Registrational Study With Omecamtiv Mecarbil (AMG 423) to Treat Chronic Heart Failure With Reduced Ejection Fraction (GALACTIC-HF)

November 2, 2021 updated by: Cytokinetics

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction (GALACTIC-HF)

The purpose of this study is to determine if treatment with omecamtiv mecarbil when added to standard of care is well tolerated and superior to placebo in reducing the risk of cardiovascular death or heart failure events in adults with chronic heart failure with reduced ejection fraction (HFrEF).

Study Overview

Status

Completed

Conditions

Detailed Description

This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021 and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics, Cytokinetics is now listed as the sponsor.

Study Type

Interventional

Enrollment (Actual)

8256

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

      • Buenos Aires, Argentina, 1425
        • Research Site
      • Corrientes, Argentina, 3400
        • Research Site
      • Corrientes, Argentina, W3400AMZ
        • Research Site
      • Córdoba, Argentina, X5003DCE
        • Research Site
      • Córdoba, Argentina, 5000
        • Research Site
      • Córdoba, Argentina, X5021FPQ
        • Research Site
      • Salta, Argentina, A4406BPF
        • Research Site
      • Santa Fe, Argentina, S3000FWO
        • Research Site
    • Buenos Aires
      • Bahia Blanca, Buenos Aires, Argentina, B8000FTD
        • Research Site
      • Caba, Buenos Aires, Argentina, C1119ACN
        • Research Site
      • Caba, Buenos Aires, Argentina, C1406BOA
        • Research Site
      • Caba, Buenos Aires, Argentina, C1407GTN
        • Research Site
      • Caba, Buenos Aires, Argentina, C1428ART
        • Research Site
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1209
        • Research Site
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1280AEB
        • Research Site
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1426ABP
        • Research Site
      • Coronel Suarez, Buenos Aires, Argentina, B7540GHD
        • Research Site
      • Mar del Plata, Buenos Aires, Argentina, B7600FZN
        • Research Site
      • Merlo, Buenos Aires, Argentina, B1722COV
        • Research Site
      • Quilmes, Buenos Aires, Argentina, 1878
        • Research Site
      • Quilmes, Buenos Aires, Argentina, B1878DVB
        • Research Site
      • Ramos Meija, Buenos Aires, Argentina, B1704ETD
        • Research Site
      • San Fernando, Buenos Aires, Argentina, B1646EBJ
        • Research Site
      • San Isidro, Buenos Aires, Argentina, B1642DSF
        • Research Site
      • San Martin, Buenos Aires, Argentina, B1650CSQ
        • Research Site
      • San Nicolas, Buenos Aires, Argentina, B2900DPA
        • Research Site
    • Córdoba
      • Cordoba, Córdoba, Argentina, X5016KEH
        • Research Site
      • Cordoba, Córdoba, Argentina, 5000
        • Research Site
      • Cordoba, Córdoba, Argentina, X5004BAL
        • Research Site
      • Cordoba, Córdoba, Argentina, X5006IKK
        • Research Site
      • Villa Maria, Córdoba, Argentina, X5900JKA
        • Research Site
    • La Pampa
      • Santa Rosa, La Pampa, Argentina, 6300
        • Research Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Research Site
      • Rosario, Santa Fe, Argentina, S2000BIF
        • Research Site
      • Venado Tuerto, Santa Fe, Argentina, 2600
        • Research Site
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina, 4000
        • Research Site
      • San Miguel de Tucuman, Tucuman, Argentina, T4000JCV
        • Research Site
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • Research Site
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Research Site
      • Darlinghurst, New South Wales, Australia, 2010
        • Research Site
      • Liverpool, New South Wales, Australia, 2170
        • Research Site
      • New Lambton Heights, New South Wales, Australia, 2305
        • Research Site
    • Queensland
      • Chermside, Queensland, Australia, 4032
        • Research Site
      • Herston, Queensland, Australia, 4029
        • Research Site
      • Woolloongabba, Queensland, Australia, 4102
        • Research Site
    • South Australia
      • Ashford, South Australia, Australia, 5035
        • Research Site
      • Bedford Park, South Australia, Australia, 5042
        • Research Site
      • Fullarton, South Australia, Australia, 5063
        • Research Site
      • Woodville South, South Australia, Australia, 5011
        • Research Site
    • Victoria
      • Bundoora, Victoria, Australia, 3083
        • Research Site
      • Frankston, Victoria, Australia, 3199
        • Research Site
      • Geelong, Victoria, Australia, 3220
        • Research Site
      • Richmond, Victoria, Australia, 3121
        • Research Site
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Research Site
      • Feldkirch, Austria, 6807
        • Research Site
      • Graz, Austria, 8036
        • Research Site
      • Innsbruck, Austria, 6020
        • Research Site
      • Linz, Austria, 4010
        • Research Site
      • Linz, Austria, 4020
        • Research Site
      • Sankt Poelten, Austria, 3100
        • Research Site
      • Villach, Austria, 9500
        • Research Site
      • Wien, Austria, 1090
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      • Wien, Austria, 1160
        • Research Site
      • Aalst, Belgium, 9300
        • Research Site
      • Genk, Belgium, 3600
        • Research Site
      • Gent, Belgium, 9000
        • Research Site
      • Leuven, Belgium, 3000
        • Research Site
      • Liège, Belgium, 4000
        • Research Site
      • Lodelinsart, Belgium, 6042
        • Research Site
      • Roeselare, Belgium, 8800
        • Research Site
      • Rio De Janeiro, Brazil, 22271-100
        • Research Site
      • São Paulo, Brazil, 05403-000
        • Research Site
      • São Paulo, Brazil, 04012-909
        • Research Site
    • Distrito Federal
      • Brasilia, Distrito Federal, Brazil, 70673-900
        • Research Site
    • Goiás
      • Goiania, Goiás, Brazil, 74223-130
        • Research Site
      • Goiania, Goiás, Brazil, 74605-020
        • Research Site
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150-240
        • Research Site
      • Belo Horizonte, Minas Gerais, Brazil, 31110-580
        • Research Site
      • Uberlandia, Minas Gerais, Brazil, 38411-186
        • Research Site
    • Paraná
      • Curitiba, Paraná, Brazil, 80045-170
        • Research Site
      • Curitiba, Paraná, Brazil, 80230-130
        • Research Site
      • Curitiba, Paraná, Brazil, 80730-150
        • Research Site
      • Londrina, Paraná, Brazil, 86038-350
        • Research Site
    • Rio Grande Do Norte
      • Natal, Rio Grande Do Norte, Brazil, 59020-035
        • Research Site
    • Rio Grande Do Sul
      • Canoas, Rio Grande Do Sul, Brazil, 92425-900
        • Research Site
      • Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080
        • Research Site
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • Research Site
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
        • Research Site
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90840-440
        • Research Site
      • Porto Alegre, Rio Grande Do Sul, Brazil, 91350-200
        • Research Site
    • Sergipe
      • Aracaju, Sergipe, Brazil, 49055-530
        • Research Site
    • São Paulo
      • Campinas, São Paulo, Brazil, 13083-888
        • Research Site
      • Campinas, São Paulo, Brazil, 13010-001
        • Research Site
      • Campinas, São Paulo, Brazil, 13060-080
        • Research Site
      • Marilia, São Paulo, Brazil, 17515-000
        • Research Site
      • Ribeirao Preto, São Paulo, Brazil, 14048-900
        • Research Site
      • Sao Jose do Rio Preto, São Paulo, Brazil, 15015-770
        • Research Site
      • Sao Paulo, São Paulo, Brazil, 01317 002
        • Research Site
      • Sao Paulo, São Paulo, Brazil, 04005-000
        • Research Site
      • Sao Paulo, São Paulo, Brazil, 08270-120
        • Research Site
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Research Site
      • Haskovo, Bulgaria, 6300
        • Research Site
      • Pleven, Bulgaria, 5800
        • Research Site
      • Sandanski, Bulgaria, 2800
        • Research Site
      • Sofia, Bulgaria, 1202
        • Research Site
      • Sofia, Bulgaria, 1407
        • Research Site
      • Sofia, Bulgaria, 1527
        • Research Site
      • Sofia, Bulgaria, 1233
        • Research Site
      • Sofia, Bulgaria, 1750
        • Research Site
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Research Site
      • Edmonton, Alberta, Canada, T6K 4C1
        • Research Site
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1V6
        • Research Site
      • New Westminster, British Columbia, Canada, V3L 3W4
        • Research Site
      • North Vancouver, British Columbia, Canada, V7M 2H4
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • Research Site
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1G 1A7
        • Research Site
    • Newfoundland and Labrador
      • St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Research Site
    • Ontario
      • Brampton, Ontario, Canada, L6Z 4N5
        • Research Site
      • Brampton, Ontario, Canada, L6W 2X7
        • Research Site
      • Cambridge, Ontario, Canada, N1R 6V6
        • Research Site
      • London, Ontario, Canada, N6A 5A5
        • Research Site
      • Oshawa, Ontario, Canada, L1J 2J9
        • Research Site
      • Ottawa, Ontario, Canada, K1Y 4W7
        • Research Site
      • Peterborough, Ontario, Canada, K9J 0B2
        • Research Site
      • Scarborough, Ontario, Canada, M1P 2V5
        • Research Site
      • Sudbury, Ontario, Canada, P3E 5M4
        • Research Site
      • Toronto, Ontario, Canada, M5B 1W8
        • Research Site
      • Waterloo, Ontario, Canada, N2T 0C1
        • Research Site
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 7K9
        • Research Site
      • Greenfield Park, Quebec, Canada, J4V 2G8
        • Research Site
      • Laval, Quebec, Canada, H7M 3L9
        • Research Site
      • Montreal, Quebec, Canada, H4A 3J1
        • Research Site
      • Montreal, Quebec, Canada, H1T 1C8
        • Research Site
      • Montreal, Quebec, Canada, H3G 1A4
        • Research Site
      • Montreal, Quebec, Canada, H1T 3Y7
        • Research Site
      • Québec, Quebec, Canada, G1V 4G5
        • Research Site
      • St Jean sur Richelieu, Quebec, Canada, J3A 1J2
        • Research Site
      • St-Jérôme, Quebec, Canada, J7Z 5T3
        • Research Site
      • Terrebonne, Quebec, Canada, J6V 2H2
