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ODYSSEY-resultater: Evaluering af kardiovaskulære resultater efter et akut koronarsyndrom under behandling med Alirocumab

15. marts 2019 opdateret af: Sanofi

En randomiseret, dobbeltblind, placebokontrolleret, parallelgruppeundersøgelse til evaluering af effekten af Alirocumab (SAR236553/REGN727) på forekomsten af kardiovaskulære hændelser hos patienter, der for nylig har oplevet et akut koronarsyndrom

Primært mål:

At sammenligne virkningen af alirocumab med placebo på forekomsten af kardiovaskulære (CV) hændelser (sammensat endepunkt af koronar hjertesygdom (CHD) død, ikke-dødelig myokardieinfarkt (MI), fatal og ikke-dødelig iskæmisk slagtilfælde, ustabil angina (UA) ) kræver hospitalsindlæggelse) hos deltagere, som oplevede en akut koronar syndrom (ACS) hændelse 4 til 52 uger før randomisering og blev behandlet med evidensbaseret medicinsk og diætmæssig behandling af dyslipidæmi.

Sekundære mål:

At evaluere effekten af alirocumab på sekundære endepunkter (enhver CHD hændelse, større CHD hændelse, enhver CV hændelse, sammensat af alle årsager mortalitet/ikke-fatal MI/ikke-dødelig iskæmisk slagtilfælde, CHD dødsfald, CV dødsfald, alle forårsager dødelighed).
For at evaluere sikkerheden og tolerabiliteten af alirocumab.
For at evaluere effekten af alirocumab på lipidparametre.

Studieoversigt

Status

Afsluttet

Betingelser

Aterosklerotisk kardiovaskulær sygdom

Intervention / Behandling

Detaljeret beskrivelse

18924 antal deltagere i alderen >= 40 år blev randomiseret i undersøgelsen.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

