An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation

NCT ID: NCT00403767

Last Updated: 2014-04-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

14269 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2010-09-30

Brief Summary

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The purpose of this study is to compare the efficacy and safety of rivaroxaban with warfarin for the prevention of blood clots in the brain (referred to as stroke) and blood clots in other parts of the body referred to as non-central nervous system systemic embolism) in patients with non-valvular atrial fibrillation (a heart rhythm disorder).

Detailed Description

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Patients with non-valvular atrial fibrillation who are at risk for stroke and non-central nervous system (non-CNS) systemic embolism, will be randomized (assigned by chance) to receive treatment with rivaroxaban or warfarin, two different anticoagulants (substances that prevent blood clots). Treatment will be double-blinded (neither the patient nor study staff will know which study drug is assigned to patients during the study). Patients assigned to rivaroxaban will receive rivaroxaban 20 mg orally (p.o.) once daily (OD) plus warfarin placebo p.o. OD titrated to a target sham international normalized ratio (INR) of 2.5. Patients with moderate renal impairment at screening will receive rivaroxaban 15 mg p.o. OD. Patients assigned to warfarin will receive warfarin p.o. OD titrated to a target INR of 2.5 plus rivaroxaban placebo p.o. OD. The maximum expected length of treatment is up to 32 months but may be extended up to 4 years.

Conditions

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Atrial Fibrillation Stroke Embolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rivaroxaban

Group Type EXPERIMENTAL

Rivaroxaban

Intervention Type DRUG

Type=exact number, unit=mg, number=20, form=tablet, route=oral use. One 20 mg tablet once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years (Patients with moderate renal impairment at screening willl have a dose adaptation to rivaroxaban 15 mg, orally, once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years)

Matching placebo for Rivaroxaban arm (Warfarin placebo)

Intervention Type DRUG

Form=tablet, route=oral. One warfarin placebo tablet taken orally once daily for up to an expected maximum treatment period of 32 months that may extend up to 4 years

Warfarin

Group Type ACTIVE_COMPARATOR

Warfarin

Intervention Type DRUG

Type=exact number, unit=mg, number=1, 2.5, or 5 mg, form=tablet, route=oral use. Number of warfarin tablets to be determined based on target INR values once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years

Matching placebo for Warfarin arm (Rivaroxaban placebo)

Intervention Type DRUG

Form-tablet, Route=oral administration. Number of rivaroxaban placebo determined by the number of warfarin tablets taken. Duration of treatment is up to an expected maximum treatment period of 32 months that may extend up to 4 years

Interventions

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Rivaroxaban

Type=exact number, unit=mg, number=20, form=tablet, route=oral use. One 20 mg tablet once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years (Patients with moderate renal impairment at screening willl have a dose adaptation to rivaroxaban 15 mg, orally, once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years)

Intervention Type DRUG

Warfarin

Type=exact number, unit=mg, number=1, 2.5, or 5 mg, form=tablet, route=oral use. Number of warfarin tablets to be determined based on target INR values once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years

Intervention Type DRUG

Matching placebo for Rivaroxaban arm (Warfarin placebo)

Form=tablet, route=oral. One warfarin placebo tablet taken orally once daily for up to an expected maximum treatment period of 32 months that may extend up to 4 years

Intervention Type DRUG

Matching placebo for Warfarin arm (Rivaroxaban placebo)

Form-tablet, Route=oral administration. Number of rivaroxaban placebo determined by the number of warfarin tablets taken. Duration of treatment is up to an expected maximum treatment period of 32 months that may extend up to 4 years

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients must have documented atrial fibrillation on 2 separate occasions within 6 months before screening
* History of a prior stroke, transient ischemic attack or non-neurologic systemic embolism believed to be cardiac in origin, or at least two of the following risk factors: heart failure, hypertension, age 75 years or greater, diabetes mellitus