        • Research Site
      • Osorno, Chile, 5311092
        • Research Site
      • Santiago, Chile
        • Research Site
      • Santiago, Chile, 7500739
        • Research Site
      • Santiago, Chile, 8207257
        • Research Site
      • Santiago, Chile, 8330034
        • Research Site
      • Santiago, Chile, 8350595
        • Research Site
      • Santiago, Chile, 8880300
        • Research Site
      • Santiago, Chile, 8910259
        • Research Site
    • Cautín
      • Temuco, Cautín, Chile, 4781156
        • Research Site
      • Temuco, Cautín, Chile, 4813299
        • Research Site
    • Concepción
      • Talcahuano, Concepción, Chile, 4270918
        • Research Site
    • Santiago
      • San Miguel, Santiago, Chile, 8900085
        • Research Site
    • Valparaíso
      • Vina del Mar, Valparaíso, Chile
        • Research Site
      • Beijing, China, 100020
        • Research Site
      • Beijing, China, 100037
        • Research Site
      • Shanghai, China, 200080
        • Research Site
    • Beijing
      • Beijing, Beijing, China, 100191
        • Research Site
      • Beijing, Beijing, China, 100043
        • Research Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Research Site
      • Guangzhou, Guangdong, China, 511400
        • Research Site
    • Hainan
      • Haikou, Hainan, China, 570102
        • Research Site
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • Research Site
    • Henan
      • Luoyang, Henan, China, 471000
        • Research Site
      • Luoyang, Henan, China, 471009
        • Research Site
      • Xinxiang, Henan, China, 453000
        • Research Site
      • Zhengzhou, Henan, China, 450052
        • Research Site
    • Hunan
      • Hengyang, Hunan, China, 421001
        • Research Site
      • Xiangtan, Hunan, China, 411100
        • Research Site
    • Inner Mongolia
      • Huhehaote, Inner Mongolia, China, 010017
        • Research Site
    • Jiangsu
      • Nanjing, Jiangsu, China, 211100
        • Research Site
      • Suzhou, Jiangsu, China, 215000
        • Research Site
      • Wuxi, Jiangsu, China, 214023
        • Research Site
      • Xuzhou, Jiangsu, China, 221006
        • Research Site
    • Jilin
      • Changchun, Jilin, China, 130021
        • Research Site
      • Changchun, Jilin, China, 130033
        • Research Site
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Research Site
      • Shenyang, Liaoning, China, 110000
        • Research Site
      • Shenyang, Liaoning, China, 110016
        • Research Site
    • Shaanxi
      • XI An, Shaanxi, China, 710061
        • Research Site
    • Shandong
      • Heze, Shandong, China, 274031
        • Research Site
      • Jinan, Shandong, China, 250012
        • Research Site
      • Jining, Shandong, China, 272009
        • Research Site
      • QingDao, Shandong, China, 266003
        • Research Site
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Research Site
      • Taiyuan, Shanxi, China, 030012
        • Research Site
      • Yuncheng, Shanxi, China, 044000
        • Research Site
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Research Site
    • Xinjiang
      • Urumqi, Xinjiang, China, 830054
        • Research Site
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Research Site
      • Linhai, Zhejiang, China, 317000
        • Research Site
      • Ningbo, Zhejiang, China, 315010
        • Research Site
      • Bogota D.C., Colombia
        • Research Site
    • Antioquia
      • Medellin, Antioquia, Colombia, 050021
        • Research Site
      • Medellin, Antioquia, Colombia, 05001000
        • Research Site
      • Medellin, Antioquia, Colombia, 050012
        • Research Site
      • Medellin, Antioquia, Colombia, 050034
        • Research Site
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 080020
        • Research Site
      • Barranquilla, Atlántico, Colombia
        • Research Site
    • Bolívar
      • Cartagena, Bolívar, Colombia, 130010
        • Research Site
    • Caldas
      • Manizales, Caldas, Colombia
        • Research Site
    • Quindío
      • Armenia, Quindío, Colombia, 630004
        • Research Site
    • Santander
      • Bucaramanga, Santander, Colombia, 680008
        • Research Site
      • Bucaramanga, Santander, Colombia, 681004
        • Research Site
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia, 760042
        • Research Site
      • Santiago de Cali, Valle Del Cauca, Colombia, 760032
        • Research Site
      • Beroun, Czechia, 266 01
        • Research Site
      • Brandys nad Labem, Czechia, 250 01
        • Research Site
      • Brno, Czechia, 602 00
        • Research Site
      • Brno, Czechia, 625 00
        • Research Site
      • Brno, Czechia, 656 91
        • Research Site
      • Brno, Czechia, 636 00
        • Research Site
      • Frydek Mistek, Czechia, 738 01
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      • Havlickuv Brod, Czechia, 580 22
        • Research Site
      • Hradec Kralove, Czechia, 500 05
        • Research Site
      • Jihlava, Czechia, 586 33
        • Research Site
      • Karlovy Vary, Czechia, 360 01
        • Research Site
      • Kladno, Czechia, 272 59
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      • Klatovy IV, Czechia, 339 01
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      • Kolin III, Czechia, 280 02
        • Research Site
      • Liberec, Czechia, 460 63
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      • Louny, Czechia, 440 01
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      • Marianske Lazne, Czechia, 353 01
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      • Mohelnice, Czechia, 789 85
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      • Opava, Czechia, 746 01
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      • Ostrava, Czechia, 728 80
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      • Policka, Czechia, 572 01
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      • Praha 1, Czechia, 110 00
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      • Praha 10, Czechia, 100 34
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      • Praha 2, Czechia, 128 08
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      • Praha 5 - Smichov, Czechia, 150 00
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      • Pribram VIII, Czechia, 261 01
        • Research Site
      • Svitavy, Czechia, 568 25
        • Research Site
      • Teplice, Czechia, 415 01
        • Research Site
      • Uherske Hradiste, Czechia, 686 01
        • Research Site
      • Zlin, Czechia, 762 75
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      • Znojmo, Czechia, 669 02
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      • Aalborg, Denmark, 9000
        • Research Site
      • Aarhus N, Denmark, 8200
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      • Esbjerg, Denmark, 6700
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      • Glostrup, Denmark, 2600
        • Research Site
      • Hellerup, Denmark, 2900
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      • Hillerod, Denmark, 3400
        • Research Site
      • Køge, Denmark, 4600
        • Research Site
      • Odense, Denmark, 5000
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      • Svendborg, Denmark, 5700
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      • Beziers cedex, France, 34525
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      • Caen Cedex 9, France, 14033
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      • Chambray les Tours, France, 37170
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      • Corbeil Essonnes, France, 91100
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      • Créteil Cedex, France, 94010
        • Research Site
      • Dijon, France, 21000
        • Research Site
      • Grenoble Cedex 9, France, 38043
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      • Le Chesnay, France, 78157
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      • Lille, France, 59000
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      • Lille Cedex, France, 59037
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      • Limoges Cedex, France, 87042
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      • Lyon Cedex 03, France, 69384
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      • Montauban, France, 82017
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      • Montpellier cedex 05, France, 34295
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      • Nantes Cedex 1, France, 44093
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      • Nantes Cedex 2, France, 44277
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      • Nimes cedex 9, France, 30029
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      • Paris, France, 75010
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      • Paris, France, 75018
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      • Paris, France, 75014
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      • Paris Cedex 13, France, 75651
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      • Pessac Cedex, France, 33604
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      • Poitiers, France, 86000
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      • Rennes Cedex 9, France, 35033
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      • Saint Denis, France, 93200
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      • Toulon Cedex, France, 83056
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      • Toulouse Cedex 9, France, 31059
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      • Tourcoing cedex, France, 59208
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      • Valenciennes, France, 59300
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      • Bad Neuheim, Germany, 61231
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      • Berlin, Germany, 13353
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      • Dortmund, Germany, 44137
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      • Düsseldorf, Germany, 40225
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      • Erfurt, Germany, 99089
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      • Erfurt, Germany, 99097
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      • Essen, Germany, 45147
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      • Frankfurt am Main, Germany, 65929
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      • Freiburg, Germany, 79106
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      • Greifswald, Germany, 17475