18924

Fase

Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Argentina
- - Adrogue, Argentina, B1846DSK
    - Investigational Site Number 032012
  - Bahia Blanca, Argentina, B8000AKK
    - Investigational Site Number 032018
  - Caba, Argentina, C1093AAS
    - Investigational Site Number 032050
  - Caba, Argentina, C1118AAE
    - Investigational Site Number 032048
  - Caba, Argentina, C1119ACN
    - Investigational Site Number 032023
  - Caba, Argentina, C1180AAX
    - Investigational Site Number 032020
  - Caba, Argentina, C1181ACH
    - Investigational Site Number 032041
  - Caba, Argentina, C1425AGC
    - Investigational Site Number 032011
  - Caba, Argentina, C1426EGR
    - Investigational Site Number 032045
  - Ciudad De Buenos Aires, Argentina, C1428DCO
    - Investigational Site Number 032010
  - Ciudadela, Argentina, B1702BML
    - Investigational Site Number 032046
  - Cordoba, Argentina, X5000AAW
    - Investigational Site Number 032032
  - Cordoba, Argentina, X5000AAX
    - Investigational Site Number 032019
  - Cordoba, Argentina, X5000EPU
    - Investigational Site Number 032021
  - Cordoba, Argentina, X5002AOQ
    - Investigational Site Number 032008
  - Cordoba, Argentina, X5004BAL
    - Investigational Site Number 032042
  - Cordoba, Argentina, X5006IKK
    - Investigational Site Number 032038
  - Cordoba, Argentina, X5016KEH
    - Investigational Site Number 032031
  - Coronel Suarez, Argentina, B7540GHD
    - Investigational Site Number 032017
  - Corrientes, Argentina, W3400AMZ
    - Investigational Site Number 032009
  - Córdoba, Argentina, X5000JHQ
    - Investigational Site Number 032026
  - Córdoba, Argentina, X5003DCE
    - Investigational Site Number 032049
  - Junin, Argentina, B6000BHA
    - Investigational Site Number 032005
  - La Plata, Argentina, B1900AXI
    - Investigational Site Number 032001
  - La Plata, Argentina, B1906ESC
    - Investigational Site Number 032040
  - Mar Del Plata, Argentina, B7600FYK
    - Investigational Site Number 032033
  - Mar Del Plata, Argentina, B7600FZN
    - Investigational Site Number 032014
  - Mendoza, Argentina, 5500
    - Investigational Site Number 032016
  - Merlo, Argentina, B1722COV
    - Investigational Site Number 032030
  - Moron, Argentina, B1708CGU
    - Investigational Site Number 032036
  - Olivos, Argentina, 1638
    - Investigational Site Number 032007
  - Olivos, Argentina, B1605DSX
    - Investigational Site Number 032044
  - Quilmes, Argentina, B1878DKF
    - Investigational Site Number 032004
  - Rafaela, Argentina, S2300MMA
    - Investigational Site Number 032025
  - Ramos Mejia, Argentina, B1704ETD
    - Investigational Site Number 032035
  - Resistencia, Argentina, H3500CDM
    - Investigational Site Number 032039
  - Rosario, Argentina, S2000DEJ
    - Investigational Site Number 032028
  - Rosario, Argentina, S2000DSR
    - Investigational Site Number 032024
  - Salta, Argentina, 4400
    - Investigational Site Number 032053
  - San Isidro, Argentina, B1642DCB
    - Investigational Site Number 032037
  - San Martin, Argentina, B1650NBN
    - Investigational Site Number 032052
  - San Martin, Argentina, B1685CSQ
    - Investigational Site Number 032013
  - San Miguel De Tucuman, Argentina, T4000ICL
    - Investigational Site Number 032002
  - San Miguel De Tucuman, Argentina, T4000IFL
    - Investigational Site Number 032034
  - San Nicolas, Argentina, B2900DMH
    - Investigational Site Number 032006
  - Santa Fe, Argentina, S3000EOZ
    - Investigational Site Number 032043
  - Santa Fe, Argentina, S3000FWO
    - Investigational Site Number 032003
  - Santa Rosa, Argentina, L6300DSD
    - Investigational Site Number 032051
  - Santiago Del Estero, Argentina, G4200AQK
    - Investigational Site Number 032047
  - Venado Tuerto, Argentina, S2600KUE
    - Investigational Site Number 032029
  - Villa Maria, Argentina, X5900JKA
    - Investigational Site Number 032022
  - Zarate, Argentina, B2800DGH
    - Investigational Site Number 032015
Australien
- - Ashford, Australien, 5035
    - Investigational Site Number 036002
  - Auchenflower, Australien, 4066
    - Investigational Site Number 036023
  - Ballarat, Australien, 3353
    - Investigational Site Number 036024
  - Bedford Park, Australien, 5042
    - Investigational Site Number 036020
  - Bruce, Australien, 2617
    - Investigational Site Number 036015
  - Cairns, Australien, 4870
    - Investigational Site Number 036026
  - Chermside, Australien, 4032
    - Investigational Site Number 036005
  - Chermside, Australien, 4032
    - Investigational Site Number 036008
  - Coffs Harbour, Australien, 2450
    - Investigational Site Number 036011
  - Concord, Australien, 2137
    - Investigational Site Number 036003
  - Elizabeth Vale, Australien, 5112
    - Investigational Site Number 036017
  - Fullarton, Australien, 5063
    - Investigational Site Number 036006
  - Gosford, Australien, 2250
    - Investigational Site Number 036004
  - Heidelberg West, Australien, 3081
    - Investigational Site Number 036019
  - Hobart, Australien, 7001
    - Investigational Site Number 036027
  - Kogarah, Australien, 2217
    - Investigational Site Number 036009
  - Mildura, Australien, 3500
    - Investigational Site Number 036012
  - Nambour, Australien, 4560
    - Investigational Site Number 036028
  - New Lambton, Australien, 2305
    - Investigational Site Number 036013
  - Perth, Australien, 6000
    - Investigational Site Number 036010
  - Prahran, Australien, 3004
    - Investigational Site Number 036014
  - Redcliffe, Australien, 4020
    - Investigational Site Number 036018
  - Richmond, Australien, 3121
    - Investigational Site Number 036022
  - Woodville South, Australien, 5011
    - Investigational Site Number 036025
  - Woolloongabba, Australien, 4102
    - Investigational Site Number 036021
Belgien
- - Aalst, Belgien, 9300
    - Investigational Site Number 056016
  - Antwerpen, Belgien, 2060
    - Investigational Site Number 056003
  - Antwerpen, Belgien, B-2020
    - Investigational Site Number 056002
  - Bonheiden, Belgien, 2820
    - Investigational Site Number 056008
  - Brasschaat, Belgien, 2930
    - Investigational Site Number 056014
  - Brussels, Belgien, 1070
    - Investigational Site Number 056021
  - Bruxelles, Belgien, 1000
    - Investigational Site Number 056005
  - Bruxelles, Belgien, 1200
    - Investigational Site Number 056004
  - Edegem, Belgien, B-2650
    - Investigational Site Number 056017
  - Genk, Belgien, 3600
    - Investigational Site Number 056024
  - Gent, Belgien, 9000
    - Investigational Site Number 056007
  - Gent, Belgien, 9000
    - Investigational Site Number 056018
  - La Louviere, Belgien, 7100
    - Investigational Site Number 056020
  - Leuven, Belgien, 3000
    - Investigational Site Number 056009
  - Liège, Belgien, 4000
    - Investigational Site Number 056015
  - Mechelen, Belgien, 2800
    - Investigational Site Number 056010
  - Mol, Belgien, 2400
    - Investigational Site Number 056013
  - Ottignies, Belgien, 1340
    - Investigational Site Number 056001
  - Overpelt, Belgien, 3900
    - Investigational Site Number 056012
  - Roeselare, Belgien, 8800
    - Investigational Site Number 056006
  - Tienen, Belgien, 3300
    - Investigational Site Number 056019
Bosnien-Hercegovina
- - Banja Luka, Bosnien-Hercegovina, 78000
    - Investigational Site Number 070001
  - Banja Luka, Bosnien-Hercegovina, 78000
    - Investigational Site Number 070002
  - Bihac, Bosnien-Hercegovina, 77000
