Evaluering av kardiovaskulære utfall hos pasienter med type 2-diabetes etter akutt koronarsyndrom under behandling med AVE0010 (Lixisenatid) (ELIXA)
31. oktober 2016 oppdatert av: Sanofi
En randomisert, dobbeltblind, placebokontrollert, parallellgruppe, multisenterstudie for å evaluere kardiovaskulære utfall under behandling med Lixisenatid hos type 2 diabetespasienter etter et akutt koronarsyndrom
Hovedmål:
- Å demonstrere at lixisenatid kan redusere kardiovaskulær (CV) morbiditet og dødelighet (sammensatt endepunkt av CV-død, ikke-dødelig hjerteinfarkt (MI), ikke-dødelig hjerneslag, sykehusinnleggelse for ustabil angina) sammenlignet med placebo hos type 2-diabetikere som nylig opplevd en akutt koronar syndrom (ACS) hendelse.
Sekundære mål:
For å demonstrere at sammenlignet med placebo, kan lixisenatid redusere:
- sammensatt endepunkt av CV-død, ikke-dødelig MI, ikke-dødelig hjerneslag, sykehusinnleggelse for ustabil angina eller sykehusinnleggelse for hjertesvikt.
- sammensatt endepunkt av CV-død, ikke-dødelig MI, ikke-dødelig hjerneslag, sykehusinnleggelse for ustabil angina, sykehusinnleggelse for hjertesvikt eller koronar revaskulariseringsprosedyre.
- utskillelse av albumin i urin (basert på forholdet mellom albumin og kreatinin i urinen).
For å vurdere sikkerheten og toleransen til lixisenatid.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Den estimerte maksimale studievarigheten for den første randomiserte deltakeren var omtrent 204 uker (± 14 dager), med en median oppfølging over alle deltakerne på omtrent 91 uker, fordelt som følger:
- placebo-innkjøringsperiode: 7 dager (+ 3 dager)
- dobbeltblind studiebehandlingsperiode: 203 uker (± 14 dager) (med omtrent 37 måneders rekrutteringsperiode)
- oppfølgingsperiode etter behandling: 3 dager (± 1 dag)
Alle deltakerne ble fulgt fra randomisering til slutten av studien, som skulle skje når den siste randomiserte deltakeren hadde blitt fulgt i omtrent 10 måneder. Den faktiske sluttdatoen for studien var "hendelsesdrevet" og studiens slutt da det var omtrent 844 positivt bedømte primære kardiovaskulære utfallshendelser.
Studietype
Intervensjonell
Registrering (Faktiske)
6068
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Adrogue, Argentina, B1846DSK
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Bahia Blanca, Argentina, B8000AKK
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Bahia Blanca, Argentina, B8000FTD
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Bahia Blanca, Argentina, B8001HXM
- Investigational Site Number 032054
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Caba, Argentina, 1120
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Caba, Argentina, 1440
- Investigational Site Number 032049
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Caba, Argentina, C1181ACL
- Investigational Site Number 032056
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Caba, Argentina, C1425AGC
- Investigational Site Number 032003
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Capital Federal, Argentina, C1056ABJ
- Investigational Site Number 032017
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Capital Federal, Argentina, C1179AAB
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Cipolletti, Argentina, 8324
- Investigational Site Number 032050
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Ciudad Autonoma De Bs.As, Argentina, 1428
- Investigational Site Number 032052
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Cordoba, Argentina, X50009BSN
- Investigational Site Number 032011
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Cordoba, Argentina, X5000AAW
- Investigational Site Number 032022
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Cordoba, Argentina, X5000AAX
- Investigational Site Number 032037
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Coronel Suarez, Argentina, B7540GHD
- Investigational Site Number 032020
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Corrientes, Argentina, 3400
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Corrientes, Argentina, W3410AVV
- Investigational Site Number 032018
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Córdoba, Argentina, 5000
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Godoy Cruz, Argentina, M5501ARP
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Haedo, Argentina, 1706
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Junin, Argentina, B6000BHA
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La Plata, Argentina, 1900
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Lanus, Argentina, 1824
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Mar Del Plata, Argentina, B7600
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Mar Del Plata, Argentina, C7600CBM
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Mendoza, Argentina, 5500
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Moron, Argentina, 1708
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Parana, Argentina, E3100BBJ
- Investigational Site Number 032002
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Qilmes, Argentina, b1878dkf
- Investigational Site Number 032023
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Rafaela, Argentina, S2300MMA
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Ramos Mejia, Argentina, 1704
- Investigational Site Number 032024
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Resistencia, Argentina, H3500CDM
- Investigational Site Number 032006
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Rosario, Argentina, 2000CVD
- Investigational Site Number 032012
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Rosario, Argentina, S2000DSR
- Investigational Site Number 032027
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Salta, Argentina, 4400
- Investigational Site Number 032055
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Salta, Argentina, 4400
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San Miguel De Tucuman, Argentina, 4000
- Investigational Site Number 032051
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San Miguel De Tucuman, Argentina, T4000ICL
- Investigational Site Number 032008
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San Nicolas, Argentina, B2900DMH
- Investigational Site Number 032033
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Santa Fe, Argentina, S3000AZG
- Investigational Site Number 032045
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Santa Fe, Argentina, S3000FWO
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Santa Rosa, Argentina, L6300DSD
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Venado Tuerto, Argentina, S2600KUE
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Villa Maria, Argentina, X5900JKA
- Investigational Site Number 032046
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Zarate, Argentina, B2800DGH
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Epping, Australia, 3076
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Fremantle, Australia, 6160
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Geelong, Australia, 3220
- Investigational Site Number 036009
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Perth, Australia, 6000
- Investigational Site Number 036011
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St Leonards, Australia, 2065
- Investigational Site Number 036005
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Townsville, Australia, 4810
- Investigational Site Number 036016
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Bruxelles, Belgia, 1200
- Investigational Site Number 056001
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Leuven, Belgia, 3000
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Belem, Brasil, 66087-660
- Investigational Site Number 076024
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Belo Horizonte, Brasil, 30150-221
- Investigational Site Number 076006
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Belo Horizonte, Brasil, 30150-221
- Investigational Site Number 076012
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Brasilia, Brasil, 70310-500
- Investigational Site Number 076021
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Campinas, Brasil, 13015-001
- Investigational Site Number 076002
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Curitiba, Brasil, 80730-150
- Investigational Site Number 076019
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Fortaleza, Brasil, 60430-370
- Investigational Site Number 076004
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Fortaleza, Brasil, 60115-282
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Fortaleza, Brasil, 60170-320
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Goiania, Brasil, 74823470
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Marilia, Brasil, 17515-240
- Investigational Site Number 076014
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Passo Fundo, Brasil, 99010-180
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Porto Alegre, Brasil, 90020-090
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Porto Alegre, Brasil, 90035-001
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Porto Alegre, Brasil, 90620-001
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Recife, Brasil, 52051-380
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Salvador, Brasil, 40050-410
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Sao Paulo, Brasil, 01323-001
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Sao Paulo, Brasil, 04012-180
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Sao Paulo, Brasil, 04024-002
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Sao Paulo, Brasil, 05403-000
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Uberlandia, Brasil, 38400-368
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Byala, Bulgaria, 7100
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Gabrovo, Bulgaria, 5300
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Kazanluk, Bulgaria, 6100
- Investigational Site Number 100001
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Lovech, Bulgaria, 5500
- Investigational Site Number 100006
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Pleven, Bulgaria, 5800
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Plovdiv, Bulgaria, 4002
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Plovdiv, Bulgaria, 4002
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Sandanski, Bulgaria, 2800
- Investigational Site Number 100016
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Sofia, Bulgaria, 1606
- Investigational Site Number 100010
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Sofia, Bulgaria, 1618
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Varna, Bulgaria, 9000
- Investigational Site Number 100005
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Calgary, Canada, T2N 4N1
- Investigational Site Number 124024
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Cambridge, Canada, N1R 7Z6
- Investigational Site Number 124016
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Edmonton, Canada, T6G 2B7
- Investigational Site Number 124026
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Laval, Canada, H7T 2P5
- Investigational Site Number 124001
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Montreal, Canada, H1T 1C8
- Investigational Site Number 124021
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Montreal, Canada, H3Z 1E5
- Investigational Site Number 124006
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Oshawa, Canada, L1J 2J9
- Investigational Site Number 124027
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Quebec, Canada, G1V 4G5
- Investigational Site Number 124025
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Red Deer, Canada, T4N 6V7
- Investigational Site Number 124028
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Sarnia, Canada, N7T 4R9
- Investigational Site Number 124007
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St-Marc-Des-Carrieres, Canada, G0A 4B0
- Investigational Site Number 124003
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Sudbury, Canada, P3C 5K7
- Investigational Site Number 124005
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Thetford Mines, Canada, G6G 2V4
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Antofagasta, Chile, 1270001
- Investigational Site Number 152024
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Concepcion, Chile, 4070038
- Investigational Site Number 152023
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Osorno, Chile, 5311092
- Investigational Site Number 152041