Exclusion Criteria

* Significant mitral stenosis
* Transient atrial fibrillation caused by a reversible disorder
* Active internal bleeding
* Severe disabling stroke
* History of intracranial bleeding
* Hemorrhagic disorders
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Locations

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Birmingham, Alabama, United States

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Dothan, Alabama, United States

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Geneva, Alabama, United States

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Mobile, Alabama, United States

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Pell City, Alabama, United States

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Glendale, Arizona, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Tucson, Arizona, United States

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Fort Smith, Arkansas, United States

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Little Rock, Arkansas, United States

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Anaheim, California, United States

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Bakersfield, California, United States

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Carmichael, California, United States

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Corona, California, United States

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Fair Oaks, California, United States

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Glendale, California, United States

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Healdsburg, California, United States

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Laguna Hills, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Los Gatos, California, United States

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Mission Viejo, California, United States

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Modesto, California, United States

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Mountain View, California, United States

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Northridge, California, United States

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Oakland, California, United States

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Orange, California, United States

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Pismo 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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San Leandro, California, United States

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Santa Clara, California, United States

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Santa Monica, California, United States

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Santa Rosa, California, United States

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Sylmar, California, United States

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Torrance, California, United States

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Ventura, California, United States

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Yuba City, California, United States

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Boulder, Colorado, United States

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Denver, Colorado, United States

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Littleton, Colorado, United States

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Pueblo, Colorado, United States

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Danbury, Connecticut, United States

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Guilford, Connecticut, United States

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Newark, Delaware, United States

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Bradenton, Florida, United States

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Clearwater, Florida, 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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Fort Lauderdale, Florida, United States

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Fort Myers, Florida, United States

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Fort Walton Beach, Florida, United States

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Hialeah, Florida, United States

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Hollywood, Florida, United States

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Hudson, Florida, United States

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Inverness, Florida, United States

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Jacksonville, Florida, United States

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Jupiter, Florida, United States

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Kissimmee, Florida, United States

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Largo, Florida, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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Miami Beach, Florida, United States

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Ocala, 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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Palm Beach Gardens, Florida, United States

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Palm Harbor, Florida, United States

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Port Charlotte, Florida, United States

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Safety Harbor, Florida, United States

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St. Petersburg, Florida, United States

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Tallahassee, Florida, United States

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Tamarac, Florida, United States

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Tampa, Florida, United States

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Albany, Georgia, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Columbus, Georgia, United States

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Savannah, Georgia, United States

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Boise, Idaho, United States

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Idaho Falls, Idaho, United States

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Nampa, Idaho, United States

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Aurora, Illinois, United States

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Bannockburn, Illinois, United States

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Chicago, Illinois, United States

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Evergreen Park, Illinois, United States

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Fulton, Illinois, United States

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Lombard, Illinois, United States

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Melrose Park, Illinois, United States

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Moline, Illinois, United States

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Park Ridge, Illinois, United States

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Peoria, Illinois, United States

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Quincy, Illinois, United States

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Rock Island, Illinois, United States

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Rockford, Illinois, United States

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Springfield, Illinois, United States

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Watseka, Illinois, United States

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Anderson, Indiana, United States

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Hammond, Indiana, United States

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Indianapolis, Indiana, United States

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Merrillville, Indiana, United States

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Muncie, Indiana, United States

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Munster, Indiana, United States

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South Bend, Indiana, United States

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Waterloo, Iowa, United States

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Crestview Hills, Kentucky, United States

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Edgewood, Kentucky, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Madisonville, Kentucky, United States

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Mount Sterling, Kentucky, United States

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Owensboro, Kentucky, United States

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Houma, Louisiana, United States

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Lake Charles, Louisiana, United States

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New Orleans, Louisiana, United States

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Thibodaux, Louisiana, United States

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Vidalia, Louisiana, United States

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Bangor, Maine, United States

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Scarborough, Maine, United States

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Annapolis, Maryland, United States