    - Investigational Site Number 070011
  - Mostar, Bosnien-Hercegovina, 8000
    - Investigational Site Number 070003
  - Mostar, Bosnien-Hercegovina, 8000
    - Investigational Site Number 070004
  - Sarajevo, Bosnien-Hercegovina, 71000
    - Investigational Site Number 070005
  - Sarajevo, Bosnien-Hercegovina, 71000
    - Investigational Site Number 070007
  - Sarajevo, Bosnien-Hercegovina, 71000
    - Investigational Site Number 070010
  - Tuzla, Bosnien-Hercegovina, 75000
    - Investigational Site Number 070008
  - Tuzla, Bosnien-Hercegovina, 75000
    - Investigational Site Number 070009
  - Zenica, Bosnien-Hercegovina, 72000
    - Investigational Site Number 070006
Brasilien
- - Aparecida De Goiania, Brasilien, 74905-410
    - Investigational Site Number 076029
  - Belem, Brasilien, 66087-660
    - Investigational Site Number 076032
  - Belo Horizonte, Brasilien, 30140-062
    - Investigational Site Number 076017
  - Belo Horizonte, Brasilien, 30150-221
    - Investigational Site Number 076004
  - Belo Horizonte, Brasilien, 30150-320
    - Investigational Site Number 076022
  - Belo Horizonte, Brasilien, 31110-580
    - Investigational Site Number 076038
  - Blumenau, Brasilien, 89010906
    - Investigational Site Number 076002
  - Brasilia, Brasilien, 70390-903
    - Investigational Site Number 076011
  - Brasilia, Brasilien, 70710-100
    - Investigational Site Number 076007
  - Campina Grande Do Sul, Brasilien, 83430-000
    - Investigational Site Number 076003
  - Campinas, Brasilien, 13015-001
    - Investigational Site Number 076006
  - Canoas, Brasilien, 92200-000
    - Investigational Site Number 076040
  - Curitiba, Brasilien, 80430-100
    - Investigational Site Number 076033
  - Curitiba, Brasilien, 80730-150
    - Investigational Site Number 076005
  - Fortaleza, Brasilien, 60110-110
    - Investigational Site Number 076009
  - Fortaleza, Brasilien, 60170-320
    - Investigational Site Number 076008
  - Goiania, Brasilien, 74223-130
    - Investigational Site Number 076012
  - Goiania, Brasilien, 74605-020
    - Investigational Site Number 076021
  - Passo Fundo, Brasilien, 99010-180
    - Investigational Site Number 076019
  - Pelotas, Brasilien, 96015290
    - Investigational Site Number 076018
  - Porto Alegre, Brasilien, 90020-090
    - Investigational Site Number 076024
  - Porto Alegre, Brasilien, 90110270
    - Investigational Site Number 076026
  - Porto Alegre, Brasilien, 90610-000
    - Investigational Site Number 076014
  - Porto Alegre, Brasilien, 90620-001
    - Investigational Site Number 076001
  - Porto Alegre, Brasilien, 91350-250
    - Investigational Site Number 076027
  - Riberao Preto, Brasilien, 14048-900
    - Investigational Site Number 076035
  - Rio De Janeiro, Brasilien, 22271-100
    - Investigational Site Number 076010
  - Salvador, Brasilien, 40050-410
    - Investigational Site Number 076015
  - Salvador, Brasilien, 40050-410
    - Investigational Site Number 076041
  - Santo Andre, Brasilien, 18270170
    - Investigational Site Number 076036
  - Sao Bernardo Do Campo, Brasilien, 9780000
    - Investigational Site Number 076031
  - Sao Jose Do Rio Preto, Brasilien, 15015-210
    - Investigational Site Number 076030
  - Sao Jose Do Rio Preto, Brasilien, 15090-000
    - Investigational Site Number 076020
  - Sao Paulo, Brasilien, 01244-030
    - Investigational Site Number 076025
  - Sao Paulo, Brasilien, 01308-050
    - Investigational Site Number 076042
  - Sao Paulo, Brasilien, 01327010
    - Investigational Site Number 076039
  - Sao Paulo, Brasilien, 01418-100
    - Investigational Site Number 076013
  - Sao Paulo, Brasilien, 04024-002
    - Investigational Site Number 076023
  - Sao Paulo, Brasilien, 05403-000
    - Investigational Site Number 076028
  - Tatuí, Brasilien, 18270-170
    - Investigational Site Number 076016
  - Uberlandia, Brasilien, 38400-368
    - Investigational Site Number 076034
Bulgarien
- - Blagoevgrad, Bulgarien, 2700
    - Investigational Site Number 100020
  - Burgas, Bulgarien, 8000
    - Investigational Site Number 100012
  - Pazardzhik, Bulgarien, 4400
    - Investigational Site Number 100011
  - Pleven, Bulgarien, 5800
    - Investigational Site Number 100013
  - Pleven, Bulgarien, 5800
    - Investigational Site Number 100018
  - Plovdiv, Bulgarien, 4002
    - Investigational Site Number 100005
  - Sandanski, Bulgarien, 2800
    - Investigational Site Number 100015
  - Smoljan, Bulgarien, 4700
    - Investigational Site Number 100023
  - Sofia, Bulgarien, 1142
    - Investigational Site Number 100017
  - Sofia, Bulgarien, 1202
    - Investigational Site Number 100007
  - Sofia, Bulgarien, 1233
    - Investigational Site Number 100001
  - Sofia, Bulgarien, 1233
    - Investigational Site Number 100004
  - Sofia, Bulgarien, 1309
    - Investigational Site Number 100010
  - Sofia, Bulgarien, 1336
    - Investigational Site Number 100019
  - Sofia, Bulgarien, 1431
    - Investigational Site Number 100016
  - Sofia, Bulgarien, 1527
    - Investigational Site Number 100003
  - Varna, Bulgarien, 9000
    - Investigational Site Number 100022
  - Veliko Tarnovo, Bulgarien, 5000
    - Investigational Site Number 100014
Canada
- - Calgary, Canada, T2N 2T8
    - Investigational Site Number 124033
  - Cambridge, Canada, N1R 7R1
    - Investigational Site Number 124017
  - Cambridge, Canada, N3H 3R8
    - Investigational Site Number 124013
  - Edmonton, Canada, T5H 3V9
    - Investigational Site Number 124026
  - Edmonton, Canada, T6G 2B7
    - Investigational Site Number 124019
  - Edmonton, Canada, T6L 5X8
    - Investigational Site Number 124016
  - Granby, Canada, J2G 1T7
    - Investigational Site Number 124027
  - Halifax, Canada, B3H 3A7
    - Investigational Site Number 124002
  - Hamilton, Canada, L8L 2X2
    - Investigational Site Number 124051
  - Joliette, Canada, J6E 6J2
    - Investigational Site Number 124043
  - Kitchener, Canada, N2M 1B2
    - Investigational Site Number 124045
  - Levis, Canada, G6V4Z5
    - Investigational Site Number 124053
  - Longueuil, Canada, J4M 2X1
    - Investigational Site Number 124015
  - Moncton, Canada, E1C 4B7
    - Investigational Site Number 124004
  - Montreal, Canada, H1T 1C8
    - Investigational Site Number 124040
  - Montreal, Canada, H2K 4L5
    - Investigational Site Number 124032
  - Montreal, Canada, H2R 1V6
    - Investigational Site Number 124036
  - Montreal, Canada, H3G 1A4
    - Investigational Site Number 124042
  - New Westminster, Canada, V3L 3W4
    - Investigational Site Number 124028
  - Newmarket, Canada, L3Y 8C3
    - Investigational Site Number 124008
  - Oshawa, Canada, L1J 2K1
    - Investigational Site Number 124005
  - Ottawa, Canada, K1Y4W7
    - Investigational Site Number 124007
  - Penticton, Canada, V2A 3G6
    - Investigational Site Number 124006
  - Red Deer, Canada, T4N 4E7
    - Investigational Site Number 124012
  - Saint-Jerome, Canada, J7Z 5T3
    - Investigational Site Number 124054
  - Sainte-Foy, Canada, G1V 4G5
    - Investigational Site Number 124024
  - Scarborough, Canada, M1E 5E9
    - Investigational Site Number 124035
  - Sherbrooke, Canada, J1H 5N4
    - Investigational Site Number 124047
  - St-Georges, Canada, G5Y 4T8
    - Investigational Site Number 124025
  - St. Catherines, Canada, L2N 7L6
    - Investigational Site Number 124044
  - St. John, Canada, NBE 2L4
    - Investigational Site Number 124021
  - St. John'S, Canada, A1B 3V6
    - Investigational Site Number 124034
  - Surrey, Canada, V3V 1N1