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Puerto Montt, Chile, 5480000
- Investigational Site Number 152040
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Punta Arenas, Chile, 6210005
- Investigational Site Number 152038
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San Felipe, Chile, 2172972
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Santiago, Chile, 7500710
- Investigational Site Number 152001
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Santiago, Chile, 7650018
- Investigational Site Number 152019
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Santiago, Chile, 285-1950
- Investigational Site Number 152035
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Santiago, Chile, 7500010
- Investigational Site Number 152020
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Santiago, Chile, 7500503
- Investigational Site Number 152028
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Santiago, Chile, 7500520
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Santiago, Chile, 7500710
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Santiago, Chile, 7591047
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Santiago, Chile, 7591047
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Santiago, Chile, 7980378
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Santiago, Chile, 80004005
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Santiago, Chile, 8053095
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Santiago, Chile, 8350595
- Investigational Site Number 152004
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Santiago, Chile, 838-0456
- Investigational Site Number 152029
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Santiago, Chile, 8380456
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Santiago, Chile, 890-0085
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Talca, Chile, 9999
- Investigational Site Number 152025
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Temuco, Chile, 4813299
- Investigational Site Number 152003
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Temuco, Chile, 4781173
- Investigational Site Number 152014
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Valdivia, Chile, 5090146
- Investigational Site Number 152037
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Valparaíso, Chile, 234-0207
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Vina Del Mar, Chile
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Viña Del Mar, Chile, 2570017
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Armenia, Colombia
- Investigational Site Number 170025
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Barranquilla, Colombia
- Investigational Site Number 170009
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Barranquilla, Colombia
- Investigational Site Number 170010
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Bogota, Colombia
- Investigational Site Number 170012
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Bogota, Colombia
- Investigational Site Number 170005
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Bogota, Colombia
- Investigational Site Number 170002
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Bogota, Colombia
- Investigational Site Number 170014
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Bogota, Colombia
- Investigational Site Number 170022
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Bucaramanga, Colombia
- Investigational Site Number 170004
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Cali, Colombia
- Investigational Site Number 170017
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Cali, Colombia
- Investigational Site Number 170024
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Cartagena, Colombia
- Investigational Site Number 170013
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Espinal - Tolima, Colombia
- Investigational Site Number 170026
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Floridablanca, Colombia
- Investigational Site Number 170007
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Floridablanca, Colombia
- Investigational Site Number 170008
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Manizales, Colombia
- Investigational Site Number 170019
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Medellin, Colombia
- Investigational Site Number 170003
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Medellin, Colombia
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Pereira, Colombia
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Aarhus, Danmark, 8000
- Investigational Site Number 208003
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Aarhus C, Danmark, 8000
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Esbjerg, Danmark, 6700
- Investigational Site Number 208011
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Farsø, Danmark, 9640
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Hellerup, Danmark, 2900
- Investigational Site Number 208002
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Herlev, Danmark, 2730
- Investigational Site Number 208010
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Hillerød, Danmark, 3400
- Investigational Site Number 208008
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Hvidovre, Danmark, 2650
- Investigational Site Number 208006
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København Nv, Danmark, 2400
- Investigational Site Number 208001
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København S, Danmark, 2300
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København Ø, Danmark, 2100
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Abu Dhabi, De forente arabiske emirater, 51900
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Dubai, De forente arabiske emirater, 4545
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Barnaul, Den russiske føderasjonen, 656055
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Kazan, Den russiske føderasjonen, 420012
- Investigational Site Number 643044
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Kemerovo, Den russiske føderasjonen, 650002
- Investigational Site Number 643005
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Kemerovo, Den russiske føderasjonen, 650002
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Krasnodar, Den russiske føderasjonen, 350063
- Investigational Site Number 643061
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Krasnodar, Den russiske føderasjonen, 350086
- Investigational Site Number 643027
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Moscow, Den russiske føderasjonen, 101990
- Investigational Site Number 643037
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Moscow, Den russiske føderasjonen, 101990
- Investigational Site Number 643038
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Moscow, Den russiske føderasjonen, 105066
- Investigational Site Number 643002
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Moscow, Den russiske føderasjonen, 117036
- Investigational Site Number 643043
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Moscow, Den russiske føderasjonen, 117292
- Investigational Site Number 643008
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Moscow, Den russiske føderasjonen, 117292
- Investigational Site Number 643009
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Moscow, Den russiske føderasjonen, 117556
- Investigational Site Number 643029
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Moscow, Den russiske føderasjonen, 119048
- Investigational Site Number 643018
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Moscow, Den russiske føderasjonen, 119435
- Investigational Site Number 643042
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Moscow, Den russiske føderasjonen, 121309
- Investigational Site Number 643052
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Moscow, Den russiske føderasjonen, 121374
- Investigational Site Number 643026
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Moscow, Den russiske føderasjonen, 121552
- Investigational Site Number 643003
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Moscow, Den russiske føderasjonen, 125284
- Investigational Site Number 643051
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Moscow, Den russiske føderasjonen, 127018
- Investigational Site Number 643013
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Moscow, Den russiske føderasjonen, 127473
- Investigational Site Number 643001
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Moscow, Den russiske føderasjonen, 127644
- Investigational Site Number 643060
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Moscow, Den russiske føderasjonen, 129327
- Investigational Site Number 643040
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Nizhny Novgorod, Den russiske føderasjonen, 603003
- Investigational Site Number 643034
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Novosibirsk, Den russiske føderasjonen, 630047
- Investigational Site Number 643054
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Novosibirsk, Den russiske føderasjonen, 630075
- Investigational Site Number 643055
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Omsk, Den russiske føderasjonen, 644043
- Investigational Site Number 643045
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Penza, Den russiske føderasjonen, 440026
- Investigational Site Number 643030
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Perm, Den russiske føderasjonen, 614077
- Investigational Site Number 643017
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Perm, Den russiske føderasjonen, 614097
- Investigational Site Number 643049
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Rostov-Na-Donu, Den russiske føderasjonen, 344068
- Investigational Site Number 643048
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Ryazan, Den russiske føderasjonen, 390026
- Investigational Site Number 643047
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Saint-Petersburg, Den russiske føderasjonen, 194156
- Investigational Site Number 643039
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Saratov, Den russiske føderasjonen, 410028
- Investigational Site Number 643025
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Saratov, Den russiske føderasjonen, 410028
- Investigational Site Number 643056
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Saratov, Den russiske føderasjonen, 410030
- Investigational Site Number 643010
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Saratov, Den russiske føderasjonen, 410039
- Investigational Site Number 643033
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Saratov, Den russiske føderasjonen, 410054
- Investigational Site Number 643019
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Smolensk, Den russiske føderasjonen, 214018
- Investigational Site Number 643014
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St-Petersburg, Den russiske føderasjonen, 190000
- Investigational Site Number 643024
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St-Petersburg, Den russiske føderasjonen, 192242
- Investigational Site Number 643031
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St-Petersburg, Den russiske føderasjonen, 193312
- Investigational Site Number 643035
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St-Petersburg, Den russiske føderasjonen, 194044
- Investigational Site Number 643022
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St-Petersburg, Den russiske føderasjonen, 194354
- Investigational Site Number 643057
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St-Petersburg, Den russiske føderasjonen, 195257
- Investigational Site Number 643041
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St-Petersburg, Den russiske føderasjonen, 197341
- Investigational Site Number 643036
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St-Petersburg, Den russiske føderasjonen, 198013
- Investigational Site Number 643011
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St-Petersburg, Den russiske føderasjonen, 199106
- Investigational Site Number 643004
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Tomsk, Den russiske føderasjonen, 634012
- Investigational Site Number 643028
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Tver, Den russiske føderasjonen, 170036
- Investigational Site Number 643016
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Tyumen, Den russiske føderasjonen, 625023
- Investigational Site Number 643012