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Beltsville, Maryland, United States

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Columbia, Maryland, United States

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Salisbury, Maryland, United States

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Boston, Massachusetts, United States

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Brighton, Massachusetts, United States

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Framingham, Massachusetts, United States

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Bay City, Michigan, United States

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Bridgman, Michigan, United States

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Chelsea, Michigan, United States

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Dearborn, Michigan, United States

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Detroit, Michigan, United States

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Lansing, Michigan, United States

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Mount Clemens, Michigan, United States

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Petoskey, Michigan, United States

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Traverse City, Michigan, United States

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Troy, Michigan, United States

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Minneapolis, Minnesota, United States

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Saint Paul, Minnesota, United States

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Picayune, Mississippi, United States

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Tupelo, Mississippi, United States

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Lexington, Missouri, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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Anaconda, Montana, United States

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Great Falls, Montana, United States

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Beatrice, Nebraska, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Pahrump, Nevada, United States

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Manchester, New Hampshire, United States

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Bridgewater, New Jersey, United States

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Elmer, New Jersey, United States

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Haddon Heights, New Jersey, United States

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New Brunswick, New Jersey, United States

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Paterson, New Jersey, United States

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Ridgewood, New Jersey, United States

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Sewell, New Jersey, United States

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Springfield, New Jersey, United States

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Toms River, New Jersey, United States

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Wayne, New Jersey, United States

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Albuquerque, New Mexico, 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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East Syracuse, New York, United States

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New York, New York, United States

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Northport, New York, United States

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Saratoga Springs, New York, United States

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Schenectady, New York, United States

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Staten Island, New York, United States

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Stony Brook, New York, United States

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Syracuse, New York, United States

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The Bronx, New York, United States

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Williamsville, New York, United States

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Asheville, North Carolina, United States

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Durham, North Carolina, United States

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Greensboro, North Carolina, United States

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Hickory, North Carolina, United States

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Jacksonville, North Carolina, United States

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New Bern, North Carolina, United States

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Raleigh, North Carolina, United States

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Reidsville, North Carolina, United States

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Rocky Mount, 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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Minot, North Dakota, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Fairfield, Ohio, United States

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Mansfield, Ohio, United States

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Massillon, Ohio, United States

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Maumee, Ohio, United States

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Toledo, Ohio, United States

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Zanesville, Ohio, United States

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Bartlesville, Oklahoma, United States

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Midwest City, Oklahoma, United States

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Norman, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Yukon, Oklahoma, United States

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Portland, Oregon, United States

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Beaver, Pennsylvania, United States

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Bethlehem, Pennsylvania, United States

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Danville, Pennsylvania, United States

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Doylestown, Pennsylvania, United States

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Jeannette, Pennsylvania, United States

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Jersey Shore, Pennsylvania, United States

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Lansdale, Pennsylvania, United States

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Leetsdale, Pennsylvania, United States

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Lewistown, Pennsylvania, United States

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Norristown, Pennsylvania, United States

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North Wales, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philipsburg, Pennsylvania, United States

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Phoenixville, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Sayre, Pennsylvania, United States

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Scranton, Pennsylvania, United States

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Shippensburg, Pennsylvania, United States

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State College, Pennsylvania, United States

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Topton, Pennsylvania, United States

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Wilkes-Barre, Pennsylvania, United States

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Wormleysburg, Pennsylvania, United States

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Wyomissing, Pennsylvania, United States

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Pawtucket, Rhode Island, United States

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Westerly, 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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Easley, South Carolina, United States

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Sumter, South Carolina, United States

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Rapid City, South Dakota, United States

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Athens, Tennessee, United States

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Bristol, Tennessee, United States

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Chattanooga, Tennessee, United States

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Harriman, Tennessee, United States

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Jackson, Tennessee, United States

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Johnson City, Tennessee, United States

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Kingsport, Tennessee, United States

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Knoxville, Tennessee, United States

