- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01215942
Um estudo aberto para participantes com artrite reumatoide
Um estudo aberto de fase 3b, multicêntrico para avaliar a segurança e a eficácia a longo prazo do LY2127399 em pacientes com artrite reumatoide (AR)
O objetivo principal deste estudo é ajudar a responder se o LY2127399 é seguro e eficaz durante o tratamento de longo prazo em participantes com artrite reumatóide.
Este estudo é composto por 2 períodos:
Período 1: Tratamento não cego por até 240 semanas para participantes que se inscreverem no Estudo H9B-MC-BCDO (BCDO) (NCT01202760) ou Estudo H9B-MC-BCDV (BCDV) (NCT01202773) ou até 168 semanas para participantes que se inscreverem no Estudo H9B-MC-BCDM (BCDM) (NCT01198002).
Período 2: acompanhamento pós-tratamento de 48 semanas
Visão geral do estudo
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
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Bad Doberan, Alemanha, 18209
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Bad Nauheim, Alemanha, 61231
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Baden-Baden, Alemanha, 76530
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Berlin, Alemanha, 14059
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Dresden, Alemanha, 01307
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Erlangen, Alemanha, 91054
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Frankfurt, Alemanha, 60590
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Göttingen, Alemanha, 37075
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Koeln, Alemanha, 50924
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Munich, Alemanha, 80639
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Buenos Aires, Argentina, C1280AEB
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Córdoba, Argentina, X5016KEH
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Lujan, Argentina, 6700
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Mar Del Plata, Argentina, B7600FZN
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Quilmes, Argentina, B1878DVC
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Rosario, Argentina, 2000
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San Juan, Argentina, 5400
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Tucuman, Argentina, 4000
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Malvern East, Austrália, 3145
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New South Wales
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Campbelltown, New South Wales, Austrália, 2560
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Kogarah, New South Wales, Austrália, 04266-010
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Queensland
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Herston, Queensland, Austrália, 4029
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Campinas, Brasil, 13059-000
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Caxias Do Sul, Brasil, 95070-560
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Curitiba, Brasil, 80060-240
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Fortaleza, Brasil, 60150-170
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Juiz De Fora, Brasil, 36010-570
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Rio De Janeiro, Brasil, 20551-030
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Setor Oeste/Goiania, Brasil, 74110-129
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São Paulo, Brasil, 05403-000
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Burgas, Bulgária, 8000
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Pleven, Bulgária, 5800
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Plovdiv, Bulgária, 4003
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Rousse, Bulgária, 7002
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Sevlievo, Bulgária, 5400
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Sofia, Bulgária, 1784
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Varna, Bulgária, 9000
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Bogota, Colômbia
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Medellin, Colômbia
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Opatija, Croácia, 51410
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Osijek, Croácia, 31000
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Rijeka, Croácia, HR-51000
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Bratislava, Eslováquia, 84231
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Dunajska Streda, Eslováquia, 929 01
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Piestany, Eslováquia, 921 12
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Barcelona, Espanha, 08034
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bilboa, Espanha, 48013
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La Coruña, Espanha, 15006
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Madrid, Espanha, 28046
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San Sebastian, Espanha, 20014
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Alabama
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Birmingham, Alabama, Estados Unidos, 35216
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Huntsville, Alabama, Estados Unidos, 35810
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Arizona
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Peoria, Arizona, Estados Unidos, 85381
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Phoenix, Arizona, Estados Unidos, 85032
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Scottsdale, Arizona, Estados Unidos, 85251
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Tucson, Arizona, Estados Unidos, 85704
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Arkansas
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Hot Springs, Arkansas, Estados Unidos, 71913
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Jonesboro, Arkansas, Estados Unidos, 72401
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Little Rock, Arkansas, Estados Unidos, 72205
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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California
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Escondido, California, Estados Unidos, 92027
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Fresno, California, Estados Unidos, 93720
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Hemet, California, Estados Unidos, 92543
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Huntington Beach, California, Estados Unidos, 92646
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La Jolla, California, Estados Unidos, 92037
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La Mesa, California, Estados Unidos, 91942
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Loma Linda, California, Estados Unidos, 92354
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Long Beach, California, Estados Unidos, 90808
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Los Angeles, California, Estados Unidos, 90022