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Vladimir, Den russiske føderasjonen, 600020
- Investigational Site Number 643059
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Voronezh, Den russiske føderasjonen, 394065
- Investigational Site Number 643058
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Yaroslavl, Den russiske føderasjonen, 150003
- Investigational Site Number 643020
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Yaroslavl, Den russiske føderasjonen, 150030
- Investigational Site Number 643062
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Guayaquil, Ecuador, EC090112
- Investigational Site Number 218001
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Guayaquil, Ecuador, EC09112
- Investigational Site Number 218005
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Quito, Ecuador, EC090112
- Investigational Site Number 218002
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Alexandria, Egypt
- Investigational Site Number 818002
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Cairo, Egypt
- Investigational Site Number 818001
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Tallinn, Estland, 13419
- Investigational Site Number 233001
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Tallinn, Estland, 10138
- Investigational Site Number 233004
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Tallinn, Estland, 13419
- Investigational Site Number 233003
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Tallinn, Estland, 13415
- Investigational Site Number 233002
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Tartu, Estland, 50406
- Investigational Site Number 233005
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Viljandimaa, Estland, 71024
- Investigational Site Number 233006
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Cavite, Filippinene
- Investigational Site Number 608006
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Iligan City, Lanao Del Norte, Filippinene, 9200
- Investigational Site Number 608009
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Makati City, Filippinene
- Investigational Site Number 608003
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Manila, Filippinene, 1008
- Investigational Site Number 608001
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Manila, Filippinene
- Investigational Site Number 608007
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Marikina City, Filippinene, 1800
- Investigational Site Number 608005
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Pasay City, Filippinene, 1300
- Investigational Site Number 608002
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Quezon City, Filippinene, 1109
- Investigational Site Number 608008
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Jyväskylä, Finland, 40620
- Investigational Site Number 246005
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Rauma, Finland, 26100
- Investigational Site Number 246003
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Tampere, Finland, 33520
- Investigational Site Number 246010
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Turku, Finland, FIN-20520
- Investigational Site Number 246009
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Valkeakoski, Finland, 37600
- Investigational Site Number 246007
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Vantaa, Finland, 01600
- Investigational Site Number 246012
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Alabama
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Birmingham, Alabama, Forente stater, 35203
- Investigational Site Number 840415
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Foley, Alabama, Forente stater, 36535
- Investigational Site Number 840307
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Mobile, Alabama, Forente stater, 36604
- Investigational Site Number 840692
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Mobile, Alabama, Forente stater, 36608
- Investigational Site Number 840037
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Mobile, Alabama, Forente stater, 36609
- Investigational Site Number 840210
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Muscle Shoals, Alabama, Forente stater, 35661
- Investigational Site Number 840326
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Toney, Alabama, Forente stater, 35773
- Investigational Site Number 840393
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Arizona
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Mesa, Arizona, Forente stater, 85206
- Investigational Site Number 840656
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Phoenix, Arizona, Forente stater, 85012
- Investigational Site Number 840506
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Phoenix, Arizona, Forente stater, 85020
- Investigational Site Number 840520
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Phoenix, Arizona, Forente stater, 85032
- Investigational Site Number 840322
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Tempe, Arizona, Forente stater, 85284
- Investigational Site Number 840250
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Tucson, Arizona, Forente stater, 85723
- Investigational Site Number 840042
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Arkansas
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Hot Springs, Arkansas, Forente stater, 71913
- Investigational Site Number 840303
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Jonesboro, Arkansas, Forente stater, 72401
- Investigational Site Number 840184
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Little Rock, Arkansas, Forente stater, 72204
- Investigational Site Number 840361
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Little Rock, Arkansas, Forente stater, 72205
- Investigational Site Number 840023
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California
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Anaheim, California, Forente stater, 92801
- Investigational Site Number 840706
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Anaheim, California, Forente stater, 92804
- Investigational Site Number 840497
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Downey, California, Forente stater, 90242
- Investigational Site Number 840667
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Fresno, California, Forente stater, 93722
- Investigational Site Number 840150
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Hawthorne, California, Forente stater, 90250
- Investigational Site Number 840624
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Inglewood, California, Forente stater, 90301
- Investigational Site Number 840623
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Inglewood, California, Forente stater, 90301
- Investigational Site Number 840636
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La Mesa, California, Forente stater, 91942
- Investigational Site Number 840455
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Loma Linda, California, Forente stater, 92354
- Investigational Site Number 840240
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Long Beach, California, Forente stater, 90806
- Investigational Site Number 840262
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Long Beach, California, Forente stater, 90813
- Investigational Site Number 840606
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Los Angeles, California, Forente stater, 90024
- Investigational Site Number 840694
-
Los Angeles, California, Forente stater, 90033
- Investigational Site Number 840431
-
Los Angeles, California, Forente stater, 90073
- Investigational Site Number 840135
-
Merced, California, Forente stater, 95348
- Investigational Site Number 840314
-
Mission Viejo, California, Forente stater, 92691
- Investigational Site Number 840290
-
National City, California, Forente stater, 91950
- Investigational Site Number 840592
-
Northridge, California, Forente stater, 91328
- Investigational Site Number 840275
-
Oakland, California, Forente stater, 94609
- Investigational Site Number 840654
-
Orange, California, Forente stater, 92868
- Investigational Site Number 840351
-
Orange, California, Forente stater, 92868
- Investigational Site Number 840689
-
Pomona, California, Forente stater, 91767
- Investigational Site Number 840582
-
Port Hueneme, California, Forente stater, 93041
- Investigational Site Number 840346
-
Roseville, California, Forente stater, 95661
- Investigational Site Number 840466
-
San Marino, California, Forente stater, 91108
- Investigational Site Number 840575
-
Santa Ana, California, Forente stater, 82705
- Investigational Site Number 840131
-
Santa Ana, California, Forente stater, 92704
- Investigational Site Number 840335
-
Simi Valley, California, Forente stater, 93065
- Investigational Site Number 840576
-
Sylmar, California, Forente stater, 91342
- Investigational Site Number 840414
-
Ventura, California, Forente stater, 93003
- Investigational Site Number 840395
-
Vista, California, Forente stater, 92081-7832
- Investigational Site Number 840206
-
Westlake Village, California, Forente stater, 91361
- Investigational Site Number 840480
-
Whittier, California, Forente stater, 90602
- Investigational Site Number 840350
-
-
Colorado
-
Colorado Springs, Colorado, Forente stater, 80910
- Investigational Site Number 840093
-
-
District of Columbia
-
Washington, District of Columbia, Forente stater, 20060
- Investigational Site Number 840631
-
Washington, District of Columbia, Forente stater, 20422
- Investigational Site Number 840044
-
-
Florida
-
Clearwater, Florida, Forente stater, 33755
- Investigational Site Number 840281
-
Homosassa, Florida, Forente stater, 34448
- Investigational Site Number 840477
-
Miami, Florida, Forente stater, 33135
- Investigational Site Number 840261
-
Miami, Florida, Forente stater, 33155
- Investigational Site Number 840459
-
Oviedo, Florida, Forente stater, 32765
- Investigational Site Number 840432
-
Panama City, Florida, Forente stater, 32401
- Investigational Site Number 840318
-
St. Petersburg, Florida, Forente stater, 33707
- Investigational Site Number 840056
-
Wellington, Florida, Forente stater, 33449
- Investigational Site Number 840295
-
-
Georgia
-
Atlanta, Georgia, Forente stater, 30322
- Investigational Site Number 840066
-
Atlanta, Georgia, Forente stater, 30322
- Investigational Site Number 840446
-
Atlanta, Georgia, Forente stater, 30322
- Investigational Site Number 840487
-
Blue Ridge, Georgia, Forente stater, 30513
- Investigational Site Number 840578
-
Columbus, Georgia, Forente stater, 31904-5245
- Investigational Site Number 840534
-
Duluth, Georgia, Forente stater, 30096
- Investigational Site Number 840447
-
Duluth, Georgia, Forente stater, 30096
- Investigational Site Number 840499
-
-
Idaho
-
Idaho Falls, Idaho, Forente stater, 83404
- Investigational Site Number 840536
-
Pocatello, Idaho, Forente stater, 83201
- Investigational Site Number 840413
-
-
Illinois
-
Arlington Heights, Illinois, Forente stater, 60005
- Investigational Site Number 840519
-
Belleville, Illinois, Forente stater, 62220
- Investigational Site Number 840589
-
Chicago, Illinois, Forente stater, 60415
- Investigational Site Number 840107
-
Chicago, Illinois, Forente stater, 60611
- Investigational Site Number 840633
-
Chicago, Illinois, Forente stater, 60612
- Investigational Site Number 840663
-
Hines, Illinois, Forente stater, 60141
- Investigational Site Number 840212
-
Joliet, Illinois, Forente stater, 60435
- Investigational Site Number 840345
-
Peoria, Illinois, Forente stater, 61602
- Investigational Site Number 840681
-
-
Indiana
-
Elwood, Indiana, Forente stater, 46036
- Investigational Site Number 840360
-
Gary, Indiana, Forente stater, 46409
- Investigational Site Number 840676
-
Hammond, Indiana, Forente stater, 46320
- Investigational Site Number 840657
-
Huntington, Indiana, Forente stater, 46750
- Investigational Site Number 840621
-
Indianapolis, Indiana, Forente stater, 46202
- Investigational Site Number 840702
-
-
Kansas
-
Topeka, Kansas, Forente stater, 66606
- Investigational Site Number 840009
-
-
Kentucky
-
Covington, Kentucky, Forente stater, 41011
- Investigational Site Number 840533
-
Madisonville, Kentucky, Forente stater, 42431
- Investigational Site Number 840251
-
Owensboro, Kentucky, Forente stater, 42303
- Investigational Site Number 840168
-
Pikeville, Kentucky, Forente stater, 41501
- Investigational Site Number 840449
-
-
Louisiana
-
Baton Rouge, Louisiana, Forente stater, 70808
- Investigational Site Number 840299
-
Hammond, Louisiana, Forente stater, 70403
