Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation
EngageAFTIMI48
A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of Edoxaban (DU-176b) Versus Warfarin In Subjects With Atrial Fibrillation - Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation (ENGAGE - AF TIMI - 48)
1 other identifier
interventional
21,105
44 countries
987
Brief Summary
This study is to demonstrate the safety and efficacy profile, in two different dose regimens of Edoxaban (DU-176b), (an investigational new drug being tested for the prevention of stroke/systemic embolic events (SEE)), in individuals with atrial fibrillation. Patients will be randomized to one of three treatment groups: High Dose Regimen, Low Dose Regimen, \& Warfarin. The expected duration of the study is 24 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 stroke
Started Nov 2008
Typical duration for phase_3 stroke
987 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
October 28, 2008
CompletedFirst Posted
Study publicly available on registry
October 29, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
March 25, 2015
CompletedMarch 5, 2019
March 1, 2015
4.4 years
October 28, 2008
February 5, 2015
February 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
The composite of stroke and Systemic Embolic Events (SEE) during the on treatment period in the mITT analysis population with a non-inferiority analysis.
on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
The composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the mITT analysis population.
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
The composite of stroke and Systemic Embolic Events (SEE) during the on treatment period in the PP (per protocol) analysis set population.
on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
The composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the PP (per protocol) analysis set population.
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Compare Edoxaban to Warfarin for Superiority for Composite of Stroke and Systemic Embolic Events (SEE).
Compare edoxaban to warfarin for the composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the ITT analysis set with a superiority analysis.
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Secondary Outcomes (4)
Compare Edoxaban to Warfarin for Composite of Stroke, Systemic Embolic Event (SEE), and Cardiovascular (CV) Mortality
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Compare Edoxaban to Warfarin for Major Adverse Cardiac Event (MACE): a Composite of Non-fatal MI, Non-fatal Stroke, Non-fatal SEE, and Death Due to CV Cause or Bleeding
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Compare Edoxaban to Warfarin for Composite of Stroke, SEE, and All-cause Mortality
overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Adjudicated Bleeding Events
on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Study Arms (3)
Warfarin/placebo edoxaban
ACTIVE COMPARATORWarfarin tablets plus placebo Edoxaban tablets
high dose edoxaban/placebo warfarin
EXPERIMENTALEdoxaban tablets (60mg) plus warfarin placebo tablets
low dose edoxaban/placebo warfarin
EXPERIMENTALEdoxaban tablets (30mg) plus warfarin placebo tablets
Interventions
Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months
Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
placebo warfarin
Eligibility Criteria
You may qualify if:
- years of age or older; male or female.
- Able to provide written informed consent.
- History of documented AF within the prior 12 months
- A moderate to high risk of stroke, as defined by CHADS2 index score of at least 2
You may not qualify if:
- Transient atrial fibrillation secondary to other reversible disorders
- Subjects with moderate or severe mitral stenosis, unresected atrial myxoma, or a mechanical heart valve
- Subjects with any contraindication for anticoagulant agents;
- Subjects with conditions associated with high risk of bleeding or have known or suspected hereditary or acquired bleeding disorders
- Females of childbearing potential including the following:
- Females with a history of tubal-ligation
- Females less than 2 years post-menopausal
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
- The TIMI Study Groupcollaborator
Study Sites (1009)
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Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Gilbert, Arizona, United States
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Glendale, Arizona, United States
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Lake Havasu City, Arizona, United States
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Sierra Vista, Arizona, 85635, United States
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Tempe, Arizona, 85283, United States
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Tucson, Arizona, United States
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Harrisburg, Arkansas, United States
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Hot Springs, Arkansas, United States
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Little Rock, Arkansas, United States
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Alhambra, California, United States
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Anaheim, California, United States
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Burbank, California, United States
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Chula Vista, California, United States
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Encinitas, California, United States
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Fountain Valley, California, United States
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Glendale, California, United States
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Healdsburg, California, United States
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Lakewood, California, United States
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Long Beach, California, United States
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Los Alamitos, California, United States
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Los Angeles, California, United States
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Los Banos, California, United States
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Mather, California, United States
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Merced, California, United States
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Newport Beach, California, United States
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Oceanside, California, United States
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Pacific Palisades, California, United States
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Palm Springs, California, United States
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Pismo Beach, California, United States
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Redondo Beach, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Santa Rosa, California, United States
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Torrance, California, United States
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Ventura, California, United States
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Aurora, Colorado, United States
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Colorado Springs, Colorado, 80904, United States
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Denver, Colorado, United States
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Englewood, Colorado, United States
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Greeley, Colorado, United States
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Bridgeport, Connecticut, United States
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Guilford, Connecticut, United States
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Hamden, Connecticut, United States
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Manchester, Connecticut, United States
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New Haven, Connecticut, United States
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North Haven, Connecticut, United States
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Shelton, Connecticut, United States
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Stamford, Connecticut, United States
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Trumbull, Connecticut, United States
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Newark, Delaware, United States
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Washington D.C., District of Columbia, United States
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Aventura, Florida, United States
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Chipley, Florida, United States
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Clearwater, Florida, United States
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Daytona Beach, Florida, 32114, United States
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Daytona Beach, Florida, United States
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DeBary, Florida, United States
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Deerfield Beach, Florida, United States
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Delray Beach, Florida, 33484, United States
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Delray Beach, Florida, United States
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Hialeah, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville Beach, Florida, United States
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Jupiter, Florida, United States
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Leesburg, Florida, 34748, United States
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Melbourne, Florida, United States
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Miami, Florida, 33173, United States
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Miami, Florida, United States
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Naples, Florida, United States
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Orange Park, Florida, United States
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Orlando, Florida, United States
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Ormond Beach, Florida, United States
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Panama City, Florida, United States
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Pembroke Pines, Florida, United States
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Pensacola, Florida, United States
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Plantation, Florida, United States
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Port Charlotte, Florida, United States
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Rockledge, Florida, United States
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Saint Augustine, Florida, United States
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Sarasota, Florida, United States
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St. Petersburg, Florida, United States
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Stuart, Florida, United States
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Tamarac, Florida, United States