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Lexington, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Amarillo, Texas, United States

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Beaumont, Texas, United States

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Brownsville, Texas, United States

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Corpus Christi, Texas, United States

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Daingerfield, Texas, United States

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Dallas, Texas, United States

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DeSoto, Texas, United States

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Fort Sam Houston, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Humble, Texas, United States

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Hurst, Texas, United States

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Kerrville, Texas, United States

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Kingwood, 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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Sugar Land, Texas, United States

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Tomball, Texas, United States

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Victoria, Texas, United States

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Murray, Utah, United States

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Salt Lake City, Utah, United States

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Burlington, Vermont, United States

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Blacksburg, Virginia, United States

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Chester, Virginia, United States

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Danville, Virginia, United States

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Fairfax, Virginia, United States

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Fredericksburg, Virginia, United States

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Lynchburg, Virginia, United States

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Richmond, Virginia, United States

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Roanoke, Virginia, United States

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Virginia Beach, Virginia, United States

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Williamsburg, Virginia, United States

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Bellingham, Washington, United States

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Port Orchard, 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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Vancouver, Washington, United States

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Burlington, Wisconsin, United States

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Elkhorn, Wisconsin, United States

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La Crosse, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Wausau, Wisconsin, United States

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Bahía Blanca, , Argentina

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Buenos Aires, , Argentina

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Cipolletti, , Argentina

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Corrientes, , Argentina

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Córdoba, , Argentina

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La Plata, , Argentina

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Mar del Plata, , Argentina

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Quilmes, , Argentina

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Rosario, , Argentina

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Salta, , Argentina

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San Martín, , Argentina

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San Miguel de Tucumán, , Argentina

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Santa Fe, , Argentina

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Adelaide, , Australia

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Auchenflower, , Australia

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Bedford Park, , Australia

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Box Hill, , Australia

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Caboolture, , Australia

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Cairns, , Australia

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Camperdown, , Australia

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Chermside, , Australia

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Clayton, , Australia

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Coffs Harbour, , Australia

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Footscray, , Australia

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Garran, , Australia

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Geelong, , Australia

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Gosford, , Australia

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Heidelberg Heights, , Australia

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Herston, , Australia

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Hobart, , Australia

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Joondalup, , Australia

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Lismore, , Australia

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Liverpool, , Australia

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Miranda, , Australia

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Nedlands, , Australia

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New Lambton Heights, , Australia

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Parkville, , Australia

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Penrith, , Australia

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Prahran, , Australia

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Reservoir, , Australia

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Southport, , Australia

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Windsor, , Australia

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Wolloongabba, , Australia

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Feldkirch Vorarlberg Vorarlber, , Austria

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Graz, , Austria

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Tulln Niederosterreich Niedero, , Austria

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Vienna, , Austria

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Wien Wien, , Austria

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Antwerp, , Belgium

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Bonheiden, , Belgium

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Brasschaat, , Belgium

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Bruges, , Belgium

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Brussels, , Belgium

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Ghent, , Belgium

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Haine-Saint-Paul, , Belgium

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Leuven, , Belgium

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Mol, , Belgium

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Nivelles, , Belgium

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Ottignies, , Belgium

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Roeselare, , Belgium

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Seraing, , Belgium

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Tienen, , 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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Campo Grande, , Brazil

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Curitiba, , Brazil

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Fortaleza, , Brazil

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Goiânia, , Brazil

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Maceió, , Brazil

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Maringá, , Brazil

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Marília, , Brazil

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Porto Alegre, , Brazil

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Recife, , Brazil

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Rio de Janeiro, , Brazil

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Rio de Janeiro Br, , Brazil

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Salvador, , Brazil

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Santo André, , Brazil

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São Caetano do Sul, , Brazil

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São José do Rio Preto, , Brazil

