Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities

NCT ID: NCT02504216

Last Updated: 2020-12-08

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

6564 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-18

Study Completion Date

2020-01-09

Brief Summary

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The purpose of study was to test whether rivaroxaban added to standard of care treatment, when compared to placebo, had the potential to reduce the incidence of the clinical events related to the clots and complications of the heart and brain (CV death, MI, or stroke) or the legs (acute limb ischemia or major amputation) in patients who had undergone recent procedure(s) to improve the blood flow of their legs.

Detailed Description

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Conditions

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Peripheral Artery Disease

Keywords

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Rivaroxaban Xarelto Aspirin Acetylic salicylic acid Anticoagulant Peripheral artery disease Peripheral arterial disease Revascularization Acute limb ischemia Amputation Cardiovascular events

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

Rivaroxaban 2.5 mg orally twice daily (5 mg cumulative daily dose)

Group Type EXPERIMENTAL

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type DRUG

2.5 mg, twice daily, orally, tablet

Placebo

Rivaroxaban-placebo orally twice daily

Group Type PLACEBO_COMPARATOR

Rivaroxaban-Placebo

Intervention Type DRUG

matching placebo, twice daily, orally, tablet

Interventions

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Rivaroxaban (Xarelto, BAY59-7939)

2.5 mg, twice daily, orally, tablet

Intervention Type DRUG

Rivaroxaban-Placebo

matching placebo, twice daily, orally, tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age ≥50
* Documented moderate to severe symptomatic lower extremity atherosclerotic peripheral artery disease
* Technically successful peripheral revascularization distal to the external iliac artery for symptomatic PAD (Peripheral artery disease) within the last 10 days prior to randomization

Exclusion Criteria

* Patients undergoing revascularization for asymptomatic PAD or mild claudication without functional limitation of the index leg.
* Patients undergoing revascularization of the index leg to treat an asymptomatic or minimally symptomatic restenosis of a bypass graft or target lesion restenosis.
* Prior revascularization on the index leg within 10 days of the qualifying revascularization.
* Planned dual antiplatelet therapy (DAPT) use for the qualifying revascularization procedure of clopidogrel in addition to Acetylic salicylic acid (ASA) for \>6 months after the qualifying revascularization procedure; it is strongly recommended that any course of clopidogrel is kept to the minimum necessary in accordance with local standard of care and international practice guidelines (typically 30 days, or up to 60 days for some drug-coated products or devices) and is only allowed for up to 6 months for complex procedures or devices in the investigator's opinion that require longer use.
* Planned use of any additional antiplatelet agent other than clopidogrel and ASA after the qualifying revascularization procedure.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role collaborator

Colorado Prevention Center

OTHER

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Alexander City, Alabama, United States

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Birmingham, Alabama, United States

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Fort Payne, Alabama, United States

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Huntsville, Alabama, United States

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Avondale, Arizona, United States

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Glendale, Arizona, United States

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Phoenix, Arizona, United States

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Mission Viejo, California, United States

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Northridge, California, United States

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Palo Alto, California, United States

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Roseville, California, United States

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Stanford, California, United States

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Torrance, California, United States

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Aurora, Colorado, United States

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Denver, Colorado, United States

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Washington D.C., District of Columbia, United States

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Washington D.C., District of Columbia, United States

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Atlantis, Florida, United States

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Clearwater, Florida, United States

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Daytona Beach, Florida, United States

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Gainesville, Florida, United States

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Hudson, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Ocala, Florida, United States

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Pensacola, Florida, United States

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Safety Harbor, Florida, United States

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Tallahassee, Florida, United States

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Wellington, Florida, United States

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Arlington Heights, Illinois, United States

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Elk Grove Village, Illinois, United States

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Springfield, Illinois, United States

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Springfield, Illinois, United States

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Urbana, Illinois, United States

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Fort Wayne, Indiana, United States

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Fort Wayne, Indiana, United States

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Merrillville, Indiana, United States

