A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction or Stroke in Participants With Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure (COMMANDER HF)
April 18, 2019 updated by: Janssen Research & Development, LLC
A Randomized, Double-blind, Event-driven, Multicenter Study Comparing the Efficacy and Safety of Rivaroxaban With Placebo for Reducing the Risk of Death, Myocardial Infarction or Stroke in Subjects With Heart Failure and Significant Coronary Artery Disease Following an Episode of Decompensated Heart Failure
The purpose of this study is to assess the effectiveness and safety of rivaroxaban compared with placebo (inactive medication), in reducing the risk of death, myocardial infarction or stroke in participants with heart failure and significant coronary artery disease following an episode of decompensated heart failure.
Study Overview
Status
Status
Completed
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), parallel group (each participant group receives different treatments simultaneously), event driven (the study duration is determined by the time taken for a specific number of events to occur), multicenter study to assess the effectiveness and safety of rivaroxaban compared with placebo, in reducing the risk of death, myocardial infarction or stroke in participants with heart failure and significant coronary artery disease following an episode of decompensated heart failure.
Participants will be randomly assigned in a 1:1 ratio to receive either rivaroxaban or placebo (each in addition to standard of care for heart failure and coronary artery disease as prescribed by their managing physician).
The study will consist of a screening phase, a double-blind treatment phase, and a follow-up after the sponsor-announced global treatment end date (GTED, defined as the date when 1200 primary efficacy outcome events are predicted to have occurred).
The double-blind treatment phase is estimated to last for 6 to 54 months.
Participants will discontinue study drug after taking both their morning and evening doses on the GTED and will return to the study center for the end-of-study visit (between 15 and 45 days but no sooner than 15 days after the GTED).
Patient safety will be monitored throughout the study.
The average study duration for participants is expected to be approximately 29 months.
The study drug, rivaroxaban, is approved in the United States and in multiple countries around the world for the prevention and treatment of a number of thrombosis-mediated conditions.
Study Type
Study Type
Interventional
Enrollment (Actual)
Enrollment
5081
Phase
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bahia Blanca, Argentina
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Buenos Aires, Argentina
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Caba, Argentina
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Ciudad Autonoma de Buenos Aires, Argentina
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Cordoba, 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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Mendoza, Argentina
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Merlo, Argentina
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Quilmes, Argentina
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Resistencia, Argentina
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Rosario, Argentina
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San Miguel de Tucuman, Argentina
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San Nicolas, Argentina
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Santa Fe, Argentina
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Santiago del Estero, Argentina
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Tucuman, Argentina
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Vicente Lopez, Argentina
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Bedford, Australia
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Cairns, Australia
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Concord, Australia
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Darlinghurst, Australia
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Hobart, Australia
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Launceston, Australia
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Perth, Australia
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Sydney, Australia
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Wollongong, Australia
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Woolloongabba, Australia
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Belo Horizonte, Brazil
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Belém, Brazil
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Blumenal, 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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Canoas, Brazil
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Curitiba, Brazil
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Goiania, Brazil
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Goiânia, Brazil
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Marília, Brazil
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Passo Fundo, Brazil
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Porto Alegre, Brazil
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Recife, Brazil
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Ribeirão Preto, Brazil
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Rio de Janeiro, Brazil
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Salvador, Brazil
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São Jose do Rio Preto, Brazil
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São Paulo, Brazil
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São Pedro, Brazil
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Tatuí, Brazil
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Uberlândia, Brazil
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Votuporanga, Brazil
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Blagoevgrad, Bulgaria
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Burgas, Bulgaria
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Dimitrovgrad, Bulgaria
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Kazanlak, Bulgaria
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Pazardzhik, Bulgaria
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Ruse, Bulgaria
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Sofia, Bulgaria
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Stara Zagora, Bulgaria
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Varna, Bulgaria
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Veliko Tarnovo, Bulgaria
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Alberta
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Edmonton, Alberta, Canada
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British Columbia
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Maple Ridge, British Columbia, Canada
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada
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Nova Scotia
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Halifax, Nova Scotia, Canada
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Ontario
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Cambridge, Ontario, Canada
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Kitchener, Ontario, Canada
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Scarborough, Ontario, Canada
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Toronto, Ontario, Canada
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Quebec
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Montreal, Quebec, Canada
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Montréal, Quebec, Canada
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Baotou, China
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Beijing, China
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Changchun, China
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Changsha, China
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Chengdu, 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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Hunan, China
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Jinan, China
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Jining, China
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Lanzhou, China
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Nanchang, China
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Nanjing, China
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Nanning, China
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Qingdao, China
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Shanghai, China
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Shenyang, China
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Shijiazhuang, China
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Suzhou, China
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Taiyuan, China
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Tianjin, China
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Wuhan, China
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Xi'an, China
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Xian, China
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Yang Zhou, China
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Yichang, China
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Brno, Czechia
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Hodonín, Czechia
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Hradec Králové, Czechia