- Investigational Site Number 840671
-
Metairie, Louisiana, Forente stater, 70006
- Investigational Site Number 840470
-
Shreveport, Louisiana, Forente stater, 71130
- Investigational Site Number 840178
-
-
Maryland
-
Annapolis, Maryland, Forente stater, 21401
- Investigational Site Number 840043
-
Catonsville, Maryland, Forente stater, 21228
- Investigational Site Number 840639
-
Rockville, Maryland, Forente stater, 20852
- Investigational Site Number 840430
-
Takoma Park, Maryland, Forente stater, 20912
- Investigational Site Number 840640
-
Towson, Maryland, Forente stater, 21204
- Investigational Site Number 840293
-
-
Michigan
-
Alpena, Michigan, Forente stater, 49707
- Investigational Site Number 840019
-
Buckley, Michigan, Forente stater, 49620
- Investigational Site Number 840352
-
Chesterfield, Michigan, Forente stater, 48047
- Investigational Site Number 840555
-
Dearborn, Michigan, Forente stater, 48124
- Investigational Site Number 840411
-
Detroit, Michigan, Forente stater, 48235
- Investigational Site Number 840205
-
Flint, Michigan, Forente stater, 48503
- Investigational Site Number 840581
-
Kalamazoo, Michigan, Forente stater, 49048
- Investigational Site Number 840404
-
Southfield, Michigan, Forente stater, 48075
- Investigational Site Number 840312
-
Sterling Heights, Michigan, Forente stater, 48310
- Investigational Site Number 840484
-
-
Minnesota
-
Duluth, Minnesota, Forente stater, 55805
- Investigational Site Number 840219
-
Eagan, Minnesota, Forente stater, 55122
- Investigational Site Number 840199
-
-
Mississippi
-
Biloxi, Mississippi, Forente stater, 39531
- Investigational Site Number 840196
-
-
Missouri
-
Kansas City, Missouri, Forente stater, 64111
- Investigational Site Number 840445
-
Kansas City, Missouri, Forente stater, 64128
- Investigational Site Number 840008
-
St. Louis, Missouri, Forente stater, 63122
- Investigational Site Number 840091
-
St. Louis, Missouri, Forente stater, 63128
- Investigational Site Number 840046
-
St. Louis, Missouri, Forente stater, 63131
- Investigational Site Number 840678
-
St. Louis, Missouri, Forente stater, 63141
- Investigational Site Number 840400
-
-
Montana
-
Kalispell, Montana, Forente stater, 59901
- Investigational Site Number 840337
-
-
Nebraska
-
Lincoln, Nebraska, Forente stater, 68521
- Investigational Site Number 840509
-
Omaha, Nebraska, Forente stater, 68131
- Investigational Site Number 840007
-
-
Nevada
-
Las Vegas, Nevada, Forente stater, 89102
- Investigational Site Number 840382
-
Las Vegas, Nevada, Forente stater, 89102
- Investigational Site Number 840680
-
Las Vegas, Nevada, Forente stater, 89148
- Investigational Site Number 840217
-
-
New Jersey
-
Linden, New Jersey, Forente stater
- Investigational Site Number 840072
-
Ridgewood, New Jersey, Forente stater, 07450
- Investigational Site Number 840628
-
Somerset, New Jersey, Forente stater, 08873
- Investigational Site Number 840162
-
-
New York
-
Albany, New York, Forente stater, 12206
- Investigational Site Number 840285
-
Jamaica, New York, Forente stater, 11432
- Investigational Site Number 840585
-
Mineola, New York, Forente stater, 11501
- Investigational Site Number 840348
-
Northport, New York, Forente stater, 11768
- Investigational Site Number 840119
-
Rosedale, New York, Forente stater, 14221
- Investigational Site Number 840696
-
-
North Carolina
-
Asheville, North Carolina, Forente stater, 28805
- Investigational Site Number 840310
-
Calabash, North Carolina, Forente stater, 28467
- Investigational Site Number 840454
-
Charlotte, North Carolina, Forente stater, 28203
- Investigational Site Number 840672
-
Charlotte, North Carolina, Forente stater, 28205
- Investigational Site Number 840152
-
Elizabeth City, North Carolina, Forente stater, 27909
- Investigational Site Number 840344
-
Greensboro, North Carolina, Forente stater, 27401
- Investigational Site Number 840328
-
Greensboro, North Carolina, Forente stater, 27405
- Investigational Site Number 840513
-
Greenville, North Carolina, Forente stater, 27858
- Investigational Site Number 840504
-
Monroe, North Carolina, Forente stater, 28110
- Investigational Site Number 840642
-
Raleigh, North Carolina, Forente stater, 27609
- Investigational Site Number 840481
-
Wilmington, North Carolina, Forente stater, 28401
- Investigational Site Number 840381
-
Winston Salem, North Carolina, Forente stater, 27157-1071
- Investigational Site Number 840532
-
-
Ohio
-
Cincinnati, Ohio, Forente stater, 45219
- Investigational Site Number 840028
-
Cincinnati, Ohio, Forente stater, 45220
- Investigational Site Number 840198
-
Columbus, Ohio, Forente stater, 43201
- Investigational Site Number 840543
-
Dayton, Ohio, Forente stater, 45439
- Investigational Site Number 840456
-
Marion, Ohio, Forente stater, 43302
- Investigational Site Number 840368
-
-
Oregon
-
Bend, Oregon, Forente stater, 97701
- Investigational Site Number 840427
-
Portland, Oregon, Forente stater, 97201-3098
- Investigational Site Number 840422
-
Portland, Oregon, Forente stater, 97227-1191
- Investigational Site Number 840511
-
-
Pennsylvania
-
Butler, Pennsylvania, Forente stater, 16001
- Investigational Site Number 840560
-
Clark Summit, Pennsylvania, Forente stater, 18411
- Investigational Site Number 840464
-
Pittsburgh, Pennsylvania, Forente stater, 15220
- Investigational Site Number 840401
-
-
Rhode Island
-
Providence, Rhode Island, Forente stater, 02908
- Investigational Site Number 840266
-
-
South Carolina
-
Anderson, South Carolina, Forente stater, 29621
- Investigational Site Number 840223
-
Columbia, South Carolina, Forente stater, 29201
- Investigational Site Number 840353
-
Green Ville, South Carolina, Forente stater, 29605
- Investigational Site Number 840529
-
Greer, South Carolina, Forente stater, 29651
- Investigational Site Number 840550
-
Myrtle Beach, South Carolina, Forente stater, 29572
- Investigational Site Number 840258
-
Taylors, South Carolina, Forente stater, 29687-4105
- Investigational Site Number 840309
-
-
South Dakota
-
Rapid City, South Dakota, Forente stater, 57701
- Investigational Site Number 840551
-
-
Tennessee
-
Bartlett, Tennessee, Forente stater, 38133
- Investigational Site Number 840524
-
Chattanooga, Tennessee, Forente stater, 37404
- Investigational Site Number 840308
-
Germantown, Tennessee, Forente stater, 38138
- Investigational Site Number 840047
-
Jackson, Tennessee, Forente stater, 38305
- Investigational Site Number 840313
-
Memphis, Tennessee, Forente stater, 38114
- Investigational Site Number 840625
-
Memphis, Tennessee, Forente stater, 38163
- Investigational Site Number 840637
-
Nashville, Tennessee, Forente stater, 37208
- Investigational Site Number 840096
-
Nashville, Tennessee, Forente stater, 37232
- Investigational Site Number 840388
-
-
Texas
-
Dallas, Texas, Forente stater, 75246
- Investigational Site Number 840473
-
Edinburg, Texas, Forente stater, 78539
- Investigational Site Number 840677
-
El Paso, Texas, Forente stater, 79925
- Investigational Site Number 840698
-
Fair Oaks Ranch, Texas, Forente stater, 78015
- Investigational Site Number 840439
-
Houston, Texas, Forente stater, 77081
- Investigational Site Number 840164
-
Longview, Texas, Forente stater, 75605
- Investigational Site Number 840545
-
Lubbock, Texas, Forente stater, 79409
- Investigational Site Number 840385
-
Lubbock, Texas, Forente stater, 79409
- Investigational Site Number 840530
-
Marshall, Texas, Forente stater, 75670
- Investigational Site Number 840174
-
Plano, Texas, Forente stater, 75024
- Investigational Site Number 840565
-
Richmond, Texas, Forente stater, 77469
- Investigational Site Number 840608
-
San Antonio, Texas, Forente stater, 78258
- Investigational Site Number 840573
-
Sugarland, Texas, Forente stater, 77479
- Investigational Site Number 840564
-
Waco, Texas, Forente stater, 76708
- Investigational Site Number 840241
-
-
Utah
-
American Fork, Utah, Forente stater, 84003
- Investigational Site Number 840232
-
Draper, Utah, Forente stater, 84020
- Investigational Site Number 840471
-
-
Virginia
-
Charlottesville, Virginia, Forente stater, 22908-0679
- Investigational Site Number 840503
-
Chesapeake, Virginia, Forente stater, 23320
- Investigational Site Number 840180
-
Chesapeake, Virginia, Forente stater, 23321
- Investigational Site Number 840465
-
Chesapeake, Virginia, Forente stater, 23323
- Investigational Site Number 840128
-
Norfolk, Virginia, Forente stater, 23502
- Investigational Site Number 840045
-
Norfolk, Virginia, Forente stater, 23510
- Investigational Site Number 840213
-
Richmond, Virginia, Forente stater, 23219
- Investigational Site Number 840001
-
Roanoke, Virginia, Forente stater, 24014
- Investigational Site Number 840286
-
-
Washington
-
Olympia, Washington, Forente stater, 98506
- Investigational Site Number 840170
-
Spokane, Washington, Forente stater, 99207
- Investigational Site Number 840094
-
Spokane, Washington, Forente stater, 99207
- Investigational Site Number 840343
-
Spokane, Washington, Forente stater, 99220
- Investigational Site Number 840268
-
Tacoma, Washington, Forente stater, 98405
- Investigational Site Number 840061
-
-
Wisconsin
-
Fairmount, Wisconsin, Forente stater, 26554
- Investigational Site Number 840613
-
Lacrosse, Wisconsin, Forente stater, 54601
- Investigational Site Number 840121
-
Milwaukee, Wisconsin, Forente stater, 53211
- Investigational Site Number 840493
-
-
-
-
-
Brest Cedex, Frankrike, 29610
- Investigational Site Number 250008
-
Corbeil Essonnes, Frankrike, 91109
- Investigational Site Number 250002
-
Nantes, Frankrike, 44093
- Investigational Site Number 250005
-
Nimes, Frankrike, 30029
- Investigational Site Number 250014
-
Paris Cedex 15, Frankrike, 75908
- Investigational Site Number 250007
-
Pessac, Frankrike, 33600
- Investigational Site Number 250011
-
Poitiers Cedex, Frankrike, 86021
- Investigational Site Number 250012
-
Rennes, Frankrike, 35700
- Investigational Site Number 250006
-
Toulouse Cedex 4, Frankrike, 31403
- Investigational Site Number 250001
-
-
-
-
-
Batumi, Georgia
- Investigational Site Number 268003
-
Kutaisi, Georgia
- Investigational Site Number 268004
-
Tbilisi, Georgia
- Investigational Site Number 268001
-
Tbilisi, Georgia
- Investigational Site Number 268002
-
-
-
-
-
Guatemala, Guatemala, 01014
- Investigational Site Number 320001
-
Guatemala, Guatemala, 01010
- Investigational Site Number 320004
-
Guatemala, Guatemala, 01010
- Investigational Site Number 320006
-
Guatemala, Guatemala, 01010
- Investigational Site Number 320012
-
Guatemala, Guatemala, 01010
- Investigational Site Number 320014
-
Guatemala, Guatemala, 01014
- Investigational Site Number 320002
-
Guatemala, Guatemala, 01014
- Investigational Site Number 320007
-
Guatemala, Guatemala, 01014
- Investigational Site Number 320008
-
Guatemala, Guatemala, 01015
- Investigational Site Number 320011
-
Quetzaltenango, Guatemala, 09001
- Investigational Site Number 320015
-
-
-
-
-
Minsk, Hviterussland, 220116
- Investigational Site Number 112001
-
Minsk, Hviterussland, 220036
- Investigational Site Number 112002
-
Minsk, Hviterussland, 220096
- Investigational Site Number 112003
-
-
-
-
-
Ahmedabad, India, 380052
- Investigational Site Number 356019
-
Bangalore, India, 560043
- Investigational Site Number 356002
-
Bangalore, India, 560092
- Investigational Site Number 356010
-
Bangalore, India, 562114
- Investigational Site Number 356026
-
Belgaum, India, 590001
- Investigational Site Number 356024
-
Chandigarh, India, 160062
- Investigational Site Number 356012
-
Cochin, India, 682026
- Investigational Site Number 356016
-
Gurgaon, India, 122002
- Investigational Site Number 356022
-
Hubli, India, 580021
- Investigational Site Number 356029
-
Hyderabad, India, 500063
- Investigational Site Number 356020
-
Jaipur, India, 302001
- Investigational Site Number 356031
-
Kolkata, India
- Investigational Site Number 356004
-
Lucknow, India, 226003
- Investigational Site Number 356015
-
Lucknow, India
- Investigational Site Number 356014
-
Ludhiana, India, 141001
- Investigational Site Number 356009
-
Madurai, India
- Investigational Site Number 356025
-
Mangalore, India, 575002
- Investigational Site Number 356032
-
Manipal, India, 576104
- Investigational Site Number 356018
-
Mysore, India, 570020
- Investigational Site Number 356023
-
Nagpur, India, 440010
- Investigational Site Number 356027
-
Nagpur, India
- Investigational Site Number 356006
-
Nashik, India, 422005
- Investigational Site Number 356034
-
Nasik, India, 422002
- Investigational Site Number 356030
-
New Delhi, India, 110017
- Investigational Site Number 356013