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Iowa City, Iowa, United States

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Lexington, Kentucky, United States

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Alexandria, Louisiana, United States

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Covington, Louisiana, United States

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Shreveport, Louisiana, United States

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Shreveport, Louisiana, United States

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Lewiston, Maine, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Clinton, Maryland, United States

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Bay City, 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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Midland, Michigan, United States

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Muskegon, Michigan, United States

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Wyoming, Michigan, United States

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Coon Rapids, Minnesota, United States

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Saint Cloud, Minnesota, United States

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Jackson, Mississippi, United States

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Tupelo, Mississippi, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Lincoln, Nebraska, United States

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Lebanon, New Hampshire, United States

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Flemington, New Jersey, United States

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Linden, New Jersey, United States

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Teaneck, New Jersey, United States

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New York, New York, United States

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New York, New York, United States

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Saratoga Springs, New York, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Minot, North Dakota, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Springfield, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Hillsboro, Oregon, United States

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Camp Hill, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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York, Pennsylvania, United States

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Greenville, South Carolina, United States

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Rapid City, South Dakota, United States

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Knoxville, Tennessee, United States

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Amarillo, Texas, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Edinburg, Texas, United States

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Houston, Texas, United States

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Humble, Texas, United States

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Huntsville, Texas, United States

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Kingwood, Texas, United States

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San Antonio, Texas, United States

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Tyler, Texas, United States

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Victoria, Texas, United States

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Madison, Wisconsin, United States

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Manitowoc, Wisconsin, United States

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Wausau, Wisconsin, United States

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Bahía Blanca, Buenos Aires, Argentina

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Ciudadela, Buenos Aires, Argentina

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Coronel Suárez, Buenos Aires, Argentina

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Junín, Buenos Aires, Argentina

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La Plata, Buenos Aires, Argentina

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La Plata, Buenos Aires, Argentina

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Mar del Plata, Buenos Aires, Argentina

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San Isidro, Buenos Aires, Argentina

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San Martín, Buenos Aires, Argentina

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Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

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Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

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Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

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Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

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Santa Rosa, La Pampa Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Ciudad Auton. de Buenos Aires, , Argentina

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Corrientes, , Argentina

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Córdoba, , Argentina

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Córdoba, , Argentina

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Córdoba, , Argentina

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Santa Fe, , Argentina

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Klagenfurt, Carinthia, Austria

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Graz, Styria, Austria

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Innsbruck, Tyrol, Austria

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Feldkirch, Vorarlberg, Austria

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Linz, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Bruxelles - Brussel, , Belgium

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Bruxelles - Brussel, , Belgium

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Bruxelles - Brussel, , Belgium

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Genk, , Belgium

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Ghent, , Belgium

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Kortrijk, , Belgium

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Leuven, , Belgium

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Fortaleza, Ceará, Brazil

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Belo Horizonte, Minas Gerais, Brazil

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Belo Horizonte, Minas Gerais, Brazil

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Belo Horizonte, Minas Gerais, Brazil

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Belo Horizonte, Minas Gerais, Brazil

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Uberlândia, Minas Gerais, Brazil

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Curitiba, Paraná, Brazil

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Canoas, Rio Grande do Sul, Brazil

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Passo Fundo, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Belo Horizonte, São Paulo, Brazil

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Campinas, São Paulo, Brazil

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Santo André, São Paulo, Brazil

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São Bernardo do Campo, São Paulo, Brazil

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São José do Rio Preto, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Tatuí, São Paulo, Brazil

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Rio de Janeiro, , Brazil

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Burgas, , Bulgaria

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Panagyurishte, , Bulgaria

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Plovdiv, , Bulgaria

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Rousse, , Bulgaria

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Rousse, , Bulgaria

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Samokov, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Stara Zagora, , Bulgaria

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Varna, , Bulgaria

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Yambol, , Bulgaria

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Winnipeg, Manitoba, Canada

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St. John's, Newfoundland and Labrador, Canada