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Hranice, Czechia
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Karlovy Vary, Czechia
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Kladno, Czechia
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Kolín, Czechia
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Litomyšl, Czechia
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Mladá Boleslav, Czechia
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Olomouc, Czechia
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Plze?-Bory, Czechia
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Praha, Czechia
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Praha 10, Czechia
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Praha 8 - Libe?, Czechia
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Slany, Czechia
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Teplice, Czechia
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Uherské Hradišt?, Czechia
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Valašské Mezi?í?í, Czechia
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Esbjerg, Denmark
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Herlev, Denmark
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Hjørring, Denmark
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Hvidovre, Denmark
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Køge, Denmark
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Tallinn, Estonia
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Besancon, France
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Bron Cedex, France
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Chambray-Lès-Tours, France
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Corbeil Essonnes, France
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Lille, France
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Montpellier, France
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Nantes, France
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Nice, France
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Pau, France
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Rouen, France
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Toulouse, France
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Vandoeuvre-les-nancy, France
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Berlin, Germany
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Bielefeld, Germany
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Bonn, Germany
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Coburg, Germany
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Dresden, Germany
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Halle, Germany
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Hamburg, Germany
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Heidelberg, Germany
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Konstanz, Germany
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Langen, Germany
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Leipzig, Germany
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Ludwigshafen, Germany
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Magdeburg, Germany
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Mainz, Germany
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Markkleeberg, Germany
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Papenburg, Germany
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Stuttgart, Germany
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Ulm, Germany
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Witten, Germany
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Athens, Greece
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Heraklion -Crete, Greece
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Larisa, Greece
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Thessalonikis, Greece
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Voula, Greece
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Balatonfüred, Hungary
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Berettyóújfalu, Hungary
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Budapest, Hungary
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Gyor, Hungary
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Miskolc, Hungary
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Nagykanizsa, Hungary
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Szekszárd, Hungary
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Szolnok, Hungary
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Székesfehérvár, Hungary
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Zalaegerszeg, Hungary
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Aichi, Japan
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Chiba, Japan
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Chikushino-shi, Japan
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Ehime, Japan
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Fukuoka, Japan
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Gifu, Japan
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Gunma, Japan
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Hatsukaichi, Japan
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Hitachi, Japan
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Hokkaido, Japan
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Hyogo, Japan
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Ibaraki, Japan
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Ishikawa, Japan
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Izumo, Japan
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Kagawa, Japan
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Kahoku-District, Japan
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Kanagawa, Japan
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Kobe-shi, Japan
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Komatsushima-shi, Japan
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Koshigaya-shi, Japan
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Kumamoto, Japan
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Kyoto, Japan
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Miyazaki, Japan
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Nagano, Japan
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Nagano-shi, Japan
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Nagasaki, Japan
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Nagoya, Japan
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Niigata, Japan
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Oita, Japan
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Okayama, Japan
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Okinawa, Japan
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Osaka, Japan
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Osaka-shi, Japan
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Saga, Japan
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Saitama, Japan
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Sapporo, Japan
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Sendai, Japan
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Shiga, Japan
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Shimane, Japan
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Shizuoka, Japan
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Tachikawa, Japan
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Takaraduka, Japan
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Tochigi, Japan
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Tokushima, Japan
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Tokyo, Japan
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Toyama, Japan
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Toyoake, Japan
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Tsu, Japan
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Wakayama, Japan
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Yamaguchi, Japan
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Yatsushiro, Japan
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Yokohama, Japan
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Yonago, Japan
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Busan, Korea, Republic of
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Cheongju, Korea, Republic of
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Daegu, Korea, Republic of
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Daejeon, Korea, Republic of
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Gwangju, Korea, Republic of
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Seongnam-si, Korea, Republic of
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Seoul, Korea, Republic of
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Wonju, Korea, Republic of
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Daugavpils, Latvia
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Kuldiga, Latvia
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Liepaja, Latvia
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Riga, Latvia
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Sigulda, Latvia
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Ventspils, Latvia
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Alytus, Lithuania
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Kaunas, Lithuania
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Klaipeda, Lithuania
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Panevezys, Lithuania
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Siauliai, Lithuania