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São Paulo, , Brazil

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Sorocaba, , Brazil

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Uberlândia, , Brazil

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Dimitrovgrad, , Bulgaria

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Pleven, , Bulgaria

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Plovdiv, , Bulgaria

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Russel, , Bulgaria

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Sofia, , Bulgaria

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Veliko Tarnovo, , Bulgaria

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Abbotsford, British Columbia, Canada

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Burnaby, British Columbia, Canada

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Campbell River, British Columbia, Canada

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Delta, British Columbia, Canada

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Kelowna, British Columbia, Canada

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Langley, British Columbia, Canada

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New Westminster, British Columbia, Canada

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Penticton, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Victoria, British Columbia, Canada

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West Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Moncton, New Brunswick, Canada

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Saint John, New Brunswick, Canada

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St. John's, Newfoundland and Labrador, Canada

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Halifax, Nova Scotia, Canada

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Sydney, Nova Scotia, Canada

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Ajax, Ontario, Canada

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Beamsville, Ontario, Canada

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Belleville, Ontario, Canada

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Brampton, Ontario, Canada

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Burlington, Ontario, Canada

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Cambridge, Ontario, Canada

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Corunna, Ontario, Canada

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Courtice, Ontario, Canada

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E. London, Ontario, Canada

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Etobicoke, Ontario, Canada

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Fort Erie, 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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Markham, Ontario, Canada

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Mississauga, Ontario, Canada

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North Bay, Ontario, Canada

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North York, Ontario, Canada

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Oakville, Ontario, Canada

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Oshawa, Ontario, Canada

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Ottawa, Ontario, Canada

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Parry Sound, Ontario, Canada

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Richmond Hill, Ontario, Canada

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Sarnia, Ontario, Canada

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Sault Ste. Marie, Ontario, Canada

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Scarborough Village, Ontario, Canada

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Strathroy, Ontario, Canada

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Thornhill, Ontario, Canada

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Thunder Bay, Ontario, Canada

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Toronto, Ontario, Canada

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Waterloo, Ontario, Canada

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Whitby, Ontario, Canada

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York, Ontario, Canada

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Chicoutimi, Quebec, Canada

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Greenfield Park, Quebec, Canada

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Joliette, Quebec, Canada

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Jonquière, Quebec, Canada

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Lachine, Quebec, Canada

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Longueuil, Quebec, Canada

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Mirabel, Quebec, Canada

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Montreal, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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Québec, Quebec, Canada

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Saint-Jérôme, Quebec, Canada

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Saint-Lambert, Quebec, Canada

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Saint-Léonard, Quebec, Canada

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Sherbrooke, Quebec, Canada

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North Battleford, Saskatchewan, Canada

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Saskatoon, Saskatchewan, Canada

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Arica I Region, , Chile

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Chila, , Chile

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Concepción VIII, , Chile

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Osorno X Region, , Chile

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Osorno X Región, , Chile

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Rancagua VI Region, , Chile

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San Felipe V Region, , Chile

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Santiago de Chile Rm, , Chile

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Santiago Rm, , Chile

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Temuco IX, , Chile

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Valdivia X Región, , Chile

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Viña Del Mar V Región, , Chile

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Beijing, , China

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Changchun, , China

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Changsha, , China

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Changzhou, , China

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Chengdu, , China

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Chongqing, , China

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Dalian, , China

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Daqing, , China

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Guangzhou, , China

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Haikou, , China

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Hangzhou, , China

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Harbin, , China

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Nanjing, , China

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Suzhou, , China

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Wuhan, , China

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Brno, , Czechia

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Copenhagen, , Denmark

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Lille, , France

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Marseille, , France

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Montbéliard, , France

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Montpellier, , France

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Paris, , France

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Strasbourg, , France

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Leipzig, , Germany

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Mainz, , Germany

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Wuppertal, , Germany

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Tripoli, , Greece

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Aberdeen, , Hong Kong

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Antalya, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Malatya Nap, , Turkey (Türkiye)