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Hamilton, Ontario, Canada

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London, Ontario, Canada

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Ottawa, Ontario, Canada

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Chicoutimi, Quebec, Canada

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Gatineau, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Saint-Jérôme, Quebec, Canada

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Montreal, Quebec, , Canada

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Québec, , Canada

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Vancouver, , Canada

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Hefei, Anhui, China

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Chongqing, Chongqing Municipality, China

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Fuzhou, Fujian, China

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Zhangzhou, Fujian, China

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Guangzhou, Guangdong, China

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Guangzhou, Guangdong, China

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Guangzhou, Guangdong, China

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Zhanjiang, Guangdong, China

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Zhongshan, Guangdong, China

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Haikou, Hainan, China

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Wuhan, Hubei, China

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Wuhan, Hubei, China

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Changsha, Hunan, China

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Changsha, Hunan, China

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Changzhou, Jiangsu, China

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Nanjing, Jiangsu, China

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Changchun, Jilin, China

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Xi'an, Shaanxi, China

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Qingdao, Shandong, China

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Taiyuan, Shanxi, China

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Taizhou, Zhejiang, China

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Wenzhou, Zhejiang, China

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Beijing, , China

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Beijing, , China

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Beijing, , China

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Beijing, , China

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Shanghai, , China

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Shanghai, , China

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Tianjin, , China

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Brno, , Czechia

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Hodonín, , Czechia

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Hradec Králové, , Czechia

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Kladno, , Czechia

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Liberec, , Czechia

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Olomouc, , Czechia

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Pilsen, , Czechia

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Prague, , Czechia

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Prostějov, , Czechia

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Vratimov, , Czechia

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Aarhus N, , Denmark

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Kolding, , Denmark

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København Ø, , Denmark

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Odense C, , Denmark

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Viborg, , Denmark

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Tallinn, , Estonia

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Tallinn, , Estonia

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Tartu, , Estonia

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Helsinki, , Finland

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Oulu, , Finland

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Tampere, , Finland

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Bordeaux, , France

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Bordeaux, , France

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Caen, , France

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Castelnau-le-Lez, , France

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Grenoble, , France

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Le Coudray, , France

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Limoges, , France

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Montpellier, , France

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Nice, , France

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Paris, , France

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Paris, , France

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Poitiers, , France

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Rennes, , France

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Strasbourg, , France

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Toulouse, , France

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Toulouse, , France

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Bad Friedrichshall, Baden-Wurttemberg, Germany

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Bad Krozingen, Baden-Wurttemberg, Germany

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Freudenstadt, Baden-Wurttemberg, Germany

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Heidelberg, Baden-Wurttemberg, Germany

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Karlsbad, Baden-Wurttemberg, Germany

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Karlsruhe, Baden-Wurttemberg, Germany

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Ulm, Baden-Wurttemberg, Germany

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Erlangen, Bavaria, Germany

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Immenstadt im Allgäu, Bavaria, Germany

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München, Bavaria, Germany

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München, Bavaria, Germany

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München, Bavaria, Germany

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Regensburg, Bavaria, Germany

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Rosenheim, Bavaria, Germany

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Bad Nauheim, Hesse, Germany

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Darmstadt, Hesse, Germany

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Frankfurt am Main, Hesse, Germany

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Frankfurt am Main, Hesse, Germany

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Frankfurt am Main, Hesse, Germany

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Arnsberg, North Rhine-Westphalia, Germany

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Bielefeld, North Rhine-Westphalia, Germany

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Cologne, North Rhine-Westphalia, Germany

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Düsseldorf, North Rhine-Westphalia, Germany

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Krefeld, North Rhine-Westphalia, Germany

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Münster, North Rhine-Westphalia, Germany

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Wesel, North Rhine-Westphalia, Germany

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Kaiserslautern, Rhineland-Palatinate, Germany

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Mainz, Rhineland-Palatinate, Germany