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      • Göttingen, Germany, 37075
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      • Haßloch, Germany, 67454
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      • Heidelberg, Germany, 69120
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      • Homburg, Germany, 66421
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      • Köln, Germany, 50937
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      • Langen, Germany, 63225
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      • Leipzig, Germany, 04289
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      • Ludwigshafen, Germany, 67063
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      • Mainz, Germany, 55131
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      • Markleeberg, Germany, 04416
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      • Witten, Germany, 58455
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      • Würzburg, Germany, 97078
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      • Alexandroupoli, Greece, 68100
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      • Athens, Greece, 11527
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      • Athens, Greece, 16673
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      • Athens, Greece, 14233
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      • Chaidari, Athens, Greece, 12462
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      • Chalkida, Greece, 34100
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      • Heraklion, Greece, 71110
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      • Ioannina, Greece, 45500
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      • Larissa, Greece, 41110
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      • Thessaloniki, Greece, 54636
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      • Thessaloniki, Greece, 56403
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      • Balatonfured, Hungary, 8230
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      • Bekescsaba, Hungary, 5600
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      • Berettyoujfalu, Hungary, 4100
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      • Budapest, Hungary, 1085
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      • Budapest, Hungary, 1125
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      • Budapest, Hungary, 1122
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      • Budapest, Hungary, 1134
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      • Budapest, Hungary, 1096
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      • Budapest, Hungary, 1037
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      • Budapest, Hungary, 1023
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      • Cegled, Hungary, 2700
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      • Dunaujvaros, Hungary, 2400
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      • Gyongyos, Hungary, 3200
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      • Gyula, Hungary, 5700
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      • Kaposvar, Hungary, 7400
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      • Komarom, Hungary, 2921
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      • Nyiregyhaza, Hungary, 4400
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      • Pecs, Hungary, 7624
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      • Sopron, Hungary, 9400
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      • Szeged, Hungary, 6725
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      • Szekszard, Hungary, 7100
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      • Szentes, Hungary, 6600
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      • Szolnok, Hungary, 5004
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      • Zalaegerszeg, Hungary, 8900
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      • Ariccia, Italy, 00072
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      • Arzignano, Italy, 36071
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      • Bergamo, Italy, 24127
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      • Bologna, Italy, 40139
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      • Brescia, Italy, 25123
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      • Cagliari, Italy, 09134
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      • Catania, Italy, 95123
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      • Catanzaro, Italy, 88100
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      • Cona FE, Italy, 44124
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      • Cuneo, Italy, 12100
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      • Foggia, Italy, 71100
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      • Milano, Italy, 20132
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      • Milano, Italy, 20162
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      • Milano, Italy, 20138
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      • Monza, Italy, 20900
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      • Monza (MB), Italy, 20900
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      • Napoli, Italy, 80131
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      • Palermo, Italy, 90146
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      • Pavia, Italy, 27100
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      • Perugia, Italy, 06156
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      • Piacenza, Italy, 29121
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      • Rimini, Italy, 47923
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      • Roma, Italy, 00163
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      • Rozzano MI, Italy, 20089
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      • Seriate, Italy, 24068
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      • Siena, Italy, 53100
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      • Torrette Di Ancona, Italy, 60126
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      • Trieste, Italy, 34149
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      • Vimercate MB, Italy, 20871
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    • Aichi
      • Ichinomiya-shi, Aichi, Japan, 491-8551
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      • Nagakute-shi, Aichi, Japan, 480-1195
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      • Nagoya-shi, Aichi, Japan, 454-8509
        • Research Site
      • Nagoya-shi, Aichi, Japan, 466-8560
        • Research Site
      • Seto-shi, Aichi, Japan, 489-8642
        • Research Site
    • Chiba
      • Asahi-shi, Chiba, Japan, 289-2511
        • Research Site
      • Chiba-shi, Chiba, Japan, 260-8606
        • Research Site
      • Funabashi-shi, Chiba, Japan, 273-8588
        • Research Site
      • Urayasu-shi, Chiba, Japan, 279-0021
        • Research Site
    • Ehime
      • Imabari-shi, Ehime, Japan, 794-0006
        • Research Site
      • Matsuyama-shi, Ehime, Japan, 790-0067
        • Research Site
    • Fukuoka
      • Chikushino-shi, Fukuoka, Japan, 818-8516
        • Research Site
      • Fukuoka-shi, Fukuoka, Japan, 814-0180
        • Research Site
      • Fukuoka-shi, Fukuoka, Japan, 815-8588
        • Research Site
      • Fukuoka-shi, Fukuoka, Japan, 810-0001
        • Research Site
      • Fukuoka-shi, Fukuoka, Japan, 810-8539
        • Research Site
      • Fukuoka-shi, Fukuoka, Japan, 811-0213
        • Research Site
      • Fukuoka-shi, Fukuoka, Japan, 812-0033
        • Research Site
      • Fukuoka-shi, Fukuoka, Japan, 815-8555
        • Research Site
      • Kasuya-gun, Fukuoka, Japan, 811-2316
        • Research Site
      • Kitakyushu-shi, Fukuoka, Japan, 802-0077
        • Research Site
      • Kitakyushu-shi, Fukuoka, Japan, 802-8555
        • Research Site
      • Kitakyushu-shi, Fukuoka, Japan, 805-8508
        • Research Site
      • Koga-shi, Fukuoka, Japan, 811-3195
        • Research Site
      • Kurume-shi, Fukuoka, Japan, 830-8577
        • Research Site
      • Kurume-shi, Fukuoka, Japan, 839-0863
        • Research Site
      • Onga-gun, Fukuoka, Japan, 807-0051
        • Research Site
    • Fukushima
      • Fukushima-shi, Fukushima, Japan, 960-1295
        • Research Site
      • Fukushima-shi, Fukushima, Japan, 960-8251
        • Research Site
      • Fukushima-shi, Fukushima, Japan, 960-8530
        • Research Site
    • Gifu
      • Ogaki-shi, Gifu, Japan, 503-8502
        • Research Site
    • Gunma
      • Maebashi-shi, Gunma, Japan, 371-8511
        • Research Site
      • Takasaki-shi, Gunma, Japan, 370-0829
        • Research Site
    • Hiroshima
      • Fukuyama-shi, Hiroshima, Japan, 721-8511
        • Research Site
      • Hiroshima-shi, Hiroshima, Japan, 734-8551
        • Research Site
      • Kure-shi, Hiroshima, Japan, 737-0023
        • Research Site
    • Hokkaido
      • Hakodate-shi, Hokkaido, Japan, 041-8512
        • Research Site
      • Sapporo-shi, Hokkaido, Japan, 063-0005
        • Research Site
    • Hyogo
      • Amagasaki-shi, Hyogo, Japan, 660-8550
        • Research Site
      • Himeji-shi, Hyogo, Japan, 670-0981
        • Research Site
      • Kawanishi-shi, Hyogo, Japan, 666-0125
        • Research Site
      • Nishinomiya-shi, Hyogo, Japan, 663-8501
        • Research Site
      • Takarazuka-shi, Hyogo, Japan, 665-0873
        • Research Site
    • Ibaraki
      • Higashiibaraki-gun, Ibaraki, Japan, 311-3193
        • Research Site
    • Ishikawa
      • Kahoku-gun, Ishikawa, Japan, 920-0293
        • Research Site
      • Kanazawa-shi, Ishikawa, Japan, 920-8650
        • Research Site
    • Iwate
      • Morioka-shi, Iwate, Japan, 020-0066
        • Research Site
    • Kagawa
      • Takamatsu-shi, Kagawa, Japan, 760-8557
        • Research Site
    • Kanagawa
      • Hayama, Kanagawa, Japan, 240-0116
        • Research Site
      • Kawasaki-shi, Kanagawa, Japan, 210-0852
        • Research Site
      • Kawasaki-shi, Kanagawa, Japan, 211-8533
        • Research Site
      • Kawasaki-shi, Kanagawa, Japan, 216-8511
        • Research Site
      • Odawara-shi, Kanagawa, Japan, 250-8558
        • Research Site
      • Sagamihara-shi, Kanagawa, Japan, 252-0392
        • Research Site
      • Sagamihara-shi, Kanagawa, Japan, 252-5188
        • Research Site
      • Yokohama-shi, Kanagawa, Japan, 227-8501
        • Research Site
      • Yokohama-shi, Kanagawa, Japan, 231-8682
        • Research Site