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Samsun, , Turkey (Türkiye)

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Donetsk, , Ukraine

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Ivano-Frankivsk, , Ukraine

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Kharkiv, , Ukraine

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Kyiv, , Ukraine

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Luhansk, , Ukraine

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Lviv, , Ukraine

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Odesa, , Ukraine

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Poltava, , Ukraine

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Simferopil, , Ukraine

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Sumy, , Ukraine

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Zaporizhzhya, , Ukraine

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Chesterfield, , United Kingdom

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Colchester, , United Kingdom

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Devon, , United Kingdom

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Glasgow, , United Kingdom

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Harrogate, , United Kingdom

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Leicester, , United Kingdom

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Lincoln, , United Kingdom

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Liverpool, , United Kingdom

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London, , United Kingdom

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Nottingham, , United Kingdom

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Plymouth, , United Kingdom

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Romford, , United Kingdom

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Sheffield, , United Kingdom

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Stirling, , United Kingdom

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Stoke-on-Trent, , United Kingdom

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York, , United Kingdom

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Caracas, , Venezuela

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Maracaibo Estado Zulia, , Venezuela

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Maracay Estado Aragua, , Venezuela

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References

Explore related publications, articles, or registry entries linked to this study.

Dobesh PP, Volkl AA, Pap AF, Damaraju CV, Levitan B, Yuan Z, Amin AN. Benefit-Risk Assessment of Rivaroxaban in Older Patients With Nonvalvular Atrial Fibrillation or Venous Thromboembolism. Drugs Aging. 2025 May;42(5):469-484. doi: 10.1007/s40266-025-01192-7. Epub 2025 Mar 31.

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Ungar L, Rodriguez F, Hellkamp AS, Becker RC, Berkowitz SD, Breithardt G, Fox KAA, Hacke W, Halperin JL, Hankey GJ, Nessel CC, Singer DE, Patel MR, Piccini JP, Mahaffey KW. Patient-Reported Satisfaction and Study Drug Discontinuation: Post-Hoc Analysis of Findings from ROCKET AF. Cardiol Ther. 2019 Dec;8(2):283-295. doi: 10.1007/s40119-019-00146-6. Epub 2019 Aug 2.

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Quinn GR, Hellkamp AS, Hankey GJ, Becker RC, Berkowitz SD, Breithardt G, Fava M, Fox KAA, Halperin JL, Mahaffey KW, Nessel CC, Patel MR, Piccini JP, Singer DE. Selective Serotonin Reuptake Inhibitors and Bleeding Risk in Anticoagulated Patients With Atrial Fibrillation: An Analysis From the ROCKET AF Trial. J Am Heart Assoc. 2018 Aug 7;7(15):e008755. doi: 10.1161/JAHA.118.008755.

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Chen ST, Hellkamp AS, Becker RC, Berkowitz SD, Breithardt G, Fox KAA, Hacke W, Halperin JL, Hankey GJ, Mahaffey KW, Nessel CC, Piccini JP, Singer DE, Patel MR, Melloni C. Efficacy and safety of rivaroxaban vs. warfarin in patients with non-valvular atrial fibrillation and a history of cancer: observations from ROCKET AF. Eur Heart J Qual Care Clin Outcomes. 2019 Apr 1;5(2):145-152. doi: 10.1093/ehjqcco/qcy040.

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Piccini JP, Hellkamp AS, Washam JB, Becker RC, Breithardt G, Berkowitz SD, Halperin JL, Hankey GJ, Hacke W, Mahaffey KW, Nessel CC, Singer DE, Fox KA, Patel MR. Polypharmacy and the Efficacy and Safety of Rivaroxaban Versus Warfarin in the Prevention of Stroke in Patients With Nonvalvular Atrial Fibrillation. Circulation. 2016 Jan 26;133(4):352-60. doi: 10.1161/CIRCULATIONAHA.115.018544. Epub 2015 Dec 16.

