A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin
NCT ID: NCT01492361
Last Updated: 2022-04-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
8179 participants
INTERVENTIONAL
2011-11-30
2018-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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AMR101
AMR101 (icosapent ethyl) + statin therapy, daily
AMR101
Parallel Assignment
Statin therapy
Stable statin therapy (± ezetimibe) for at least 28 days before lipid qualification measurement (LDL-C \>40 mg/dL and ≤100 mg/dL)
Placebo
Placebo + statin therapy, daily
Placebo
Parallel Assignment
Statin therapy
Stable statin therapy (± ezetimibe) for at least 28 days before lipid qualification measurement (LDL-C \>40 mg/dL and ≤100 mg/dL)
Interventions
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AMR101
Parallel Assignment
Placebo
Parallel Assignment
Statin therapy
Stable statin therapy (± ezetimibe) for at least 28 days before lipid qualification measurement (LDL-C \>40 mg/dL and ≤100 mg/dL)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hypertriglyceridemia
* On statin therapy for at least four weeks
* Either having established cardiovascular disease or at high risk for cardiovascular disease
Exclusion Criteria
* Any life-threatening disease other than cardiovascular disease
* Active severe liver disease
* Hemoglobin A1c \>10.0%
* Poorly controlled hypertension
* Planned coronary intervention (such as stent placement or heart bypass) or any non-cardiac major surgical procedure
* Known familial lipoprotein lipase deficiency (Fredrickson Type I), apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia (Fredrickson Type III)
* Known hypersensitivity to the study product, fish and/or shellfish, or placebo
* History of acute or chronic pancreatitis
* Patients are excluded if using the following medications:
* PCSK9 inhibitors
* niacin \>200 mg/day or fibrates;
* any omega-3 fatty acid medications ;
* dietary supplements containing omega-3 fatty acids (e.g., flaxseed oil, fish oil, krill oil, or algal oil);
* bile acid sequestrants
45 Years
ALL
No
Sponsors
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Amarin Pharma Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Deepak L. Bhatt, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital, 75 Francis Street, Boston
Locations
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Amarin Investigational Site
Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Muscle Shoals, Alabama, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Beverly Hills, California, United States
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Chino, California, United States
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Concord, California, United States
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El Cajon, California, United States
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Encino, California, United States
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Fair Oaks, California, United States
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Hawaiian Gardens, California, United States
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Lancaster, California, United States
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Lincoln, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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National City, California, United States
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Orange, California, United States
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Paramount, California, United States
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Roseville, California, United States
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San Diego, California, United States
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Torrance, California, United States
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Ventura, California, United States
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Walnut Creek, California, United States
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Aurora, Colorado, United States
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Colorado Springs, Colorado, United States
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Golden, Colorado, United States
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Guilford, Connecticut, United States
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Hartford, Connecticut, United States
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Newark, Delaware, United States
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Wilmington, Delaware, United States
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Washington D.C., District of Columbia, United States
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Boynton Beach, Florida, United States
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Bradenton, Florida, United States
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Clearwater, Florida, United States
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Edgewater, Florida, United States
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Fleming Island, Florida, United States
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Fort Lauderdale, Florida, United States
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Fort Lauderdale, Florida, United States
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Inverness, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami Beach, Florida, United States
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Miami Lakes, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Pembroke Pines, Florida, United States
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Plantation, Florida, United States
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Safety Harbor, Florida, United States
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Sarasota, Florida, United States
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St. Petersburg, Florida, United States
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Vero Beach, Florida, United States
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West Palm Beach, Florida, United States
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Conyers, Georgia, United States
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Covington, Georgia, United States
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Cumming, Georgia, United States
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Roswell, Georgia, United States
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Honolulu, Hawaii, United States
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Addison, Illinois, United States
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Chicago, Illinois, United States
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Norman, Illinois, United States
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North Chicago, Illinois, United States
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Peoria, Illinois, United States
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Winfield, Illinois, United States
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Evansville, Indiana, United States
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Iowa City, Iowa, United States
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Wichita, Kansas, United States
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Wichita, Kansas, United States