      • Yokohama-shi, Kanagawa, Japan, 247-8581
        • Research Site
    • Kochi
      • Nankoku-shi, Kochi, Japan, 783-8505
        • Research Site
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan, 861-4193
        • Research Site
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 980-8574
        • Research Site
    • Nagano
      • Nagano-shi, Nagano, Japan, 381-8551
        • Research Site
    • Nara
      • Kashihara-shi, Nara, Japan, 634-8522
        • Research Site
    • Oita
      • Oita-shi, Oita, Japan, 870-0192
        • Research Site
    • Okayama
      • Okayama-shi, Okayama, Japan, 700-8558
        • Research Site
    • Okinawa
      • Naha-shi, Okinawa, Japan, 902-8511
        • Research Site
      • Shimajiri-gun, Okinawa, Japan, 901-0493
        • Research Site
      • Urasoe-shi, Okinawa, Japan, 901-2132
        • Research Site
    • Osaka
      • Higashiosaka-shi, Osaka, Japan, 579-8056
        • Research Site
      • Matsubara-shi, Osaka, Japan, 580-0032
        • Research Site
      • Osaka-shi, Osaka, Japan, 540-0006
        • Research Site
      • Osaka-shi, Osaka, Japan, 559-0012
        • Research Site
      • Osaka-shi, Osaka, Japan, 530-0001
        • Research Site
      • Osaka-shi, Osaka, Japan, 533-0024
        • Research Site
      • Osaka-shi, Osaka, Japan, 556-0017
        • Research Site
      • Suita-shi, Osaka, Japan, 565-0871
        • Research Site
    • Saga
      • Saga-shi, Saga, Japan, 849-8501
        • Research Site
      • Ureshino-shi, Saga, Japan, 843-0301
        • Research Site
    • Saitama
      • Ageo-shi, Saitama, Japan, 362-8588
        • Research Site
      • Koshigaya-shi, Saitama, Japan, 343-8577
        • Research Site
      • Wako-shi, Saitama, Japan, 351-0102
        • Research Site
    • Shiga
      • Kusatsu-shi, Shiga, Japan, 525-8585
        • Research Site
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 411-8611
        • Research Site
    • Tokyo
      • Akishima-shi, Tokyo, Japan, 196-0003
        • Research Site
      • Bunkyo-ku, Tokyo, Japan, 113-8519
        • Research Site
      • Bunkyo-ku, Tokyo, Japan, 113-8603
        • Research Site
      • Chuo-ku, Tokyo, Japan, 104-8560
        • Research Site
      • Fussa-shi, Tokyo, Japan, 197-8511
        • Research Site
      • Hachioji-shi, Tokyo, Japan, 192-0918
        • Research Site
      • Itabashi-ku, Tokyo, Japan, 173-8610
        • Research Site
      • Kodaira-shi, Tokyo, Japan, 187-8510
        • Research Site
      • Meguro-ku, Tokyo, Japan, 152-8902
        • Research Site
      • Minato-ku, Tokyo, Japan, 108-8642
        • Research Site
      • Shinagawa-ku, Tokyo, Japan, 140-8522
        • Research Site
      • Shinjuku-ku, Tokyo, Japan, 162-8655
        • Research Site
    • Toyama
      • Toyama-shi, Toyama, Japan, 939-8511
        • Research Site
      • Kaunas, Lithuania, 50009
        • Research Site
      • Klaipeda, Lithuania, 92288
        • Research Site
      • Vilnius, Lithuania, 08661
        • Research Site
      • Vilnius, Lithuania, 08861
        • Research Site
      • Aguascalientes, Mexico, 20230
        • Research Site
    • Coahuila
      • Torreon, Coahuila, Mexico, 27000
        • Research Site
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 11650
        • Research Site
      • Mexico City, Distrito Federal, Mexico, 14080
        • Research Site
      • Mexico City, Distrito Federal, Mexico, 06700
        • Research Site
    • Hidalgo
      • Pachuca, Hidalgo, Mexico, 42070
        • Research Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • Research Site
      • Guadalajara, Jalisco, Mexico, 44340
        • Research Site
      • Guadalajara, Jalisco, Mexico, 44670
        • Research Site
      • Zapopan, Jalisco, Mexico, 45030
        • Research Site
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Research Site
      • Monterrey, Nuevo León, Mexico, 64060
        • Research Site
    • Querétaro
      • Queretaro, Querétaro, Mexico, 76000
        • Research Site
    • San Luis Potosí
      • San Luis Potosi, San Luis Potosí, Mexico, 78200
        • Research Site
    • Sinaloa
      • Culiacan, Sinaloa, Mexico, 80230
        • Research Site
    • Veracruz
      • Xalapa, Veracruz, Mexico, 91193
        • Research Site
      • 's Hertogenbosch, Netherlands, 5223 GZ
        • Research Site
      • Almelo, Netherlands, 7609 PP
        • Research Site
      • Arnhem, Netherlands, 6815 AD
        • Research Site
      • Breda, Netherlands, 4818 CK
        • Research Site
      • Capelle Aan De IJssel, Netherlands, 2906 ZC
        • Research Site
      • Den Helder, Netherlands, 1782 GZ
        • Research Site
      • Deventer, Netherlands, 7416 SE
        • Research Site
      • Doetinchem, Netherlands, 7009 BL
        • Research Site
      • Emmen, Netherlands, 7824 AA
        • Research Site
      • Goes, Netherlands, 4462 RA
        • Research Site
      • Groningen, Netherlands, 9713 GZ
        • Research Site
      • Groningen, Netherlands, 9728 NT
        • Research Site
      • Leiderdorp, Netherlands, 2353 GA
        • Research Site
      • Nijmegen, Netherlands, 6532 SZ
        • Research Site
      • Tiel, Netherlands, 4002 WP
        • Research Site
      • Tilburg, Netherlands, 5042 AD
        • Research Site
      • Tilburg, Netherlands, 5022 GC
        • Research Site
      • Uden, Netherlands, 5406 PT
        • Research Site
      • Zwolle, Netherlands, 8025 AB
        • Research Site
      • Christchurch, New Zealand, 8011
        • Research Site
      • Papatoetoe, Auckland, New Zealand, 2025
        • Research Site
      • Takapuna, Auckland, New Zealand, 0620
        • Research Site
      • Bialystok, Poland, 15-276
        • Research Site
      • Bytom, Poland, 41-902
        • Research Site
      • Gdansk, Poland, 80-262
        • Research Site
      • Gdynia, Poland, 81-157
        • Research Site
      • Gdynia, Poland, 81-423
        • Research Site
      • Gizycko, Poland, 11-500
        • Research Site
      • Kazimierza Wielka, Poland, 28-500
        • Research Site
      • Kielce, Poland, 25-736
        • Research Site
      • Klodzko, Poland, 57-300
        • Research Site
      • Krakow, Poland, 31-202
        • Research Site
      • Krakow, Poland, 30-069
        • Research Site
      • Krakow, Poland, 30-082
        • Research Site
      • Lodz, Poland, 90-549
        • Research Site
      • Lodz, Poland, 91-347
        • Research Site
      • Lodz, Poland, 92-213
        • Research Site
      • Lublin, Poland, 20-078
        • Research Site
      • Lublin, Poland, 20-857
        • Research Site
      • Miechow, Poland, 32-200
        • Research Site
      • Olawa, Poland, 55-200
        • Research Site
      • Piotrkow Trybunalski, Poland, 97-300
        • Research Site
      • Poznan, Poland, 61-848
        • Research Site
      • Ruda Slaska, Poland, 41-709
        • Research Site
      • Skierniewice, Poland, 96-100
        • Research Site
      • Stalowa Wola, Poland, 37-450
        • Research Site
      • Swidnik, Poland, 21-040
        • Research Site
      • Tarnow, Poland, 33-100
        • Research Site
      • Torun, Poland, 87-100
        • Research Site
      • Warszawa, Poland, 02-097
        • Research Site
      • Warszawa, Poland, 04-628
        • Research Site
      • Wloclawek, Poland, 87-800
        • Research Site
      • Wroclaw, Poland, 51-124
        • Research Site
      • Zabrze, Poland, 41-800
        • Research Site
      • Aveiro, Portugal, 3814-501
        • Research Site
      • Coimbra, Portugal, 3000-075
        • Research Site
      • Covilha, Portugal, 6200-251
        • Research Site
      • Guimaraes, Portugal, 4835-044
        • Research Site
      • Lisboa, Portugal, 1649-035
        • Research Site
      • Lisboa, Portugal, 1500-650
        • Research Site
      • Lisboa, Portugal, 1449-005
        • Research Site
      • Setubal, Portugal, 2910-446
        • Research Site
      • San Juan, Puerto Rico, 00926-2832
        • Research Site
      • Bucarest, Romania, 014461
        • Research Site
      • Bucharest, Romania, 050098
        • Research Site
      • Bucuresti, Romania, 021659
        • Research Site
      • Bucuresti, Romania, 022322
        • Research Site
      • Cluj-Napoca, Romania, 400347
        • Research Site
      • Craiova, Romania, 200642
        • Research Site
      • Craiova, Romania, 200383
        • Research Site
      • Iasi, Romania, 700661
        • Research Site
      • Iasi, Romania, 700732
        • Research Site
      • Oradea, Romania, 410169
        • Research Site
      • Pitesti, Romania, 110438
        • Research Site
      • Targoviste, Romania, 130095
        • Research Site
      • Targu Mures, Romania, 540143
        • Research Site
      • Timisoara, Romania, 300079
        • Research Site
      • Arkhangelsk, Russian Federation, 163001
        • Research Site
      • Barnaul, Russian Federation, 656038
        • Research Site
      • Ekaterinburg, Russian Federation, 620102
        • Research Site
      • Ivanovo, Russian Federation, 153012
        • Research Site
      • Izhevsk, Russian Federation, 426063
        • Research Site
      • Kemerovo, Russian Federation, 650002
        • Research Site
      • Kemerovo, Russian Federation, 650099
        • Research Site
      • Kirov, Russian Federation, 610014
        • Research Site
      • Korolev, Russian Federation, 141060
        • Research Site
      • Krasnodar, Russian Federation, 350086
        • Research Site
      • Lomonosov, Russian Federation, 198412
        • Research Site
      • Moscow, Russian Federation, 101990
        • Research Site
      • Moscow, Russian Federation, 129090
        • Research Site
      • Moscow, Russian Federation, 121552
        • Research Site
      • Moscow, Russian Federation, 129327
        • Research Site
      • Moscow, Russian Federation, 123182
        • Research Site
      • Moscow, Russian Federation, 117292
        • Research Site
      • Moscow, Russian Federation, 127299
        • Research Site
      • Moscow, Russian Federation, 119192
        • Research Site
      • Nizhniy Novgorod, Russian Federation, 603076
        • Research Site
      • Nizhny Novgorod, Russian Federation, 603126
        • Research Site
      • Novosibirsk, Russian Federation, 630008
        • Research Site
      • Novosibirsk, Russian Federation, 630087
        • Research Site
      • Novosibirsk, Russian Federation, 630089
        • Research Site
      • Omsk, Russian Federation, 644018
        • Research Site
      • Saint Petersburg, Russian Federation, 198205
        • Research Site
      • Saint Petersburg, Russian Federation, 197022
        • Research Site
      • Saint Petersburg, Russian Federation, 194156