-
New Delhi, India, 122001
- Investigational Site Number 356017
-
Pune, India, 411001
- Investigational Site Number 356021
-
Pune, India, 411019
- Investigational Site Number 356028
-
-
-
-
-
Afula, Israel, 18101
- Investigational Site Number 376010
-
Givatayim, Israel, 53583
- Investigational Site Number 376006
-
Haifa, Israel, 31096
- Investigational Site Number 376002
-
Haifa, Israel, 35251
- Investigational Site Number 376008
-
Holon, Israel, 58100
- Investigational Site Number 376001
-
Jerusalem, Israel, 91120
- Investigational Site Number 376012
-
Nahariya, Israel, 22100
- Investigational Site Number 376011
-
Safed, Israel, 13100
- Investigational Site Number 376005
-
Tel Aviv, Israel, 64239
- Investigational Site Number 376004
-
Tel Hashomer, Israel, 52621
- Investigational Site Number 376003
-
Tzrifin, Israel, 70300
- Investigational Site Number 376009
-
-
-
-
-
Carpi, Italia, 41012
- Investigational Site Number 380024
-
Chieri, Italia, 10023
- Investigational Site Number 380004
-
Chieti, Italia, 66013
- Investigational Site Number 380002
-
Fermo, Italia, 63023
- Investigational Site Number 380006
-
Firenze, Italia, 50141
- Investigational Site Number 380010
-
Genova, Italia, 16011
- Investigational Site Number 380009
-
Messina, Italia, 98124
- Investigational Site Number 380016
-
Milano, Italia, 20122
- Investigational Site Number 380023
-
Milano, Italia, 20132
- Investigational Site Number 380011
-
Milano, Italia, 20142
- Investigational Site Number 380012
-
Napoli, Italia, 80131
- Investigational Site Number 380014
-
Novara, Italia, 28100
- Investigational Site Number 380019
-
Palermo, Italia, 90127
- Investigational Site Number 380005
-
Pisa, Italia, 56124
- Investigational Site Number 380001
-
Roma, Italia, 00128
- Investigational Site Number 380013
-
Rozzano, Italia, 20089
- Investigational Site Number 380020
-
-
-
-
-
Chuo-Ku, Japan
- Investigational Site Number 392011
-
Fuchu-Shi, Japan
- Investigational Site Number 392015
-
Fujisawa-Shi, Japan
- Investigational Site Number 392012
-
Hachioji-Shi, Japan
- Investigational Site Number 392025
-
Hakusan-Shi, Japan
- Investigational Site Number 392027
-
Hamamatsu-Shi, Japan
- Investigational Site Number 392005
-
Hitachi-Shi, Japan
- Investigational Site Number 392022
-
Itabashi-Ku, Japan
- Investigational Site Number 392003
-
Itabashi-Ku, Japan
- Investigational Site Number 392017
-
Kawanishi-Shi, Japan
- Investigational Site Number 392019
-
Kobe-Shi, Japan
- Investigational Site Number 392013
-
Matsuyama-Shi, Japan
- Investigational Site Number 392007
-
Matsuyama-Shi, Japan
- Investigational Site Number 392008
-
Nagasaki-Shi, Japan
- Investigational Site Number 392009
-
Noda-Shi, Japan
- Investigational Site Number 392002
-
Osaka-Shi, Japan
- Investigational Site Number 392021
-
Osaka-Shi, Japan
- Investigational Site Number 392020
-
Sapporo-Shi, Japan
- Investigational Site Number 392001
-
Sapporo-Shi, Japan
- Investigational Site Number 392010
-
Setagaya-Ku, Japan
- Investigational Site Number 392024
-
Shinagawa-Ku, Japan
- Investigational Site Number 392004
-
Shirakawa-Shi, Japan
- Investigational Site Number 392014
-
Suita-Shi, Japan
- Investigational Site Number 392018
-
Tachikawa-Shi, Japan
- Investigational Site Number 392016
-
Takasaki-Shi, Japan
- Investigational Site Number 392023
-
-
-
-
-
Beijing, Kina, 100853
- Investigational Site Number 156001
-
Beijing, Kina, 100029
- Investigational Site Number 156016
-
Beijing, Kina, 100029
- Investigational Site Number 156034
-
Beijing, Kina, 100034
- Investigational Site Number 156024
-
Beijing, Kina, 100037
- Investigational Site Number 156028
-
Beijing, Kina, 100088
- Investigational Site Number 156014
-
Beijing, Kina, 100730
- Investigational Site Number 156005
-
Beijing, Kina, 100730
- Investigational Site Number 156006
-
Dalian, Kina, 116011
- Investigational Site Number 156008
-
Guangzhou, Kina, 510080
- Investigational Site Number 156020
-
Jinan, Kina, 250012
- Investigational Site Number 156023
-
Jinan, Kina, 250013
- Investigational Site Number 156015
-
Nanjing, Kina, 210008
- Investigational Site Number 156009
-
Shanghai, Kina, 200003
- Investigational Site Number 156013
-
Shanghai, Kina, 200080
- Investigational Site Number 156019
-
Shenyang, Kina, 110004
- Investigational Site Number 156032
-
Shenyang, Kina, 110016
- Investigational Site Number 156022
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Suzhou, Kina, 215006
- Investigational Site Number 156004
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Urumchi, Kina, 830054
- Investigational Site Number 156033
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-
-
-
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Bucheon, Korea, Republikken, 420-767
- Investigational Site Number 410012
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Daegu, Korea, Republikken, 705-717
- Investigational Site Number 410006
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Gwangju, Korea, Republikken, 501-757
- Investigational Site Number 410009
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Incheon, Korea, Republikken, 400-711
- Investigational Site Number 410008
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Incheon, Korea, Republikken, 405-760
- Investigational Site Number 410001
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Seongnam, Korea, Republikken, 463-707
- Investigational Site Number 410004
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Seoul, Korea, Republikken, 110-744
- Investigational Site Number 410014
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Seoul, Korea, Republikken, 134-727
- Investigational Site Number 410013
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Seoul, Korea, Republikken, 135-720
- Investigational Site Number 410002
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Seoul, Korea, Republikken, 152-703
- Investigational Site Number 410011
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Seoul, Korea, Republikken, 156-755
- Investigational Site Number 410010
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Wonju, Korea, Republikken, 220-701
- Investigational Site Number 410007
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-
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-
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Cesis, Latvia, LV-4101
- Investigational Site Number 428005
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Daugavpils, Latvia, LV-5417
- Investigational Site Number 428001
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Liepaja, Latvia, LV-3414
- Investigational Site Number 428002
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Riga, Latvia, LV-1002
- Investigational Site Number 428003
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Riga, Latvia, LV-1011
- Investigational Site Number 428007
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Riga, Latvia, LV-1038
- Investigational Site Number 428004
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Sigulda, Latvia, LV-2150
- Investigational Site Number 428006
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-
-
-
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Kaunas, Litauen, LT-50009
- Investigational Site Number 440002
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Kaunas, Litauen, LT-49456
- Investigational Site Number 440003
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Klaipeda, Litauen, LT-91131
- Investigational Site Number 440004
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Klaipeda, Litauen, LT-92304
- Investigational Site Number 440006
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Panevezys, Litauen, LT-37355
- Investigational Site Number 440005
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Vilnius, Litauen, LT-08661
- Investigational Site Number 440001
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-
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-
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Acapulco, Mexico, 39670
- Investigational Site Number 484011
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Aguascalientes, Mexico, 20230
- Investigational Site Number 484008
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Aguascalientes, Mexico, 20230
- Investigational Site Number 484033
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Chihuahua, Mexico, 31000
- Investigational Site Number 484016
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Ciudad Madero, Mexico, 89440
- Investigational Site Number 484023
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Durango, Mexico, 34000
- Investigational Site Number 484007
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Durango, Mexico, 34080
- Investigational Site Number 484001
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Durango, Mexico, 34080
- Investigational Site Number 484041
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Guadalajara, Mexico, 44150
- Investigational Site Number 484032
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Guadalajara, Mexico, 44160
- Investigational Site Number 484034
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Guadalajara, Mexico, 44210
- Investigational Site Number 484014
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Guadalajara, Mexico, 44210
- Investigational Site Number 484028
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Guadalajara, Mexico, 44670
- Investigational Site Number 484021
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Guadalajara, Mexico, 44680
- Investigational Site Number 484006
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Guadalajara, Mexico, 45200
- Investigational Site Number 484018
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Leon, Mexico, 37150
- Investigational Site Number 484024
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Mexico City, Mexico, 06470
- Investigational Site Number 484026
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Mexico City, Mexico, 07300
- Investigational Site Number 484022
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Mexico City, Mexico, 14000
- Investigational Site Number 484013
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Monterrey, Mexico, 64460
- Investigational Site Number 484005
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Monterrey, Mexico, 64460
- Investigational Site Number 484002
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Monterrey, Mexico, 64020
- Investigational Site Number 484003
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Monterrey, Mexico, 64060
- Investigational Site Number 484025
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Monterrey, Mexico, 64620
- Investigational Site Number 484004
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Morelia, Mexico, 58260
- Investigational Site Number 484035
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San Luis Potosi, Mexico, 78200
- Investigational Site Number 484020
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Tlalnepantla, Mexico, 54055
- Investigational Site Number 484017
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Xalapa, Mexico, 91020
- Investigational Site Number 484031
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-
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Alkmaar, Nederland, 1815 JD
- Investigational Site Number 528005
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Den Haag, Nederland, 2597 AX
- Investigational Site Number 528007
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Deventer, Nederland, 7416 SE
- Investigational Site Number 528008
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Hoorn, Nederland, 1625 HV
- Investigational Site Number 528004
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Rotterdam, Nederland, 3045 PM
- Investigational Site Number 528001
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Tilburg, Nederland, 5022 GC
- Investigational Site Number 528003
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Venlo, Nederland, 5912 BL
- Investigational Site Number 528006
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-
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Bodø, Norge, 8092
- Investigational Site Number 578003
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Haugesund, Norge, 5528
- Investigational Site Number 578002
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Stavanger, Norge, 4095
- Investigational Site Number 578001
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-
-
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Cuidad De Panama, Panama
- Investigational Site Number 591001