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Louisville, Kentucky, United States
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Alexandria, Louisiana, United States
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Eunice, Louisiana, United States
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Marrero, Louisiana, United States
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Auburn, Maine, United States
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Baltimore, Maryland, United States
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Lutherville, Maryland, United States
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Takoma Park, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Fall River, Massachusetts, United States
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Lansing, Michigan, United States
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Marquette, Michigan, United States
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Troy, Michigan, United States
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Saint Cloud, Minnesota, United States
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Biloxi, Mississippi, United States
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Tupelo, Mississippi, United States
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Chesterfield, Missouri, United States
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City of Saint Peters, Missouri, United States
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Florissant, Missouri, United States
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Jefferson City, Missouri, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Hastings, Nebraska, United States
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Omaha, Nebraska, United States
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Omaha, Nebraska, United States
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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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Ocean City, New Jersey, United States
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Albuquerque, New Mexico, United States
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Albany, New York, United States
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Brooklyn, New York, United States
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Great Neck, New York, United States
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Liverpool, New York, United States
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New York, New York, United States
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New York, New York, United States
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North Massapequa, New York, United States
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Smithtown, New York, United States
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Vestal, New York, United States
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West Seneca, New York, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Gastonia, North Carolina, United States
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Kernersville, North Carolina, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Fargo, North Dakota, United States
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Cincinnati, Ohio, United States
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Dayton, Ohio, United States
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Lorain, Ohio, United States
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Sandusky, Ohio, United States
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Tulsa, Oklahoma, United States
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Bend, Oregon, United States
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Portland, Oregon, United States
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Beaver, Pennsylvania, United States
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Doylestown, Pennsylvania, United States
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Jersey Shore, Pennsylvania, United States
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Newport, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Phoenixville, Pennsylvania, United States
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Sellersville, Pennsylvania, United States
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Tipton, Pennsylvania, United States
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Wyomissing, Pennsylvania, United States
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Yardley, Pennsylvania, United States
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Lancaster, South Carolina, United States
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Simpsonville, South Carolina, United States
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Rapid City, South Dakota, United States
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Bristol, Tennessee, United States
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Columbia, Tennessee, United States
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Germantown, Tennessee, United States
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Jackson, Tennessee, United States
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Knoxville, Tennessee, United States
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Smyrna, Tennessee, United States
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Austin, Texas, United States
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Beaumont, Texas, United States
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Carrollton, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Hurst, Texas, United States
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New Braunfels, Texas, United States
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Plano, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Splendora, Texas, United States
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Tomball, Texas, United States
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West Jordan, Utah, United States
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Falls Church, Virginia, United States
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Manassas, Virginia, United States
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Midlothian, Virginia, United States
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Newport News, Virginia, United States
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Burien, Washington, United States
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Tacoma, Washington, United States
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Huntington, West Virginia, United States
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Camperdown, New South Wales, Australia
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Lismore, New South Wales, Australia
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Brisbane, Queensland, Australia
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Chermside, Queensland, Australia
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Bedford Park, South Australia, Australia
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Launceston, Tasmania, Australia
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Fitzroy, Victoria, Australia