        • Research Site
      • Saint Petersburg, Russian Federation, 195112
        • Research Site
      • Saint-Petersburg, Russian Federation, 197022
        • Research Site
      • Saint-Petersburg, Russian Federation, 199106
        • Research Site
      • Saint-Petersburg, Russian Federation, 192242
        • Research Site
      • Saint-Petersburg, Russian Federation, 196601
        • Research Site
      • Saratov, Russian Federation, 410054
        • Research Site
      • St. Petersburg, Russian Federation, 191015
        • Research Site
      • Tomsk, Russian Federation, 634012
        • Research Site
      • Village Novoseltsy, Russian Federation, 214016
        • Research Site
      • Vladimir, Russian Federation, 600020
        • Research Site
      • Yaroslavl, Russian Federation, 150030
        • Research Site
      • Banska Bystrica, Slovakia, 974 01
        • Research Site
      • Bardejov, Slovakia, 085 01
        • Research Site
      • Bratislava, Slovakia, 826 06
        • Research Site
      • Bratislava, Slovakia, 811 08
        • Research Site
      • Bratislava, Slovakia, 833 48
        • Research Site
      • Brezno, Slovakia, 977 42
        • Research Site
      • Kosice, Slovakia, 040 01
        • Research Site
      • Levice, Slovakia, 934 01
        • Research Site
      • Nitra, Slovakia, 950 01
        • Research Site
      • Presov, Slovakia, 080 01
        • Research Site
      • Rimavska Sobota, Slovakia, 979 01
        • Research Site
      • Snina, Slovakia, 069 01
        • Research Site
      • Svidnik, Slovakia, 089 01
        • Research Site
      • Trnava, Slovakia, 917 75
        • Research Site
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Research Site
    • Gauteng
      • Parktown, Gauteng, South Africa, 2193
        • Research Site
      • Soweto, Gauteng, South Africa, 2013
        • Research Site
      • Sunninghill, Gauteng, South Africa, 2157
        • Research Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4001
        • Research Site
      • Umhlanga, KwaZulu-Natal, South Africa, 4320
        • Research Site
    • Western Cape
      • Parow, Western Cape, South Africa, 7505
        • Research Site
      • Somerset West, Western Cape, South Africa, 7130
        • Research Site
      • Worcester, Western Cape, South Africa, 6850
        • Research Site
      • Madrid, Spain, 28041
        • Research Site
      • Madrid, Spain, 28040
        • Research Site
      • Madrid, Spain, 28007
        • Research Site
    • Andalucía
      • Cordoba, Andalucía, Spain, 14004
        • Research Site
      • Granada, Andalucía, Spain, 18014
        • Research Site
      • Malaga, Andalucía, Spain, 29010
        • Research Site
      • Sevilla, Andalucía, Spain, 41009
        • Research Site
      • Ubeda, Andalucía, Spain, 23400
        • Research Site
    • Aragón
      • Zaragoza, Aragón, Spain, 50009
        • Research Site
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Research Site
    • Canarias
      • La laguna, Canarias, Spain, 38320
        • Research Site
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Research Site
    • Castilla León
      • Valladolid, Castilla León, Spain, 47005
        • Research Site
    • Cataluña
      • Barcelona, Cataluña, Spain, 08041
        • Research Site
    • Comunidad Valenciana
      • Alicante, Comunidad Valenciana, Spain, 03010
        • Research Site
      • Valencia, Comunidad Valenciana, Spain, 46026
        • Research Site
      • Valencia, Comunidad Valenciana, Spain, 46010
        • Research Site
    • Galicia
      • A Coruña, Galicia, Spain, 15006
        • Research Site
      • Santiago de Compostela, Galicia, Spain, 15706
        • Research Site
      • Vigo, Galicia, Spain, 36312
        • Research Site
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Research Site
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Research Site
      • Falun, Sweden, 791 82
        • Research Site
      • Jonkoping, Sweden, 553 05
        • Research Site
      • Lidköping, Sweden, 531 85
        • Research Site
      • Linkoping, Sweden, 581 85
        • Research Site
      • Lund, Sweden, 222 21
        • Research Site
      • Orebro, Sweden, 701 85
        • Research Site
      • Skelleftea, Sweden, 931 86
        • Research Site
      • Basel, Switzerland, 4031
        • Research Site
      • Bern, Switzerland, 3010
        • Research Site
      • Fribourg, Switzerland, 1708
        • Research Site
      • Geneva 14, Switzerland, 1211
        • Research Site
      • Lausanne, Switzerland, 1011
        • Research Site
      • Lugano, Switzerland, 6900
        • Research Site
      • Zurich, Switzerland, 8032
        • Research Site
      • Adana, Turkey, 01330
        • Research Site
      • Afyonkarahisar, Turkey, 03218
        • Research Site
      • Ankara, Turkey, 06490
        • Research Site
      • Ankara, Turkey, 06100
        • Research Site
      • Corum, Turkey, 19040
        • Research Site
      • Eskisehir, Turkey, 26040
        • Research Site
      • Istanbul, Turkey, 34098
        • Research Site
      • Istanbul, Turkey, 34096
        • Research Site
      • Istanbul, Turkey, 34200
        • Research Site
      • Istanbul, Turkey, 34865
        • Research Site
      • Izmir, Turkey, 35100
        • Research Site
      • Izmir, Turkey, 35340
        • Research Site
      • Kirikkale, Turkey, 71100
        • Research Site
      • Kocaeli, Turkey, 41380
        • Research Site
      • Konya, Turkey, 42080
        • Research Site
      • Mersin, Turkey, 33343
        • Research Site
      • Sakarya, Turkey, 54100
        • Research Site
      • Sivas, Turkey, 58140
        • Research Site
      • Van, Turkey, 65100
        • Research Site
      • Dnipropetrovsk, Ukraine, 49060
        • Research Site
      • Ivano-Frankivsk, Ukraine, 76018
        • Research Site
      • Kharkiv, Ukraine, 61002
        • Research Site
      • Kharkiv, Ukraine, 61039
        • Research Site
      • Kharkiv, Ukraine, 61176
        • Research Site
      • Kharkiv, Ukraine, 61018
        • Research Site
      • Kharkiv, Ukraine, 61106
        • Research Site
      • Kyiv, Ukraine, 01601
        • Research Site
      • Kyiv, Ukraine, 02091
        • Research Site
      • Kyiv, Ukraine, 02232
        • Research Site
      • Kyiv, Ukraine, 02660
        • Research Site
      • Kyiv, Ukraine, 03680
        • Research Site
      • Kyiv, Ukraine, 03151
        • Research Site
      • Lutsk, Ukraine, 43024
        • Research Site
      • Uzhgorod, Ukraine, 88014
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      • Vinnytsia, Ukraine, 21029
        • Research Site
      • Vinnytsia, Ukraine, 21018
        • Research Site
      • Vinnytsya, Ukraine, 21001
        • Research Site
      • Zaporizhzhia, Ukraine, 69035
        • Research Site
      • Zaporizhzhya, Ukraine, 69600
        • Research Site
      • Ayr, United Kingdom, KA6 6DX
        • Research Site
      • Basingstoke, United Kingdom, RG24 9NA
        • Research Site
      • Belfast, United Kingdom, BT16 1RH
        • Research Site
      • Blackpool, United Kingdom, FY3 8NR
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      • Corby, United Kingdom, NN17 2UR
        • Research Site
      • Cottingham, United Kingdom, HU16 5JQ
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      • Dudley, United Kingdom, DY1 2HQ
        • Research Site
      • Dundee, United Kingdom, DD1 9SY
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      • Exeter, United Kingdom, EX2 5DW
        • Research Site
      • Gillingham, United Kingdom, ME7 5NY
        • Research Site
      • Glasgow, United Kingdom, G75 8RG
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      • Harlow, United Kingdom, CM20 1QX
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      • High Wycombe, United Kingdom, HP11 2TT
        • Research Site
      • London, United Kingdom, SW3 6NP
        • Research Site
      • London, United Kingdom, W12 0HS
        • Research Site
      • London, United Kingdom, N18 1QX
        • Research Site
      • Merthyr Tydfil, United Kingdom, CF47 9DT
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      • Newport, United Kingdom, PO30 5TG
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      • Northampton, United Kingdom, NN1 5BD
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      • Northwood, United Kingdom, HA6 2RN
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      • Norwich, United Kingdom, NR4 7UY
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      • Peterborough, United Kingdom, PE3 9GZ
        • Research Site
      • Portsmouth, United Kingdom, PO6 3LY
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      • Romford, United Kingdom, RM1 3PJ
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      • Sheffield, United Kingdom, S5 7AU
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      • Shipley, United Kingdom, BD18 3SA
        • Research Site
      • Sidcup, United Kingdom, DA14 6LT
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      • Solihull, United Kingdom, B91 2JL
        • Research Site
      • Stevenage, United Kingdom, SG1 4AB
        • Research Site
      • Sunderland, United Kingdom, SR4 7TP
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      • Swindon, United Kingdom, SN3 6BB
        • Research Site
      • Taunton, United Kingdom, TA1 5DA
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      • Torquay, United Kingdom, TQ2 7AA
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      • Worcester, United Kingdom, WR5 1DD
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    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Research Site
      • Birmingham, Alabama, United States, 35243
        • Research Site
      • Birmingham, Alabama, United States, 35233
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      • Fort Payne, Alabama, United States, 35967
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      • Huntsville, Alabama, United States, 35801
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      • Mobile, Alabama, United States, 36608
        • Research Site
      • Scottsboro, Alabama, United States, 35768
        • Research Site
      • Tuscumbia, Alabama, United States, 35674
        • Research Site
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Research Site
      • Phoenix, Arizona, United States, 85032
        • Research Site
      • Tucson, Arizona, United States, 85724
        • Research Site
      • Tucson, Arizona, United States, 85710
        • Research Site
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Research Site
      • Little Rock, Arkansas, United States, 72205