    - Investigational Site Number 124009
  - Sydney, Canada, B1P 1P3
    - Investigational Site Number 124022
  - Thetford Mines, Canada, G6G 2V4
    - Investigational Site Number 124048
  - Thunder Bay, Canada, P7B 6V4
    - Investigational Site Number 124037
  - Toronto, Canada, M5B 1W8
    - Investigational Site Number 124001
  - Trois-Rivieres, Canada, G8Z 3R6
    - Investigational Site Number 124049
  - Vancouver, Canada, V5Z 1M9
    - Investigational Site Number 124039
  - Victoria, Canada, V8R 4R2
    - Investigational Site Number 124023
  - Victoria, Canada, V8T 5G4
    - Investigational Site Number 124041
  - Winnipeg, Canada, R2H 2A6
    - Investigational Site Number 124038
Chile
- - Concepcion, Chile, 4070038
    - Investigational Site Number 152013
  - Osorno, Chile, 5311092
    - Investigational Site Number 152003
  - Punta Arenas, Chile, 6210005
    - Investigational Site Number 152017
  - Santiago, Chile, 8053095
    - Investigational Site Number 152012
  - Santiago, Chile, 7500710
    - Investigational Site Number 152004
  - Santiago, Chile, 7500710
    - Investigational Site Number 152014
  - Santiago, Chile, 7500922
    - Investigational Site Number 152001
  - Santiago, Chile, 7650018
    - Investigational Site Number 152019
  - Santiago, Chile, 7650568
    - Investigational Site Number 152007
  - Santiago, Chile, 832 0000
    - Investigational Site Number 152011
  - Santiago, Chile, 8380456
    - Investigational Site Number 152006
  - Santiago, Chile, 8900085
    - Investigational Site Number 152016
  - Santiago, Chile
    - Investigational Site Number 152015
  - Talca, Chile
    - Investigational Site Number 152009
  - Temuco, Chile, 4781156
    - Investigational Site Number 152002
  - Valdivia, Chile, 5090145
    - Investigational Site Number 152008
  - Viña Del Mar, Chile, 2520000
    - Investigational Site Number 152010
  - Viña Del Mar, Chile, 2520997
    - Investigational Site Number 152018
Colombia
- - Armenia, Colombia, 630004
    - Investigational Site Number 170006
  - Barranquilla, Colombia, 08013
    - Investigational Site Number 170003
  - Barranquilla, Colombia
    - Investigational Site Number 170011
  - Barranquilla, Colombia
    - Investigational Site Number 170013
  - Bogota, Colombia, 11001000
    - Investigational Site Number 170018
  - Bogota, Colombia, 111211
    - Investigational Site Number 170016
  - Bogota D.C., Colombia
    - Investigational Site Number 170022
  - Cali, Colombia, 572
    - Investigational Site Number 170010
  - Cali, Colombia
    - Investigational Site Number 170001
  - Cartagena, Colombia, 130010
    - Investigational Site Number 170017
  - Cartagena, Colombia
    - Investigational Site Number 170004
  - Espinal - Tolima, Colombia
    - Investigational Site Number 170008
  - Floridablanca, Colombia, 681004
    - Investigational Site Number 170005
  - Manizales, Colombia, 170004
    - Investigational Site Number 170002
  - Medellin, Colombia
    - Investigational Site Number 170009
  - Medellin, Colombia, 050012
    - Investigational Site Number 170007
  - Medellin, Colombia
    - Investigational Site Number 170021
Danmark
- - Aabenraa, Danmark, 6200
    - Investigational Site Number 208016
  - Aalborg, Danmark, 9000
    - Investigational Site Number 208012
  - Aarhus N, Danmark, 8200
    - Investigational Site Number 208011
  - Copenhagen, Danmark, 2100
    - Investigational Site Number 208002
  - Glostrup, Danmark, 2600
    - Investigational Site Number 208003
  - Hellerup, Danmark, 2900
    - Investigational Site Number 208007
  - Herning, Danmark, 7400
    - Investigational Site Number 208006
  - Hillerød, Danmark, 3400
    - Investigational Site Number 208018
  - Holbaek, Danmark, 4300
    - Investigational Site Number 208014
  - Hvidovre, Danmark, 2650
    - Investigational Site Number 208013
  - Køge, Danmark, 4600
    - Investigational Site Number 208004
  - Næstved, Danmark, 4700
    - Investigational Site Number 208017
  - Odense C, Danmark, 5000
    - Investigational Site Number 208009
  - Silkeborg, Danmark, 8600
    - Investigational Site Number 208015
  - Slagelse, Danmark, 4200
    - Investigational Site Number 208008
  - Vejle, Danmark, 7100
    - Investigational Site Number 208001
  - Viborg, Danmark, 8800
    - Investigational Site Number 208010
Den Russiske Føderation
- - Barnaul, Den Russiske Føderation, 656055
    - Investigational Site Number 643027
  - Kazan, Den Russiske Føderation, 420012
    - Investigational Site Number 643037
  - Kemerovo, Den Russiske Føderation, 650002
    - Investigational Site Number 643013
  - Krasnodar, Den Russiske Føderation, 350042
    - Investigational Site Number 643020
  - Krasnodar, Den Russiske Føderation, 350086
    - Investigational Site Number 643053
  - Moscow, Den Russiske Føderation, 101990
    - Investigational Site Number 643033
  - Moscow, Den Russiske Føderation, 111539
    - Investigational Site Number 643002
  - Moscow, Den Russiske Føderation, 117292
    - Investigational Site Number 643011
  - Moscow, Den Russiske Føderation, 121356
    - Investigational Site Number 643029
  - Moscow, Den Russiske Føderation, 121552
    - Investigational Site Number 643028
  - Moscow, Den Russiske Føderation, 125284
    - Investigational Site Number 643004
  - Moscow, Den Russiske Føderation, 125284
    - Investigational Site Number 643016
  - Moscow, Den Russiske Føderation, 127473
    - Investigational Site Number 643023
  - Moscow, Den Russiske Føderation, 127644
    - Investigational Site Number 643044
  - Moscow, Den Russiske Føderation, 129301
    - Investigational Site Number 643022
  - Moscow, Den Russiske Føderation, 129327
    - Investigational Site Number 643031
  - Nizhny Novgorod, Den Russiske Føderation, 603005
    - Investigational Site Number 643043
  - Novosibirsk, Den Russiske Føderation, 630075
    - Investigational Site Number 643034
  - Novosibirsk, Den Russiske Føderation, 630089
    - Investigational Site Number 643052
  - Novosibirsk, Den Russiske Føderation
    - Investigational Site Number 643050
  - Omsk, Den Russiske Føderation, 644112
    - Investigational Site Number 643035
  - Perm, Den Russiske Føderation, 614077
    - Investigational Site Number 643039
  - Rostov-Na-Donu, Den Russiske Føderation, 344068
    - Investigational Site Number 643008
  - Ryazan, Den Russiske Føderation, 390026
    - Investigational Site Number 643017
  - Saint - Petersburg, Den Russiske Føderation, 190013
    - Investigational Site Number 643006
  - Saint - Petersburg, Den Russiske Føderation, 190013
    - Investigational Site Number 643015
  - Saint Petersburg, Den Russiske Føderation, 194044
    - Investigational Site Number 643001
  - Saint Petersburg, Den Russiske Føderation, 196601
    - Investigational Site Number 643007
  - Saint-Petersburg, Den Russiske Føderation, 192242
    - Investigational Site Number 643051
  - Saint-Petersburg, Den Russiske Føderation, 194354
    - Investigational Site Number 643042
  - Saint-Petersburg, Den Russiske Føderation, 197022
    - Investigational Site Number 643040
  - Saratov, Den Russiske Føderation, 410028
    - Investigational Site Number 643012
  - Saratov, Den Russiske Føderation, 410028
    - Investigational Site Number 643021
  - Saratov, Den Russiske Føderation, 410053
    - Investigational Site Number 643003
  - Saratov, Den Russiske Føderation, 410054
    - Investigational Site Number 643014
  - St-Petersburg, Den Russiske Føderation, 194044
    - Investigational Site Number 643030
  - St-Petersburg, Den Russiske Føderation, 194291