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Dresden, Saxony, Germany

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Dresden, Saxony, Germany

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Leipzig, Saxony, Germany

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Magdeburg, Saxony-Anhalt, Germany

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Lübeck, Schleswig-Holstein, Germany

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Jena, Thuringia, Germany

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Sonneberg, Thuringia, Germany

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Berlin, , Germany

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Berlin, , Germany

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Bremen, , Germany

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Dresden, , Germany

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Hamburg, , Germany

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Budapest, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Debrecen, , Hungary

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Győr, , Hungary

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Kaposvár, , Hungary

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Kistarcsa, , Hungary

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Miskolc, , Hungary

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Nyíregyháza, , Hungary

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Pécs, , Hungary

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Szeged, , Hungary

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Székesfehérvár, , Hungary

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Szombathely, , Hungary

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Lecce, Apulia, Italy

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Potenza, Basilicate, Italy

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Avellino, Campania, Italy

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Napoli, Campania, Italy

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Bologna, Emilia-Romagna, Italy

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Ravenna, Emilia-Romagna, Italy

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Reggio Emilia, Emilia-Romagna, Italy

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Rome, Lazio, Italy

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Milan, Lombardy, Italy

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Varese, Lombardy, Italy

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Turin, Piedmont, Italy

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Palermo, Sicily, Italy

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Ragusa, Sicily, Italy

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Macerata, The Marches, Italy

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Florence, Tuscany, Italy

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Perugia, Umbria, Italy

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Nagakute, Aichi-ken, Japan

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Matsuyama, Ehime, Japan

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Kitakyushu, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Kurume, Fukuoka, Japan

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Shibukawa, Gunma, Japan

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Hatsukaichi, Hiroshima, Japan

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Asahikwa, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Tomakomai, Hokkaido, Japan

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Amagasaki, Hyōgo, Japan

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Himeji, Hyōgo, Japan

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Himeji, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Takarazuka, Hyōgo, Japan

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Morioka, Iwate, Japan

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Takamatsu, Kagawa-ken, Japan

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Kawasaki, Kanagawa, Japan

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Sagamihara, Kanagawa, Japan

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Matsusaka, Mie-ken, Japan

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Matsumoto, Nagano, Japan

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Kashihara, Nara, Japan

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Beppu, Oita Prefecture, Japan

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Habikino, Osaka, Japan

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Kawagoe, Saitama, Japan

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Ōmihachiman, Shiga, Japan

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Hamada, Shimane, Japan

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Bunkyo-ku, Tokyo, Japan

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Fuchū, Tokyo, Japan

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Itabashi-ku, Tokyo, Japan

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Itabashi-ku, Tokyo, Japan

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Meguro-ku, Tokyo, Japan

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Minato, Tokyo, Japan

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Minato-ku, Tokyo, Japan

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Suginami-ku, Tokyo, Japan

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Gifu, , Japan

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Kagoshima, , Japan

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Kumamoto, , Japan

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Kyoto, , Japan

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Kyoto, , Japan

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Miyazaki, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Saitama, , Japan

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Shizuoka, , Japan

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Daugavpils, , Latvia

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Liepāja, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Kaunas, , Lithuania

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Kaunas, , Lithuania

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Panevezys, , Lithuania

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Vilnius, , Lithuania

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Vilnius, , Lithuania

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's-Hertogenbosch, , Netherlands

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Eindhoven, , Netherlands

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Enschede, , Netherlands

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Heerlen, , Netherlands

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Utrecht, , Netherlands

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Veldhoven, , Netherlands

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Zwolle, , Netherlands

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Bialystok, , Poland

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Bydgoszcz, , Poland

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Gdynia, , Poland

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Katowice, , Poland

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Krakow, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Lublin, , Poland

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Poznan, , Poland

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Szczecin, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Almada, Setúbal District, Portugal

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Lisbon, , Portugal

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Ponta Delgada, , Portugal

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Porto, , Portugal

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Porto, , Portugal

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Vila Nova de Gaia, , Portugal