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Geelong, Victoria, Australia
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Heidelberg Heights, Victoria, Australia
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Melbourne, Victoria, Australia
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Fremantle, Western Australia, Australia
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Joondalup, Western Australia, Australia
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Murdoch, Western Australia, Australia
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Nedlands, Western Australia, Australia
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Perth, Western Australia, Australia
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Edmonton, Alberta, Canada
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Coquitlam, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Brampton, Ontario, Canada
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Collingwood, Ontario, Canada
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Corunna, Ontario, Canada
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Newmarket, Ontario, Canada
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Sarnia, Ontario, Canada
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Strathroy, Ontario, Canada
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Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Saint-Charles-Borromée, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Québec, , Canada
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Québec, , Canada
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Hyderabad, Andhra Pradesh, India
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Hyderabad, Andhra Pradesh, India
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Secunderabad, Andhra Pradesh, India
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Visakhapatnam, Andhra Pradesh, India
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Bangalore, Karnataka, India
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Bangalore, Karnataka, India
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Bangalore, Karnataka, India
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Mysore, Karnataka, India
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Mysore, Karnataka, India
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Kottayam, Kerala, India
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Mumbai, Maharashtra, India
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Nashik, Maharashtra, India
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Pune, Maharashtra, India
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New Delhi, National Capital Territory of Delhi, India
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New Delhi, National Capital Territory of Delhi, India
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Chennai, Tamil Nadu, India
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Coimbatore, Tamil Nadu, India
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Almelo, , Netherlands
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Amersfoort, , Netherlands
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Blaricum, , Netherlands
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Capelle aan den IJssel, , Netherlands
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Den Helder, , Netherlands
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Deventer, , Netherlands
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Ede, , Netherlands
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Eindhoven, , Netherlands
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Enschede, , Netherlands
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Goes, , Netherlands
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Gorinchem, , Netherlands
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Gouda, , Netherlands
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Groningen, , Netherlands
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Haarlem, , Netherlands
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Harderwijk, , Netherlands
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Heerenveen, , Netherlands
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Heerlen, , Netherlands
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Hoofddorp, , Netherlands
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Leeuwarden, , Netherlands
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Leiderdorp, , Netherlands
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Nijmegen, , Netherlands
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Roosendaal, , Netherlands
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Rotterdam, , Netherlands
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Rotterdam, , Netherlands
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Rotterdam, , Netherlands
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s'Hertogenbosch, , Netherlands
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Schiedam, , Netherlands
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Sneek, , Netherlands
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The Hague, , Netherlands
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Tilburg, , Netherlands
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Tilburg, , Netherlands
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Uden, , Netherlands
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Veldhoven, , Netherlands
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Zoetermeer, , Netherlands
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Zutphen, , Netherlands
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Takapuna, Auckland, New Zealand
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Christchurch, , New Zealand
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Dunedin, , New Zealand
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Hamilton, , New Zealand
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Hastings, , New Zealand
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Nelson, , New Zealand
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New Plymouth, , New Zealand
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Takapuna Auckland, , New Zealand
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Tauranga, , New Zealand
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Whangarei, , New Zealand
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Bialystok, , Poland
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Bialystok, , Poland
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Katowice, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Mikolów, , Poland
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Skierniewice, , Poland
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Tarnów, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warszawska, , Poland
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Wroclaw, , Poland
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Wroclaw, , Poland
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Zgierz, , Poland
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Argeş, , Romania
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Brăila, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Constanța, , Romania
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Craiova, Dolj, , Romania
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Iași, , Romania
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Maramureş, , Romania
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Mureş, , Romania
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Sibiu, , Romania
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Târgu Mureş, , Romania
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Timișoara, , Romania
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Arkhangelsk, , Russia
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Arkhangelsk, , Russia
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Arkhangelsk, , Russia
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Kazan', , Russia
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Kazan', , Russia
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Kemerovo, , Russia
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Kemerovo, , Russia
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Kirovsk, Leningradskaya Region, , Russia
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Krasnodar, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Novosibirsk, , Russia
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Novosibirsk, , Russia
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Novosibirsk, , Russia
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Petrozavodsk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saratov, , Russia
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Saratov, , Russia
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Sestroretsk, Saint-Petersburg, , Russia
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Tomsk, , Russia
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Tomsk, , Russia
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Volgograd, , Russia
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Voronezh, , Russia
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Voronezh, , Russia
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Yaroslavl, , Russia
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Yaroslavl, , Russia
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Yekaterinburg, , Russia
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Yekaterinburg, , Russia
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Bloemfontein, Freestate, South Africa
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Benoni, Gauteng, South Africa
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Pretoria, Gauteng, South Africa
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Soweto, Gauteng, South Africa
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Witbank, Gauteng, South Africa
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Durban, KwaZulu-Natal, South Africa
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Newlands, KwaZulu-Natal, South Africa
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Bellville, Western Cape, South Africa
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Cape Town, Western Cape, South Africa
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Durbanville, Western Cape, South Africa
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Goodwood, Western Cape, South Africa
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Kraaifontein, Western Cape, South Africa
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Paarl, Western Cape, South Africa
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Panorama, Western Cape, South Africa
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Parow, Western Cape, South Africa
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Pinelands, Western Cape, South Africa
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Somerset West, Western Cape, South Africa
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Worcester, Western Cape, South Africa
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Lutsk, Volyn Oblast, Ukraine
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Cherkasy, , Ukraine
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Chernivtsi, , Ukraine
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Dnipropetrovsk, , Ukraine
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Dnipropetrovsk, , Ukraine
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Dnipropetrovsk, , Ukraine
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Donetsk, , Ukraine
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Donetsk, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kharkiv, , Ukraine
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Kharkiv, , Ukraine
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Kharkiv, , Ukraine
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Kharkiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Luhansk, , Ukraine
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Lutsk, , Ukraine
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Lviv, , Ukraine
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Odesa, , Ukraine
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Odesa, , Ukraine
Amarin Investigational Site
Odesa, , Ukraine
Amarin Investigational Site
Poltava, , Ukraine
Amarin Investigational Site
Ternopil, , Ukraine
Amarin Investigational Site
Uzhhorod, , Ukraine
Amarin Investigational Site
Uzhhorod, , Ukraine
Amarin Investigational Site
Vinnytsia, , Ukraine
Amarin Investigational Site
Vinnytsia, , Ukraine
Amarin Investigational Site
Zaporizhzhia, , Ukraine
Amarin Investigational Site
Zaporizhzhia, , Ukraine
Amarin Investigational Site
Zaporizhzhia, , Ukraine
Amarin Investigational Site
Zaporizhzhia, , Ukraine
Countries
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References
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Bhatt DL, Steg PG, Brinton EA, Jacobson TA, Miller M, Tardif JC, Ketchum SB, Doyle RT Jr, Murphy SA, Soni PN, Braeckman RA, Juliano RA, Ballantyne CM; REDUCE-IT Investigators. Rationale and design of REDUCE-IT: Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial. Clin Cardiol. 2017 Mar;40(3):138-148. doi: 10.1002/clc.22692. Epub 2017 Mar 15.
Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Doyle RT Jr, Juliano RA, Jiao L, Granowitz C, Tardif JC, Ballantyne CM; REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019 Jan 3;380(1):11-22. doi: 10.1056/NEJMoa1812792. Epub 2018 Nov 10.
Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Doyle RT Jr, Juliano RA, Jiao L, Granowitz C, Tardif JC, Gregson J, Pocock SJ, Ballantyne CM; REDUCE-IT Investigators. Effects of Icosapent Ethyl on Total Ischemic Events: From REDUCE-IT. J Am Coll Cardiol. 2019 Jun 11;73(22):2791-2802. doi: 10.1016/j.jacc.2019.02.032. Epub 2019 Mar 18.
Bhatt DL, Miller M, Brinton EA, Jacobson TA, Steg PG, Ketchum SB, Doyle RT Jr, Juliano RA, Jiao L, Granowitz C, Tardif JC, Olshansky B, Chung MK, Gibson CM, Giugliano RP, Budoff MJ, Ballantyne CM; REDUCE-IT Investigators. REDUCE-IT USA: Results From the 3146 Patients Randomized in the United States. Circulation. 2020 Feb 4;141(5):367-375. doi: 10.1161/CIRCULATIONAHA.119.044440. Epub 2019 Nov 11.
Olshansky B, Bhatt DL, Miller M, Steg PG, Brinton EA, Jacobson TA, Ketchum SB, Doyle RT Jr, Juliano RA, Jiao L, Granowitz C, Tardif JC, Mehta C, Mukherjee R, Ballantyne CM, Chung MK; REDUCE-IT Investigators. REDUCE-IT INTERIM: accumulation of data across prespecified interim analyses to final results. Eur Heart J Cardiovasc Pharmacother. 2021 May 23;7(3):e61-e63. doi: 10.1093/ehjcvp/pvaa118. No abstract available.
Peterson BE, Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Juliano RA, Jiao L, Doyle RT Jr, Granowitz C, Gibson CM, Pinto D, Giugliano RP, Budoff MJ, Tardif JC, Verma S, Ballantyne CM; REDUCE-IT Investigators. Reduction in Revascularization With Icosapent Ethyl: Insights From REDUCE-IT Revascularization Analyses. Circulation. 2021 Jan 5;143(1):33-44. doi: 10.1161/CIRCULATIONAHA.120.050276. Epub 2020 Nov 5.
Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Jiao L, Tardif JC, Gregson J, Pocock SJ, Ballantyne CM; REDUCE-IT Investigators. Reduction in First and Total Ischemic Events With Icosapent Ethyl Across Baseline Triglyceride Tertiles. J Am Coll Cardiol. 2019 Aug 27;74(8):1159-1161. doi: 10.1016/j.jacc.2019.06.043. No abstract available.
Gaba P, Bhatt DL, Giugliano RP, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Juliano RA, Jiao L, Doyle RT Jr, Granowitz C, Tardif JC, Ballantyne CM, Pinto DS, Budoff MJ, Gibson CM. Comparative Reductions in Investigator-Reported and Adjudicated Ischemic Events in REDUCE-IT. J Am Coll Cardiol. 2021 Oct 12;78(15):1525-1537. doi: 10.1016/j.jacc.2021.08.009.
Majithia A, Bhatt DL, Friedman AN, Miller M, Steg PG, Brinton EA, Jacobson TA, Ketchum SB, Juliano RA, Jiao L, Doyle RT Jr, Granowitz C, Budoff M, Preston Mason R, Tardif JC, Boden WE, Ballantyne CM. Benefits of Icosapent Ethyl Across the Range of Kidney Function in Patients With Established Cardiovascular Disease or Diabetes: REDUCE-IT RENAL. Circulation. 2021 Nov 30;144(22):1750-1759. doi: 10.1161/CIRCULATIONAHA.121.055560. Epub 2021 Oct 28.
Verma S, Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Dhingra NK, Ketchum SB, Juliano RA, Jiao L, Doyle RT Jr, Granowitz C, Gibson CM, Pinto D, Giugliano RP, Budoff MJ, Mason RP, Tardif JC, Ballantyne CM; REDUCE-IT Investigators. Icosapent Ethyl Reduces Ischemic Events in Patients With a History of Previous Coronary Artery Bypass Grafting: REDUCE-IT CABG. Circulation. 2021 Dec 7;144(23):1845-1855. doi: 10.1161/CIRCULATIONAHA.121.056290. Epub 2021 Oct 28.
Singh N, Bhatt DL, Miller M, Steg PG, Brinton EA, Jacobson TA, Jiao L, Tardif JC, Mason RP, Ballantyne CM; REDUCE-IT Investigators. Consistency of Benefit of Icosapent Ethyl by Background Statin Type in REDUCE-IT. J Am Coll Cardiol. 2022 Jan 18;79(2):220-222. doi: 10.1016/j.jacc.2021.11.005. No abstract available.
Gurevitz C, Bhatt DL, Giugliano RP, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Lira Pineda A, Doyle RT Jr, Giugliano G, Mason RP, Tardif JC, Martens FMAC, Ballantyne CM, Budoff MJ, Gibson CM. Benefit of Icosapent Ethyl Across Types and Sizes of Myocardial Infarction in REDUCE-IT. Eur J Prev Cardiol. 2025 Sep 22:zwaf602. doi: 10.1093/eurjpc/zwaf602. Online ahead of print.
Aggarwal R, Bhatt DL, Steg PG, Miller M, Brinton EA, Dunbar RL, Ketchum SB, Tardif JC, Martens FMAC, Ballantyne CM, Szarek M, Mason RP; REDUCE-IT Investigators. Cardiovascular Outcomes With Icosapent Ethyl by Baseline Low-Density Lipoprotein Cholesterol: A Secondary Analysis of the REDUCE-IT Randomized Trial. J Am Heart Assoc. 2025 Mar 4;14(5):e038656. doi: 10.1161/JAHA.124.038656. Epub 2025 Feb 19.
Weintraub WS, Bhatt DL, Zhang Z, Dolman S, Boden WE, Bress AP, Bellows BK, Derington CG, Philip S, Steg G, Miller M, Brinton EA, Jacobson TA, Tardif JC, Ballantyne CM, Kolm P. Cost-Effectiveness of Icosapent Ethyl in REDUCE-IT USA: Results From Patients Randomized in the United States. J Am Heart Assoc. 2024 Jan 2;13(1):e032413. doi: 10.1161/JAHA.123.032413. Epub 2023 Dec 29.
Miller M, Bhatt DL, Brinton EA, Jacobson TA, Steg PG, Pineda AL, Ketchum SB, Doyle RT Jr, Tardif JC, Ballantyne CM. Effectiveness of icosapent ethyl on first and total cardiovascular events in patients with metabolic syndrome, but without diabetes: REDUCE-IT MetSyn. Eur Heart J Open. 2023 Nov 12;3(6):oead114. doi: 10.1093/ehjopen/oead114. eCollection 2023 Nov.
Olshansky B, Bhatt DL, Miller M, Steg PG, Brinton EA, Jacobson TA, Ketchum SB, Doyle RT Jr, Juliano RA, Jiao L, Kowey PR, Reiffel JA, Tardif JC, Ballantyne CM, Chung MK; REDUCE-IT Investigators. Cardiovascular Benefits of Icosapent Ethyl in Patients With and Without Atrial Fibrillation in REDUCE-IT. J Am Heart Assoc. 2023 Mar 7;12(5):e026756. doi: 10.1161/JAHA.121.026756. Epub 2023 Feb 21.
Ridker PM, Rifai N, MacFadyen J, Glynn RJ, Jiao L, Steg PG, Miller M, Brinton EA, Jacobson TA, Tardif JC, Ballantyne CM, Mason RP, Bhatt DL. Effects of Randomized Treatment With Icosapent Ethyl and a Mineral Oil Comparator on Interleukin-1beta, Interleukin-6, C-Reactive Protein, Oxidized Low-Density Lipoprotein Cholesterol, Homocysteine, Lipoprotein(a), and Lipoprotein-Associated Phospholipase A2: A REDUCE-IT Biomarker Substudy. Circulation. 2022 Aug 2;146(5):372-379. doi: 10.1161/CIRCULATIONAHA.122.059410. Epub 2022 Jun 28.
Gaba P, Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Juliano RA, Jiao L, Doyle RT Jr, Granowitz C, Tardif JC, Giugliano RP, Martens FMAC, Gibson CM, Ballantyne CM; REDUCE-IT Investigators. Prevention of Cardiovascular Events and Mortality With Icosapent Ethyl in Patients With Prior Myocardial Infarction. J Am Coll Cardiol. 2022 May 3;79(17):1660-1671. doi: 10.1016/j.jacc.2022.02.035.
Selvaraj S, Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Juliano RA, Jiao L, Tardif JC, Ballantyne CM; REDUCE-IT Investigators. Impact of Icosapent Ethyl on Cardiovascular Risk Reduction in Patients With Heart Failure in REDUCE-IT. J Am Heart Assoc. 2022 Apr 5;11(7):e024999. doi: 10.1161/JAHA.121.024999. Epub 2022 Apr 4.
Peterson BE, Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Juliano RA, Jiao L, Doyle RT Jr, Granowitz C, Gibson CM, Pinto D, Giugliano RP, Budoff MJ, Tardif JC, Verma S, Ballantyne CM; REDUCE-IT Investigators. Treatment With Icosapent Ethyl to Reduce Ischemic Events in Patients With Prior Percutaneous Coronary Intervention: Insights From REDUCE-IT PCI. J Am Heart Assoc. 2022 Mar 15;11(6):e022937. doi: 10.1161/JAHA.121.022937. Epub 2022 Mar 9.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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AMR-01-01-0019
Identifier Type: -
Identifier Source: org_study_id
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