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Vilnius, Lithuania
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Cheras, Malaysia
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Johor Bahru, Malaysia
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Kota Kinabalu, Malaysia
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Kuala Lumpur, Malaysia
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Kuching, Malaysia
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Penang, Malaysia
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Selangor, Malaysia
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Selayang, Malaysia
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Aguascalientes, Mexico
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Benito Juárez, Mexico
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Chihuahua, Mexico
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Culiacan, Mexico
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Durango, Mexico
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Guadalajara, Mexico
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León, Mexico
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Mexico, Mexico
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Mexico City, Mexico
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Oaxaca, Mexico
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Pachuca, Mexico
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Puebla, Mexico
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Queretaro, Mexico
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San Luis Potosí, Mexico
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Tampico, Mexico
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Veracruz, Mexico
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Almere, Netherlands
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Amsterdam, Netherlands
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Blaricum, Netherlands
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Breda, Netherlands
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Deventer, Netherlands
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Doetinchem, Netherlands
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Ede, Netherlands
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Groningen, Netherlands
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Heerlen, Netherlands
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Helmond, Netherlands
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Maastricht, Netherlands
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Meppel, Netherlands
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Tilburg, Netherlands
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Będzin, Poland
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Gdynia, Poland
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Gliwice, Poland
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Grodzisk Mazowiecki, Poland
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Inowrocław, Poland
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Katowice, Poland
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Kielce, Poland
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Krakow, Poland
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Kraków, Poland
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Kutno, Poland
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Lodz, Poland
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Lubin, Poland
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Lublin, Poland
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Myslenice, Poland
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Olsztyn, Poland
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Ostroleka, Poland
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Ostrowiec Swietokrzyski, Poland
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Oswiecim, Poland
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Plock, Poland
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Pulawy, Poland
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Rabka-Zdrój, Poland
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Skierniewice, Poland
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Starogard Gdanski, Poland
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Szczecin, Poland
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Torun, Poland
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Warszawa, Poland
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Wloclawek, Poland
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Wrocław, Poland
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Zabrze, Poland
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Zamosc, Poland
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Łódż, Poland
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Almada, Portugal
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Aveiro, Portugal
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Braga, Portugal
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Carnaxide, Portugal
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Coimbra, Portugal
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Covilhã, Portugal
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Leiria, Portugal
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Lisboa, Portugal
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Matosinhos, Portugal
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Viana do Castelo, Portugal
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Vila Real, Portugal
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Bacau, Romania
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Baia Mare, Romania
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Braila, Romania
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Brasov, Romania
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Bucharest, Romania
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Bucuresti, Romania
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Buzau, Romania
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Cluj Napoca, Romania
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Cluj-Napoca, Romania
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Craiova, Romania
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Focsani, Romania
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Galati, Romania
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Iasi, Romania
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Oradea, Romania
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Pitesti, Romania
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Sibiu, Romania
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Targu Mures, Romania
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Targu-Mures, Romania
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Timisoara, Romania
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Arkhangelsk, Russian Federation
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Barnaul, Russian Federation
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Chita, Russian Federation
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Ekaterinburg, Russian Federation
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Ivanovo, Russian Federation
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Izhevsk, Russian Federation
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Kaluga, Russian Federation
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Kemerovo, Russian Federation
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Kirov, Russian Federation
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Krasnoyarsk, Russian Federation
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Kursk, Russian Federation
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Moscow, Russian Federation
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Moscow, Zelenograd, Russian Federation
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Nizhniy Novgorod, Russian Federation
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Nizhny Novgorod, Russian Federation
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Novosibirsk, Russian Federation
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Orenburg, Russian Federation
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Perm, Russian Federation
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Rostov on Don, Russian Federation
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Ryazan, Russian Federation
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Saint Petersburg, Russian Federation
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Samara, Russian Federation
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Saratov, Russian Federation
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Syktyvkar, Russian Federation
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Tomsk, Russian Federation
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Tyumen, Russian Federation
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Voronezh, Russian Federation
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Yaroslavl, Russian Federation
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Banska Bystrica, Slovakia
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Bardejov, Slovakia
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Kosice, Slovakia
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Lucenec, Slovakia
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Moldava nad Bodvou, Slovakia
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Nitra, Slovakia