        • Research Site
    • California
      • Anaheim, California, United States, 92801
        • Research Site
      • Beverly Hills, California, United States, 90211
        • Research Site
      • Burbank, California, United States, 91505
        • Research Site
      • Carmichael, California, United States, 95608
        • Research Site
      • Fresno, California, United States, 93701
        • Research Site
      • Huntington Beach, California, United States, 92648
        • Research Site
      • Loma Linda, California, United States, 92357
        • Research Site
      • Long Beach, California, United States, 90806
        • Research Site
      • Long Beach, California, United States, 90822
        • Research Site
      • Los Alamitos, California, United States, 90720
        • Research Site
      • Los Angeles, California, United States, 90073
        • Research Site
      • Los Angeles, California, United States, 90033
        • Research Site
      • Mission Viejo, California, United States, 92691
        • Research Site
      • Newport Beach, California, United States, 92663
        • Research Site
      • Northridge, California, United States, 91325
        • Research Site
      • Redondo Beach, California, United States, 90277
        • Research Site
      • Riverside, California, United States, 92506
        • Research Site
      • Sacramento, California, United States, 95819
        • Research Site
      • San Francisco, California, United States, 94115
        • Research Site
      • San Pedro, California, United States, 90732
        • Research Site
      • Santa Ana, California, United States, 92704
        • Research Site
      • Santa Rosa, California, United States, 95405
        • Research Site
      • Stanford, California, United States, 94305
        • Research Site
      • Stockton, California, United States, 95204
        • Research Site
      • Torrance, California, United States, 90502
        • Research Site
      • Torrance, California, United States, 90503
        • Research Site
      • Tustin, California, United States, 92780
        • Research Site
      • Ventura, California, United States, 93003
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Research Site
      • Colorado Springs, Colorado, United States, 80909
        • Research Site
      • Denver, Colorado, United States, 80218
        • Research Site
      • Denver, Colorado, United States, 80204
        • Research Site
      • Littleton, Colorado, United States, 80120
        • Research Site
      • Wheat Ridge, Colorado, United States, 80033
        • Research Site
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Research Site
      • Stamford, Connecticut, United States, 06905
        • Research Site
      • Waterbury, Connecticut, United States, 06708
        • Research Site
      • West Haven, Connecticut, United States, 06516
        • Research Site
    • Delaware
      • Newark, Delaware, United States, 19718
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Research Site
      • Washington, District of Columbia, United States, 20010
        • Research Site
      • Washington, District of Columbia, United States, 20422
        • Research Site
    • Florida
      • Altamonte Springs, Florida, United States, 32714
        • Research Site
      • Aventura, Florida, United States, 33180
        • Research Site
      • Bay Pines, Florida, United States, 33744
        • Research Site
      • Boynton Beach, Florida, United States, 33472
        • Research Site
      • Crystal River, Florida, United States, 34429
        • Research Site
      • Daytona Beach, Florida, United States, 32117
        • Research Site
      • Doral, Florida, United States, 33126
        • Research Site
      • Gainesville, Florida, United States, 32608
        • Research Site
      • Hialeah, Florida, United States, 33012
        • Research Site
      • Hialeah, Florida, United States, 33013
        • Research Site
      • Inverness, Florida, United States, 34452
        • Research Site
      • Jacksonville, Florida, United States, 32209
        • Research Site
      • Jacksonville, Florida, United States, 32216
        • Research Site
      • Miami, Florida, United States, 33126
        • Research Site
      • Miami, Florida, United States, 33165
        • Research Site
      • Miami, Florida, United States, 33136
        • Research Site
      • Miami, Florida, United States, 33144
        • Research Site
      • Miami, Florida, United States, 33145
        • Research Site
      • Miami, Florida, United States, 33125
        • Research Site
      • Miami, Florida, United States, 33174
        • Research Site
      • Miami, Florida, United States, 33147
        • Research Site
      • Miami, Florida, United States, 33032
        • Research Site
      • Miami, Florida, United States, 33166
        • Research Site
      • Miami Beach, Florida, United States, 33140
        • Research Site
      • Naples, Florida, United States, 34102
        • Research Site
      • Ocala, Florida, United States, 34471
        • Research Site
      • Palm Harbor, Florida, United States, 34684
        • Research Site
      • Pembroke Pines, Florida, United States, 33028
        • Research Site
      • Sarasota, Florida, United States, 34232
        • Research Site
      • Tampa, Florida, United States, 33613
        • Research Site
      • Zephyrhills, Florida, United States, 33541
        • Research Site
    • Georgia
      • Athens, Georgia, United States, 30606
        • Research Site
      • Atlanta, Georgia, United States, 30309
        • Research Site
      • Atlanta, Georgia, United States, 30303
        • Research Site
      • Augusta, Georgia, United States, 30909
        • Research Site
      • Columbus, Georgia, United States, 31904
        • Research Site
      • Smyrna, Georgia, United States, 30082
        • Research Site
      • Woodstock, Georgia, United States, 30189
        • Research Site
    • Hawaii
      • 'Aiea, Hawaii, United States, 96701
        • Research Site
      • Honolulu, Hawaii, United States, 96813
        • Research Site
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Research Site
      • Champaign, Illinois, United States, 61820
        • Research Site
      • Chicago, Illinois, United States, 60612
        • Research Site
      • Fairview Heights, Illinois, United States, 62208
        • Research Site
      • Hazel Crest, Illinois, United States, 60429
        • Research Site
      • Maywood, Illinois, United States, 60153
        • Research Site
      • Oak Lawn, Illinois, United States, 60453
        • Research Site
      • Peoria, Illinois, United States, 61606
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46227
        • Research Site
      • Merrillville, Indiana, United States, 46410
        • Research Site
      • Muncie, Indiana, United States, 47303
        • Research Site
      • Munster, Indiana, United States, 46321
        • Research Site
      • Richmond, Indiana, United States, 47374
        • Research Site
      • Valparaiso, Indiana, United States, 46383
        • Research Site
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Research Site
      • Iowa City, Iowa, United States, 52242
        • Research Site
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Research Site
      • Overland Park, Kansas, United States, 66209
        • Research Site
      • Wichita, Kansas, United States, 67214
        • Research Site
      • Wichita, Kansas, United States, 67226
        • Research Site
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017
        • Research Site
      • Lexington, Kentucky, United States, 40503
        • Research Site
      • Louisville, Kentucky, United States, 40202
        • Research Site
      • Louisville, Kentucky, United States, 40206
        • Research Site
      • Louisville, Kentucky, United States, 40216
        • Research Site
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • Research Site
      • Lake Charles, Louisiana, United States, 70601
        • Research Site
      • Monroe, Louisiana, United States, 71201
        • Research Site
      • New Orleans, Louisiana, United States, 70112
        • Research Site
      • Shreveport, Louisiana, United States, 71103
        • Research Site
      • Shreveport, Louisiana, United States, 71105
        • Research Site
      • West Monroe, Louisiana, United States, 71291
        • Research Site
    • Maine
      • Bangor, Maine, United States, 04401
        • Research Site
      • Biddeford, Maine, United States, 04005
        • Research Site
      • Portland, Maine, United States, 04101
        • Research Site
      • Scarborough, Maine, United States, 04074
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Research Site
      • Baltimore, Maryland, United States, 21229
        • Research Site
      • Baltimore, Maryland, United States, 21236
        • Research Site
      • Columbia, Maryland, United States, 21044
        • Research Site
      • Hagerstown, Maryland, United States, 21740
        • Research Site
      • Prince Frederick, Maryland, United States, 20678
        • Research Site
      • Salisbury, Maryland, United States, 21804
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Research Site
      • Haverhill, Massachusetts, United States, 01830
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Research Site
      • Detroit, Michigan, United States, 48202
        • Research Site
      • Grand Blanc, Michigan, United States, 48439
        • Research Site
      • Kalamazoo, Michigan, United States, 49008
        • Research Site
      • Midland, Michigan, United States, 48670
        • Research Site
      • Royal Oak, Michigan, United States, 48073
        • Research Site
      • Saginaw, Michigan, United States, 48601
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Research Site
      • Saint Paul, Minnesota, United States, 55101
        • Research Site
    • Mississippi
      • Port Gibson, Mississippi, United States, 39150
        • Research Site
      • Tupelo, Mississippi, United States, 38801
        • Research Site
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Research Site
      • Columbia, Missouri, United States, 65212
        • Research Site
      • Jefferson City, Missouri, United States, 65109
        • Research Site
      • Kansas City, Missouri, United States, 64108
        • Research Site
      • Kansas City, Missouri, United States, 64128
        • Research Site
      • Saint Louis, Missouri, United States, 63110
        • Research Site
      • Springfield, Missouri, United States, 65807
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Research Site
      • Omaha, Nebraska, United States, 68198