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Piteşti, Argeş, Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Cluj-Napoca, , Romania

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Iași, , Romania

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Oradea, , Romania

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Târgu Mureş, , Romania

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Timișoara, , Romania

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Kemerovo, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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Novosibirsk, , Russia

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Novosibirsk, , Russia

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Rostov-on-Don, , Russia

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Ryazan, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Tomsk, , Russia

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Tver', , Russia

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Voronezh, , Russia

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Belgrade, , Serbia

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Belgrade, , Serbia

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Belgrade, , Serbia

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Niš, , Serbia

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Bardejov, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Dunajská Streda, , Slovakia

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Košice, , Slovakia

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Nitra, , Slovakia

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Nové Zámky, , Slovakia

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Trnava, , Slovakia

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Žilina, , Slovakia

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Goyang-si, Gyeonggido, South Korea

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Seongnam-si, Gyeonggido, South Korea

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Incheon, Incheon Gwang''yeogsi, South Korea

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Busan, , South Korea

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Daegu, , South Korea

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Daegu, , South Korea

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Daejeon, , South Korea

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Jung-gu Daejeon, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Cadiz, Andalusia, Spain

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L'Hospitalet de Llobregat, Barcelona, Spain

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Sabadell, Barcelona, Spain

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A Coruña, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Ciudad Real, , Spain

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Granada, , Spain

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Madrid, , Spain

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Pamplona, , Spain

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Tarragona, , Spain

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Gothenburg, , Sweden

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Linköping, , Sweden

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Malmo, , Sweden

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Solna, , Sweden

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Vaxjo, , Sweden

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Basel, Canton of Basel-City, Switzerland

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Sankt Gallen, Canton of St. Gallen, Switzerland

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Chur, Kanton Graubünden, Switzerland

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Baden, , Switzerland

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Bern, , Switzerland

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Fribourg, , Switzerland

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Geneva, , Switzerland

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Lucerne, , Switzerland

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Hsinchu, , Taiwan

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Kaohsiung City, , Taiwan

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Kaohsiung City, , Taiwan

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Tainan City, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

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Taoyuan District, , Taiwan

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Bangkok, , Thailand

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Bangkok, , Thailand

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Bangkok, , Thailand

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Bangkok, , Thailand

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Khon Kaen, , Thailand

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Songkhla, , Thailand

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Dnipro, , Ukraine

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Ivano-Frankivsk, , Ukraine

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Ivano-Frankivsk, , Ukraine

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Kharkiv, , Ukraine

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Kiev, , Ukraine

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Kyiv, , Ukraine

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Lviv, , Ukraine

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Vinnytsia, , Ukraine

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Zaporizhzhya, , Ukraine

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Carlisle, Cumbria, United Kingdom

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Hull, Humberside, United Kingdom

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Harrow, London, United Kingdom

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Doncaster, South Yorkshire, United Kingdom

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Newcastle upon Tyne, Tyne and Wear, United Kingdom

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Birmingham, West Midlands, United Kingdom

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Leeds, West Yorkshire, United Kingdom

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Worcester, Worcestershire, United Kingdom

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Cambridge, , United Kingdom

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Cheltenham, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Manchester, , United Kingdom

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Sheffield, , United Kingdom

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Countries

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United States Argentina Austria Belgium Brazil Bulgaria Canada China Czechia Denmark Estonia Finland France Germany Hungary Italy Japan Latvia Lithuania Netherlands Poland Portugal Romania Russia Serbia Slovakia South Korea Spain Sweden Switzerland Taiwan Thailand Ukraine United Kingdom

References

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Hogan S, Szarek M, Debus ES, Nehler M, Anand SS, Patel MR, Pap AF, Deng H, Hodge S, Haskell LP, Muehlhofer E, Berkowitz SE, Bauersachs RM, Bonaca MP. Rivaroxaban in Peripheral Artery Disease After Revascularization: Worst Events and Net Outcomes in VOYAGER PAD. J Am Heart Assoc. 2025 Oct 23:e039752. doi: 10.1161/JAHA.124.039752. Online ahead of print.