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Sacramento, California, Estados Unidos, 95825
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San Diego, California, Estados Unidos, 92108
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Santa Monica, California, Estados Unidos, 90404
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Torrance, California, Estados Unidos, 90505
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tustin, California, Estados Unidos, 92780
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Upland, California, Estados Unidos, 91786
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wildomar, California, Estados Unidos, 92595
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Colorado
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Colorado Springs, Colorado, Estados Unidos, 80910
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Denver, Colorado, Estados Unidos, 80209
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Delaware
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Lewes, Delaware, Estados Unidos, 19958
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Florida
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Aventura, Florida, Estados Unidos, 33180
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Boca Raton, Florida, Estados Unidos, 33486
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Boynton Beach, Florida, Estados Unidos, 33472
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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DeBary, Florida, Estados Unidos, 32713
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Miami, Florida, Estados Unidos, 33173
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New Port Richey, Florida, Estados Unidos, 34652
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Palm Harbor, Florida, Estados Unidos, 34684
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pinellas Park, Florida, Estados Unidos, 33781
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Saint Petersburg, Florida, Estados Unidos, 33716
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tamarac, Florida, Estados Unidos, 33321
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tampa, Florida, Estados Unidos, 33609
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Venice, Florida, Estados Unidos, 34292
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Vero Beach, Florida, Estados Unidos, 32960
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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West Palm Beach, Florida, Estados Unidos, 33401
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Zephyrhills, Florida, Estados Unidos, 33542
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Georgia
-
Atlanta, Georgia, Estados Unidos, 30342
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Decatur, Georgia, Estados Unidos, 30033
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Dunwoody, Georgia, Estados Unidos, 30338
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Gainesville, Georgia, Estados Unidos, 30501
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lawrenceville, Georgia, Estados Unidos, 30045
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Marietta, Georgia, Estados Unidos, 30060
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Savannah, Georgia, Estados Unidos, 31405
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Stockbridge, Georgia, Estados Unidos, 30281
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Idaho
-
Eagle, Idaho, Estados Unidos, 83616
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Idaho Falls, Idaho, Estados Unidos, 83404
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Illinois
-
Morton Grove, Illinois, Estados Unidos, 60053
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Peoria, Illinois, Estados Unidos, 61636
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Rockford, Illinois, Estados Unidos, 61103
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Indiana
-
Brownsburg, Indiana, Estados Unidos, 46112
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Evansville, Indiana, Estados Unidos, 47714
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Indianapolis, Indiana, Estados Unidos, 46227
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Kansas
-
Kansas City, Kansas, Estados Unidos, 66160
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Shawnee Mission, Kansas, Estados Unidos, 66218
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Wichita, Kansas, Estados Unidos, 67208
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Kentucky
-
Bowling Green, Kentucky, Estados Unidos, 42101
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Owensboro, Kentucky, Estados Unidos, 42303
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Louisiana
-
Monroe, Louisiana, Estados Unidos, 71203
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Maryland
-
Cumberland, Maryland, Estados Unidos, 21502
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Wheaton, Maryland, Estados Unidos, 20902
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Massachusetts
-
Haverhill, Massachusetts, Estados Unidos, 01830
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Worcester, Massachusetts, Estados Unidos, 01605
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Michigan
-
Bingham Farms, Michigan, Estados Unidos, 48025
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Saint Clair Shores, Michigan, Estados Unidos, 48081
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Mississippi
-
Flowood, Mississippi, Estados Unidos, 39232
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Jackson, Mississippi, Estados Unidos, 39202
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Missouri
-
Florissant, Missouri, Estados Unidos, 63031
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Saint Louis, Missouri, Estados Unidos, 63131
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Montana
-
Kalispell, Montana, Estados Unidos, 59901
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Nebraska
-
Lincoln, Nebraska, Estados Unidos, 68516
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Omaha, Nebraska, Estados Unidos, 68134
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nevada
-
Las Vegas, Nevada, Estados Unidos, 89128
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New Hampshire
-
Nashua, New Hampshire, Estados Unidos, 03060
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New Jersey
-
Berkeley Heights, New Jersey, Estados Unidos, 07922
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Clifton, New Jersey, Estados Unidos, 07012
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New Mexico
-
Albuquerque, New Mexico, Estados Unidos, 87108
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New York
-
Brooklyn, New York, Estados Unidos, 11201
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-
Roslyn, New York, Estados Unidos, 11576
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Syracuse, New York, Estados Unidos, 13210
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