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Povazska Bystrica, Slovakia
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Svidnik, Slovakia
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Bloemfontein, South Africa
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Cape Town, South Africa
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Centurion, South Africa
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Durban, South Africa
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Pinelands, South Africa
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Pretoria, South Africa
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Tongaat, South Africa
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A Coruña, Spain
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Alicante, Spain
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Almería, Spain
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Avila, Spain
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Barcelona, Spain
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Burgos, Spain
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Cáceres, Spain
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Elche, Spain
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Granada, Spain
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La Coruña, Spain
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Lorca, Spain
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Madrid, Spain
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Majadahonda, Spain
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Murcia, Spain
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Olot, Spain
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Orihuela, Spain
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Palma de Mallorca, Spain
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San Juan, Spain
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Sanlúcar de Barrameda, Spain
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Sant Joan Despí, Spain
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Santander, Spain
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Sevilla, Spain
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Terrassa, Spain
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Torrevieja, Spain
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Valencia, Spain
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Vigo, Spain
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Viladecans, Spain
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Falun, Sweden
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Jönköping, Sweden
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Ljungby, Sweden
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Stockholm, Sweden
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Uppsala, Sweden
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Ankara, Turkey
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Bursa, Turkey
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Diyarbakir, Turkey
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Eskisehir, Turkey
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Istanbul, Turkey
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Kahramanmaras, Turkey
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Kocaeli, Turkey
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Konya, Turkey
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Kırıkkale, Turkey
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Mersin, Turkey
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Sivas, Turkey
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Cherkassy, Ukraine
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Cherkasy, Ukraine
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Dnipro, Ukraine
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Donetsk, Ukraine
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Kharkiv, Ukraine
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Kyiv, Ukraine
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Lutsk, Ukraine
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Lviv, Ukraine
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Odesa, Ukraine
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Poltava, Ukraine
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Sumy, Ukraine
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Vinnitsa, Ukraine
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Vinnytsia, Ukraine
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Zaporizhzhia, Ukraine
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Zaporizhzhya, Ukraine
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Zhytomir, Ukraine
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Aberdeen, United Kingdom
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Airdrie, United Kingdom
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Birmingham, United Kingdom
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Chesterfield, United Kingdom
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Chichester, United Kingdom
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Clydebank, United Kingdom
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Cottingham, United Kingdom
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Dudley, United Kingdom
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Dundee, United Kingdom
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East Kilbride, United Kingdom
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Exeter, United Kingdom
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Inverness, United Kingdom
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Manchester, United Kingdom
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Ta1 5da, United Kingdom
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Wirral, United Kingdom
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Alabama
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Alexander City, Alabama, United States
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Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Alaska
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Anchorage, Alaska, United States
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Arizona
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Tucson, Arizona, United States
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Arkansas
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Jonesboro, Arkansas, United States
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California
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Beverly Hills, California, United States
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Chula Vista, California, United States
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El Cajon, California, United States
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Glendale, California, United States
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La Mesa, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Orange, California, United States
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Stockton, California, United States
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Torrance, California, United States
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Colorado
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Aurora, Colorado, United States
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Denver, Colorado, United States
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Connecticut
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New Haven, Connecticut, United States
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Florida
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Atlantis, Florida, United States
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Daytona Beach, Florida, United States
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Jupiter, Florida, United States
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Orlando, Florida, United States
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Saint Petersburg, Florida, United States
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Tallahassee, Florida, United States
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Wellington, Florida, United States
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Winter Haven, Florida, United States
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Georgia
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Athens, Georgia, United States
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Atlanta, Georgia, United States
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Cumming, Georgia, United States
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Macon, Georgia, United States
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Tucker, Georgia, United States
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Illinois
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Chicago, Illinois, United States
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Evanston, Illinois, United States
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Fairview Heights, Illinois, United States
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Peoria, Illinois, United States
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Rockford, Illinois, United States
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Urbana, Illinois, United States
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Indiana
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Anderson, Indiana, United States
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Indianapolis, Indiana, United States
