006, Romania
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Cluj-Napoca, 400349, Romania
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Craiova, 200147, Romania
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Iași, 700111, Romania
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Oradea, 410169, Romania
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Ploieşti, 100477, Romania
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Satu Mare, 440055, Romania
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Timișoara, 300125, Romania
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Timișoara, 300456, Romania
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Zalău, 450129, Romania
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Kemerovo, 650002, Russia
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Krasnoyarsk, 660022, Russia
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Moscow, 105120, Russia
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Moscow, 129110, Russia
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Nizhny Novgorod, 603018, Russia
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Novosibirsk, 630087, Russia
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Saint Peterburg, 195112, Russia
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Saint Petersburg, 196601, Russia
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St.Рetersburg, 198035, Russia
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Thymen, 625023, Russia
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Tomsk, 634012, Russia
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Tomsk, 634050, Russia
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Yaroslavl, 150010, Russia
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Yaroslavl, 150062, Russia
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Yekaterinburg, 620219, Russia
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Bardejov, 085 01, Slovakia
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Bratislava, 813 69, Slovakia
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Bratislava, 82606, Slovakia
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Košice, 040 01, Slovakia
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Košice, 04022, Slovakia
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Košice, 044 24, Slovakia
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Lučenec, 984 01, Slovakia
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Prešov, 080 01, Slovakia
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Rožňava, 048 01, Slovakia
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Trebišov, 075 01, Slovakia
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Žilina, 010 01, Slovakia
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Boksburg, 1459, South Africa
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Brits, 0250, South Africa
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Cape Town, 7460, South Africa
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Cape Town, 7500, South Africa
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Cape Town, 7700, South Africa
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Centurion, 0157, South Africa
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Durban, 4001, South Africa
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Durban, 4052, South Africa
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eMkhomazi, 4170, South Africa
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Johannesburg, 2198, South Africa
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Kempton Park, 1619, South Africa
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Lenasia, 1827, South Africa
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Paarl, 7646, South Africa
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Parktown, 2193, South Africa
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Phoenix, 4068, South Africa
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Port Elizabeth, 6014, South Africa
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Potchefstroom, 2531, South Africa
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Pretoria, 0001, South Africa
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Pretoria, 0014, South Africa
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Pretoria, 0101, South Africa
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Somerset West, 7130, South Africa
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Soweto, 2013, South Africa
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Busan, 49241, South Korea
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Daegu, 41931, South Korea
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Daegu, 700-721, South Korea
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Daegu, 705-718, South Korea
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Gwangjin-gu, 110-744, South Korea
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Gyeonggi-do, 411-706, South Korea
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Incheon, 403-720, South Korea
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Seongnam, 463-707, South Korea
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Seoul, 08308, South Korea
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Seoul, 110746, South Korea
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Seoul, 134-727, South Korea
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Seoul, 135-720, South Korea
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Seoul, 137-701, South Korea
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Suwon, 16247, South Korea
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Suwon, 443-721, South Korea
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Ulsan, 682-714, South Korea
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A Coruña, 15006, Spain
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Alcalá de Henares, 28805, Spain
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Ávila, 05004, Spain
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Ferrol, 15405, Spain
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Girona, 17007, Spain
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Granada, 18004, Spain
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Granada, 18012, Spain
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Lleida, 25198, Spain
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Madrid, 28007, Spain
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Madrid, 28034, Spain
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Madrid, 28046, Spain
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Madrid, 28702, Spain