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Cuidad De Panama, Panama
- Investigational Site Number 591003
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La Chorrera, Panama
- Investigational Site Number 591004
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Penonome, Panama
- Investigational Site Number 591002
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-
-
-
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Arequipa, Peru, 5154
- Investigational Site Number 604007
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Callao, Peru, CALLAO 2
- Investigational Site Number 604014
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Lima, Peru, 051
- Investigational Site Number 604011
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Lima, Peru, 27
- Investigational Site Number 604002
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Lima, Peru, 051
- Investigational Site Number 604019
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Lima, Peru, 11
- Investigational Site Number 604013
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Lima, Peru, 12
- Investigational Site Number 604010
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Lima, Peru, 27
- Investigational Site Number 604006
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Lima, Peru, 511
- Investigational Site Number 604015
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Lima, Peru, 511
- Investigational Site Number 604016
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Lima, Peru, LIMA 01
- Investigational Site Number 604017
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Lima, Peru, LIMA 11
- Investigational Site Number 604018
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Lima, Peru, LIMA 14
- Investigational Site Number 604005
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Lima, Peru, LIMA 27
- Investigational Site Number 604009
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Lima, Peru, LIMA 31
- Investigational Site Number 604001
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-
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?ód?, Polen, 91-087
- Investigational Site Number 616005
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Bialystok, Polen, 15-276
- Investigational Site Number 616008
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Bydgoszcz, Polen, 85-046
- Investigational Site Number 616019
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Czeladz, Polen, 41-250
- Investigational Site Number 616012
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Czestochowa, Polen, 42-217
- Investigational Site Number 616007
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Gdynia, Polen, 81-394
- Investigational Site Number 616014
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Gliwice, Polen, 44-100
- Investigational Site Number 616013
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Grodzisk Mazowiecki, Polen, 05-825
- Investigational Site Number 616028
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Katowice, Polen, 40-767
- Investigational Site Number 616022
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Krakow, Polen, 30-082
- Investigational Site Number 616001
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Krakow, Polen, 31-024
- Investigational Site Number 616024
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Leczyca, Polen, 99-100
- Investigational Site Number 616029
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Poland, Polen, 42-500
- Investigational Site Number 616023
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Pulawy, Polen, 24-100
- Investigational Site Number 616021
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Ruda Slaska, Polen, 41-706
- Investigational Site Number 616006
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Szczecin, Polen, 70-506
- Investigational Site Number 616025
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Warszawa, Polen, 00-685
- Investigational Site Number 616032
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Wroclaw, Polen, 50-088
- Investigational Site Number 616020
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Wroclaw, Polen, 50-981
- Investigational Site Number 616011
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Zgierz, Polen, 95-100
- Investigational Site Number 616031
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Amadora, Portugal, 2720-276
- Investigational Site Number 620005
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Coimbra, Portugal, 3000-075
- Investigational Site Number 620003
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Lisboa, Portugal, 1349-019
- Investigational Site Number 620001
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Penafiel, Portugal, 4564-007
- Investigational Site Number 620007
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Porto, Portugal, 4200
- Investigational Site Number 620006
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-
-
-
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Arad, Romania, 310158
- Investigational Site Number 642029
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Baia Mare, Romania, 430123
- Investigational Site Number 642020
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Braila, Romania, 810249
- Investigational Site Number 642019
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Brasov, Romania, 500365
- Investigational Site Number 642003
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Bucharest, Romania, 010825
- Investigational Site Number 642034
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Bucuresti, Romania, 020475
- Investigational Site Number 642022
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Bucuresti, Romania, 021392
- Investigational Site Number 642001
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Bucuresti, Romania, 050098
- Investigational Site Number 642013
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Cluj Napoca, Romania, 40001
- Investigational Site Number 642026
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Craiova, Romania, 200147
- Investigational Site Number 642030
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Craiova, Romania, 200642
- Investigational Site Number 642015
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Deva, Romania, 330084
- Investigational Site Number 642007
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Iasi, Romania, 700547
- Investigational Site Number 642011
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Iasi, Romania, 700732
- Investigational Site Number 642010
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Oradea, Romania, 410598
- Investigational Site Number 642016
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Pitesti, Romania, 110084
- Investigational Site Number 642033
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Ploiesti, Romania, 100097
- Investigational Site Number 642002
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Suceava, Romania, 720262
- Investigational Site Number 642009
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Targu Mures, Romania, 540099
- Investigational Site Number 642014
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Targu Mures, Romania, 540142
- Investigational Site Number 642012
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Timisoara, Romania, 300174
- Investigational Site Number 642018
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Timisoara, Romania, 300736
- Investigational Site Number 642031
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Belgrade, Serbia, 11000
- Investigational Site Number 688002
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Belgrade, Serbia, 11000
- Investigational Site Number 688003
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Belgrade, Serbia, 11000
- Investigational Site Number 688006
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Belgrade, Serbia, 11000
- Investigational Site Number 688008
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Belgrade, Serbia, 11000
- Investigational Site Number 688010
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Belgrade, Serbia, 11000
- Investigational Site Number 688004
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Belgrade, Serbia, 11000
- Investigational Site Number 688009
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Belgrade, Serbia, 11040
- Investigational Site Number 688001
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Nis, Serbia, 18000
- Investigational Site Number 688005
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Nis, Serbia, 18000
- Investigational Site Number 688007
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-
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-
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Alcalá De Henares, Spania, 28805
- Investigational Site Number 724005
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Almería, Spania, 04120
- Investigational Site Number 724016
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Barakaldo, Spania, 48903
- Investigational Site Number 724012
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Barcelona, Spania, 08036
- Investigational Site Number 724018
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Bilbao, Spania, 48013
- Investigational Site Number 724014
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Cáceres, Spania, 10003
- Investigational Site Number 724015
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La Coruña, Spania, 15006
- Investigational Site Number 724013
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Lérida, Spania, 25198
- Investigational Site Number 724008
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Madrid, Spania, 28046
- Investigational Site Number 724011
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Murcia, Spania, 30120
- Investigational Site Number 724017
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Oviedo, Spania, 33006
- Investigational Site Number 724022
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Pontevedra, Spania, 36071
- Investigational Site Number 724003
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Sevilla, Spania, 41014
- Investigational Site Number 724001
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Valencia, Spania, 46010
- Investigational Site Number 724020
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Vigo, Spania, 36211
- Investigational Site Number 724004
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-
-
-
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Antrim, Storbritannia, BT41 2RL
- Investigational Site Number 826042
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Ashton-Under-Lyne, Storbritannia, OL6 9RW
- Investigational Site Number 826002
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Barnstaple, Storbritannia, EX31 4JB
- Investigational Site Number 826026
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Bath, Storbritannia, BA1 3NG
- Investigational Site Number 826017
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Birmingham, Storbritannia, B9 5SS
- Investigational Site Number 826034
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Bolton, Storbritannia, BL1 4AL
- Investigational Site Number 826052
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Bradford, Storbritannia, BD5 0NA
- Investigational Site Number 826005
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Carmarthen, Storbritannia, SA31 2AF
- Investigational Site Number 826048
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Chester, Storbritannia, CH2 1UL
- Investigational Site Number 826037
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Dumfries, Storbritannia, DG1 4AP
- Investigational Site Number 826011
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East Kilbride, Storbritannia, G75 8RG
- Investigational Site Number 826044
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Edinburgh, Storbritannia, EH3 9YW
- Investigational Site Number 826023
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Glasgow, Storbritannia, G11 6NT
- Investigational Site Number 826008
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Harrogate, Storbritannia, HG2 7SX
- Investigational Site Number 826010
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Ipswich, Storbritannia, IP4 5PD
- Investigational Site Number 826040
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Larbert, Storbritannia, FK5 4WR
- Investigational Site Number 826033
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Liverpool, Storbritannia, L9 7AL
- Investigational Site Number 826027