Reference Type DERIVED
PMID: 41128134 (View on PubMed)

Rogers RK, Herold J, Govsyeyev N, Iezzi R, Morrison J, Hogan SE, Nehler M, Bricker R, Andring B, Bergmark B, Cavender M, Malgor E, Jacobs D, Young MN, Capell W, Ycas JW, Anand SS, Berkowitz SD, Debus ES, Haskell LP, Muehlhofer E, Patel MR, Hess CN, Bauersachs RM, Anderson V, Bonaca MP. Methods, design, and initial results of an angiographic core lab from VOYAGER-PAD. Vasc Med. 2024 Apr;29(2):143-152. doi: 10.1177/1358863X241228542. Epub 2024 Mar 17.

Reference Type DERIVED
PMID: 38493348 (View on PubMed)

Hogan SE, Debus ES, Nehler MR, Patel MR, Anand SS, Muehlhofer E, Haskell LP, Berkowitz SD, Bauersachs RM, Bonaca MP. Unplanned Index Limb Revascularization With Rivaroxaban Versus Placebo in Patients With Critical Limb-Threatening Ischemia After Endovascular and Surgical Treatment: Insights From VOYAGER PAD. Circulation. 2024 Feb 20;149(8):635-637. doi: 10.1161/CIRCULATIONAHA.123.065330. Epub 2024 Feb 20. No abstract available.

Reference Type DERIVED
PMID: 38377256 (View on PubMed)

Govsyeyev N, Nehler M, Conte MS, Debus S, Chung J, Dorigo W, Gudz I, Krievins D, Mills J, Moll F, Norgren L, Piffaretti G, Powell R, Szalay D, Sillesen H, Wohlauer M, Szarek M, Bauersachs RM, Anand SS, Patel MR, Capell WH, Jaeger N, Hess CN, Muehlhofer E, Haskell LP, Berkowitz SD, Bonaca MP. Rivaroxaban in patients with symptomatic peripheral artery disease after lower extremity bypass surgery with venous and prosthetic conduits. J Vasc Surg. 2023 Apr;77(4):1107-1118.e2. doi: 10.1016/j.jvs.2022.11.062. Epub 2022 Dec 5.

Reference Type DERIVED
PMID: 36470531 (View on PubMed)

Hess CN, Baumgartner I, Anand SS, Nehler MR, Patel MR, Debus ES, Szarek M, Capell W, Muehlhofer E, Berkowitz SD, Haskell LP, Bauersachs RM, Bonaca MP, Hsia J. Sex-Based Differences in Outcomes Following Peripheral Artery Revascularization: Insights From VOYAGER PAD. J Am Heart Assoc. 2022 Jun 21;11(12):e024655. doi: 10.1161/JAHA.121.024655. Epub 2022 Jun 14.

Reference Type DERIVED
PMID: 35699170 (View on PubMed)

Hogan SE, Nehler MR, Anand S, Patel MR, Debus S, Jackson MT, Buchanan C, King RW, Hess C, Muehlhofer E, Haskell LP, Bauersachs RM, Berkowitz SD, Hsia J, Bonaca MP. Improvement in walking impairment following surgical and endovascular revascularization: Insights from VOYAGER PAD. Vasc Med. 2022 Aug;27(4):343-349. doi: 10.1177/1358863X221085606. Epub 2022 Apr 25.

Reference Type DERIVED
PMID: 35467452 (View on PubMed)

Hess CN, Patel MR, Bauersachs RM, Anand SS, Debus ES, Nehler MR, Fanelli F, Yeh RW, Secemsky EA, Beckman JA, Mauri L, Govsyeyev N, Capell WH, Brackin T, Berkowitz SD, Muehlhofer E, Haskell LP, Hiatt WR, Bonaca MP. Safety and Effectiveness of Paclitaxel Drug-Coated Devices in Peripheral Artery Revascularization: Insights From VOYAGER PAD. J Am Coll Cardiol. 2021 Nov 2;78(18):1768-1778. doi: 10.1016/j.jacc.2021.08.052.