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89118
        • Research Site
      • Las Vegas, Nevada, United States, 89128
        • Research Site
      • North Las Vegas, Nevada, United States, 89086
        • Research Site
      • Reno, Nevada, United States, 89502
        • Research Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Research Site
    • New Jersey
      • Eatontown, New Jersey, United States, 07724
        • Research Site
      • Moorestown, New Jersey, United States, 08057
        • Research Site
      • Morristown, New Jersey, United States, 07960
        • Research Site
      • Newark, New Jersey, United States, 07112
        • Research Site
      • Ridgewood, New Jersey, United States, 07450
        • Research Site
      • Somerset, New Jersey, United States, 08873
        • Research Site
      • Voorhees, New Jersey, United States, 08043
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Research Site
    • New York
      • Albany, New York, United States, 12208
        • Research Site
      • Bronx, New York, United States, 10467
        • Research Site
      • Brooklyn, New York, United States, 11215
        • Research Site
      • Buffalo, New York, United States, 14215
        • Research Site
      • Cortlandt Manor, New York, United States, 10567
        • Research Site
      • Johnson City, New York, United States, 13790
        • Research Site
      • Kingston, New York, United States, 12401
        • Research Site
      • Laurelton, New York, United States, 11413
        • Research Site
      • Mineola, New York, United States, 11501
        • Research Site
      • New York, New York, United States, 10016
        • Research Site
      • New York, New York, United States, 10029
        • Research Site
      • New York, New York, United States, 10025
        • Research Site
      • Rochester, New York, United States, 14621
        • Research Site
      • Roslyn, New York, United States, 11576
        • Research Site
      • Saratoga Springs, New York, United States, 12866
        • Research Site
      • Stony Brook, New York, United States, 11794
        • Research Site
      • Valhalla, New York, United States, 10595
        • Research Site
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Research Site
      • Cary, North Carolina, United States, 27518
        • Research Site
      • Chapel Hill, North Carolina, United States, 27599
        • Research Site
      • Charlotte, North Carolina, United States, 28203
        • Research Site
      • Durham, North Carolina, United States, 27705
        • Research Site
      • Greensboro, North Carolina, United States, 27401
        • Research Site
      • Hickory, North Carolina, United States, 28601
        • Research Site
      • Lenoir, North Carolina, United States, 28645
        • Research Site
      • Lumberton, North Carolina, United States, 28358
        • Research Site
      • Mooresville, North Carolina, United States, 28117
        • Research Site
      • Pinehurst, North Carolina, United States, 28374
        • Research Site
      • Tabor City, North Carolina, United States, 28463
        • Research Site
      • Wilmington, North Carolina, United States, 28401
        • Research Site
      • Winston-Salem, North Carolina, United States, 27103
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Research Site
      • Cincinnati, Ohio, United States, 45267
        • Research Site
      • Cincinnati, Ohio, United States, 45220
        • Research Site
      • Cleveland, Ohio, United States, 44195
        • Research Site
      • Cleveland, Ohio, United States, 44106
        • Research Site
      • Columbus, Ohio, United States, 43210
        • Research Site
      • Columbus, Ohio, United States, 43214
        • Research Site
      • Dayton, Ohio, United States, 45414
        • Research Site
      • Dayton, Ohio, United States, 45419
        • Research Site
      • Kettering, Ohio, United States, 45429
        • Research Site
      • Marion, Ohio, United States, 43302
        • Research Site
      • Sandusky, Ohio, United States, 44870
        • Research Site
      • Wiloughby, Ohio, United States, 44094
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73135
        • Research Site
      • Tulsa, Oklahoma, United States, 74127
        • Research Site
      • Tulsa, Oklahoma, United States, 74104
        • Research Site
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Research Site
      • Altoona, Pennsylvania, United States, 16602
        • Research Site
      • Butler, Pennsylvania, United States, 16001
        • Research Site
      • Camp Hill, Pennsylvania, United States, 17011
        • Research Site
      • Erie, Pennsylvania, United States, 16502
        • Research Site
      • Hershey, Pennsylvania, United States, 17033
        • Research Site
      • Jersey Shore, Pennsylvania, United States, 17740
        • Research Site
      • Lancaster, Pennsylvania, United States, 17603
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19114
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19102
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19141
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15212
        • Research Site
      • Sayre, Pennsylvania, United States, 18840
        • Research Site
      • Yardley, Pennsylvania, United States, 19067
        • Research Site
      • York, Pennsylvania, United States, 17403
        • Research Site
    • Rhode Island
      • Pawtucket, Rhode Island, United States, 02860
        • Research Site
      • Providence, Rhode Island, United States, 02908
        • Research Site
      • Providence, Rhode Island, United States, 02906
        • Research Site
      • Warwick, Rhode Island, United States, 02886
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Research Site
      • Charleston, South Carolina, United States, 29407
        • Research Site
      • Charleston, South Carolina, United States, 29401
        • Research Site
      • Fort Mill, South Carolina, United States, 29707
        • Research Site
      • Greenville, South Carolina, United States, 29605
        • Research Site
      • Rock Hill, South Carolina, United States, 29732
        • Research Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Research Site
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Research Site
      • Jackson, Tennessee, United States, 38305
        • Research Site
      • Jackson, Tennessee, United States, 38301
        • Research Site
      • Knoxville, Tennessee, United States, 37934
        • Research Site
      • Memphis, Tennessee, United States, 38104
        • Research Site
      • Nashville, Tennessee, United States, 37232
        • Research Site
      • Nashville, Tennessee, United States, 37212
        • Research Site
      • Nashville, Tennessee, United States, 37208
        • Research Site
      • Oak Ridge, Tennessee, United States, 37830
        • Research Site
      • Powell, Tennessee, United States, 37849
        • Research Site
      • Tullahoma, Tennessee, United States, 37388
        • Research Site
    • Texas
      • Amarillo, Texas, United States, 79106
        • Research Site
      • Carrollton, Texas, United States, 75010
        • Research Site
      • Carrollton, Texas, United States, 75006
        • Research Site
      • Dallas, Texas, United States, 75246
        • Research Site
      • Dallas, Texas, United States, 75231
        • Research Site
      • Dallas, Texas, United States, 75216
        • Research Site
      • Denison, Texas, United States, 75020
        • Research Site
      • El Paso, Texas, United States, 79935
        • Research Site
      • Fort Sam Houston, Texas, United States, 78234
        • Research Site
      • Fort Worth, Texas, United States, 76104
        • Research Site
      • Galveston, Texas, United States, 77555-0158
        • Research Site
      • Gonzales, Texas, United States, 78629
        • Research Site
      • Houston, Texas, United States, 77030
        • Research Site
      • Houston, Texas, United States, 77025
        • Research Site
      • Huntsville, Texas, United States, 77340
        • Research Site
      • Lubbock, Texas, United States, 79430
        • Research Site
      • McKinney, Texas, United States, 75071
        • Research Site
      • Odessa, Texas, United States, 79761
        • Research Site
      • Plano, Texas, United States, 75024
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Research Site
      • Tomball, Texas, United States, 77375
        • Research Site
      • Wichita Falls, Texas, United States, 76301
        • Research Site
    • Utah
      • Farmington, Utah, United States, 84025
        • Research Site
      • Murray, Utah, United States, 84107
        • Research Site
      • Salt Lake City, Utah, United States, 84132
        • Research Site
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Research Site
      • White River Junction, Vermont, United States, 05009
        • Research Site
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Research Site
      • Leesburg, Virginia, United States, 20176
        • Research Site
      • Lynchburg, Virginia, United States, 24501
        • Research Site
      • Manassas, Virginia, United States, 20109
        • Research Site
      • Norfolk, Virginia, United States, 23510
        • Research Site
      • Richmond, Virginia, United States, 23226
        • Research Site
      • Richmond, Virginia, United States, 23298
        • Research Site
      • Richmond, Virginia, United States, 23249
        • Research Site
      • Virginia Beach, Virginia, United States, 23454
        • Research Site
    • Washington
      • Puyallup, Washington, United States, 98372
        • Research Site
      • Seattle, Washington, United States, 98122
        • Research Site
      • Spokane, Washington, United States, 99204
        • Research Site
    • West Virginia
      • Huntington, West Virginia, United States, 25702
        • Research Site
      • Morgantown, West Virginia, United States, 26506
        • Research Site
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • Research Site
      • Madison, Wisconsin, United States, 53792
        • Research Site
      • Madison, Wisconsin, United States, 53705
        • Research Site
      • Madison, Wisconsin, United States, 53713
        • Research Site
      • Manitowoc, Wisconsin, United States, 54220
        • Research Site
      • Milwaukee, Wisconsin, United States, 53226
        • Research Site
      • Milwaukee, Wisconsin, United States, 53201
        • Research Site
      • Milwaukee, Wisconsin, United States, 53295
        • Research Site
      • Waukesha, Wisconsin, United States, 53188
        • Research Site