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Tampa, Florida, United States
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The Villages, 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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Athens, Georgia, United States
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Atlanta, Georgia, United States
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Conyers, Georgia, 30013, United States
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Covington, Georgia, United States
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Cumming, Georgia, United States
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Savannah, Georgia, United States
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Snellville, Georgia, 30039, United States
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Tucker, Georgia, United States
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Watkinsville, Georgia, United States
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Waycross, Georgia, United States
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Woodstock, Georgia, 30188, United States
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Honolulu, Hawaii, United States
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Boise, Idaho, United States
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Hayden Lake, Idaho, United States
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Bannockburn, Illinois, United States
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Belleville, Illinois, 82220, United States
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Chicago, Illinois, United States
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Elgin, Illinois, United States
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Joliet, Illinois, United States
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Libertyville, Illinois, United States
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Maywood, Illinois, United States
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Melrose Park, Illinois, United States
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Oak Lawn, Illinois, United States
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Springfield, Illinois, United States
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Winfield, Illinois, United States
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Bloomington, Indiana, United States
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Munster, Indiana, United States
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Ames, Iowa, United States
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Council Bluffs, Iowa, United States
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Iowa City, Iowa, United States
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Shell Rock, Iowa, United States
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Wichita, Kansas, United States
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Bowling Green, Kentucky, United States
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Campbellsville, Kentucky, United States
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Elizabethtown, Kentucky, United States
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Richmond, Kentucky, United States
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Marrero, Louisiana, United States
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West Monroe, Louisiana, 71291, United States
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West Monroe, Louisiana, United States
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Auburn, Maine, United States
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Biddeford, Maine, United States
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Baltimore, Maryland, United States
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Bel Air, Maryland, United States
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Bethesda, Maryland, United States
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Lexington Park, Maryland, United States
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Rockville, Maryland, United States
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Salisbury, Maryland, United States
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Towson, Maryland, United States
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Westminster, Maryland, United States
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Ayer, Massachusetts, United States
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Boston, Massachusetts, United States
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Concord, Massachusetts, United States
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East Bridgewater, Massachusetts, United States
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Haverhill, Massachusetts, United States
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Methuen, Massachusetts, United States
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Worcester, Massachusetts, United States
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Bay City, Michigan, United States
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Benzonia, Michigan, United States
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Chelsea, Michigan, United States
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Commerce, Michigan, United States
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Detroit, Michigan, United States
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Grand Rapids, Michigan, United States
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Interlochen, Michigan, United States
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Kalamazoo, Michigan, United States
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Lapeer, Michigan, United States
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Midland, Michigan, United States
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Rochester Hills, Michigan, United States
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Saginaw, Michigan, United States
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Troy, Michigan, United States
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Warren, Michigan, United States
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Golden Valley, Minnesota, United States
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Minneapolis, Minnesota, United States
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Saint Paul, Minnesota, United States
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Biloxi, Mississippi, United States
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Chesterfield, Missouri, United States
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Joplin, Missouri, United States
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Kansas City, Missouri, United States
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Saint Charles, Missouri, United States
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St Louis, Missouri, United States
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Kalispell, Montana, United States
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Fremont, Nebraska, 68025, United States
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Grand Island, Nebraska, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Henderson, Nevada, United States
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Belvidere, New Jersey, United States
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Brick, New Jersey, United States
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Bridgewater, New Jersey, United States
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Browns Mills, New Jersey, United States
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Cherry Hill, New Jersey, United States
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Elizabeth, New Jersey, United States
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Haddon Heights, New Jersey, United States
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Hamilton, New Jersey, United States
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Mine Hill, New Jersey, United States
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Ocean City, New Jersey, United States
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Passaic, New Jersey, United States
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Ridgewood, New Jersey, United States
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Somerset, New Jersey, United States
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Toms River, 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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Buffalo, New York, United States
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Cortlandt Manor, New York, United States
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Hawthorne, New York, United States
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Jamaica, New York, United States
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Mineola, 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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Saratoga Springs, New York, United States
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Troy, New York, United States
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Cary, North Carolina, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, 28207, United States
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Greensboro, North Carolina, 27408, United States
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Mooresville, North Carolina, United States
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Morehead City, North Carolina, 28557, United States
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Morganton, North Carolina, 28655, United States
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Morganton, North Carolina, United States
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Oxford, North Carolina, United States
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Pinehurst, North Carolina, United States
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Statesville, 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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Oakes, North Dakota, United States
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Akron, Ohio, United States
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Canal Fulton, Ohio, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Cuyahoga Falls, Ohio, United States
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Dayton, Ohio, United States
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Fairfield, Ohio, United States
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Marion, Ohio, United States
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Middletown, Ohio, United States
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Pitsburg, Ohio, United States
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Springfield, Ohio, 45505, United States
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Thornville, Ohio, United States
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Toledo, Ohio, United States