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North Carolina
-
Charlotte, North Carolina, Estados Unidos, 28210
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Hickory, North Carolina, Estados Unidos, 28601
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Raleigh, North Carolina, Estados Unidos, 27609
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Sanford, North Carolina, Estados Unidos, 27330
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
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North Dakota
-
Bismarck, North Dakota, Estados Unidos, 58502
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ohio
-
Cincinnati, Ohio, Estados Unidos, 45242
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
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Oklahoma
-
Oklahoma City, Oklahoma, Estados Unidos, 73104
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Tulsa, Oklahoma, Estados Unidos, 74135
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
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Oregon
-
Bend, Oregon, Estados Unidos, 97701
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pennsylvania
-
Bethlehem, Pennsylvania, Estados Unidos, 18017
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Erie, Pennsylvania, Estados Unidos, 16508
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Limerick, Pennsylvania, Estados Unidos, 19468
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Philadelphia, Pennsylvania, Estados Unidos, 19152
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Pottstown, Pennsylvania, Estados Unidos, 19464
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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South Carolina
-
Columbia, South Carolina, Estados Unidos, 29204
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Greenville, South Carolina, Estados Unidos, 29601
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Greer, South Carolina, Estados Unidos, 29650
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Myrtle Beach, South Carolina, Estados Unidos, 29572
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
North Charleston, South Carolina, Estados Unidos, 29406
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Taylors, South Carolina, Estados Unidos, 29687
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tennessee
-
Knoxville, Tennessee, Estados Unidos, 37909
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Memphis, Tennessee, Estados Unidos, 38119
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Nashville, Tennessee, Estados Unidos, 37205
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
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Texas
-
Austin, Texas, Estados Unidos, 78731
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Dallas, Texas, Estados Unidos, 75231
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Houston, Texas, Estados Unidos, 77090
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-
Lake Jackson, Texas, Estados Unidos, 77566
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-
Lubbock, Texas, Estados Unidos, 79424
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-
Mesquite, Texas, Estados Unidos, 75150
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nassau Bay, Texas, Estados Unidos, 77058
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-
North Richland Hills, Texas, Estados Unidos, 76180
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
San Antonio, Texas, Estados Unidos, 78217
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Sugar Land, Texas, Estados Unidos, 77478
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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-
Vermont
-
Burlington, Vermont, Estados Unidos, 05401
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Virginia
-
Richmond, Virginia, Estados Unidos, 23225
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
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Washington
-
Spokane, Washington, Estados Unidos, 99204
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Tacoma, Washington, Estados Unidos, 98405
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Wenatchee, Washington, Estados Unidos, 98801
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
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West Virginia
-
Clarksburg, West Virginia, Estados Unidos, 26301
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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-
Wisconsin
-
Milwaukee, Wisconsin, Estados Unidos, 53226
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Racine, Wisconsin, Estados Unidos, 53406
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Barnaul, Federação Russa, 656038
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Kazan, Federação Russa, 420029
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kemerovo, Federação Russa, 650066
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Khanty-Mansiysk, Federação Russa, 628012
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Kursk, Federação Russa, 305007
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Moscow, Federação Russa, 125299
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Nizhny Novgorod, Federação Russa, 603005
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Novosibirsk, Federação Russa, 630047
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Petrozavodsk, Federação Russa, 185019
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Ryazan, Federação Russa, 390026
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Saint Petersburg, Federação Russa, 197022
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Saratov, Federação Russa, 410002
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Stavropol, Federação Russa, 355017
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Voronezh, Federação Russa, 394066
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Yaroslavl, Federação Russa, 150062
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Montpellier, França, 34295
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Nice, França, 06202
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Orleans, França, 45000
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Paris, França, 75022
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Saint-Etienne Cedex 02, França, 42055
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Strasbourg, França, 67 098
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Toulouse, França, 31059
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Haidari/Athens, Grécia, 12462
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Heraklion, Grécia, 71110
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Larissa, Grécia, 411 10
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Thessaloniki, Grécia, 54636
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Baja, Hungria, 6500
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Balassagyarmat, Hungria, 2660
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Budapest, Hungria, 1062
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Debrecen, Hungria, 4032