    - Investigational Site Number 643010
  - St-Petersburg, Den Russiske Føderation, 199106
    - Investigational Site Number 643054
  - Tomsk, Den Russiske Føderation, 634012
    - Investigational Site Number 643049
  - Tyumen, Den Russiske Føderation, 625000
    - Investigational Site Number 643019
  - Tyumen, Den Russiske Føderation, 625026
    - Investigational Site Number 643025
  - Voronezh, Den Russiske Føderation, 394065
    - Investigational Site Number 643045
  - Yaroslavl, Den Russiske Føderation, 150029
    - Investigational Site Number 643009
Det Forenede Kongerige
- - Basildon, Det Forenede Kongerige, SS16 5NL
    - Investigational Site Number 826018
  - Birmingham, Det Forenede Kongerige, B18 7QH
    - Investigational Site Number 826015
  - Birmingham, Det Forenede Kongerige, B9 5SS
    - Investigational Site Number 826030
  - Bournemouth, Det Forenede Kongerige, BH7 7DW
    - Investigational Site Number 826038
  - Bradford, Det Forenede Kongerige, BD9 6RJ
    - Investigational Site Number 826025
  - Burton On Trent, Det Forenede Kongerige, DE13 0RB
    - Investigational Site Number 826027
  - Cardiff, Det Forenede Kongerige, CF14 4XW
    - Investigational Site Number 826017
  - Chertsey, Det Forenede Kongerige, KT16 0PZ
    - Investigational Site Number 826010
  - Chesterfield, Det Forenede Kongerige, S44 5BL
    - Investigational Site Number 826012
  - Chichester, Det Forenede Kongerige, PO19 4SE
    - Investigational Site Number 826039
  - Cumbria, Det Forenede Kongerige, LA14 4LF
    - Investigational Site Number 826024
  - Dudley, Det Forenede Kongerige, DY1 2HQ
    - Investigational Site Number 826041
  - Harrow, Det Forenede Kongerige, HA1 3UJ
    - Investigational Site Number 826021
  - High Wycombe, Det Forenede Kongerige, HP11 2TT
    - Investigational Site Number 826026
  - Hull, Det Forenede Kongerige, HU16 5JQ
    - Investigational Site Number 826028
  - London, Det Forenede Kongerige, E2 9JX
    - Investigational Site Number 826034
  - Manchester, Det Forenede Kongerige, M13 9WL
    - Investigational Site Number 826004
  - Newcastle Upon Tyne, Det Forenede Kongerige, NE7 7DN
    - Investigational Site Number 826011
  - Northampton, Det Forenede Kongerige, NN1 5BD
    - Investigational Site Number 826036
  - Peterborough, Det Forenede Kongerige, PE3 9GZ
    - Investigational Site Number 826019
  - Plymouth, Det Forenede Kongerige, PL6 8DH
    - Investigational Site Number 826020
  - Portadown, Det Forenede Kongerige, BT63 5QQ
    - Investigational Site Number 826040
  - Portsmouth, Det Forenede Kongerige, PO6 3LY
    - Investigational Site Number 826016
  - Redhill, Det Forenede Kongerige, RH1 5RH
    - Investigational Site Number 826014
  - Rhyl, Det Forenede Kongerige, LL18 5UJ
    - Investigational Site Number 826007
  - Romford, Det Forenede Kongerige, RM7 0AG
    - Investigational Site Number 826001
  - Rotherham, Det Forenede Kongerige, S60 2UD
    - Investigational Site Number 826009
  - Sheffield, Det Forenede Kongerige, S10 2RX
    - Investigational Site Number 826002
  - South Shields, Det Forenede Kongerige, NE34 0PL
    - Investigational Site Number 826032
  - St Leonards, Det Forenede Kongerige, TN37 7RD
    - Investigational Site Number 826013
  - Stoke-On-Trent, Det Forenede Kongerige, ST4 6QG
    - Investigational Site Number 826005
  - Sunderland, Det Forenede Kongerige, SR4 7TP
    - Investigational Site Number 826031
  - Truro, Det Forenede Kongerige, TR1 3LJ
    - Investigational Site Number 826022
  - Wigan, Det Forenede Kongerige, WN1 2NN
    - Investigational Site Number 826035
  - Worcester, Det Forenede Kongerige, WR5 1DD
    - Investigational Site Number 826003
Estland
- - Pärnu, Estland, 80010
    - Investigational Site Number 233007
  - Tallinn, Estland, 10138
    - Investigational Site Number 233004
  - Tallinn, Estland, 11913
    - Investigational Site Number 233002
  - Tallinn, Estland, 13415
    - Investigational Site Number 233001
  - Tallinn, Estland, 13419
    - Investigational Site Number 233005
  - Tartu, Estland, 50406
    - Investigational Site Number 233003
  - Viljandimaa, Estland, 71024
    - Investigational Site Number 233006
Filippinerne
- - Cavite, Filippinerne
    - Investigational Site Number 608012
  - Cebu City, Filippinerne, 6000
    - Investigational Site Number 608003
  - Cebu City, Filippinerne, 6000
    - Investigational Site Number 608013
  - Davao, Filippinerne, 8000
    - Investigational Site Number 608010
  - Davao City, Filippinerne, 8000
    - Investigational Site Number 608011
  - Iloilo City, Filippinerne, 5000
    - Investigational Site Number 608006
  - Makati City, Filippinerne, 1218
    - Investigational Site Number 608002
  - Manila, Filippinerne, 1000
    - Investigational Site Number 608004
  - Manila, Filippinerne, 1000
    - Investigational Site Number 608014
  - Quezon, Filippinerne, 1102
    - Investigational Site Number 608005
  - Quezon City, Filippinerne, 1100
    - Investigational Site Number 608001
  - Quezon City, Filippinerne, 1109
    - Investigational Site Number 608009
  - San Juan, Filippinerne, 1500
    - Investigational Site Number 608008
Finland
- - Helsinki, Finland, 00029 HUS
    - Investigational Site Number 246004
  - Oulu, Finland, 90220
    - Investigational Site Number 246001
  - Tampere, Finland, 33520
    - Investigational Site Number 246003
  - Turku, Finland, 20520
    - Investigational Site Number 246002
Forenede Stater
- Alabama
  - Birmingham, Alabama, Forenede Stater, 35235
    - Investigational Site Number 840163
  - Birmingham, Alabama, Forenede Stater, 35294
    - Investigational Site Number 840060
  - Huntsville, Alabama, Forenede Stater, 35801
    - Investigational Site Number 840117
  - Huntsville, Alabama, Forenede Stater, 35801
    - Investigational Site Number 840192
  - Mobile, Alabama, Forenede Stater, 36604
    - Investigational Site Number 840121
  - Mobile, Alabama, Forenede Stater, 36695
    - Investigational Site Number 840319
- Arizona
  - Atlantis, Arizona, Forenede Stater, 33462
    - Investigational Site Number 840332
  - Newport Beach, Arizona, Forenede Stater, 92663
    - Investigational Site Number 840320
  - Tucson, Arizona, Forenede Stater, 85724
    - Investigational Site Number 840103
  - Tucson, Arizona, Forenede Stater
    - Investigational Site Number 840084
- California
  - Banning, California, Forenede Stater
    - Investigational Site Number 840139
  - Beverly Hills, California, Forenede Stater, 90210
    - Investigational Site Number 840286
  - Beverly Hills, California, Forenede Stater, 90211
    - Investigational Site Number 840246
  - Beverly Hills, California, Forenede Stater, 90211
    - Investigational Site Number 840353
  - Carmichael, California, Forenede Stater, 95608
    - Investigational Site Number 840341
  - Chula Vista, California, Forenede Stater, 91910
    - Investigational Site Number 840299
  - Fresno, California, Forenede Stater, 93721
    - Investigational Site Number 840164
  - Fullerton, California, Forenede Stater, 92835
    - Investigational Site Number 840076
  - Huntington Beach, California, Forenede Stater, 92648
    - Investigational Site Number 840073
  - La Jolla, California, Forenede Stater, 92093
    - Investigational Site Number 840092
  - Long Beach, California, Forenede Stater, 90801
    - Investigational Site Number 840208
  - Long Beach, California, Forenede Stater, 90822
    - Investigational Site Number 840068
  - Los Alamitos, California, Forenede Stater, 90720