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Bansilal S, Bloomgarden Z, Halperin JL, Hellkamp AS, Lokhnygina Y, Patel MR, Becker RC, Breithardt G, Hacke W, Hankey GJ, Nessel CC, Singer DE, Berkowitz SD, Piccini JP, Mahaffey KW, Fox KA; ROCKET AF Steering Committee and Investigators. Efficacy and safety of rivaroxaban in patients with diabetes and nonvalvular atrial fibrillation: the Rivaroxaban Once-daily, Oral, Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF Trial). Am Heart J. 2015 Oct;170(4):675-682.e8. doi: 10.1016/j.ahj.2015.07.006. Epub 2015 Jul 17.

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Washam JB, Stevens SR, Lokhnygina Y, Halperin JL, Breithardt G, Singer DE, Mahaffey KW, Hankey GJ, Berkowitz SD, Nessel CC, Fox KA, Califf RM, Piccini JP, Patel MR; ROCKET AF Steering Committee and Investigators. Digoxin use in patients with atrial fibrillation and adverse cardiovascular outcomes: a retrospective analysis of the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF). Lancet. 2015 Jun 13;385(9985):2363-70. doi: 10.1016/S0140-6736(14)61836-5. Epub 2015 Mar 6.

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Singer DE, Hellkamp AS, Yuan Z, Lokhnygina Y, Patel MR, Piccini JP, Hankey GJ, Breithardt G, Halperin JL, Becker RC, Hacke W, Nessel CC, Mahaffey KW, Fox KA, Califf RM; ROCKET AF Investigators. Alternative calculations of individual patient time in therapeutic range while taking warfarin: results from the ROCKET AF trial. J Am Heart Assoc. 2015 Mar 3;4(3):e001349. doi: 10.1161/JAHA.114.001349.

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Girgis IG, Patel MR, Peters GR, Moore KT, Mahaffey KW, Nessel CC, Halperin JL, Califf RM, Fox KA, Becker RC. Population pharmacokinetics and pharmacodynamics of rivaroxaban in patients with non-valvular atrial fibrillation: results from ROCKET AF. J Clin Pharmacol. 2014 Aug;54(8):917-27. doi: 10.1002/jcph.288. Epub 2014 Mar 26.

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Sherwood MW, Douketis JD, Patel MR, Piccini JP, Hellkamp AS, Lokhnygina Y, Spyropoulos AC, Hankey GJ, Singer DE, Nessel CC, Mahaffey KW, Fox KA, Califf RM, Becker RC; ROCKET AF Investigators. Outcomes of temporary interruption of rivaroxaban compared with warfarin in patients with nonvalvular atrial fibrillation: results from the rivaroxaban once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation (ROCKET AF). Circulation. 2014 May 6;129(18):1850-9. doi: 10.1161/CIRCULATIONAHA.113.005754. Epub 2014 Feb 19.

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Goodman SG, Wojdyla DM, Piccini JP, White HD, Paolini JF, Nessel CC, Berkowitz SD, Mahaffey KW, Patel MR, Sherwood MW, Becker RC, Halperin JL, Hacke W, Singer DE, Hankey GJ, Breithardt G, Fox KA, Califf RM; ROCKET AF Investigators. Factors associated with major bleeding events: insights from the ROCKET AF trial (rivaroxaban once-daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation). J Am Coll Cardiol. 2014 Mar 11;63(9):891-900. doi: 10.1016/j.jacc.2013.11.013. Epub 2013 Dec 4.

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Mahaffey KW, Wojdyla D, Hankey GJ, White HD, Nessel CC, Piccini JP, Patel MR, Berkowitz SD, Becker RC, Halperin JL, Singer DE, Califf RM, Fox KA, Breithardt G, Hacke W. Clinical outcomes with rivaroxaban in patients transitioned from vitamin K antagonist therapy: a subgroup analysis of a randomized trial. Ann Intern Med. 2013 Jun 18;158(12):861-8. doi: 10.7326/0003-4819-158-12-201306180-00003.