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Esztergom, Hungria, 2500
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Kiskunhalas, Hungria, 6400
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Nyiregyhaza, Hungria, 4400
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Satoraljaujhely, Hungria, 3980
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Szikszo, Hungria, 3800
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Veszprem, Hungria, 8200
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Aichi, Japão, 460-0001
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Chiba, Japão, 260-8712
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Fukuoka, Japão, 807-8555
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Gunma, Japão, 370-0053
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hokkaido, Japão, 063-0811
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hyogo, Japão, 650-0017
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Ibaragi, Japão, 316-0035
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Ibaraki, Japão, 305-8576
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Japan, Japão, 275-0006
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Kagoshima, Japão, 891-0133
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kanagawa, Japão, 252-0392
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kumamoto, Japão, 861-8520
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Mie, Japão, 514-1101
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Miyagi, Japão, 982-0032
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Miyazaki, Japão, 880-0122
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nagano, Japão, 380-8582
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nagasaki, Japão, 857-1195
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nara, Japão, 634-0007
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Ohita, Japão, 874-0011
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Okayama, Japão, 710-0016
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Osaka, Japão, 586-8521
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Saga, Japão, 843-0393
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Saitama, Japão, 337-0012
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Sapporo-Shi, Japão, 060-8648
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Shizuoka, Japão, 420-8623
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tokushima, Japão, 770-8503
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tokyo, Japão, 113-0034
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Toyama, Japão, 933-0874
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Alytus, Lituânia, 62114
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kaunas, Lituânia, 49475
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Klaipedos, Lituânia, 92288
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Siauliai, Lituânia, 73231
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Vilnius, Lituânia, LT-08661
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Batu Caves, Malásia, 68100
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kota Bahru, Malásia, 15586
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kuantan Pahang, Malásia, 25100
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Perak, Malásia, 30990
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Putrajaya, Malásia, 62250
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Sarawak, Malásia, 93586
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Aguascalientes, México, 20000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Barrio San Mateo, México, 52140
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Chihuahua, México, 31000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Guadalajara, México, 44690
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Mexicali, México, 21100
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Mexico City, México, 03720
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Monterrey, México, 64460
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Morelia, México, 58070
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Queretaro, México, 76000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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San Luis Potosi, México, 78200
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tijuana, México, 22010
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Hamilton, Nova Zelândia, 3204
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Rotorua, Nova Zelândia, 3010
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tauranga, Nova Zelândia, 3140
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Timaru, Nova Zelândia
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bydgoszcz, Polônia, 85-168
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Dzialdowo, Polônia, 13-200
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Elblag, Polônia, 82-300
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Gdynia, Polônia, 81-384
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Krakow, Polônia, 30-510
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lublin, Polônia, 20-607
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Plock, Polônia, 09-400
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Torun, Polônia, 87-100
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Warsaw, Polônia, 01-192
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Wloszczowa, Polônia, 29-100
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Busan, Republica da Coréia, 602-715
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Daegu, Republica da Coréia, 700-721
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Daejeon, Republica da Coréia, 301-721
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Incheon, Republica da Coréia, 400-711
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Seongnam-Si, Republica da Coréia, 463-707
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Seoul, Republica da Coréia, 143-729
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Suwon-City, Republica da Coréia, 442-721
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Brasov, Romênia, 500365
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Cluj-Napoca, Romênia, 400130
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Iasi, Romênia, 700656
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Ploiesti, Romênia, 100337
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Colombo, Sri Lanka
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Galle, Sri Lanka
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Kalubowila, Sri Lanka
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Nugegoda, Sri Lanka
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Keelung, Taiwan, 204
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Kuei Shan Hsiang, Taiwan, 33305
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Niao Sung Hsiang, Taiwan, 833
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Taichung, Taiwan, 40705