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

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Subject has provided informed consent
  • Male or female, ≥ 18 to ≤ 85 years
  • History of chronic heart failure (HF), defined as requiring treatment for HF for a minimum of 30 days before randomization
  • Left ventricle ejection fraction (LVEF) ≤ 35%, per subjects most recent medical record, within 12 months prior to screening.
  • New York Heart Association (NYHA) class II to IV at most recent screening assessment.
  • Managed with HF standard of care (SoC) therapies consistent with regional clinical practice guidelines according to investigator judgment of subject's clinical status
  • Current hospitalization with primary reason of HF OR one of the following events within 1 year of screening: hospitalization with primary reason of HF; urgent visit to emergency department (ED) with primary reason of HF.
  • Elevated B-type natriuretic peptide (BNP) or n-terminal-prohormone brain natriuretic peptide (NT-proBNP)

Other Inclusion Criteria May apply

Key Exclusion Criteria:

  • Currently receiving treatment in another investigational device or drug study, or < 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
  • Malignancy within 5 years prior to randomization with the following exceptions: localized basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, stage 1 prostate carcinoma, breast ductal carcinoma in situ.
  • Subject has known sensitivity to any of the products or components to be administered during testing

Other Exclusion Criteria May apply

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Omecamtiv Mecarbil
Participants received oral omecamtiv mecarbil (OM) twice daily in addition to standard heart failure therapy. The starting dose of OM was 25 mg; At week 4, participants with week 2 OM predose plasma concentrations < 200 ng/mL had their dose increased to 50 mg BID; participants with week 2 predose plasma concentrations ≥ 200 and < 300 ng/mL had their dose increased to 37.5 mg BID and participants with week 2 predose plasma concentrations ≥ 300 ng/mL and < 1000 ng/mL maintained a 25 mg BID dosing regimen.
Omecamtiv mecarbil tablets for oral administration
Other Names:
  • AMG 423
Participants were required to be optimally managed with standard of care therapies for chronic HF (eg, beta blockers, renin angiotensin aldosterone system inhibitors), consistent with regional clinical practice guidelines, unless contraindicated.
Placebo Comparator: Placebo
Participants received matching placebo tablets twice a day in addition to standard heart failure therapy.
Matching placebo tablets
Participants were required to be optimally managed with standard of care therapies for chronic HF (eg, beta blockers, renin angiotensin aldosterone system inhibitors), consistent with regional clinical practice guidelines, unless contraindicated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Cardiovascular Death or First Heart Failure Event
Time Frame: From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.

The primary outcome was a composite of a heart-failure (HF) event or cardiovascular (CV) death, whichever occurred first, in a time-to-event analysis.

A heart-failure event was defined as an urgent clinic visit, emergency department visit, or hospitalization for subjectively and objectively worsening heart failure leading to treatment intensification beyond a change in oral diuretic therapy.

All deaths and HF events were adjudicated by an independent external clinical events committee (CEC) at the Duke Clinical Research Institute, using standardized definitions based on the recent American College of Cardiology/American Heart Association (ACC/AHA) standards for endpoint definitions in cardiovascular clinical trials.

Time to cardiovascular death or first HF event was analyzed using Kaplan-Meier (KM) methods. Since the median was not calculated, the percentage of participants with a positively adjudicated event during the study is reported.

From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Cardiovascular Death
Time Frame: From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.

Cardiovascular death includes acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, death due to cardiovascular (CV) procedures, death due to CV hemorrhage, and death due to other CV causes.

All deaths were adjudicated by an independent external clinical-events committee at the Duke Clinical Research Institute, using standardized definitions based on the recent ACC/AHA standards for endpoint definitions in cardiovascular clinical trials.

Time to cardiovascular death was analyzed using Kaplan-Meier methods. Since the median was not calculated, the percentage of participants with a positively adjudicated event during the study is reported.

From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.
Change From Baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ TSS) at Week 24
Time Frame: Baseline and Week 24

The Kansas City Cardiomyopathy Questionnaire is a self-administered questionnaire with a 2-week recall period that includes 23 items that map to 7 domains: symptom frequency; symptom burden; symptom stability; physical limitations; social limitations; quality of life; and self-efficacy (the patient's understanding of how to manage their heart failure). The symptom frequency and symptom burden domains are merged into a total symptom score. Scores are represented on a 0-to-100-point scale, where lower scores represent more frequent and severe symptoms and scores of 100 indicate no symptoms.

The change from baseline in KCCQ TSS was analyzed separately for each randomization setting (inpatient and outpatient).

Least squares means are from the mixed model which includes baseline total symptom score value, region, baseline eGFR, scheduled visit, treatment group and interaction of treatment with scheduled visit as covariates.

Baseline and Week 24
Time to First Heart Failure Hospitalization
Time Frame: From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.

A HF hospitalization is defined as an event that met all of the following criteria:

  1. The participant was admitted to the hospital with a primary diagnosis of HF;
  2. The length of stay in the hospital extended for at least 24 hours;
  3. The participant exhibited documented new or worsening symptoms due to HF on presentation;
  4. The participant had objective evidence of new or worsening HF;
  5. The participant received initiation or intensification of treatment specifically for HF, including an intravenous diuretic or vasoactive agent, mechanical or surgical intervention, or mechanical fluid removal.

Events were adjudicated by an independent external CEC at the Duke Clinical Research Institute using standardized definitions based on the ACC/AHA standards for endpoint definitions in CV clinical trials.

Time to first HF hospitalization was analyzed using KM methods. Since the median was not calculated, the percentage of participants with a positively adjudicated event is reported.

From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.
Time to All-cause Death
Time Frame: From randomization up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.

All events were adjudicated by an independent external clinical-events committee at the Duke Clinical Research Institute, using standardized definitions based on the recent ACC/AHA standards for endpoint definitions in cardiovascular clinical trials.

Time to all-cause death was analyzed using Kaplan-Meier methods. Since the median was not calculated, the percentage of participants with an event are reported. Events that occurred up to the earliest of last confirmed survival status date or analysis cut-off date (07 August 2020) are included.

From randomization up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

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)

January 6, 2017

Primary Completion (Actual)

September 14, 2020

Study Completion (Actual)

September 14, 2020

Study Registration Dates

First Submitted

September 30, 2016

First Submitted That Met QC Criteria

October 7, 2016

First Posted (Estimate)

October 11, 2016

Study Record Updates

Last Update Posted (Actual)

November 5, 2021

Last Update Submitted That Met QC Criteria

November 2, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20110203
  • 2016-002299-28 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

IPD Sharing Time Frame

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

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.

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