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Manacor, 07500, Spain
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Málaga, 29006, Spain
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Palma de Mallorca, 07198, Spain
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Palma deMallorca, 07010, Spain
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Salamanca, 37003, Spain
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Seville, 41010, Spain
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Tarragona, 43007, Spain
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Changhua, 500, Taiwan
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Kaohsiung City, 80756, Taiwan
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Kaohsiung Hsien, 83301, Taiwan
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Kweishan Shiang, 333, Taiwan
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New Taipei City, 23148, Taiwan
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Taichung, 40705, Taiwan
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Taichung, 433, Taiwan
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Tainan County, Taiwan
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Taipei, 100, Taiwan
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Taipei, 11490, Taiwan
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Bangkok, 10400, Thailand
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Chernivtsi, 58022, Ukraine
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Dnipro, 49006, Ukraine
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Dnipropetrovsk, 49027, Ukraine
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Donetck, 83045, Ukraine
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Donetsk, 83059, Ukraine
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Donetsk, 83114, Ukraine
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Ivano-Frankivsk, 76000, Ukraine
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Kharkiv, 61029, Ukraine
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Kharkiv, 61037, Ukraine
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Kharkiv, 61039, Ukraine
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Kharkiv, 61178, Ukraine
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Kiev, 04114, Ukraine
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Kiev, 07050, Ukraine
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Kyiv, 2091, Ukraine
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Kyiv, 3680, Ukraine
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Odesa, 65025, Ukraine
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Odesa, 65114, Ukraine
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Sumy, 40022, Ukraine
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Ternopil, 46002, Ukraine
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Uzhhorod, 88014, Ukraine
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Vinnytsia, 21010, Ukraine
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Zaporizhia, 69001, Ukraine
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Zaporizhzhya, 69118, Ukraine
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Zhytomyr, 10002, Ukraine
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Aberdeen, AB25 2ZD, United Kingdom
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Addlestone, KT15 2BH, United Kingdom
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Birmingham, B9 5SS, United Kingdom
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Blackpool, FY4 3AD, United Kingdom
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Bradford, BD9 6RJ, United Kingdom
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Bristol, BS10 5NB, United Kingdom
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Cambridge, CB2 0QQ, United Kingdom
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Chippenham, SN14 6GT, United Kingdom
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Coventry, CV2 2DX, United Kingdom
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Dundee, DD1 9SY, United Kingdom
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Edinburgh, EH4 2XU, United Kingdom
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Glasgow, G12 8TA, United Kingdom
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Hull, HU3 2JZ, United Kingdom
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Inverness, IV2 3JH, United Kingdom
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Irvine, KA12 0AY, United Kingdom
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Leicester, LE5 4PW, United Kingdom
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Liverpool, L7 8XP, United Kingdom
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Manchester, M8 5RB, United Kingdom
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Northampton, NN1 5BD, United Kingdom
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Ormskirk, L39 2AZ, United Kingdom
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Peterborough, PE8 6PL, United Kingdom
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Plymouth, PL5 3JB, United Kingdom
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Plymouth, PL6 8BX, United Kingdom
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Redhill, RH1 5RH, United Kingdom
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Sheffield, S5 7AU, United Kingdom
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Suffolk, IP33 2QZ, United Kingdom
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Swansea, SN6 6NL, United Kingdom
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Trowbridge, BA14 8QA, United Kingdom
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West Sussex, RH10 7DX, United Kingdom
Related Publications (18)
Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.
PMID: 39963952DERIVEDKoychev I, Reid G, Nguyen M, Mentz RJ, Joyce D, Shah SH, Holman RR. Inflammatory proteins associated with Alzheimer's disease reduced by a GLP1 receptor agonist: a post hoc analysis of the EXSCEL randomized placebo controlled trial. Alzheimers Res Ther. 2024 Oct 2;16(1):212. doi: 10.1186/s13195-024-01573-x.
PMID: 39358806DERIVEDGao N, Dakin HA, Holman RR, Lim LL, Leal J, Clarke P. Estimating Risk Factor Time Paths Among People with Type 2 Diabetes and QALY Gains from Risk Factor Management. Pharmacoeconomics. 2024 Sep;42(9):1017-1028. doi: 10.1007/s40273-024-01398-4. Epub 2024 Jun 26.
PMID: 38922488DERIVEDDavis TME, Giczewska A, Lokhnygina Y, Mentz RJ, Sattar N, Holman RR; EXSCEL Study Group. Effect of race on cardiometabolic responses to once-weekly exenatide: insights from the Exenatide Study of Cardiovascular Event Lowering (EXSCEL). Cardiovasc Diabetol. 2022 Jun 27;21(1):116. doi: 10.1186/s12933-022-01555-z.
PMID: 35761271DERIVEDBecker F, Dakin HA, Reed SD, Li Y, Leal J, Gustavson SM, Wittbrodt E, Hernandez AF, Gray AM, Holman RR. Lifetime cost-effectiveness simulation of once-weekly exenatide in type 2 diabetes: A cost-utility analysis based on the EXSCEL trial. Diabetes Res Clin Pract. 2022 Jan;183:109152. doi: 10.1016/j.diabres.2021.109152. Epub 2021 Nov 20.
PMID: 34813910DERIVEDBethel MA, Stevens SR, Buse JB, Choi J, Gustavson SM, Iqbal N, Lokhnygina Y, Mentz RJ, Patel RA, Ohman P, Schernthaner G, Lecube A, Hernandez AF, Holman RR. Exploring the Possible Impact of Unbalanced Open-Label Drop-In of Glucose-Lowering Medications on EXSCEL Outcomes. Circulation. 2020 Apr 28;141(17):1360-1370. doi: 10.1161/CIRCULATIONAHA.119.043353. Epub 2020 Feb 26.
PMID: 32098501DERIVEDStandl E, Stevens SR, Lokhnygina Y, Bethel MA, Buse JB, Gustavson SM, Maggioni AP, Mentz RJ, Hernandez AF, Holman RR; EXSCEL Study Group. Confirming the Bidirectional Nature of the Association Between Severe Hypoglycemic and Cardiovascular Events in Type 2 Diabetes: Insights From EXSCEL. Diabetes Care. 2020 Mar;43(3):643-652. doi: 10.2337/dc19-1079. Epub 2019 Dec 27.
PMID: 31882409DERIVEDReed SD, Li Y, Dakin HA, Becker F, Leal J, Gustavson SM, Kartman B, Wittbrodt E, Mentz RJ, Pagidipati NJ, Bethel MA, Gray AM, Holman RR, Hernandez AF; EXSCEL Study Group. Within-Trial Evaluation of Medical Resources, Costs, and Quality of Life Among Patients With Type 2 Diabetes Participating in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL). Diabetes Care. 2020 Feb;43(2):374-381. doi: 10.2337/dc19-0950. Epub 2019 Dec 5.
PMID: 31806653DERIVEDBadjatiya A, Merrill P, Buse JB, Goodman SG, Katona B, Iqbal N, Pagidipati NJ, Sattar N, Holman RR, Hernandez AF, Mentz RJ, Patel MR, Jones WS. Clinical Outcomes in Patients With Type 2 Diabetes Mellitus and Peripheral Artery Disease: Results From the EXSCEL Trial. Circ Cardiovasc Interv. 2019 Dec;12(12):e008018. doi: 10.1161/CIRCINTERVENTIONS.119.008018. Epub 2019 Nov 22.
PMID: 31752517DERIVEDClegg LE, Penland RC, Bachina S, Boulton DW, Thuresson M, Heerspink HJL, Gustavson S, Sjostrom CD, Ruggles JA, Hernandez AF, Buse JB, Mentz RJ, Holman RR. Effects of exenatide and open-label SGLT2 inhibitor treatment, given in parallel or sequentially, on mortality and cardiovascular and renal outcomes in type 2 diabetes: insights from the EXSCEL trial. Cardiovasc Diabetol. 2019 Oct 22;18(1):138. doi: 10.1186/s12933-019-0942-x.
PMID: 31640705DERIVEDFudim M, White J, Pagidipati NJ, Lokhnygina Y, Wainstein J, Murin J, Iqbal N, Ohman P, Lopes RD, Reicher B, Holman RR, Hernandez AF, Mentz RJ. Effect of Once-Weekly Exenatide in Patients With Type 2 Diabetes Mellitus With and Without Heart Failure and Heart Failure-Related Outcomes: Insights From the EXSCEL Trial. Circulation. 2019 Nov 12;140(20):1613-1622. doi: 10.1161/CIRCULATIONAHA.119.041659. Epub 2019 Sep 23.
PMID: 31542942DERIVEDBethel MA, Patel RA, Thompson VP, Merrill P, Reed SD, Li Y, Ahmadi S, Katona BG, Gustavson SM, Ohman P, Iqbal N, Gagel RF, Hernandez AF, Buse JB, Holman RR; EXSCEL Study Group. Changes in Serum Calcitonin Concentrations, Incidence of Medullary Thyroid Carcinoma, and Impact of Routine Calcitonin Concentration Monitoring in the EXenatide Study of Cardiovascular Event Lowering (EXSCEL). Diabetes Care. 2019 Jun;42(6):1075-1080. doi: 10.2337/dc18-2028. Epub 2019 Apr 22.
PMID: 31010875DERIVEDMentz RJ, Bethel MA, Merrill P, Lokhnygina Y, Buse JB, Chan JC, Felicio JS, Goodman SG, Choi J, Gustavson SM, Iqbal N, Lopes RD, Maggioni AP, Ohman P, Pagidipati NJ, Poulter NR, Ramachandran A, Reicher B, Holman RR, Hernandez AF; EXSCEL Study Group. Effect of Once-Weekly Exenatide on Clinical Outcomes According to Baseline Risk in Patients With Type 2 Diabetes Mellitus: Insights From the EXSCEL Trial. J Am Heart Assoc. 2018 Oct 2;7(19):e009304. doi: 10.1161/JAHA.118.009304.
PMID: 30371301DERIVEDWittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Am J Manag Care. 2018 Apr;24(8 Suppl):S146-S155.
PMID: 29693361DERIVEDHolman RR, Bethel MA, Mentz RJ, Thompson VP, Lokhnygina Y, Buse JB, Chan JC, Choi J, Gustavson SM, Iqbal N, Maggioni AP, Marso SP, Ohman P, Pagidipati NJ, Poulter N, Ramachandran A, Zinman B, Hernandez AF; EXSCEL Study Group. Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2017 Sep 28;377(13):1228-1239. doi: 10.1056/NEJMoa1612917. Epub 2017 Sep 14.
PMID: 28910237DERIVEDMentz RJ, Bethel MA, Gustavson S, Thompson VP, Pagidipati NJ, Buse JB, Chan JC, Iqbal N, Maggioni AP, Marso SP, Ohman P, Poulter N, Ramachandran A, Zinman B, Hernandez AF, Holman RR. Baseline characteristics of patients enrolled in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL). Am Heart J. 2017 May;187:1-9. doi: 10.1016/j.ahj.2017.02.005. Epub 2017 Feb 12.
PMID: 28454792DERIVEDHolman RR, Bethel MA, George J, Sourij H, Doran Z, Keenan J, Khurmi NS, Mentz RJ, Oulhaj A, Buse JB, Chan JC, Iqbal N, Kundu S, Maggioni AP, Marso SP, Ohman P, Pencina MJ, Poulter N, Porter LE, Ramachandran A, Zinman B, Hernandez AF. Rationale and design of the EXenatide Study of Cardiovascular Event Lowering (EXSCEL) trial. Am Heart J. 2016 Apr;174:103-10. doi: 10.1016/j.ahj.2015.12.009. Epub 2015 Dec 21.
PMID: 26995376DERIVEDGaebler JA, Soto-Campos G, Alperin P, Cohen M, Blickensderfer A, Wintle M, Maggs D, Hoogwerf B, Han J, Pencek R, Peskin B. Health and economic outcomes for exenatide once weekly, insulin, and pioglitazone therapies in the treatment of type 2 diabetes: a simulation analysis. Vasc Health Risk Manag. 2012;8:255-64. doi: 10.2147/VHRM.S28744. Epub 2012 Apr 23.
PMID: 22566747DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Only SAE are collected in this study.
Results Point of Contact
- Title
- Peter Ohman
- Organization
- Astrazaneca Inc.
Study Officials
- STUDY DIRECTOR
Stephanie Gustavson, PhD
AstraZeneca
- STUDY DIRECTOR
Group Director Global Clinical Research
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2010
First Posted
June 15, 2010
Study Start
June 18, 2010
Primary Completion
April 21, 2017
Study Completion
April 24, 2017
Last Updated
August 8, 2018
Results First Posted
August 8, 2018
Record last verified: 2018-07