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Taipei, Taiwan, 112
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Dnipropetrovsk, Ucrânia, 49008
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Donetsk, Ucrânia, 83114
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Kharkiv, Ucrânia, 61178
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Kiev, Ucrânia, 04114
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Kyiv, Ucrânia, 03151
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Odesa, Ucrânia, 65026
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Poltava, Ucrânia, 36038
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Simferopol, Ucrânia, 95017
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Vinnitsa, Ucrânia, 21000
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Vinnytsya, Ucrânia, 21018
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Benoni, África do Sul, 1500
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Bloemfontein, África do Sul, 9301
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Breyten, África do Sul, 2330
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Cape Town, África do Sul, 7925
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Durban, África do Sul, 4092
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Limpopo, África do Sul, 0380
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Pretoria, África do Sul, 0184
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Somerset West, África do Sul, 7130
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Stellenbosch, África do Sul, 7600
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Ahmedabad, Índia, 3800015
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Bangalore, Índia, 5600092
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Chennai, Índia, 600100
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Hyderabaad, Índia, 500082
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Jaipur, Índia, 302023
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Lucknow, Índia, 226 014
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Mysore, Índia, 570023
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Nellore, Índia, 524003
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New Delhi, Índia, 110 076
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Secunderabad, Índia, 500 003
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Surat, Índia, 395003
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Critério de inclusão:
- Ter completado 24 semanas de participação no Estudo H9B-MC-BCDO ou Estudo H9B-MC-BCDV, ou ter completado 100 semanas de participação no Estudo H9B-MC-BCDM
- A mulher não deve estar grávida, amamentando ou engravidar durante o estudo
Critério de exclusão:
- Presença atual de um distúrbio ou doença grave
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: 120 miligramas (mg) de LY2127399
Dado a cada 4 semanas por 240 semanas para os participantes do Estudo BCDO ou Estudo BCDV. Os participantes que receberam placebo imediatamente antes da inscrição receberão uma dose de carga de 240 mg ao iniciar o tratamento. Ou Dado a cada 4 semanas durante 168 semanas para os participantes do Estudo BCDM. |
Administrado por via subcutânea
Outros nomes:
|
Experimental: 90 mg LY2127399
Dado a cada 2 semanas durante 240 semanas para os participantes do Estudo BCDO ou Estudo BCDV. Os participantes que receberam placebo imediatamente antes da inscrição receberão uma dose de ataque de 180 mg ao iniciar o tratamento. Ou Dado a cada 2 semanas durante 168 semanas para os participantes do Estudo BCDM. |
Administrado por via subcutânea
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Número de participantes que tiveram eventos adversos emergentes do tratamento (TEAEs), eventos adversos graves (SAEs) e eventos adversos de interesse especial (AESI) durante o período de tratamento
Prazo: até 84,4 semanas durante o período de tratamento
|
Um TEAE foi definido como um evento que ocorreu pela primeira vez ou piorou em gravidade na data ou após a primeira injeção e antes do término do estudo.
AESI são infecção, reações no local da injeção, malignidade, eventos cardiovasculares adversos maiores (MACE), alergia e hipersensibilidade, depressão, suicídio/automutilação e gravidez.
MACE foram definidos como 1 dos eventos adjudicados: morte cardiovascular, infarto do miocárdio (IM), acidente vascular cerebral, hospitalização por angina instável, hospitalização por insuficiência cardíaca, procedimento de revascularização coronária, procedimento de revascularização periférica, choque cardiogênico devido a infarto do miocárdio, morte súbita ressuscitada, grave arritmia, hospitalização por hipertensão, evento arterial periférico.
Um resumo de EAGs e outros EAs não graves, independentemente da causalidade, está localizado no módulo de Eventos Adversos Relatados.
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até 84,4 semanas durante o período de tratamento
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Porcentagem de participantes que desenvolveram anticorpos anti-LY2127399
Prazo: Linha de base até as semanas 4, 24, 48 e 72
|
Os participantes com anticorpos anti-LY2127399 emergentes do tratamento eram participantes que tinham quaisquer amostras da linha de base até e até a Semana 72 que era um aumento de 4 vezes (aumento de 2 diluições) no título de imunogenicidade em relação ao título da linha de base, ou participantes que testaram negativo na linha de base e positivo pós-basal (no título de ≥1:20).
A linha de base é definida como a última observação não omissa na data ou antes da primeira injeção de LY2127399 em estudos anteriores ou no Estudo BCDP.
Porcentagem de participantes com anticorpos anti-LY2127399=(número de participantes com anticorpos anti-LY2127399 emergentes do tratamento / número de participantes avaliados)*100.
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Linha de base até as semanas 4, 24, 48 e 72
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Mudança da linha de base em contagens absolutas de células B
Prazo: Linha de base, Semana 48
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A designação de agrupamento de marcadores de superfície celular (CD) 3 negativo, CD20 positivo (CD3-CD20+) define o total de células B maduras.
O antígeno do linfócito B CD20 é uma fosfoproteína glicosilada ativada expressa na superfície de todas as células B maduras.
A contagem de células B da linha de base é a média dos valores na data ou antes da data da primeira injeção do tratamento do estudo em estudos anteriores, incluindo visitas não agendadas.
Uma mudança positiva ou negativa indicou um aumento ou diminuição, respectivamente, na contagem de células B.
|
Linha de base, Semana 48
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Alteração da linha de base nos níveis séricos de imunoglobulina (Ig)
Prazo: Linha de base, Semana 48
|
Imunoglobulinas (Ig), ou anticorpos, são grandes proteínas usadas pelo sistema imunológico para identificar e neutralizar partículas estranhas, como bactérias e vírus.