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Merrillville, Indiana, United States
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Munster, Indiana, United States
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South Bend, Indiana, United States
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Iowa
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Iowa City, Iowa, United States
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Kentucky
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Elizabethtown, Kentucky, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Owensboro, Kentucky, United States
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Louisiana
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Bossier City, Louisiana, United States
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Hammond, Louisiana, United States
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Shreveport, Louisiana, United States
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Slidell, Louisiana, United States
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Maine
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Biddeford, Maine, United States
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Maryland
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Baltimore, Maryland, United States
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Columbia, Maryland, United States
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Randallstown, Maryland, United States
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Michigan
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Bay City, Michigan, United States
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Grand Blanc, Michigan, United States
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Mount Clemens, Michigan, United States
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Pontiac, Michigan, United States
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Ypsilanti, Michigan, United States
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Minnesota
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Saint Paul, Minnesota, United States
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Missouri
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Saint Louis, Missouri, United States
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Springfield, Missouri, United States
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Washington, Missouri, United States
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Nebraska
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Lincoln, Nebraska, United States
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Nevada
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Las Vegas, Nevada, United States
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New Jersey
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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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Manalapan, 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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New Mexico
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Albuquerque, New Mexico, United States
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New York
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Buffalo, New York, United States
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Cortlandt Manor, New York, United States
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Jamaica, New York, United States
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Mineola, New York, United States
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New York, New York, United States
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North Carolina
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Charlotte, North Carolina, United States
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High Point, North Carolina, United States
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Pinehurst, North Carolina, United States
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Ohio
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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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Kettering, Ohio, United States
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Oklahoma
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Bartlesville, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Oregon
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Portland, Oregon, United States
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Pennsylvania
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Doylestown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Sayre, Pennsylvania, United States
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Sellersville, Pennsylvania, United States
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Wynnewood, Pennsylvania, United States
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Yardley, Pennsylvania, United States
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York, Pennsylvania, United States
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South Carolina
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Charleston, South Carolina, United States
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South Dakota
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Sioux Falls, South Dakota, United States
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Tennessee
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Nashville, Tennessee, United States
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Texas
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Cypress, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Huntsville, Texas, United States
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Kingwood, Texas, United States
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Lubbock, Texas, United States
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McKinney, Texas, United States
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Vermont
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Burlington, Vermont, United States
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Virginia
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Newport News, Virginia, United States
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Washington
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Bellingham, Washington, United States
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Tacoma, Washington, United States
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West Virginia
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Huntington, West Virginia, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
14 years to 91 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Must have symptomatic heart failure for at least 3 months prior to Screening
- Participants must have an episode of decompensated heart failure (index event) requiring (a) an overnight stay [that is, staying past midnight] in a hospital, emergency department, or medical facility with the capability of treating with intravenous medications and observing heart failure patients before randomization or (b) an unscheduled outpatient visit to a heart failure management center, where parenteral therapy is required for heart failure stabilization. An episode of decompensated heart failure is defined as symptoms of worsening dyspnea or fatigue, objective signs of congestion such as peripheral edema or ascites, and/or adjustment of pre-hospitalization/outpatient visit heart failure medications. Participants are eligible for randomization at discharge from the facility treating the index event and up to 30 days after discharge if they are in stable condition
- Must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40 percent (%) within 1 year before randomization
- Must have evidence of significant coronary artery disease
- Must be medically stable in terms of their heart failure clinical status at the time of randomization
- Must have a brain natriuretic peptide (BNP) level greater than or equal to (>=) 200 picogram per milliliter (pg/mL) or N-terminal-proBNP (NT-proBNP) level >=800 pg/mL (preferred assay) during the Screening period and before randomization
Exclusion Criteria:
- Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding, such as, but not limited to, active internal bleeding, clinically significant bleeding, bleeding at a noncompressible site, or bleeding diathesis within 28 days of randomization
- Severe concomitant disease such as (a) atrial fibrillation (AFib) or another condition that requires chronic anticoagulation (participants with isolated transient AFib may be allowed at the discretion of the treating physician investigator) and (b) Documented acute myocardial infarction (MI) during index event
- Prior stroke within 90 days of randomization
- Has been hospitalized for longer than 21 days during the index event
- Planned intermittent outpatient treatment with positive inotropic drugs administered intravenously
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Number of Arms
2
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Rivaroxaban 2.5 mg
Each participant will receive 2.5 mg of rivaroxaban twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
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Each participant, randomly allocated to the rivaroxaban arm, will receive one 2.5 mg tablet of rivaroxaban orally (by mouth) twice daily (once in the morning and once in the evening at approximately the same time each day) until the global treatment end date (GTED) (defined as the date when 1200 primary efficacy outcome events have occurred).