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Willoughby Hills, Ohio, United States
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Bartlesville, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Bend, Oregon, United States
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Corvallis, Oregon, United States
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Altoona, Pennsylvania, 16602, United States
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Beaver, Pennsylvania, United States
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Chester, Pennsylvania, United States
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Clymer, Pennsylvania, United States
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Danville, Pennsylvania, United States
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Doylestown, Pennsylvania, United States
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Ephrata, Pennsylvania, United States
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Feasterville, Pennsylvania, United States
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Fleetwood, Pennsylvania, 19522, United States
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Greenville, Pennsylvania, United States
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Johnstown, Pennsylvania, United States
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Lancaster, Pennsylvania, United States
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Lewistown, Pennsylvania, United States
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Newport, Pennsylvania, United States
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Norristown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Pottstown, Pennsylvania, United States
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Scranton, Pennsylvania, United States
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Sellersville, Pennsylvania, United States
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Somerset, Pennsylvania, United States
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State College, Pennsylvania, United States
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Uniontown, Pennsylvania, United States
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Wilkes-Barre, Pennsylvania, United States
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Wynnewood, Pennsylvania, United States
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Yardley, Pennsylvania, United States
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Providence, Rhode Island, United States
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Anderson, South Carolina, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Florence, South Carolina, United States
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Greenville, South Carolina, United States
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Greer, South Carolina, 29651, United States
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Mt. Pleasant, South Carolina, United States
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Spartanburg, South Carolina, 29302, United States
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Summerville, South Carolina, United States
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Taylors, South Carolina, United States
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Walterboro, South Carolina, United States
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Rapid City, South Dakota, United States
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Columbia, Tennessee, United States
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Jackson, Tennessee, United States
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Johnson City, Tennessee, United States
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Nashville, Tennessee, United States
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Oak Ridge, Tennessee, United States
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Arlington, Texas, United States
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Austin, Texas, United States
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Carrollton, Texas, United States
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Corsicana, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Georgetown, Texas, United States
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Grapevine, Texas, United States
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Houston, Texas, United States
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Lubbock, Texas, United States
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McAllen, Texas, United States
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Odessa, Texas, United States
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Plano, Texas, United States
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San Antonio, Texas, United States
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Tomball, Texas, United States
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Wichita Falls, Texas, United States
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Provo, Utah, United States
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West Valley City, Utah, 84120, United States
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Danville, Virginia, United States
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Hopewell, Virginia, United States
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Newport News, Virginia, United States
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Norfolk, Virginia, 23502, United States
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Richmond, Virginia, 23294, United States
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Springfield, Virginia, United States
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Suffolk, Virginia, United States
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Virginia Beach, Virginia, United States
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Winchester, Virginia, United States
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Bellevue, Washington, United States
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Kirkland, Washington, United States
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Renton, Washington, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Clarksburg, West Virginia, United States
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Madison, Wisconsin, United States
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Manitowoc, Wisconsin, United States
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Menomonee Falls, Wisconsin, United States
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Bahía Blanca, Argentina
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Buenos Aires, Argentina
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Corrientes, Argentina
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Córdoba, Argentina
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Formosa, Argentina
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Godoy Cruz, Argentina
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Mar del Plata, Argentina
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Mendoza, Argentina
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Paraguay, Argentina
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Provincia de Chaco, Argentina
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Provincia de Rio Negro, Argentina
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Provincia de Salta, Argentina
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San Luis, Argentina
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San Miguel de Tucumán, Argentina
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San Salvador de Jujuy, Argentina
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Santa Fe, Argentina
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Sante Fe, Argentina
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Broken Hill, New South Wales, Australia
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East Gosford, New South Wales, Australia
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Carina Heights, Queensland, Australia
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Milton, Queensland, Australia
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Adelaide, South Australia, Australia
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Frankston, Victoria, Australia
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Ashford, Australia
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Camperdown, Australia
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Elizabeth Vale, Australia
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Joondalup, Australia
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Melbourne, Australia
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Parkville, Australia
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Perth, Australia
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Antwerp, Belgium
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Arlon, Belgium
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Bruges, Belgium
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Brussels, Belgium
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Genk, Belgium
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Hasselt, Belgium
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Leuven, Belgium
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Liège, Belgium
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Mechelen, Belgium
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Merksem, Belgium
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Moerkerke, Belgium
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Montegnée, Belgium
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Mousron, Belgium
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Torhout, Belgium
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Veurne, Belgium
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Wetteren, Belgium
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Belo Horizonte, Brazil
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Blumenau, Brazil
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Brasília, Brazil
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Campina Grande do Sul, Brazil
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Campinas, Brazil
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Caxias do Sul, Brazil
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Curitiba, Brazil
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Goiânia, Brazil
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Lajeados, Brazil
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Maceió, Brazil
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Marília, Brazil
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Passo Fundo, Brazil
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Porto Alegre, Brazil
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Recife, Brazil
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Ribeirão Preto, Brazil
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Rio de Janeiro, Brazil