    - Investigational Site Number 840269
  - Los Angeles, California, Forenede Stater, 90073
    - Investigational Site Number 840009
  - Los Angeles, California, Forenede Stater, 90095
    - Investigational Site Number 840282
  - Mission Viejo, California, Forenede Stater, 92691
    - Investigational Site Number 840019
  - Moreno Valley, California, Forenede Stater, 92553
    - Investigational Site Number 840336
  - Northridge, California, Forenede Stater, 91325
    - Investigational Site Number 840124
  - Pasadena, California, Forenede Stater, 91105
    - Investigational Site Number 840251
  - Pasadena, California, Forenede Stater, 91105
    - Investigational Site Number 840289
  - Port Hueneme, California, Forenede Stater, 93041
    - Investigational Site Number 840312
  - San Diego, California, Forenede Stater, 92120
    - Investigational Site Number 840261
  - San Diego, California, Forenede Stater, 92120
    - Investigational Site Number 840310
  - San Diego, California, Forenede Stater
    - Investigational Site Number 840024
  - Santa Ana, California, Forenede Stater, 92704
    - Investigational Site Number 840071
  - Santa Rosa, California, Forenede Stater, 95405
    - Investigational Site Number 840236
  - Torrance, California, Forenede Stater
    - Investigational Site Number 840012
- Colorado
  - Aurora, Colorado, Forenede Stater, 80012
    - Investigational Site Number 840096
  - Colorado Springs, Colorado, Forenede Stater, 80909
    - Investigational Site Number 840037
  - Denver, Colorado, Forenede Stater, 80220
    - Investigational Site Number 840189
- Connecticut
  - Bridgeport, Connecticut, Forenede Stater, 06606
    - Investigational Site Number 840122
  - Guilford, Connecticut, Forenede Stater, 06437
    - Investigational Site Number 840219
- Florida
  - Altamonte Springs, Florida, Forenede Stater, 32714
    - Investigational Site Number 840347
  - Clearwater, Florida, Forenede Stater, 33756
    - Investigational Site Number 840066
  - Daytona Beach, Florida, Forenede Stater, 32114
    - Investigational Site Number 840079
  - Daytona Beach, Florida, Forenede Stater, 32117
    - Investigational Site Number 840051
  - Delray Beach, Florida, Forenede Stater, 33484
    - Investigational Site Number 840368
  - Fort Lauderdale, Florida, Forenede Stater, 33308
    - Investigational Site Number 840242
  - Gainesville, Florida, Forenede Stater, 32608
    - Investigational Site Number 840134
  - Hollywood, Florida, Forenede Stater, 33021
    - Investigational Site Number 840327
  - Hudson, Florida, Forenede Stater, 34667
    - Investigational Site Number 840153
  - Hudson, Florida, Forenede Stater
    - Investigational Site Number 840105
  - Jacksonville, Florida, Forenede Stater, 32204
    - Investigational Site Number 840253
  - Jacksonville, Florida, Forenede Stater, 32209
    - Investigational Site Number 840141
  - Jacksonville, Florida, Forenede Stater, 32216
    - Investigational Site Number 840042
  - Jacksonville, Florida, Forenede Stater, 32216
    - Investigational Site Number 840206
  - Jacksonville, Florida, Forenede Stater, 32258
    - Investigational Site Number 840063
  - Jupiter, Florida, Forenede Stater, 33458
    - Investigational Site Number 840002
  - Largo, Florida, Forenede Stater
    - Investigational Site Number 840119
  - Miami Beach, Florida, Forenede Stater, 33140
    - Investigational Site Number 840241
  - Mount Clemens, Florida, Forenede Stater
    - Investigational Site Number 840210
  - New Port Richey, Florida, Forenede Stater, 34653
    - Investigational Site Number 840366
  - Palm Beach Gardens, Florida, Forenede Stater, 33410
    - Investigational Site Number 840311
  - Palm Harbor, Florida, Forenede Stater, 34684
    - Investigational Site Number 840280
  - Panama City, Florida, Forenede Stater, 32401
    - Investigational Site Number 840054
  - Pembroke Pines, Florida, Forenede Stater, 33024
    - Investigational Site Number 840239
  - Pensacola, Florida, Forenede Stater, 32501
    - Investigational Site Number 840044
  - Plantation, Florida, Forenede Stater, 33317
    - Investigational Site Number 840367
  - Safety Harbor, Florida, Forenede Stater, 34695
    - Investigational Site Number 840132
  - Safety Harbor, Florida, Forenede Stater
    - Investigational Site Number 840061
  - Sarasota, Florida, Forenede Stater, 34239
    - Investigational Site Number 840247
  - Tampa, Florida, Forenede Stater, 33606
    - Investigational Site Number 840264
  - Tampa, Florida, Forenede Stater, 33613
    - Investigational Site Number 840082
  - Trinity, Florida, Forenede Stater, 34655
    - Investigational Site Number 840213
  - Wellington, Florida, Forenede Stater, 33449
    - Investigational Site Number 840165
  - West Palm Beach, Florida, Forenede Stater, 33401
    - Investigational Site Number 840323
- Georgia
  - Atlanta, Georgia, Forenede Stater
    - Investigational Site Number 840075
  - Augusta, Georgia, Forenede Stater, 30901
    - Investigational Site Number 840176
  - Covington, Georgia, Forenede Stater, 30014
    - Investigational Site Number 840048
  - Cumming, Georgia, Forenede Stater, 30041
    - Investigational Site Number 840065
  - Thomasville, Georgia, Forenede Stater, 31792
    - Investigational Site Number 840356
  - Tucker, Georgia, Forenede Stater, 30084
    - Investigational Site Number 840114
- Idaho
  - Idaho Falls, Idaho, Forenede Stater, 83404
    - Investigational Site Number 840211
- Illinois
  - Arlington Heights, Illinois, Forenede Stater, 60005
    - Investigational Site Number 840237
  - Chicago, Illinois, Forenede Stater, 60612
    - Investigational Site Number 840292
  - Harvey, Illinois, Forenede Stater, 60426
    - Investigational Site Number 840146
  - Joliet, Illinois, Forenede Stater, 60435
    - Investigational Site Number 840340
  - Peoria, Illinois, Forenede Stater, 61614
    - Investigational Site Number 840196
  - Rock Island, Illinois, Forenede Stater, 61201
    - Investigational Site Number 840081
  - Rock Island, Illinois, Forenede Stater, 61201
    - Investigational Site Number 840090
- Indiana
  - Elkhart, Indiana, Forenede Stater, 46514
    - Investigational Site Number 840358
  - Hammond, Indiana, Forenede Stater, 46320
    - Investigational Site Number 840036
  - Indianapolis, Indiana, Forenede Stater
    - Investigational Site Number 840026
  - Muncie, Indiana, Forenede Stater, 47303-3400
    - Investigational Site Number 840102
  - South Bend, Indiana, Forenede Stater, 46601-1075
    - Investigational Site Number 840145
- Iowa
  - Ames, Iowa, Forenede Stater, 50010
    - Investigational Site Number 840154
  - Iowa City, Iowa, Forenede Stater
    - Investigational Site Number 840345
  - West Des Moines, Iowa, Forenede Stater, 50266
    - Investigational Site Number 840283
- Kansas
  - Kansas City, Kansas, Forenede Stater, 64116
    - Investigational Site Number 840335
  - Kansas City, Kansas, Forenede Stater, 66160-7321
    - Investigational Site Number 840089
  - Kansas City, Kansas, Forenede Stater
    - Investigational Site Number 840218
  - Overland Park, Kansas, Forenede Stater, 66209
    - Investigational Site Number 840140
- Kentucky
  - Lexington, Kentucky, Forenede Stater
    - Investigational Site Number 840030
  - Louisville, Kentucky, Forenede Stater, 40205
    - Investigational Site Number 840023
  - Louisville, Kentucky, Forenede Stater, 40207
    - Investigational Site Number 840007
  - Owensboro, Kentucky, Forenede Stater, 42303
    - Investigational Site Number 840279