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van Diepen S, Hellkamp AS, Patel MR, Becker RC, Breithardt G, Hacke W, Halperin JL, Hankey GJ, Nessel CC, Singer DE, Berkowitz SD, Califf RM, Fox KA, Mahaffey KW. Efficacy and safety of rivaroxaban in patients with heart failure and nonvalvular atrial fibrillation: insights from ROCKET AF. Circ Heart Fail. 2013 Jul;6(4):740-7. doi: 10.1161/CIRCHEARTFAILURE.113.000212. Epub 2013 May 30.

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Singer DE, Hellkamp AS, Piccini JP, Mahaffey KW, Lokhnygina Y, Pan G, Halperin JL, Becker RC, Breithardt G, Hankey GJ, Hacke W, Nessel CC, Patel MR, Califf RM, Fox KA; ROCKET AF Investigators. Impact of global geographic region on time in therapeutic range on warfarin anticoagulant therapy: data from the ROCKET AF clinical trial. J Am Heart Assoc. 2013 Feb 19;2(1):e000067. doi: 10.1161/JAHA.112.000067.

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Piccini JP, Stevens SR, Lokhnygina Y, Patel MR, Halperin JL, Singer DE, Hankey GJ, Hacke W, Becker RC, Nessel CC, Mahaffey KW, Fox KA, Califf RM, Breithardt G; ROCKET AF Steering Committee & Investigators. Outcomes after cardioversion and atrial fibrillation ablation in patients treated with rivaroxaban and warfarin in the ROCKET AF trial. J Am Coll Cardiol. 2013 May 14;61(19):1998-2006. doi: 10.1016/j.jacc.2013.02.025. Epub 2013 Mar 14.

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Piccini JP, Stevens SR, Chang Y, Singer DE, Lokhnygina Y, Go AS, Patel MR, Mahaffey KW, Halperin JL, Breithardt G, Hankey GJ, Hacke W, Becker RC, Nessel CC, Fox KA, Califf RM; ROCKET AF Steering Committee and Investigators. Renal dysfunction as a predictor of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: validation of the R(2)CHADS(2) index in the ROCKET AF (Rivaroxaban Once-daily, oral, direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation) and ATRIA (AnTicoagulation and Risk factors In Atrial fibrillation) study cohorts. Circulation. 2013 Jan 15;127(2):224-32. doi: 10.1161/CIRCULATIONAHA.112.107128. Epub 2012 Dec 3.

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Hankey GJ, Patel MR, Stevens SR, Becker RC, Breithardt G, Carolei A, Diener HC, Donnan GA, Halperin JL, Mahaffey KW, Mas JL, Massaro A, Norrving B, Nessel CC, Paolini JF, Roine RO, Singer DE, Wong L, Califf RM, Fox KA, Hacke W; ROCKET AF Steering Committee Investigators. Rivaroxaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of ROCKET AF. Lancet Neurol. 2012 Apr;11(4):315-22. doi: 10.1016/S1474-4422(12)70042-X. Epub 2012 Mar 7.

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PMID: 22402056 (View on PubMed)

Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011 Sep 8;365(10):883-91. doi: 10.1056/NEJMoa1009638. Epub 2011 Aug 10.

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PMID: 21830957 (View on PubMed)

ROCKET AF Study Investigators. Rivaroxaban-once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: rationale and design of the ROCKET AF study. Am Heart J. 2010 Mar;159(3):340-347.e1. doi: 10.1016/j.ahj.2009.11.025.

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PMID: 20211293 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

39039039AFL3001

Identifier Type: OTHER

Identifier Source: secondary_id

ROCKET AF

Identifier Type: OTHER

Identifier Source: secondary_id

2006-004595-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR012157

Identifier Type: -

Identifier Source: org_study_id

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