Seus níveis sanguíneos normais indicam um estado imunológico adequado.
Alterações dos níveis séricos basais de imunoglobulina A (IgA), imunoglobulina G (IgG) e imunoglobulina M (IgM) são relatadas.
Uma alteração negativa indicou uma diminuição nos níveis de Ig.
A linha de base é definida como a última observação não omissa na data ou antes da primeira injeção de LY2127399 em estudos anteriores ou no Estudo BCDP.
|
Linha de base, Semana 48
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Porcentagem de participantes com resposta de 20% do American College of Rheumatology (ACR20)
Prazo: Linha de base até as semanas 12, 24 e 48
|
O ACR Responder Index é um composto de medidas clínicas, laboratoriais e funcionais da artrite reumatoide (AR).
Respondedores ACR20: tiveram melhora ≥20% desde o início em ambas as contagens de 68 articulações dolorosas e 66 inchadas e melhora ≥20% em pelo menos 3 de 5 critérios: avaliação global do participante e do médico da atividade da doença, Questionário de Avaliação de Saúde-Índice de Incapacidade (HAQ- DI) (que mediu o grau percebido de dificuldade dos participantes em realizar atividades diárias), dor nas articulações e proteína C-reativa (PCR).
A linha de base é definida como a última observação não omissa na data ou antes da primeira injeção de LY2127399 em estudos anteriores ou no Estudo BCDP.
Porcentagem de participantes que atingiram a resposta ACR20 = (número de respondedores ACR20 / número de participantes tratados) * 100.
Todos os participantes que interromperam o tratamento do estudo por qualquer motivo foram definidos como NR naquele momento e daqui para frente.
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Linha de base até as semanas 12, 24 e 48
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Mudança da linha de base na pontuação da atividade da doença com base na contagem de 28 articulações e nível de proteína C-reativa (DAS28-CRP)
Prazo: Linha de base, 240 semanas
|
Linha de base, 240 semanas
|
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Porcentagem de participantes com resposta da Liga Europeia contra o Reumatismo (EULAR-28) baseada em DAS28
Prazo: Linha de base até 240 semanas
|
Linha de base até 240 semanas
|
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Mudança da linha de base no estudo de resultados médicos 36 itens do formulário curto (SF-36) Pontuações de domínio de pesquisa de saúde e pontuações resumidas
Prazo: Linha de base, 240 semanas
|
Linha de base, 240 semanas
|
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Alteração da linha de base na contagem de juntas de concurso (68 contagens de juntas)
Prazo: Linha de base, 240 semanas
|
Linha de base, 240 semanas
|
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Mudança da linha de base na contagem de articulações inchadas (contagem de 66 articulações)
Prazo: Linha de base, 240 semanas
|
Linha de base, 240 semanas
|
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Mudança da linha de base na avaliação da dor do participante [Escala Visual Analógica (VAS)]
Prazo: Linha de base, 240 semanas
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Linha de base, 240 semanas
|
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Mudança da linha de base na avaliação global da atividade da doença (VAS) dos participantes
Prazo: Linha de base, 240 semanas
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Linha de base, 240 semanas
|
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Mudança da linha de base na avaliação global da atividade da doença (VAS) pelos médicos
Prazo: Linha de base, 240 semanas
|
Linha de base, 240 semanas
|
|
Alteração da linha de base no Questionário de Avaliação de Saúde-Índice de Incapacidade (HAQ-DI)
Prazo: Linha de base, 240 semanas
|
Linha de base, 240 semanas
|
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Mudança da linha de base em CRP
Prazo: Linha de base, 240 semanas
|
Linha de base, 240 semanas
|
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Melhoria Percentual do Colégio Americano de Reumatologia (ACR-N)
Prazo: Linha de base até 240 semanas
|
Linha de base até 240 semanas
|
Outras medidas de resultado
Medida de resultado |
Prazo |
---|---|
Número de participantes que morreram durante o período de tratamento e período de acompanhamento pós-tratamento
Prazo: Até 84,4 semanas durante o período de tratamento e descontinuação do tratamento do estudo até 48 semanas durante o período de acompanhamento
|
Até 84,4 semanas durante o período de tratamento e descontinuação do tratamento do estudo até 48 semanas durante o período de acompanhamento
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UCT/GMT - 5 hours, EST), Eli Lilly and Company
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 13419 (Company internal)
- H9B-MC-BCDP (Outro identificador: Eli Lilly and Company)
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