  - Pikeville, Kentucky, Forenede Stater, 41501
    - Investigational Site Number 840308
  - Saint Paul, Kentucky, Forenede Stater, 55102
    - Investigational Site Number 840181
- Louisiana
  - Alexandria, Louisiana, Forenede Stater, 71301
    - Investigational Site Number 840254
  - Lafayette, Louisiana, Forenede Stater, 70503
    - Investigational Site Number 840344
  - Lake Charles, Louisiana, Forenede Stater, 70601
    - Investigational Site Number 840187
  - Minden, Louisiana, Forenede Stater, 71055
    - Investigational Site Number 840291
  - New Orleans, Louisiana, Forenede Stater, 70112
    - Investigational Site Number 840278
  - Shreveport, Louisiana, Forenede Stater, 71103
    - Investigational Site Number 840290
- Maine
  - Auburn, Maine, Forenede Stater, 04210
    - Investigational Site Number 840142
  - Auburn, Maine, Forenede Stater
    - Investigational Site Number 840148
  - Bangor, Maine, Forenede Stater, 04401
    - Investigational Site Number 840097
  - Framingham, Maine, Forenede Stater, 01702
    - Investigational Site Number 840234
  - Scarborough, Maine, Forenede Stater, 04074
    - Investigational Site Number 840276
- Maryland
  - Annapolis, Maryland, Forenede Stater, 21401
    - Investigational Site Number 840351
  - Beltsville, Maryland, Forenede Stater
    - Investigational Site Number 840072
  - Bethesda, Maryland, Forenede Stater, 20817
    - Investigational Site Number 840193
  - Columbia, Maryland, Forenede Stater, 21044
    - Investigational Site Number 840200
  - Rockville, Maryland, Forenede Stater, 20850
    - Investigational Site Number 840349
  - Winfield, Maryland, Forenede Stater
    - Investigational Site Number 840111
- Massachusetts
  - Boston, Massachusetts, Forenede Stater, 02111
    - Investigational Site Number 840056
- Michigan
  - Flint, Michigan, Forenede Stater, 48532
    - Investigational Site Number 840144
  - Grandville, Michigan, Forenede Stater, 49418
    - Investigational Site Number 840365
  - Kalamazoo, Michigan, Forenede Stater
    - Investigational Site Number 840093
  - Lansing, Michigan, Forenede Stater, 48910
    - Investigational Site Number 840198
  - Rochester Hills, Michigan, Forenede Stater, 48085
    - Investigational Site Number 840087
  - Springfield, Michigan, Forenede Stater, 65807
    - Investigational Site Number 840004
  - Springfield, Michigan, Forenede Stater
    - Investigational Site Number 840267
  - Ypsilanti, Michigan, Forenede Stater, 48197
    - Investigational Site Number 840035
- Minnesota
  - Duluth, Minnesota, Forenede Stater, 55805
    - Investigational Site Number 840199
  - Edina, Minnesota, Forenede Stater, 55435
    - Investigational Site Number 840116
  - Minneapolis, Minnesota, Forenede Stater, 55407
    - Investigational Site Number 840281
  - Saint Cloud, Minnesota, Forenede Stater, 56303
    - Investigational Site Number 840094
  - Saint Paul, Minnesota, Forenede Stater, 55101
    - Investigational Site Number 840324
- Missouri
  - Columbia, Missouri, Forenede Stater, 65201
    - Investigational Site Number 840046
  - Independence, Missouri, Forenede Stater, 64057
    - Investigational Site Number 840180
  - Little Rock, Missouri, Forenede Stater
    - Investigational Site Number 840274
  - Marquette, Missouri, Forenede Stater
    - Investigational Site Number 840013
  - Overland, Missouri, Forenede Stater
    - Investigational Site Number 840179
  - Saint Louis, Missouri, Forenede Stater, 63128
    - Investigational Site Number 840228
  - Saint Louis, Missouri, Forenede Stater, 63128
    - Investigational Site Number 840233
  - Saint Louis, Missouri, Forenede Stater, 63128
    - Investigational Site Number 840235
  - Saint Louis, Missouri, Forenede Stater, 63136
    - Investigational Site Number 840175
  - Saint Louis, Missouri, Forenede Stater, 63141
    - Investigational Site Number 840125
  - Saint Louis, Missouri, Forenede Stater
    - Investigational Site Number 840168
- Montana
  - Kalispell, Montana, Forenede Stater, 59901
    - Investigational Site Number 840032
- Nebraska
  - Grand Island, Nebraska, Forenede Stater, 68803
    - Investigational Site Number 840033
  - Omaha, Nebraska, Forenede Stater, 68122
    - Investigational Site Number 840015
  - Omaha, Nebraska, Forenede Stater, 68122
    - Investigational Site Number 840021
  - Omaha, Nebraska, Forenede Stater
    - Investigational Site Number 840001
- Nevada
  - Las Vegas, Nevada, Forenede Stater, 89146
    - Investigational Site Number 840221
- New Hampshire
  - Nashua, New Hampshire, Forenede Stater, 03060
    - Investigational Site Number 840062
- New Jersey
  - Bridgewater, New Jersey, Forenede Stater, 08807
    - Investigational Site Number 840077
  - Bridgewater, New Jersey, Forenede Stater
    - Investigational Site Number 840173
  - Flemington, New Jersey, Forenede Stater, 08822
    - Investigational Site Number 840127
  - Hackensack, New Jersey, Forenede Stater, 07601
    - Investigational Site Number 840359
  - Moorestown, New Jersey, Forenede Stater, 08057
    - Investigational Site Number 840348
  - New Brunswick, New Jersey, Forenede Stater, 08903-0019
    - Investigational Site Number 840128
  - Pomona, New Jersey, Forenede Stater, 08240
    - Investigational Site Number 840167
  - Ridgewood, New Jersey, Forenede Stater, 07506
    - Investigational Site Number 840067
  - Somerset, New Jersey, Forenede Stater, 08873
    - Investigational Site Number 840250
  - Voorhees, New Jersey, Forenede Stater, 08043
    - Investigational Site Number 840277
  - Westwood, New Jersey, Forenede Stater
    - Investigational Site Number 840083
- New York
  - Bronx, New York, Forenede Stater, 10467
    - Investigational Site Number 840222
  - Buffalo, New York, Forenede Stater, 14215
    - Investigational Site Number 840322
  - New York, New York, Forenede Stater, 10016
    - Investigational Site Number 840248
  - New York, New York, Forenede Stater
    - Investigational Site Number 840371
  - Newburgh, New York, Forenede Stater, 47630
    - Investigational Site Number 840333
  - Poughkeepsie, New York, Forenede Stater, 12601
    - Investigational Site Number 840017
  - Valhalla, New York, Forenede Stater, 10595
    - Investigational Site Number 840166
  - Williamsville, New York, Forenede Stater, 14221
    - Investigational Site Number 840354
- North Carolina
  - Elizabeth City, North Carolina, Forenede Stater, 27909
    - Investigational Site Number 840070
  - Greenville, North Carolina, Forenede Stater, 27834
    - Investigational Site Number 840303
  - Greenville, North Carolina, Forenede Stater
    - Investigational Site Number 840182
  - Raleigh, North Carolina, Forenede Stater, 27610
    - Investigational Site Number 840243
  - Raleigh, North Carolina, Forenede Stater, 27610
    - Investigational Site Number 840342
  - Rocky Mount, North Carolina, Forenede Stater, 27804
    - Investigational Site Number 840293
  - Statesville, North Carolina, Forenede Stater, 28627
    - Investigational Site Number 840088
  - Wilmington, North Carolina, Forenede Stater, 28401
    - Investigational Site Number 840052
- North Dakota
  - Baltimore, North Dakota, Forenede Stater, 21229
    - Investigational Site Number 840306
  - Fargo, North Dakota, Forenede Stater
    - Investigational Site Number 840214
  - Minot, North Dakota, Forenede Stater, 58701
    - Investigational Site Number 840095
  - Mountain Lakes, North Dakota, Forenede Stater
    - Investigational Site Number 840257
- Ohio
  - Akron, Ohio, Forenede Stater, 44304