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Salvador, Brazil
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Santo André, Brazil
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São José, Brazil
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São Paulo, Brazil
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Uberlândia, Brazil
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Burgas, Bulgaria
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Dimitrovgrad, Bulgaria
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Haskovo, Bulgaria
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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Calgary, Alberta, Canada
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Campbell River, British Columbia, Canada
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Chilliwack, British Columbia, Canada
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Coquitlam, British Columbia, Canada
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Kamloops, British Columbia, Canada
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Kelowna, British Columbia, Canada
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New Westminster, British Columbia, Canada
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Penticton, British Columbia, Canada
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Quesnel, British Columbia, Canada
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Victoria, British Columbia, Canada
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Saint John, New Brunswick, Canada
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Bridgewater, Nova Scotia, Canada
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Halifax, Nova Scotia, Canada
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Liverpool, Nova Scotia, Canada
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Ajax, Ontario, Canada
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Beamsville, Ontario, Canada
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Brampton, Ontario, Canada
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Corunna, Ontario, Canada
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Greater Sudbury, Ontario, Canada
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Hamilton, Ontario, Canada
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Kitchener, Ontario, Canada
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Listowel, Ontario, Canada
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London, Ontario, Canada
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Oshawa, Ontario, Canada
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Ottawa, Ontario, Canada
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Richmond Hill, Ontario, Canada
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Sarnia, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Toronto, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Longueuil, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Saint Georges de Beauce, Quebec, Canada
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Saint-Charles-Borromée, Quebec, Canada
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Saint-Jérôme, Quebec, Canada
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Saint-Lambert, Quebec, Canada
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Terrebonne, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Westmount, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Mount Pearl, Canada
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St. John's, Canada
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Iquique, Chile
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La Serena, Chile
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Osorno, Chile
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Port Montt, Chile
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Rancagua, Chile
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Santiago, Chile
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Talcahuano, Chile
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Temuco, Chile
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Victoria, Chile
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Viña del Mar, Chile
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Baotou, China
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Beijing, China
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Changchun, China
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Changsha, China
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Chendu, China
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Chongqing, China
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Guangxi, China
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Guangzhou, China
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Hainan Province, China
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Hangzhou, China
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Harbin, China
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Jinzhou, China
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Lanzhou, China
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Liaoning Province, China
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Nanchang, China
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Shaanxi Province, China
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Shanghai, China
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Shenyang, China
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Shijiazhuang, China
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Tianjin, China
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Wenzhou, China
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Wuhan, China
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Antioquia, Colombia
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Armenia, Colombia
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Barranquilla, Colombia
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Bogotá, Colombia
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Bucaramanga, Colombia
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Cartagena, Colombia
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Envigado, Colombia
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Manizales, Colombia
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Medellín, Colombia
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Dubrovnik, Croatia
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Karlovac, Croatia
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Koprivnica, Croatia
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Krapinski Toplice, Croatia
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Osijek, Croatia
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Rijeka, Croatia
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Slavonski Brod, Croatia
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Split, Croatia
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Varaždin, Croatia
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Zadar, Croatia
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Zagreb, Croatia
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Benátky nad Jizerou, Czechia
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Benešov, Czechia
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Bílovec, Czechia
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Brno, Czechia
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Brno-Lesna, Czechia
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Chrudim, Czechia
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Český Krumlov, Czechia
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Hranice, Czechia
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Prague, Czechia
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Aarhus N, Denmark
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Copenhagen, Denmark
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Esbjerg, Denmark
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Frederiksberg, Denmark
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Glostrup Municipality, Denmark
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Haabneeme, Harju, Estonia
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Jyväskylä, Finland
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Potsdam, Germany
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New Delhi, India
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Afula, Israel
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Tel Litwinsky, Israel
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Ostia Antica, Italy
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Roma, Italy
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Santa Maria Capua Vetere, Italy
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Sassari, Italy
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Siena, Italy
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Trieste, Italy
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Venezia Mestre, Italy
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Kyoto, Kyoto, Japan
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Lida-shi, Nagano, Japan
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Ueda-shi, Nagano, Japan
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Minato-ku, Tokyo, Japan
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Aichi, Japan
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Chiaki, Japan
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Chiba, Japan
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Ehime, Japan
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Fukuoka, Japan
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Fukushima, Japan
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Gunma, Japan
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Kyoda, Japan
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Mie, Japan
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Miyagi, Japan
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Okayama, Japan
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Tokyo, Japan
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Yamaguchi, Japan
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Yokohama, Japan
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Guadalajara, Jalisco, Mexico
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Almere Stad, Netherlands
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Lower Hutt, Wellington Region, New Zealand
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Rud, Norway
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Arequipa, Peru
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Lima, Peru
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Cebu, Philippines
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Davao City, Philippines
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Quezon City, Philippines
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Ostrów, Mazowiecka, Poland
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Libiąż, Poland
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Amadora, Portugal
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Leiria, Portugal
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Lisbon, Portugal
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Setúbal, Portugal
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Viseu, Portugal
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Bacau, Romania
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Dambovita, Romania
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Iași, Romania
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Judetul Maramures, Romania
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Oradea, Romania
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Timișoara, Romania
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Barnaul, Russia
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Perm, Russia
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Saint Petersburg, Russia
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Tula, Russia
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Yaroslavl, Russia
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Belgrade, Serbia
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Kamenitz, Serbia
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Niš, Serbia
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Niška Banja, Serbia
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Zemun, Serbia
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Zmaj Jovina, Serbia
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Bardejov, Slovakia
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Nové Zámky, Slovakia
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Prešov, Slovakia
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Rimavská Sobota, Slovakia
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Alberton, South Africa
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Benoni, South Africa
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Cape Town, South Africa
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Durban, South Africa
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Parktown West, South Africa
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Port Elizabeth, South Africa
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Pretoria, South Africa
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Somerset West, South Africa
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Worcester, South Africa
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Busan, South Korea
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Daejeon, South Korea
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Gwangju, South Korea
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Incheon, South Korea
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Seoul, South Korea
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A Coruña, Spain
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Alcoy, Spain
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Almería, Spain
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Barcelona, Spain
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Bilbao, Spain
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De La Castellana, Spain
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Donostia / San Sebastian, Spain
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Figueras, Spain
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Jaén, Spain
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Lleida, Spain
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Madrid, Spain
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Murcia, Spain
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Santiago de Compostela, Spain
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Seville, Spain
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Vigo, Spain
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Vitoria-Gasteiz, Spain
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Alingsås, Sweden
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Enköping, Sweden
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Gothenburg, Sweden
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Halmstad, Sweden
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Karlshamn, Sweden
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Köping, Sweden
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Lindesberg, Sweden
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Lund, Sweden
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Malmo, Sweden
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Mölndal, Sweden
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Örebro, Sweden
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Skene, Sweden
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Umeå, Sweden
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Uppsala, Sweden
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Varberg, Sweden
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Lausanne, Switzerland
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Lugano, Switzerland
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Changhua, Taiwan
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Hualien City, Taiwan
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Taipei, Taiwan
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Taoyuan, Taiwan
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Yongkang District, Taiwan
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Bangkok, Thailand
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Chang Mai, Thailand
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Khon Kaen, Thailand
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Nakhon Ratchasima, Thailand
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Pathum Thani, Thailand
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Sai Mai, Thailand
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Songkhla, Thailand
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Adana, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Antalya, Turkey (Türkiye)
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Aydin, Turkey (Türkiye)
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Erzurum, Turkey (Türkiye)
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Eskişehir, Turkey (Türkiye)
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Isparta, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Konya, Turkey (Türkiye)
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Sivas, Turkey (Türkiye)
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Cherkasy, Ukraine
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Chernihiv, Ukraine
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Dnipropetrovsk, Ukraine
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Donetsk, Ukraine
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Ivano-Frankivsh, Ukraine
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Ivano-Frankivsk, Ukraine
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Kharkiv, Ukraine
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Kherson, 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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Mykolayiv, Ukraine
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Odesa, Ukraine
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Poltava, Ukraine
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Uzhhorod, Ukraine
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Vinnytsia, Ukraine
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Zaporizhzhya, Ukraine
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Birmingham, United Kingdom
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Blackpool, United Kingdom
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Bournemouth, United Kingdom
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Bradford, United Kingdom
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Cambridge, United Kingdom
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Chesterfield, United Kingdom
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Coventry, United Kingdom
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Devon, United Kingdom
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Dundee, United Kingdom
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East Horsley, United Kingdom
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East Sussex, United Kingdom
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Edinburgh, United Kingdom
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Essex, United Kingdom
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Glasgow, United Kingdom
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Harrow, United Kingdom
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Leicester, United Kingdom
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Liverpool, United Kingdom
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London, United Kingdom
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Middlesbrough, United Kingdom
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Orpington, United Kingdom
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Peterborough, United Kingdom
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Portadown, United Kingdom
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Sheffield, United Kingdom
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Stirling, United Kingdom
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Stockport, United Kingdom
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Surrey, United Kingdom
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Sutton Coldfield, United Kingdom
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Wolverhampton, United Kingdom
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York, United Kingdom
Related Publications (35)
Semco RS, Bergmark RW, Murphy SA, Cange AL, Unverdorben M, Chen CZL, Ruff CT, Antman EM, Giugliano RP, Bergmark BA. Epistaxis Versus Nonepistaxis Bleeding in Anticoagulated Patients With Atrial Fibrillation: Results From the ENGAGE AF-TIMI 48 Trial. J Am Heart Assoc. 2025 Jan 21;14(2):e031434. doi: 10.1161/JAHA.123.031434. Epub 2025 Jan 10.
PMID: 39791401DERIVEDZimerman A, Braunwald E, Steffel J, Van Mieghem NM, Palazzolo MG, Murphy SA, Chen CZL, Unverdorben M, Ruff CT, Antman EM, Giugliano RP. Dose Reduction of Edoxaban in Patients 80 Years and Older With Atrial Fibrillation: Post Hoc Analysis of the ENGAGE AF-TIMI 48 Randomized Clinical Trial. JAMA Cardiol. 2024 Sep 1;9(9):817-825. doi: 10.1001/jamacardio.2024.1793.
PMID: 38985461DERIVEDBergmark BA, Park JG, Hamershock RA, Melloni GEM, De Caterina R, Antman EM, Ruff CT, Rutman H, Mercuri MF, Lanz HJ, Braunwald E, Giugliano RP. Application of the Win Ratio Method in the ENGAGE AF-TIMI 48 Trial Comparing Edoxaban With Warfarin in Patients With Atrial Fibrillation. Circ Cardiovasc Qual Outcomes. 2024 Jul;17(7):e010561. doi: 10.1161/CIRCOUTCOMES.123.010561. Epub 2024 Jun 3.
PMID: 38828563DERIVEDInciardi RM, Giugliano RP, Park JG, Nordio F, Ruff CT, Chen C, Lanz HJ, Antman EM, Braunwald E, Solomon SD. Risks of Heart Failure, Stroke, and Bleeding in Atrial Fibrillation According to Heart Failure Phenotypes. JACC Clin Electrophysiol. 2023 Apr;9(4):569-580. doi: 10.1016/j.jacep.2022.11.032. Epub 2023 Feb 22.
PMID: 37100536DERIVEDOyama K, Giugliano RP, Ruff CT, Berg DD, Jarolim P, Tang M, Park JG, Lanz HJ, Antman EM, Braunwald E, Morrow DA. Serial assessment of biomarkers and heart failure outcomes in patients with atrial fibrillation. Eur J Heart Fail. 2023 Jun;25(6):832-841. doi: 10.1002/ejhf.2844. Epub 2023 Apr 18.
PMID: 36987929DERIVEDBonaca MP, Antman EM, Cunningham JW, Wiviott SD, Murphy SA, Halperin JL, Weitz JI, Grosso MA, Lanz HJ, Braunwald E, Giugliano RP, Ruff CT. Ischaemic and bleeding risk in atrial fibrillation with and without peripheral artery disease and efficacy and safety of full- and half-dose edoxaban vs. warfarin: insights from ENGAGE AF-TIMI 48. Eur Heart J Cardiovasc Pharmacother. 2022 Sep 29;8(7):695-706. doi: 10.1093/ehjcvp/pvab089.
PMID: 34962979DERIVEDOyama K, Giugliano RP, Berg DD, Ruff CT, Jarolim P, Tang M, Murphy SA, Lanz HJ, Grosso MA, Antman EM, Braunwald E, Morrow DA. Serial assessment of biomarkers and the risk of stroke or systemic embolism and bleeding in patients with atrial fibrillation in the ENGAGE AF-TIMI 48 trial. Eur Heart J. 2021 May 1;42(17):1698-1706. doi: 10.1093/eurheartj/ehab141.
PMID: 33760027DERIVEDSteffel J, Ruff CT, Yin O, Braunwald E, Park JG, Murphy SA, Connolly S, Antman EM, Giugliano RP. Randomized, Double-Blind Comparison of Half-Dose Versus Full-Dose Edoxaban in 14,014 Patients With Atrial Fibrillation. J Am Coll Cardiol. 2021 Mar 9;77(9):1197-1207. doi: 10.1016/j.jacc.2020.12.053.
PMID: 33663737DERIVEDWilkinson C, Wu J, Searle SD, Todd O, Hall M, Kunadian V, Clegg A, Rockwood K, Gale CP. Clinical outcomes in patients with atrial fibrillation and frailty: insights from the ENGAGE AF-TIMI 48 trial. BMC Med. 2020 Dec 24;18(1):401. doi: 10.1186/s12916-020-01870-w.
PMID: 33357217DERIVEDVilain K, Li H, Kwong WJ, Antman EM, Ruff CT, Braunwald E, Cohen DJ, Giugliano RP, Magnuson EA; ENGAGE AF-TIMI 48 Trial Investigators. Cardiovascular- and Bleeding-Related Hospitalization Rates With Edoxaban Versus Warfarin in Patients With Atrial Fibrillation Based on Results of the ENGAGE AF-TIMI 48 Trial. Circ Cardiovasc Qual Outcomes. 2020 Nov;13(11):e006511. doi: 10.1161/CIRCOUTCOMES.120.006511. Epub 2020 Nov 5.
PMID: 33148013DERIVEDInciardi RM, Giugliano RP, Claggett B, Gupta DK, Chandra A, Ruff CT, Antman EM, Mercuri MF, Grosso MA, Braunwald E, Solomon SD; ENGAGE AF-TIMI 48 Investigators. Left atrial structure and function and the risk of death or heart failure in atrial fibrillation. Eur J Heart Fail. 2019 Dec;21(12):1571-1579. doi: 10.1002/ejhf.1606. Epub 2019 Nov 27.
PMID: 31777160DERIVEDBergmark BA, Kamphuisen PW, Wiviott SD, Ruff CT, Antman EM, Nordio F, Kuder JF, Mercuri MF, Lanz HJ, Braunwald E, Giugliano RP. Comparison of Events Across Bleeding Scales in the ENGAGE AF-TIMI 48 Trial. Circulation. 2019 Nov 26;140(22):1792-1801. doi: 10.1161/CIRCULATIONAHA.119.041346. Epub 2019 Oct 10.
PMID: 31597460DERIVEDBerg DD, Ruff CT, Jarolim P, Giugliano RP, Nordio F, Lanz HJ, Mercuri MF, Antman EM, Braunwald E, Morrow DA. Performance of the ABC Scores for Assessing the Risk of Stroke or Systemic Embolism and Bleeding in Patients With Atrial Fibrillation in ENGAGE AF-TIMI 48. Circulation. 2019 Feb 5;139(6):760-771. doi: 10.1161/CIRCULATIONAHA.118.038312.
PMID: 30586727DERIVEDCorbalan R, Nicolau JC, Lopez-Sendon J, Garcia-Castillo A, Botero R, Sotomora G, Horna M, Ruff CT, Hamershock RA, Grip LT, Antman EM, Braunwald E, Giugliano RP. Edoxaban Versus Warfarin in Latin American Patients With Atrial Fibrillation: The ENGAGE AF-TIMI 48 Trial. J Am Coll Cardiol. 2018 Sep 25;72(13):1466-1475. doi: 10.1016/j.jacc.2018.07.037.
PMID: 30236308DERIVEDYin OQP, Antman EM, Braunwald E, Mercuri MF, Miller R, Morrow D, Ruff CT, Truitt K, Weitz JI, Giugliano RP. Linking Endogenous Factor Xa Activity, a Biologically Relevant Pharmacodynamic Marker, to Edoxaban Plasma Concentrations and Clinical Outcomes in the ENGAGE AF-TIMI 48 Trial. Circulation. 2018 Oct 30;138(18):1963-1973. doi: 10.1161/CIRCULATIONAHA.118.033933.
PMID: 29967197DERIVEDAisenberg J, Chatterjee-Murphy P, Friedman Flack K, Weitz JI, Ruff CT, Nordio F, Mercuri MF, Choi Y, Antman EM, Braunwald E, Giugliano RP. Gastrointestinal Bleeding With Edoxaban Versus Warfarin: Results From the ENGAGE AF-TIMI 48 Trial (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis In Myocardial Infarction). Circ Cardiovasc Qual Outcomes. 2018 May;11(5):e003998. doi: 10.1161/CIRCOUTCOMES.117.003998.
PMID: 29748353DERIVEDWang K, Li H, Kwong WJ, Antman EM, Ruff CT, Giugliano RP, Cohen DJ, Magnuson EA; ENGAGE AF-TIMI 48 Trial Investigators. Impact of Spontaneous Extracranial Bleeding Events on Health State Utility in Patients with Atrial Fibrillation: Results from the ENGAGE AF-TIMI 48 Trial. J Am Heart Assoc. 2017 Aug 11;6(8):e006703. doi: 10.1161/JAHA.117.006703.
PMID: 28862934DERIVEDEisen A, Ruff CT, Braunwald E, Hamershock RA, Lewis BS, Hassager C, Chao TF, Le Heuzey JY, Mercuri M, Rutman H, Antman EM, Giugliano RP. Digoxin Use and Subsequent Clinical Outcomes in Patients With Atrial Fibrillation With or Without Heart Failure in the ENGAGE AF-TIMI 48 Trial. J Am Heart Assoc. 2017 Jun 30;6(7):e006035. doi: 10.1161/JAHA.117.006035.
PMID: 28666993DERIVEDDe Caterina R, Renda G, Carnicelli AP, Nordio F, Trevisan M, Mercuri MF, Ruff CT, Antman EM, Braunwald E, Giugliano RP. Valvular Heart Disease Patients on Edoxaban or Warfarin in the ENGAGE AF-TIMI 48 Trial. J Am Coll Cardiol. 2017 Mar 21;69(11):1372-1382. doi: 10.1016/j.jacc.2016.12.031.
PMID: 28302288DERIVEDLink MS, Giugliano RP, Ruff CT, Scirica BM, Huikuri H, Oto A, Crompton AE, Murphy SA, Lanz H, Mercuri MF, Antman EM, Braunwald E; ENGAGE AF-TIMI 48 Investigators. Stroke and Mortality Risk in Patients With Various Patterns of Atrial Fibrillation: Results From the ENGAGE AF-TIMI 48 Trial (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48). Circ Arrhythm Electrophysiol. 2017 Jan;10(1):e004267. doi: 10.1161/CIRCEP.116.004267.
PMID: 28077507DERIVEDRuff CT, Giugliano RP, Braunwald E, Murphy SA, Brown K, Jarolim P, Mercuri M, Antman EM, Morrow DA. Cardiovascular Biomarker Score and Clinical Outcomes in Patients With Atrial Fibrillation: A Subanalysis of the ENGAGE AF-TIMI 48 Randomized Clinical Trial. JAMA Cardiol. 2016 Dec 1;1(9):999-1006. doi: 10.1001/jamacardio.2016.3311.
PMID: 27706467DERIVEDSteffel J, Giugliano RP, Braunwald E, Murphy SA, Mercuri M, Choi Y, Aylward P, White H, Zamorano JL, Antman EM, Ruff CT. Edoxaban Versus Warfarin in Atrial Fibrillation Patients at Risk of Falling: ENGAGE AF-TIMI 48 Analysis. J Am Coll Cardiol. 2016 Sep 13;68(11):1169-1178. doi: 10.1016/j.jacc.2016.06.034.
PMID: 27609678DERIVEDEisen A, Ruff CT, Braunwald E, Nordio F, Corbalan R, Dalby A, Dorobantu M, Mercuri M, Lanz H, Rutman H, Wiviott SD, Antman EM, Giugliano RP. Sudden Cardiac Death in Patients With Atrial Fibrillation: Insights From the ENGAGE AF-TIMI 48 Trial. J Am Heart Assoc. 2016 Jul 8;5(7):e003735. doi: 10.1161/JAHA.116.003735.
PMID: 27402235DERIVEDRost NS, Giugliano RP, Ruff CT, Murphy SA, Crompton AE, Norden AD, Silverman S, Singhal AB, Nicolau JC, SomaRaju B, Mercuri MF, Antman EM, Braunwald E; ENGAGE AF-TIMI 48 Investigators. Outcomes With Edoxaban Versus Warfarin in Patients With Previous Cerebrovascular Events: Findings From ENGAGE AF-TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48). Stroke. 2016 Aug;47(8):2075-82. doi: 10.1161/STROKEAHA.116.013540. Epub 2016 Jul 7.
PMID: 27387994DERIVEDBohula EA, Giugliano RP, Ruff CT, Kuder JF, Murphy SA, Antman EM, Braunwald E. Impact of Renal Function on Outcomes With Edoxaban in the ENGAGE AF-TIMI 48 Trial. Circulation. 2016 Jul 5;134(1):24-36. doi: 10.1161/CIRCULATIONAHA.116.022361.
PMID: 27358434DERIVEDKato ET, Giugliano RP, Ruff CT, Koretsune Y, Yamashita T, Kiss RG, Nordio F, Murphy SA, Kimura T, Jin J, Lanz H, Mercuri M, Braunwald E, Antman EM. Efficacy and Safety of Edoxaban in Elderly Patients With Atrial Fibrillation in the ENGAGE AF-TIMI 48 Trial. J Am Heart Assoc. 2016 May 20;5(5):e003432. doi: 10.1161/JAHA.116.003432.
PMID: 27207971DERIVEDXu H, Ruff CT, Giugliano RP, Murphy SA, Nordio F, Patel I, Shi M, Mercuri M, Antman EM, Braunwald E. Concomitant Use of Single Antiplatelet Therapy With Edoxaban or Warfarin in Patients With Atrial Fibrillation: Analysis From the ENGAGE AF-TIMI48 Trial. J Am Heart Assoc. 2016 Feb 23;5(2):e002587. doi: 10.1161/JAHA.115.002587.
PMID: 26908401DERIVEDRuff CT, Giugliano RP, Braunwald E, Morrow DA, Murphy SA, Kuder JF, Deenadayalu N, Jarolim P, Betcher J, Shi M, Brown K, Patel I, Mercuri M, Antman EM. Association between edoxaban dose, concentration, anti-Factor Xa activity, and outcomes: an analysis of data from the randomised, double-blind ENGAGE AF-TIMI 48 trial. Lancet. 2015 Jun 6;385(9984):2288-95. doi: 10.1016/S0140-6736(14)61943-7. Epub 2015 Mar 11.
PMID: 25769361DERIVEDMega JL, Walker JR, Ruff CT, Vandell AG, Nordio F, Deenadayalu N, Murphy SA, Lee J, Mercuri MF, Giugliano RP, Antman EM, Braunwald E, Sabatine MS. Genetics and the clinical response to warfarin and edoxaban: findings from the randomised, double-blind ENGAGE AF-TIMI 48 trial. Lancet. 2015 Jun 6;385(9984):2280-7. doi: 10.1016/S0140-6736(14)61994-2. Epub 2015 Mar 11.
PMID: 25769357DERIVEDRuff CT, Giugliano RP, Braunwald E, Mercuri M, Curt V, Betcher J, Grip L, Cange AL, Crompton AE, Murphy SA, Deenadayalu N, Antman EM. Transition of patients from blinded study drug to open-label anticoagulation: the ENGAGE AF-TIMI 48 trial. J Am Coll Cardiol. 2014 Aug 12;64(6):576-84. doi: 10.1016/j.jacc.2014.05.028.
PMID: 25104527DERIVEDGiugliano RP, Ruff CT, Rost NS, Silverman S, Wiviott SD, Lowe C, Deenadayalu N, Murphy SA, Grip LT, Betcher JM, Duggal A, Dave J, Shi M, Mercuri M, Antman EM, Braunwald E; ENGAGE AF-TIMI 48 Investigators. Cerebrovascular events in 21 105 patients with atrial fibrillation randomized to edoxaban versus warfarin: Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48. Stroke. 2014 Aug;45(8):2372-8. doi: 10.1161/STROKEAHA.114.006025. Epub 2014 Jun 19.
PMID: 24947287DERIVEDGupta DK, Shah AM, Giugliano RP, Ruff CT, Antman EM, Grip LT, Deenadayalu N, Hoffman E, Patel I, Shi M, Mercuri M, Mitrovic V, Braunwald E, Solomon SD; Effective aNticoaGulation with factor xA next GEneration in AF-Thrombolysis In Myocardial Infarction 48 Echocardiographic Study Investigators. Left atrial structure and function in atrial fibrillation: ENGAGE AF-TIMI 48. Eur Heart J. 2014 Jun 7;35(22):1457-65. doi: 10.1093/eurheartj/eht500. Epub 2013 Dec 2.
PMID: 24302269DERIVEDGiugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Spinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM; ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013 Nov 28;369(22):2093-104. doi: 10.1056/NEJMoa1310907. Epub 2013 Nov 19.
PMID: 24251359DERIVEDSalazar DE, Mendell J, Kastrissios H, Green M, Carrothers TJ, Song S, Patel I, Bocanegra TS, Antman EM, Giugliano RP, Kunitada S, Dornseif B, Shi M, Tachibana M, Zhou S, Rohatagi S. Modelling and simulation of edoxaban exposure and response relationships in patients with atrial fibrillation. Thromb Haemost. 2012 May;107(5):925-36. doi: 10.1160/TH11-08-0566. Epub 2012 Mar 8.
PMID: 22398655DERIVEDRuff CT, Giugliano RP, Antman EM, Crugnale SE, Bocanegra T, Mercuri M, Hanyok J, Patel I, Shi M, Salazar D, McCabe CH, Braunwald E. Evaluation of the novel factor Xa inhibitor edoxaban compared with warfarin in patients with atrial fibrillation: design and rationale for the Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation-Thrombolysis In Myocardial Infarction study 48 (ENGAGE AF-TIMI 48). Am Heart J. 2010 Oct;160(4):635-41. doi: 10.1016/j.ahj.2010.06.042.
PMID: 20934556DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- James Hanyok, Sr. Director
- Organization
- Daiichi Sankyo, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2008
First Posted
October 29, 2008
Study Start
November 1, 2008
Primary Completion
April 1, 2013
Study Completion
May 1, 2013
Last Updated
March 5, 2019
Results First Posted
March 25, 2015
Record last verified: 2015-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
- Access Criteria
- Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/