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Londonderry, Storbritannia, BT47 6SB
- Investigational Site Number 826039
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Manchester, Storbritannia, M13 9WL
- Investigational Site Number 826036
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Manchester, Storbritannia, M23 9LT
- Investigational Site Number 826021
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Manchester, Storbritannia, M8 6RB
- Investigational Site Number 826006
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Norwich, Storbritannia, NR1 3SR
- Investigational Site Number 826049
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Nuneaton, Storbritannia, CV10 7DJ
- Investigational Site Number 826020
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Oldham, Storbritannia, OL1 2JH
- Investigational Site Number 826009
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Salford, Storbritannia, M6 8HD
- Investigational Site Number 826007
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Stoke-On-Trent, Storbritannia, ST4 6QG
- Investigational Site Number 826045
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Swansea, Storbritannia, SA6 6NL
- Investigational Site Number 826038
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Taunton, Storbritannia, TA1 5DA
- Investigational Site Number 826018
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Truro, Storbritannia, TR1 3LJ
- Investigational Site Number 826016
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Wolverhampton, Storbritannia, WV10 0QP
- Investigational Site Number 826046
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Yeovil, Storbritannia, BA21 4AT
- Investigational Site Number 826019
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-
-
-
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Lugano, Sveits, 6900
- Investigational Site Number 756003
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-
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-
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Karlstad, Sverige, 651 85
- Investigational Site Number 752012
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Kristianstad, Sverige, 29185
- Investigational Site Number 752011
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Ljungby, Sverige, 341 82
- Investigational Site Number 752006
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Oskarshamn, Sverige, 572 28
- Investigational Site Number 752009
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Stockholm, Sverige, 118 83
- Investigational Site Number 752004
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Stockholm, Sverige, 182 88
- Investigational Site Number 752007
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Växjö, Sverige, 351 85
- Investigational Site Number 752002
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-
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-
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Alberton, Sør-Afrika, 1450
- Investigational Site Number 710020
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Cape Town, Sør-Afrika, 7405
- Investigational Site Number 710017
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Cape Town, Sør-Afrika, 7530
- Investigational Site Number 710006
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Cape Town, Sør-Afrika, 7764
- Investigational Site Number 710010
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Cape Town, Sør-Afrika, 7925
- Investigational Site Number 710025
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Chatsworth, Sør-Afrika, 4091
- Investigational Site Number 710008
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Durban, Sør-Afrika
- Investigational Site Number 710011
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George, Sør-Afrika, 6529
- Investigational Site Number 710015
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Kempton Park, Sør-Afrika, 1619
- Investigational Site Number 710019
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Paarl, Sør-Afrika, 7646
- Investigational Site Number 710014
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Parow, Sør-Afrika, 7500
- Investigational Site Number 710023
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Pretoria, Sør-Afrika, 0002
- Investigational Site Number 710002
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Pretoria, Sør-Afrika, 181
- Investigational Site Number 710001
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Richards Bay, Sør-Afrika, 3900
- Investigational Site Number 710005
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Somerset West, Sør-Afrika, 7130
- Investigational Site Number 710007
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Worcester, Sør-Afrika, 6850
- Investigational Site Number 710004
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-
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Chia-Yi, Taiwan, 60002
- Investigational Site Number 158005
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Taichung, Taiwan, 402
- Investigational Site Number 158004
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Tainan Hsien, Taiwan, 710
- Investigational Site Number 158006
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Taipei, Taiwan, 112
- Investigational Site Number 158001
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Taipei, Taiwan, 100
- Investigational Site Number 158002
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Taipei, Taiwan, 220
- Investigational Site Number 158008
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Taipei 111, Taiwan, 111
- Investigational Site Number 158007
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Taipei Hsien, Taiwan, 23137
- Investigational Site Number 158003
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-
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-
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Sfax, Tunisia, 3029
- Investigational Site Number 788003
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Tunis, Tunisia, 1006
- Investigational Site Number 788005
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Tunis, Tunisia, 1007
- Investigational Site Number 788004
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Tunis, Tunisia, 1008
- Investigational Site Number 788002
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Tunis, Tunisia, 1027
- Investigational Site Number 788001
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-
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Ankara, Tyrkia, 06110
- Investigational Site Number 792004
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Ankara, Tyrkia, 06490
- Investigational Site Number 792002
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Ankara, Tyrkia
- Investigational Site Number 792012
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Capa / Istanbul, Tyrkia, 34390
- Investigational Site Number 792001
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Istanbul, Tyrkia, 34010
- Investigational Site Number 792015
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Istanbul, Tyrkia, 34034
- Investigational Site Number 792008
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Istanbul, Tyrkia, 34385
- Investigational Site Number 792014
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Izmir, Tyrkia, 35100
- Investigational Site Number 792003
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Izmir, Tyrkia, 35100
- Investigational Site Number 792007
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Mersin, Tyrkia, 33169
- Investigational Site Number 792011
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Samsun, Tyrkia, 55200
- Investigational Site Number 792013
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-
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-
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Berlin, Tyskland, 13347
- Investigational Site Number 276003
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Bochum, Tyskland, 44787
- Investigational Site Number 276022
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Chemnitz, Tyskland, 09111
- Investigational Site Number 276005
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Dresden, Tyskland, 01067
- Investigational Site Number 276021
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Dresden, Tyskland, 01099
- Investigational Site Number 276024
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Elsterwerda, Tyskland, 04910
- Investigational Site Number 276007
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Frankfurt A.M., Tyskland, 60596
- Investigational Site Number 276018
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Frankfurt Am Main, Tyskland, 60389
- Investigational Site Number 276011
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Görlitz, Tyskland, 02826
- Investigational Site Number 276017
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Haßloch, Tyskland, 67454
- Investigational Site Number 276025
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Heidelberg, Tyskland, 69120
- Investigational Site Number 276009
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Leipzig, Tyskland, 04103
- Investigational Site Number 276019
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Magdeburg, Tyskland, 39104
- Investigational Site Number 276020
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Mühldorf Am Inn, Tyskland, 84453
- Investigational Site Number 276028
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Pirna, Tyskland, 01796
- Investigational Site Number 276014
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Pohlheim, Tyskland, 35415
- Investigational Site Number 276016
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Rotenburg An Der Fulda, Tyskland, 36199
- Investigational Site Number 276026
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-
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Chernivtsi, Ukraina, 58022
- Investigational Site Number 804004
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Dnepropetrovsk, Ukraina, 49023
- Investigational Site Number 804006
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Dnipropetrovsk, Ukraina, 49006
- Investigational Site Number 804002
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Kharkiv, Ukraina, 61176
- Investigational Site Number 804010
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Kharkov, Ukraina, 61022
- Investigational Site Number 804009
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Kiev, Ukraina, 02091
- Investigational Site Number 804003
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Kiev, Ukraina, 02660
- Investigational Site Number 804011
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Kyiv, Ukraina, 03680
- Investigational Site Number 804012
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Kyiv, Ukraina, 04114
- Investigational Site Number 804013
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Lviv, Ukraina, 79015
- Investigational Site Number 804005
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Odessa, Ukraina, 65025
- Investigational Site Number 804007
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Odessa, Ukraina, 65059
- Investigational Site Number 804008
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Graz, Østerrike, 8036
- Investigational Site Number 040002
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Wien, Østerrike, 1160
- Investigational Site Number 040001
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
30 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inklusjonskriterier:
- Menn og kvinner som opplevde en spontan ACS-hendelse (dvs. ST-segment elevation myokardinfarkt (STEMI) eller ikke-ST-segment elevation MI (NSTEMI) eller ustabil angina) med en dokumentert økning over det normale referanseområdet for en hjertebiomarkør ( Troponin eller kreatininkinase (CK)-MB) og den kliniske presentasjonen samsvarer med en ACS som førte til innleggelse til et akuttmottak innen 180 dager etter ACS-hendelsen og før screening.
- Deltakere med en historie med type 2-diabetes (for deltakere som nylig ble diagnostisert, var diagnosen basert på Verdens helseorganisasjons (WHO) kriterier: dvs. enten en fastende venøs plasmaglukosekonsentrasjon ≥ 7,0 mmol/L [126 mg/dL] eller 2- time etter glukosebelastning venøs plasmaglukose ≥ 11,1 mmol/L [200 mg/dL], bekreftet ved 2 anledninger) før screeningbesøket.
Ekskluderingskriterier:
- Type 1 diabetes mellitus eller historie med ketoacidose innen 6 måneder før screening.
- Glykosylert hemoglobin (HbA1c) <5,5 % eller >11 % målt ved screeningbesøk.