Reference Type DERIVED
PMID: 34711335 (View on PubMed)

Debus ES, Nehler MR, Govsyeyev N, Bauersachs RM, Anand SS, Patel MR, Fanelli F, Capell WH, Brackin T, Hinterreiter F, Krievins D, Nault P, Piffaretti G, Svetlikov A, Jaeger N, Hess CN, Sillesen HH, Conte M, Mills J, Muehlhofer E, Haskell LP, Berkowitz SD, Hiatt WR, Bonaca MP. Effect of Rivaroxaban and Aspirin in Patients With Peripheral Artery Disease Undergoing Surgical Revascularization: Insights From the VOYAGER PAD Trial. Circulation. 2021 Oct 5;144(14):1104-1116. doi: 10.1161/CIRCULATIONAHA.121.054835. Epub 2021 Aug 12.

Reference Type DERIVED
PMID: 34380322 (View on PubMed)

Bauersachs RM, Szarek M, Brodmann M, Gudz I, Debus ES, Nehler MR, Anand SS, Patel MR, Hess CN, Capell WH, Rogers K, Muehlhofer E, Haskell LP, Berkowitz SD, Hiatt WR, Bonaca MP; VOYAGER PAD Committees and Investigators. Total Ischemic Event Reduction With Rivaroxaban After Peripheral Arterial Revascularization in the VOYAGER PAD Trial. J Am Coll Cardiol. 2021 Jul 27;78(4):317-326. doi: 10.1016/j.jacc.2021.05.003. Epub 2021 May 16.

Reference Type DERIVED
PMID: 34010631 (View on PubMed)

Hiatt WR, Bonaca MP, Patel MR, Nehler MR, Debus ES, Anand SS, Capell WH, Brackin T, Jaeger N, Hess CN, Pap AF, Berkowitz SD, Muehlhofer E, Haskell L, Brasil D, Madaric J, Sillesen H, Szalay D, Bauersachs R. Rivaroxaban and Aspirin in Peripheral Artery Disease Lower Extremity Revascularization: Impact of Concomitant Clopidogrel on Efficacy and Safety. Circulation. 2020 Dec 8;142(23):2219-2230. doi: 10.1161/CIRCULATIONAHA.120.050465. Epub 2020 Nov 3.

Reference Type DERIVED
PMID: 33138628 (View on PubMed)

Bonaca MP, Bauersachs RM, Anand SS, Debus ES, Nehler MR, Patel MR, Fanelli F, Capell WH, Diao L, Jaeger N, Hess CN, Pap AF, Kittelson JM, Gudz I, Matyas L, Krievins DK, Diaz R, Brodmann M, Muehlhofer E, Haskell LP, Berkowitz SD, Hiatt WR. Rivaroxaban in Peripheral Artery Disease after Revascularization. N Engl J Med. 2020 May 21;382(21):1994-2004. doi: 10.1056/NEJMoa2000052. Epub 2020 Mar 28.

Reference Type DERIVED
PMID: 32222135 (View on PubMed)

Capell WH, Bonaca MP, Nehler MR, Chen E, Kittelson JM, Anand SS, Berkowitz SD, Debus ES, Fanelli F, Haskell L, Patel MR, Bauersachs R, Hiatt WR. Rationale and design for the Vascular Outcomes study of ASA along with rivaroxaban in endovascular or surgical limb revascularization for peripheral artery disease (VOYAGER PAD). Am Heart J. 2018 May;199:83-91. doi: 10.1016/j.ahj.2018.01.011. Epub 2018 Feb 3.

Reference Type DERIVED
PMID: 29754671 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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2014-005569-58

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

17454

Identifier Type: -

Identifier Source: org_study_id