Rivaroxaban will be given with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
Each participant's standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician) should be continued throughout the study.
|
|
Placebo Comparator: Placebo
Each participant will receive matching placebo twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
|
Each participant's standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician) should be continued throughout the study.
Each participant, randomly allocated to the placebo arm, will receive one matching placebo tablet orally twice daily (once in the morning and once in the evening at approximately the same time each day) until the GTED.
Placebo will be given with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Event Rate of All-Cause Mortality, Myocardial Infarction (MI), or Stroke
Time Frame: Up to Global treatment end date (approximately 54 months)
|
Event Rate of all-cause mortality (ACM), MI, or stroke were assessed.
Event rate estimated based on the time to the first occurrence of the event were reported in the study.
Event Rate / (100 patient [pt]-year [yr]) = 100*n/(total risk exposure), where n is the number of events.
|
Up to Global treatment end date (approximately 54 months)
|
|
Event Rate of Either Fatal Bleeding or Bleeding Into a Critical Space With Potential for Permanent Disability
Time Frame: Up to 227 Weeks
|
Event rate of either fatal bleeding or bleeding into critical space with potential for permanent disability were assessed.
Fatal bleeding event was death within 7 days after a bleeding event which required hospitalization or met International Society on Thrombosis and Haemostasis(ISTH) major bleeding definition criteria.
Fatal bleeding events included those met criteria in 3 categories: 1: Any ISTH major bleeding event consider primary cause of death by investigator; 2: Any ISTH major bleeding event not considered to be primary cause of death by investigator but resulted in death within 7 days;3: Any bleeding event resulted in hospital stay and death within 7 days.
Bleeding into critical space with potential for permanent disability included 7 critical spaces: intracranial, intraspinal, intraocular.
Event rate estimated based on time to first occurrence of event were reported in the study.
Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.
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Up to 227 Weeks
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Event Rate of Cardio Vascular Death or Re-Hospitalization for Worsening of Heart Failure (RHHF)
Time Frame: Up to Global treatment end date (approximately 54 months)
|
Event rate of cardio vascular (CV) death or re-hospitalization for worsening of heart failure were assessed.
Event rate estimated based on the time to the first occurrence of the event were reported in the study.
Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.
|
Up to Global treatment end date (approximately 54 months)
|
|
Event Rate of Cardio Vascular Death
Time Frame: Up to Global treatment end date (approximately 54 months)
|
Event rate of cardio vascular death were assessed.
CV death included deaths due to spontaneous bleeding, MI, stroke, worsening HF and arrhythmias, death due to CV procedures and sudden death.
Event rate estimated based on the time to the first occurrence of the event were reported in the study.
Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.
|
Up to Global treatment end date (approximately 54 months)
|
|
Event Rate of Re-Hospitalization for Worsening of Heart Failure
Time Frame: Up to Global treatment end date (approximately 54 months)
|
Event rate of re-hospitalization for worsening of heart failure were assessed.
Event rate estimated based on the time to the first occurrence of the event were reported in the study.
Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.
|
Up to Global treatment end date (approximately 54 months)
|
|
Event Rate of Re-Hospitalization for Cardio Vascular Events (RHCV)
Time Frame: Up to Global treatment end date (approximately 54 months)
|
Event rate due to cardio vascular events were assessed.
Hospitalization for a CV Event required that participants be hospitalized (in-patient or emergency department) for greater than 24 hours and must have met the following criterion:Discharge summary with primary reason for admission listed as CV in nature (example, bleeding, arrhythmia, ACS, MI) other than HF which was captured in the HF re-hospitalization.
Event rate estimated based on the time to the first occurrence of the event were reported in the study.
Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.
|
Up to Global treatment end date (approximately 54 months)
|
|
Event Rate of All-Cause Mortality (ACM) or Re-Hospitalization for Worsening Heart Failure
Time Frame: Up to Global treatment end date (approximately 54 months)
|
Event rate of all-Cause Mortality (ACM) or re-Hospitalization for worsening heart failure were assessed.
Event rate estimated based on the time to the first occurrence of the event were reported in the study.
Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.
|
Up to Global treatment end date (approximately 54 months)
|
|
Event Rate of Bleeding Events That Requiring Hospitalization
Time Frame: Up to 227 Weeks
|
Event rate of bleeding events and required Hospitalization were assessed.
Event rate estimated based on the time to the first occurrence of the event were reported in the study.
Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.
|
Up to 227 Weeks
|
|
Event Rate of International Society on Thrombosis and Haemostasis (ISTH) Major Bleeding Event
Time Frame: Up to 227 Weeks
|
Event rate of ISTH major bleeding event were assessed.
Event rate estimated based on the time to the first occurrence of the event were reported in the study.
Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.
|
Up to 227 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Sponsor
Collaborators
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ferreira JP, Cleland JG, Lam CSP, Anker SD, Mehra MR, van Veldhuisen DJ, Byra WM, La Police DA, Pitt B, Greenberg B, Zannad F. Heart failure re-hospitalizations and subsequent fatal events in coronary artery disease: insights from COMMANDER-HF, EPHESUS, and EXAMINE. Clin Res Cardiol. 2021 Oct;110(10):1554-1563. doi: 10.1007/s00392-021-01830-1. Epub 2021 Mar 8.
- Ferreira JP, Cleland JGF, Lam CSP, van Veldhuisen DJ, Byra WM, La Police DA, Anker SD, Mehra MR, Leroy C, Eschwege V, Toussaint-Hacquard M, Rossignol P, Greenberg B, Zannad F. Impact of Geographic Region on the COMMANDER-HF Trial. JACC Heart Fail. 2021 Mar;9(3):201-211. doi: 10.1016/j.jchf.2020.11.007. Epub 2021 Feb 3.
- Cunningham JW, Ferreira JP, Deng H, Anker SD, Byra WM, Cleland JGF, Gheorghiade M, Lam CSP, La Police D, Mehra MR, Neaton JD, Spiro TE, van Veldhuisen DJ, Greenberg B, Zannad F. Natriuretic Peptide-Based Inclusion Criteria in a Heart Failure Clinical Trial: Insights From COMMANDER HF. JACC Heart Fail. 2020 May;8(5):359-368. doi: 10.1016/j.jchf.2019.12.009. Epub 2020 Mar 11.
- Mehra MR, Vaduganathan M, Fu M, Ferreira JP, Anker SD, Cleland JGF, Lam CSP, van Veldhuisen DJ, Byra WM, Spiro TE, Deng H, Zannad F, Greenberg B. A comprehensive analysis of the effects of rivaroxaban on stroke or transient ischaemic attack in patients with heart failure, coronary artery disease, and sinus rhythm: the COMMANDER HF trial. Eur Heart J. 2019 Nov 21;40(44):3593-3602. doi: 10.1093/eurheartj/ehz427.
- Greenberg B, Neaton JD, Anker SD, Byra WM, Cleland JGF, Deng H, Fu M, La Police DA, Lam CSP, Mehra MR, Nessel CC, Spiro TE, van Veldhuisen DJ, Vanden Boom CM, Zannad F. Association of Rivaroxaban With Thromboembolic Events in Patients With Heart Failure, Coronary Disease, and Sinus Rhythm: A Post Hoc Analysis of the COMMANDER HF Trial. JAMA Cardiol. 2019 Jun 1;4(6):515-523. doi: 10.1001/jamacardio.2019.1049.
- Zannad F, Anker SD, Byra WM, Cleland JGF, Fu M, Gheorghiade M, Lam CSP, Mehra MR, Neaton JD, Nessel CC, Spiro TE, van Veldhuisen DJ, Greenberg B; COMMANDER HF Investigators. Rivaroxaban in Patients with Heart Failure, Sinus Rhythm, and Coronary Disease. N Engl J Med. 2018 Oct 4;379(14):1332-1342. doi: 10.1056/NEJMoa1808848. Epub 2018 Aug 27.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
Study Start
September 10, 2013
Primary Completion (Actual)
Primary Completion
April 19, 2018
Study Completion (Actual)
Study Completion
April 19, 2018
Study Registration Dates
First Submitted
First Submitted
June 12, 2013
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
June 12, 2013
First Posted (Estimate)
First Posted
June 14, 2013
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
May 10, 2019
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
April 18, 2019
Last Verified
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Myocardial Infarction
- Infarction
- Heart Failure
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protease Inhibitors
- Factor Xa Inhibitors
- Antithrombins
- Serine Proteinase Inhibitors
- Anticoagulants
- Rivaroxaban
Other Study ID Numbers
Other Study ID Numbers
- CR101940
- RIVAROXHFA3001 (Other Identifier: Janssen Research & Development, LLC)
- 2013-000046-19 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.