- Nødvendig for å bruke inkretinbaserte midler (f.eks. Glukagon-lignende peptid -1 (GLP-1) agonister eller Dipeptidyl Peptidase-4 (DPP-4) hemmere) andre enn studiemedisinen under den dobbeltblinde behandlingsperioden.
- Deltakere som hadde gjennomgått koronar bypass-operasjon (CABG) etter den kvalifiserende ACS-hendelsen.
- Deltakere som hadde gjennomgått perkutan koronar intervensjon (PCI) innen 15 dager før screening.
- Deltakere med planlagt revaskulariseringsprosedyre (PCI eller CABG) eller koronar angiogram innen 90 dager etter screeningbesøk.
- Historie med uforklarlig pankreatitt, kronisk pankreatitt, pankreatektomi, mage/gastrisk kirurgi, inflammatorisk tarmsykdom, personlig eller familiehistorie med medullær skjoldbruskkjertelkreft (MTC), eller genetiske tilstander som disponerer for MTC (f.eks. multiple endokrine neoplasisyndromer).
- Enhver klinisk signifikant abnormitet identifisert på screeningstidspunktet som etter etterforskerens eller en annen underforskers vurdering vil utelukke sikker fullføring av studien eller begrense endepunktsvurderingen, for eksempel alvorlige systemiske sykdommer.
Informasjonen ovenfor er ikke ment å inneholde alle hensyn som er relevante for en deltakers potensielle deltakelse i en klinisk studie.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Placebo
Placebo matchet med lixisenatid én gang daglig (QD) frem til slutten av behandlingen.
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Farmasøytisk form: Steril vandig løsning; Administrasjonsvei: Subkutant innen 1 time før frokost.
|
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Eksperimentell: Lixisenatid
Lixisenatid 10 mcg QD i 2 uker etter randomisering, deretter i en vedlikeholdsdose på 20 mcg QD frem til slutten av behandlingen.
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Farmasøytisk form: Steril vandig løsning; Administrasjonsvei: Subkutant innen 1 time før frokost med selvinjektorpenn (Opticlik®).
Hvis vedlikeholdsdosen på 20 mcg ikke ble tolerert, kan dosen reduseres til 15 eller 10 mcg.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Tid til første forekomst av primær CV-hendelse: CV-død, ikke-fatal MI, ikke-fatal hjerneslag eller sykehusinnleggelse for ustabil angina
Tidsramme: Fra randomisering til slutten av studien (median oppfølging på 25 måneder)
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Kaplan Meier-plott av den kumulative forekomsten etter behandlingsgrupper ble brukt for å skildre begynnelsen av primært CV-endepunkt over tid.
Antall observerte deltakere med endepunkthendelser ble rapportert.
En CV-begivenhetsvurderingskomité (CAC) gjennomgikk og dømte, på en blind måte, alle potensielle hendelser.
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Fra randomisering til slutten av studien (median oppfølging på 25 måneder)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Tid til første forekomst av CV-hendelse: CV-død, ikke-fatal MI, ikke-dødelig hjerneslag, sykehusinnleggelse for ustabil angina eller sykehusinnleggelse for hjertesvikt
Tidsramme: Fra randomisering til slutten av studien (median oppfølging på 25 måneder)
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Alle CV-hendelser ble positivt bedømt av CAC, brukt i analysen av det sammensatte CV-endepunktet bestående av CV-død, ikke-dødelig MI, ikke-dødelig hjerneslag, sykehusinnleggelse for ustabil angina eller sykehusinnleggelse for hjertesvikt.
Antall observerte deltakere med endepunkthendelser ble rapportert.
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Fra randomisering til slutten av studien (median oppfølging på 25 måneder)
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Tid til første forekomst av CV-hendelse: CV-død, ikke-fatal MI, ikke-dødelig hjerneslag, sykehusinnleggelse for ustabil angina, sykehusinnleggelse for hjertesvikt eller koronar revaskulariseringsprosedyre
Tidsramme: Fra randomisering til slutten av studien (median oppfølging på 25 måneder)
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Alle CV-hendelser ble positivt bedømt av CAC, brukt i analysen av det sammensatte CV-endepunktet bestående av CV-død, ikke-fatal MI, ikke-dødelig hjerneslag, sykehusinnleggelse for ustabil angina, sykehusinnleggelse for hjertesvikt eller koronar revaskulariseringsprosedyre.
Antall observerte deltakere med endepunkthendelser ble rapportert.
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Fra randomisering til slutten av studien (median oppfølging på 25 måneder)
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Prosentvis endring fra baseline i urinalbumin/kreatinin-forholdet (UACR) ved uke 108
Tidsramme: Grunnlinje til uke 108 (LOCF)
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Tilstedeværelse av albumin i urin er en markør for nefropati, en viktig mikrovaskulær komplikasjon av diabetes.
UACR ble definert som forholdet: mg albumin per gram kreatinin.
UACR-data ble loggtransformert før analysen.
Beregningen var basert på geometrisk gjennomsnitt.
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Grunnlinje til uke 108 (LOCF)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Am J Manag Care. 2018 Apr;24(8 Suppl):S146-S155.
- Bentley-Lewis R, Aguilar D, Riddle MC, Claggett B, Diaz R, Dickstein K, Gerstein HC, Johnston P, Kober LV, Lawson F, Lewis EF, Maggioni AP, McMurray JJ, Ping L, Probstfield JL, Solomon SD, Tardif JC, Wu Y, Pfeffer MA; ELIXA Investigators. Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo. Am Heart J. 2015 May;169(5):631-638.e7. doi: 10.1016/j.ahj.2015.02.002. Epub 2015 Feb 12.
- Pfeffer MA, Claggett B, Diaz R, Dickstein K, Gerstein HC, Kober LV, Lawson FC, Ping L, Wei X, Lewis EF, Maggioni AP, McMurray JJ, Probstfield JL, Riddle MC, Solomon SD, Tardif JC; ELIXA Investigators. Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome. N Engl J Med. 2015 Dec 3;373(23):2247-57. doi: 10.1056/NEJMoa1509225.
- Gerstein HC, Hess S, Claggett B, Dickstein K, Kober L, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Tardif JC, Pfeffer MA. Protein Biomarkers and Cardiovascular Outcomes in People With Type 2 Diabetes and Acute Coronary Syndrome: The ELIXA Biomarker Study. Diabetes Care. 2022 Sep 1;45(9):2152-2155. doi: 10.2337/dc22-0453.
- Wijkman MO, Claggett B, Diaz R, Gerstein HC, Kober L, Lewis E, Maggioni AP, Wolsk E, Aguilar D, Bentley-Lewis R, McMurray JJ, Probstfield J, Riddle M, Tardif JC, Solomon SD, Pfeffer MA. Blood pressure and mortality in patients with type 2 diabetes and a recent coronary event in the ELIXA trial. Cardiovasc Diabetol. 2020 Oct 12;19(1):175. doi: 10.1186/s12933-020-01150-0.
- Shin SH, Claggett B, Pfeffer MA, Skali H, Liu J, Aguilar D, Diaz R, Dickstein K, Gerstein HC, Kober LV, Lawson FC, Lewis EF, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Tardif JC, Solomon SD; ELIXA Investigators. Hyperglycaemia, ejection fraction and the risk of heart failure or cardiovascular death in patients with type 2 diabetes and a recent acute coronary syndrome. Eur J Heart Fail. 2020 Jul;22(7):1133-1143. doi: 10.1002/ejhf.1790. Epub 2020 Mar 25.
- Seferovic JP, Bentley-Lewis R, Claggett B, Diaz R, Gerstein HC, Kober LV, Lawson FC, Lewis EF, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Solomon SD, Tardif JC, Pfeffer MA. Retinopathy, Neuropathy, and Subsequent Cardiovascular Events in Patients with Type 2 Diabetes and Acute Coronary Syndrome in the ELIXA: The Importance of Disease Duration. J Diabetes Res. 2018 Dec 16;2018:1631263. doi: 10.1155/2018/1631263. eCollection 2018.
- Muskiet MHA, Tonneijck L, Huang Y, Liu M, Saremi A, Heerspink HJL, van Raalte DH. Lixisenatide and renal outcomes in patients with type 2 diabetes and acute coronary syndrome: an exploratory analysis of the ELIXA randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2018 Nov;6(11):859-869. doi: 10.1016/S2213-8587(18)30268-7. Epub 2018 Oct 3.
- Wolsk E, Claggett B, Pfeffer MA, Diaz R, Dickstein K, Gerstein HC, Lawson FC, Lewis EF, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Solomon SD, Tardif JC, Kober L. Role of B-Type Natriuretic Peptide and N-Terminal Prohormone BNP as Predictors of Cardiovascular Morbidity and Mortality in Patients With a Recent Coronary Event and Type 2 Diabetes Mellitus. J Am Heart Assoc. 2017 May 29;6(6):e004743. doi: 10.1161/JAHA.116.004743.
- Wohlfart P, Linz W, Hubschle T, Linz D, Huber J, Hess S, Crowther D, Werner U, Ruetten H. Cardioprotective effects of lixisenatide in rat myocardial ischemia-reperfusion injury studies. J Transl Med. 2013 Mar 28;11:84. doi: 10.1186/1479-5876-11-84.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juni 2010
Primær fullføring (Faktiske)
1. februar 2015
Studiet fullført (Faktiske)
1. februar 2015
Datoer for studieregistrering
Først innsendt
17. juni 2010
Først innsendt som oppfylte QC-kriteriene
17. juni 2010
Først lagt ut (Anslag)
22. juni 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
20. desember 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. oktober 2016
Sist bekreftet
1. oktober 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EFC11319
- 2009-012852-26 (EudraCT-nummer)
- U1111-1116-5558 (Annen identifikator: UTN)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .