Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia
STRENGTH
A Long-Term Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh Cardiovascular Risk PatienTs With Hypertriglyceridemia (STRENGTH)
2 other identifiers
interventional
13,078
22 countries
684
Brief Summary
The study is a randomized, double-blind, placebo-controlled (corn oil), parallel group design that will enroll approximately 13,000 patients with hypertriglyceridemia and low HDL and high risk for CVD to be randomized 1:1 to either corn oil + statin or Epanova + statin, once daily, for approximately 3-5 years as determined when the number of MACE outcomes is reached.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2014
Longer than P75 for phase_3
684 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
April 2, 2014
CompletedFirst Posted
Study publicly available on registry
April 4, 2014
CompletedStudy Start
First participant enrolled
October 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 27, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 27, 2020
CompletedResults Posted
Study results publicly available
July 28, 2021
CompletedAugust 17, 2021
August 1, 2021
5.6 years
April 2, 2014
May 25, 2021
August 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Composite of Major Adverse Cardiovascular Events (MACE)
MACE components include: cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Secondary Outcomes (9)
The Composite of MACE in the Subgroup of Participants With Established CV Disease(CVD) at Baseline
From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
The Composite of CV Events
From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
The Composite of CV Events in the Subgroup of Participants With Established CV Disease (CVD) at Baseline
From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
The Composite of Coronary Events
From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
The Composite of Coronary Events in the Subgroup of Participants With Established CVD at Baseline
From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
- +4 more secondary outcomes
Other Outcomes (4)
Emergent/Elective Coronary Revascularization
From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Hospitalization for Unstable Angina
From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Non-fatal Myocardial Infarction
From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
- +1 more other outcomes
Study Arms (2)
EPANOVA
EXPERIMENTALEpanova + statin, once daily
Corn oil
ACTIVE COMPARATORCorn oil + Statin
Interventions
Adjunct to statin therapy and diet in high risk adult patients for the prevention and reduction of major adverse cardiovascular events (MACE)
Eligibility Criteria
You may qualify if:
- Men or women, ≥18 years of age.
- Patient must be on a stable diet and statin\* therapy at least 4 weeks prior to randomization (Visit 2) and meet the following criteria:
- LDL-C \<100 mg/dL
- TG level ≥180 and \<500 mg/dL and HDL-C \<42 mg/dL for men or HDL-C \<47 mg/dL for women
- Patient is at high risk for a future cardiovascular event if at least one of the following criteria (3a, 3b or 3c)\* is present via patient history, physical exam, or medical records at the time of screening:
- Any atherosclerotic CVD as defined in protocol.
- History of diabetes mellitus (type 1 or 2) and ≥40 years of age for men and ≥50 years of age for women, plus one of the risk factors defined in protocol.
- Male patients \>50 years of age or females \>60 years of age, with at least one of the risk factors defined in protocol.
You may not qualify if:
- \. Allergy or intolerance to omega-3 carboxylic acids, omega-3 fatty acids, omega-3-acid ethyl esters, or corn oil. 2.Use of fibrates, bile acid sequestrants, or niacin or its analogues (\>250 mg/day) within 4 weeks prior to Visit 2. 3.Statin naïve at Visit 1.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- The Cleveland Cliniccollaborator
- IQVIA RDS Inc.collaborator
Study Sites (684)
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Birmingham, Alabama, 35205, United States
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Birmingham, Alabama, 35211, United States
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Birmingham, Alabama, 35233, United States
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Birmingham, Alabama, 35235, United States
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Huntsville, Alabama, 35801, United States
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Muscle Shoals, Alabama, 35662, United States
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Chandler, Arizona, 85224, United States
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Gilbert, Arizona, 85295, United States
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Glendale, Arizona, 85308, United States
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Mesa, Arizona, 85206, United States
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Mesa, Arizona, 85213, United States
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Phoenix, Arizona, 85032, United States
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Tempe, Arizona, 85283, United States
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Tucson, Arizona, 85710, United States
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Tucson, Arizona, 85712, United States
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Tucson, Arizona, 85741, United States
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Little Rock, Arkansas, 72205, United States
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Little Rock, Arkansas, 72211, United States
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Carlsbad, California, 92008, United States
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Fresno, California, 93720, United States
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Fresno, California, 93721, United States
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Greenbrae, California, 94904, United States
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Long Beach, California, 90807, United States
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Los Angeles, California, 90069, United States
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Milpitas, California, 95035, United States
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Newport Beach, California, 92663, United States
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Northridge, California, 91325-4139, United States
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Palm Springs, California, 92262, United States
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San Diego, California, 92103-6204, United States
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Santa Ana, California, 92705, United States
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Santa Rosa, California, 95405, United States
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Tarzana, California, 91356, United States
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Colorado Springs, Colorado, 80909, United States
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Denver, Colorado, 80239-3133, United States
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Denver, Colorado, 80239, United States
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Denver, Colorado, 80246, United States
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Waterbury, Connecticut, 06708, United States
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Boca Raton, Florida, 33431, United States
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Clearwater, Florida, 33756, United States
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Coral Gables, Florida, 33134, United States
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Davie, Florida, 33330, United States
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Delray Beach, Florida, 33446, United States
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Fort Lauderdale, Florida, 33308, United States
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Hialeah, Florida, 33012, United States
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Homestead, Florida, 33130, United States
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Jacksonville, Florida, 32216, United States
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Jacksonville, Florida, 32277, United States
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Lake Worth, Florida, 33461, United States
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Lakeland, Florida, 33805, United States
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Miami, Florida, 33142, United States
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Miami, Florida, 33173, United States
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Miami, Florida, 33176, United States
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New Port Richey, Florida, 34652, United States
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Pembroke Pines, Florida, 33026, United States
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Pembroke Pines, Florida, 33027, United States
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Pensacola, Florida, 32501, United States
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Pinellas Park, Florida, 33781, United States
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Port Charlotte, Florida, 33952, United States
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Spring Hill, Florida, 34609, United States
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Tamarac, Florida, 33321, United States
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Atlanta, Georgia, 30308, United States
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Marietta, Georgia, 30067, United States
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Sandy Springs, Georgia, 30328, United States
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Savannah, Georgia, 31405, United States
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Arlington Heights, Illinois, 60005, United States
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Blue Island, Illinois, 60406, United States
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Champaign, Illinois, 61820, United States
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Chicago, Illinois, 60637, United States
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Chicago, Illinois, 60654, United States
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Evanston, Illinois, 60201, United States
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Naperville, Illinois, 60566-7226, United States
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Oakbrook Terrace, Illinois, 60181, United States
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Sterling, Illinois, 61081, United States
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Anderson, Indiana, 46011, United States
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Avon, Indiana, 46123, United States
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Elkhart, Indiana, 46514, United States
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Evansville, Indiana, 47714, United States
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Evansville, Indiana, 47715, United States
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Fort Wayne, Indiana, 46845, United States
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Franklin, Indiana, 46131, United States
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Greenfield, Indiana, 46140, United States
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Muncie, Indiana, 47304, United States
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Valparaiso, Indiana, 46383, United States
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Iowa City, Iowa, 52242, United States
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Augusta, Kansas, 67010, United States
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Overland Park, Kansas, 66210, United States
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Louisville, Kentucky, 40213, United States
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Monroe, Louisiana, 71203, United States
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Shreveport, Louisiana, 71101, United States
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Slidell, Louisiana, 70458, United States
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Auburn, Maine, 04210, United States
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Baltimore, Maryland, 21228, United States
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Baltimore, Maryland, 21229, United States
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Elkridge, Maryland, 21075, United States
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Hyannis, Massachusetts, 02601, United States
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Quincy, Massachusetts, 02169, United States
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Bay City, Michigan, 48708, United States
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Cadillac, Michigan, 49601, United States
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Kalamazoo, Michigan, 49048, United States
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Saginaw, Michigan, 48601, United States
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Saginaw, Michigan, 48602, United States
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Traverse City, Michigan, 49684, United States
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Edina, Minnesota, 55435, United States
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Minneapolis, Minnesota, 55455, United States
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Port Gibson, Mississippi, 39150, United States
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Tupelo, Mississippi, 38801, United States
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Bridgeton, Missouri, 63044, United States
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Hazelwood, Missouri, 63042, United States
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Omaha, Nebraska, 68114-1119, United States
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Omaha, Nebraska, 68114, United States
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Omaha, Nebraska, 68131, United States
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Omaha, Nebraska, 68144, United States
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Las Vegas, Nevada, 89120, United States
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Bridgewater, New Jersey, 08807, United States
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Camden, New Jersey, 08103, United States
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Elmer, New Jersey, 08318, United States
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Haddon Heights, New Jersey, 08035, United States
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Sewell, New Jersey, 08080, United States
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Sicklerville, New Jersey, 08081, United States
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Albany, New York, 12205, United States
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Albany, New York, 12208, United States
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Albany, New York, 12211, United States
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Binghamton, New York, 13901, United States
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Laurelton, New York, 11413, United States
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Lawrence, New York, 11559, United States
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New York, New York, 10029, United States
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Saratoga Springs, New York, 12866, United States
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Southampton, New York, 11968, United States
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Troy, New York, 12180, United States
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Asheville, North Carolina, 28801, United States
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Cary, North Carolina, 27518, United States
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Charlotte, North Carolina, 28204, United States
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Charlotte, North Carolina, 28207, United States
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Charlotte, North Carolina, 28209, United States
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Charlotte, North Carolina, 28277, United States
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Greensboro, North Carolina, 27408, United States
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Greenville, North Carolina, 27834, 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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Morganton, North Carolina, 28655, United States
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Raleigh, North Carolina, 27607, United States
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Rocky Mount, North Carolina, 27804, United States
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Salisbury, North Carolina, 28144, 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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Grand Forks, North Dakota, 58201, United States
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Akron, Ohio, 44311, United States
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Cincinnati, Ohio, 45219, United States
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Cincinnati, Ohio, 45227, United States
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Cincinnati, Ohio, 45236, United States
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Cincinnati, Ohio, 45246, United States
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Cleveland, Ohio, 44195, United States
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Columbus, Ohio, 43210, United States
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Marion, Ohio, 43302, United States
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Maumee, Ohio, 43537, United States
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Middleburg Hts, Ohio, 44130, United States
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Midwest City, Oklahoma, 73110, United States
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Norman, Oklahoma, 73069, United States
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Oklahoma City, Oklahoma, 73112-4703, United States
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Oklahoma City, Oklahoma, 73135, United States
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Bend, Oregon, 97701, United States
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Corvallis, Oregon, 97330, United States
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Portland, Oregon, 97229, United States
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Portland, Oregon, 97239, United States
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Allentown, Pennsylvania, 18103, United States
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Beaver, Pennsylvania, 15009, United States
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Danville, Pennsylvania, 17822, United States
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Doylestown, Pennsylvania, 18901, United States
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Ephrata, Pennsylvania, 17522, United States
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Flourtown, Pennsylvania, 19031, United States
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Johnstown, Pennsylvania, 15905, United States
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Natrona Heights, Pennsylvania, 15065, United States
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Newport, Pennsylvania, 17011, United States
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Philadelphia, Pennsylvania, 19104, United States
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Port Matilda, Pennsylvania, 16870-7153, United States
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Tipton, Pennsylvania, 16684, United States
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Wilkes-Barre, Pennsylvania, 18711, United States
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Anderson, South Carolina, 29621, United States
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Charleston, South Carolina, 29407, United States
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Charleston, South Carolina, 29425, United States
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Fountain Inn, South Carolina, 29681, United States
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Greer, South Carolina, 29650, United States
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Greer, South Carolina, 29651, United States
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Mt. Pleasant, South Carolina, 29464, United States
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Rock Hill, South Carolina, 29732, United States
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Simpsonville, South Carolina, 29681, United States
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Spartanburg, South Carolina, 29302, 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, 37421, United States
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Johnson City, Tennessee, 37604, United States
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Kingsport, Tennessee, 37660, United States
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Knoxville, Tennessee, 37912, United States
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Knoxville, Tennessee, 37934, United States
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Arlington, Texas, 76012, United States
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Austin, Texas, 78758, United States
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Corpus Christi, Texas, 78413, United States
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Dallas, Texas, 75390, United States
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Fort Worth, Texas, 76107, United States
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Fort Worth, Texas, 76117, United States
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Fort Worth, Texas, 76132, United States
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Houston, Texas, 77030, United States
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Houston, Texas, 77070, United States
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Houston, Texas, 77079, United States
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Irving, Texas, 75061, United States
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Mission, Texas, 78572, United States
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Odessa, Texas, 79761, United States
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Plano, Texas, 75093, United States
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San Antonio, Texas, 78212, United States
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San Antonio, Texas, 78217, United States
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San Antonio, Texas, 78228, United States
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Victoria, Texas, 77901, United States
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Clinton, Utah, 84015, United States
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Ogden, Utah, 84405, United States
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Orem, Utah, 84058, United States
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Salt Lake City, Utah, 84102, United States
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Salt Lake City, Utah, 84107, United States
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Salt Lake City, Utah, 84124, United States
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Burke, Virginia, 22015, United States
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Danville, Virginia, 24541, United States
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Herndon, Virginia, 20171, United States
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Lynchburg, Virginia, 24501, United States
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Manassas, Virginia, 20109, United States
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Manassas, Virginia, 20110, United States
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Port Orchard, Washington, 98366, United States
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Green Bay, Wisconsin, 54301, United States
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La Crosse, Wisconsin, 54601, United States
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Madison, Wisconsin, 53715, United States
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Wausau, Wisconsin, 54401, United States
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Adelaide, 5000, Australia
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Blacktown, 2148, Australia
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Box Hill, 3128, Australia
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Cowra, 2794, Australia
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Forbes, 2871, Australia
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Fremantle, 6160, Australia
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Herston, 4029, Australia
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Joondalup, 6027, Australia
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Maroubra, 2035, Australia
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Milton, 4064, Australia
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South Brisbane, 4101, Australia
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Southport, 4215, Australia
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Tumbi Vmbi, 2261, Australia
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Wollongong, 2500, Australia
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Aalst, 9300, Belgium
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Antwerp, 2060, Belgium
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Bruges, 8000, Belgium
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Brussels, 1070, Belgium
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Brussels, 1200, Belgium
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Genk, 3600, Belgium
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Halen, 3545, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Mol, 2400, Belgium
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Mons, 7000, Belgium
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New Westminster, British Columbia, V3L 3W4, Canada
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Vancouver, British Columbia, V5E 4E1, Canada
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Barrie, Ontario, L4M 7G1, Canada
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Brampton, Ontario, L6Z 4N5, Canada
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Cambridge, Ontario, N1R 3G2, Canada
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Etobicoke, Ontario, M9R 4E1, Canada
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Newmarket, Ontario, L3Y 5G8, Canada
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North York, Ontario, M3M 3E5, Canada
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Peterborough, Ontario, K9J 0B2, Canada
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Thornhill, Ontario, L4J 8L7, Canada
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Toronto, Ontario, L6H 3P1, Canada
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Toronto, Ontario, M5N 1C1, Canada
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Toronto, Ontario, M9V 4B4, Canada
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Granby, Quebec, J2G 8Z9, Canada
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Laval, Quebec, H7T 2P5, Canada
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Longueuil, Quebec, J4M 2X1, Canada
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Mirabel, Quebec, J7J 2K8, Canada
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Québec, Quebec, G1G 4A2, Canada
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Québec, Quebec, G1W 4R4, Canada
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Sherbrooke, Quebec, J1L 0H8, Canada
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Beijing, 100035, China
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Beijing, 100044, China
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Beijing, 100070, China
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Changchun, 130021, China
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Changchun, 130033, China
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Changsha, 410011, China
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Changsha, 410013, China
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Chengdu, 610041, China
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Chongqing, 400010, China
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Guangzhou, 510080, China
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Guangzhou, 510100, China
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Guangzhou, 510515, China
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Guangzhou, 510630, China
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Haerbin, 150001, China
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Haikou, 570102, China
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Hohhot, 010017, China
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Jilin, 132000, China
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Lanzhou, 730030, China
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Nanchang, 330006, China
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Nanjing, 210011, China
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Nanning, 530021, China
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Shanghai, 200025, China
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Shanghai, 200062, China
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Shanghai, 200065, China
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Shanghai, 200090, China
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Shenyang, 110001, China
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Suzhou, 215028, China
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Taiyuan, 030001, China
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Tianjin, 300052, China
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Tianjin, 300457, China
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Ürümqi, 830054, China
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Xi'an, 710061, China
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Xuzhou, 221006, China
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Yanji, 133000, China
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Yinchuan, 750004, China
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Yueyang, 414000, China
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Zhanjiang, 524001, China
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Zhenjiang, 212002, China
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Beroun, 266 01, Czechia
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Brno, 615 00, Czechia
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Brno, 656 91, Czechia
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Choceň, 565 01, Czechia
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Chrudim, 537 02, Czechia
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Hodonín, 695 01, Czechia
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Hostivice, 253 01, Czechia
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Hradec Králové, 500 02, Czechia
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Hradec Králové, 500 05, Czechia
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Jindřichův Hradec, 377 01, Czechia
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Olomouc, 77900, Czechia
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Ostrava, 702 00, Czechia
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Pardubice, 530 02, Czechia
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Prague, 140 59, Czechia
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Prague, 150 06, Czechia
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Prague, 158 00, Czechia
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Prague, 181 00, Czechia
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Praha 10 - Strasnice, 100 00, Czechia
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Přerov, 750 00, Czechia
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Slaný, 274 01, Czechia
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Trutnov, 541 01, Czechia
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Třemošná, 33011, Czechia
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Zlín, 762 75, Czechia
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Aalborg, 9100, Denmark
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Århus N, 8200, Denmark
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Hellerup, 2900, Denmark
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Herlev, 2730, Denmark
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København Ø, 2100, Denmark
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Svendborg, 5700, Denmark
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Viborg, 8800, Denmark
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Haabneeme, 74001, Estonia
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Pärnu, 80018, Estonia
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Tallinn, 01138, Estonia
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Tallinn, 10617, Estonia
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Tallinn, 13419, Estonia
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Tartu, 50107, Estonia
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Tartu, 50406, Estonia
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Baja, 6500, Hungary
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Balatonfüred, 8230, Hungary
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Balatongyörök, 8313, Hungary
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Ballasagyarmat, 2660, Hungary
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Békéscsaba, 5600, Hungary
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Budapest, 1033, Hungary
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Budapest, 1036, Hungary
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Budapest, 1083, Hungary
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Budapest, 1122, Hungary
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Budapest, 1125, Hungary
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Budapest, 1134, Hungary
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Budapest, 1135, Hungary
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Csorna, 9300, Hungary
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Debrecen, 4025, Hungary
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Debrecen, 4032, Hungary
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Eger, 3300, Hungary
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Gödöllő, 2100, Hungary
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Gyula, 5700, Hungary
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Hajdúszoboszló, 4200, Hungary
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Hatvan, 3000, Hungary
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Kalocsa, 6300, Hungary
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Kiskunhalas, 6400, Hungary
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Komárom, 2921, Hungary
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Létavértes, 4281, Hungary
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Mohács, 7700, Hungary
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Nagykanizsa, 8800, Hungary
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Nyíregyháza, 4400, Hungary
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Nyíregyháza, 4405, Hungary
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Szeged, 6720, Hungary
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Szeged, 6722, Hungary
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Szekszárd, 7100, Hungary
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Szentes, 6600, Hungary
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Székesfehérvár, 8000, Hungary
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Veszprém, 8200, Hungary
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Zalaegerszeg, 8900, Hungary
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Bergamo, 24127, Italy
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Bologna, 40138, Italy
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Brescia, 25100, Italy
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Cinisello Balsamo, 20092, Italy
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Cona, 44124, Italy
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L’Aquila, 67100, Italy
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Milan, 20132, Italy
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Milan, 20138, Italy
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Milan, 20162, Italy
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Napoli, 80131, Italy
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Parma, 43100, Italy
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Pavia, 27100, Italy
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Perugia, 06156, Italy
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Roma, 00133, Italy
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San Giovanni Rotondo, 71013, Italy
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Trieste, 34142, Italy
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Adachi-ku, 120-0006, Japan
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Adachi-ku, 120-0022, Japan
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Akishima-shi, 196-0003, Japan
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Akita, 010-1423, Japan
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Amagasaki-shi, 660-0807, Japan
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Chikushi-gun, 811-1244, Japan
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Chikushino-shi, 818-8516, Japan
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Chūōku, 103-0027, Japan
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Chūōku, 104-0031, Japan
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Fujisawa-shi, 251-8550, Japan
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Gifu, 500-8384, Japan
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Hachioji-shi, 192-0918, Japan
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Hachioji-shi, 193-0811, Japan
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Hakusan-shi, 924-8588, Japan
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Related Publications (2)
Nissen SE, Lincoff AM, Wolski K, Ballantyne CM, Kastelein JJP, Ridker PM, Ray KK, McGuire DK, Mozaffarian D, Koenig W, Davidson MH, Garcia M, Katona BG, Himmelmann A, Loss LE, Poole M, Menon V, Nicholls SJ. Association Between Achieved omega-3 Fatty Acid Levels and Major Adverse Cardiovascular Outcomes in Patients With High Cardiovascular Risk: A Secondary Analysis of the STRENGTH Trial. JAMA Cardiol. 2021 Aug 1;6(8):910-917. doi: 10.1001/jamacardio.2021.1157.
PMID: 33993205DERIVEDNicholls SJ, Lincoff AM, Garcia M, Bash D, Ballantyne CM, Barter PJ, Davidson MH, Kastelein JJP, Koenig W, McGuire DK, Mozaffarian D, Ridker PM, Ray KK, Katona BG, Himmelmann A, Loss LE, Rensfeldt M, Lundstrom T, Agrawal R, Menon V, Wolski K, Nissen SE. Effect of High-Dose Omega-3 Fatty Acids vs Corn Oil on Major Adverse Cardiovascular Events in Patients at High Cardiovascular Risk: The STRENGTH Randomized Clinical Trial. JAMA. 2020 Dec 8;324(22):2268-2280. doi: 10.1001/jama.2020.22258.
PMID: 33190147DERIVED
Related Links
Results Point of Contact
- Title
- AstraZenenca Information Center
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Nissen, MD
The Cleveland Clinic
- PRINCIPAL INVESTIGATOR
Michael Lincoff, MD
The Cleveland Clinic
- PRINCIPAL INVESTIGATOR
Stephen Nicholls, MD
MonashHeart
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
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
April 2, 2014
First Posted
April 4, 2014
Study Start
October 30, 2014
Primary Completion
May 27, 2020
Study Completion
May 27, 2020
Last Updated
August 17, 2021
Results First Posted
July 28, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.