    - Investigational Site Number 840364
  - Cincinnati, Ohio, Forenede Stater
    - Investigational Site Number 840131
  - Columbus, Ohio, Forenede Stater, 43210
    - Investigational Site Number 840045
  - Columbus, Ohio, Forenede Stater, 43210
    - Investigational Site Number 840265
  - Lorain, Ohio, Forenede Stater, 44053
    - Investigational Site Number 840113
  - Lorain, Ohio, Forenede Stater, 44053
    - Investigational Site Number 840115
  - Maumee, Ohio, Forenede Stater, 43537
    - Investigational Site Number 840309
  - Springfield, Ohio, Forenede Stater, 45505
    - Investigational Site Number 840297
  - Toledo, Ohio, Forenede Stater, 43623
    - Investigational Site Number 840172
  - Youngstown, Ohio, Forenede Stater, 44501
    - Investigational Site Number 840263
- Oklahoma
  - Oklahoma City, Oklahoma, Forenede Stater, 73104
    - Investigational Site Number 840334
  - Oklahoma City, Oklahoma, Forenede Stater, 73120
    - Investigational Site Number 840337
  - Tulsa, Oklahoma, Forenede Stater, 74104
    - Investigational Site Number 840018
- Oregon
  - Portland, Oregon, Forenede Stater, 97239
    - Investigational Site Number 840184
- Pennsylvania
  - Allentown, Pennsylvania, Forenede Stater, 18102
    - Investigational Site Number 840133
  - Beaver, Pennsylvania, Forenede Stater, 15009
    - Investigational Site Number 840104
  - Camp Hill, Pennsylvania, Forenede Stater, 17011
    - Investigational Site Number 840170
  - Doylestown, Pennsylvania, Forenede Stater, 18901
    - Investigational Site Number 840020
  - Erie, Pennsylvania, Forenede Stater, 16502-4604
    - Investigational Site Number 840016
  - Goodyear, Pennsylvania, Forenede Stater, 85395
    - Investigational Site Number 840329
  - Knoxville, Pennsylvania, Forenede Stater
    - Investigational Site Number 840126
  - Lancaster, Pennsylvania, Forenede Stater, 17603
    - Investigational Site Number 840249
  - Lancaster, Pennsylvania, Forenede Stater
    - Investigational Site Number 840150
  - Philadelphia, Pennsylvania, Forenede Stater, 19085
    - Investigational Site Number 840231
  - Philadelphia, Pennsylvania, Forenede Stater, 19104
    - Investigational Site Number 840339
  - Pittsburgh, Pennsylvania, Forenede Stater, 15240
    - Investigational Site Number 840230
  - Sayre, Pennsylvania, Forenede Stater, 18840
    - Investigational Site Number 840028
  - Scranton, Pennsylvania, Forenede Stater, 18503
    - Investigational Site Number 840069
  - Scranton, Pennsylvania, Forenede Stater, 18510
    - Investigational Site Number 840316
  - Seven Fields, Pennsylvania, Forenede Stater, 16046
    - Investigational Site Number 840273
  - Washington, Pennsylvania, Forenede Stater
    - Investigational Site Number 840227
- Rhode Island
  - Pawtucket, Rhode Island, Forenede Stater, 02860
    - Investigational Site Number 840129
- South Carolina
  - Anderson, South Carolina, Forenede Stater, 29621
    - Investigational Site Number 840118
  - Greenwood, South Carolina, Forenede Stater
    - Investigational Site Number 840190
  - Lancaster, South Carolina, Forenede Stater, 29720
    - Investigational Site Number 840360
  - Myrtle Beach, South Carolina, Forenede Stater, 29572
    - Investigational Site Number 840314
- South Dakota
  - Rapid City, South Dakota, Forenede Stater, 57701
    - Investigational Site Number 840008
- Tennessee
  - Chattanooga, Tennessee, Forenede Stater, 37421
    - Investigational Site Number 840285
  - Jackson, Tennessee, Forenede Stater, 38301
    - Investigational Site Number 840287
  - Johnson City, Tennessee, Forenede Stater, 37604
    - Investigational Site Number 840040
  - Knoxville, Tennessee, Forenede Stater, 37917-4524
    - Investigational Site Number 840238
  - Oak Ridge, Tennessee, Forenede Stater, 37830
    - Investigational Site Number 840195
- Texas
  - Amarillo, Texas, Forenede Stater, 79106
    - Investigational Site Number 840205
  - Amarillo, Texas, Forenede Stater, 79106
    - Investigational Site Number 840352
  - Austin, Texas, Forenede Stater, 78756
    - Investigational Site Number 840135
  - Dallas, Texas, Forenede Stater, 75226
    - Investigational Site Number 840301
  - Dallas, Texas, Forenede Stater, 75231
    - Investigational Site Number 840152
  - Dallas, Texas, Forenede Stater, 75390
    - Investigational Site Number 840157
  - Fort Worth, Texas, Forenede Stater, 76104
    - Investigational Site Number 840229
  - Fort Worth, Texas, Forenede Stater, 76107
    - Investigational Site Number 840120
  - Fort Worth, Texas, Forenede Stater
    - Investigational Site Number 840258
  - Kingwood, Texas, Forenede Stater, 77339
    - Investigational Site Number 840136
  - Lubbock, Texas, Forenede Stater, 79410
    - Investigational Site Number 840027
  - Lufkin, Texas, Forenede Stater, 75904
    - Investigational Site Number 840202
  - Odessa, Texas, Forenede Stater, 79761
    - Investigational Site Number 840270
  - San Antonio, Texas, Forenede Stater, 78229
    - Investigational Site Number 840162
  - San Antonio, Texas, Forenede Stater, 78229
    - Investigational Site Number 840232
  - Schertz, Texas, Forenede Stater, 78154
    - Investigational Site Number 840328
  - Tyler, Texas, Forenede Stater, 75701
    - Investigational Site Number 840158
  - Victoria, Texas, Forenede Stater, 77901
    - Investigational Site Number 840318
  - Wichita Falls, Texas, Forenede Stater
    - Investigational Site Number 840245
- Utah
  - Orem, Utah, Forenede Stater, 84058
    - Investigational Site Number 840256
  - Salt Lake City, Utah, Forenede Stater, 84124
    - Investigational Site Number 840296
- Vermont
  - Burlington, Vermont, Forenede Stater, 05401
    - Investigational Site Number 840053
- Virginia
  - Charlottesville, Virginia, Forenede Stater, 22908-0679
    - Investigational Site Number 840049
  - Charlottesville, Virginia, Forenede Stater
    - Investigational Site Number 840260
  - Harrisonburg, Virginia, Forenede Stater, 22801
    - Investigational Site Number 840350
  - Leesburg, Virginia, Forenede Stater
    - Investigational Site Number 840215
  - Lynchburg, Virginia, Forenede Stater, 24501
    - Investigational Site Number 840010
  - Manassas, Virginia, Forenede Stater, 20109
    - Investigational Site Number 840225
  - Richmond, Virginia, Forenede Stater, 23225
    - Investigational Site Number 840022
  - Richmond, Virginia, Forenede Stater, 23249
    - Investigational Site Number 840078
  - Richmond, Virginia, Forenede Stater, 23298
    - Investigational Site Number 840110
  - Roanoke, Virginia, Forenede Stater, 24014
    - Investigational Site Number 840149
  - Winchester, Virginia, Forenede Stater, 22601
    - Investigational Site Number 840223
- Washington
  - Bellevue, Washington, Forenede Stater, 98004
    - Investigational Site Number 840025
  - Everett, Washington, Forenede Stater, 98201
    - Investigational Site Number 840321
  - Spokane, Washington, Forenede Stater, 99204
    - Investigational Site Number 840326
  - Tacoma, Washington, Forenede Stater, 98415-0299
    - Investigational Site Number 840086
  - Walla Walla, Washington, Forenede Stater, 99362
    - Investigational Site Number 840295
- Wisconsin
  - Burlington, Wisconsin, Forenede Stater, 53105
    - Investigational Site Number 840262
  - Green Bay, Wisconsin, Forenede Stater, 54303
    - Investigational Site Number 840298
  - Green Bay, Wisconsin, Forenede Stater
    - Investigational Site Number 840059
  - La Crosse, Wisconsin, Forenede Stater, 54601
    - Investigational Site Number 840177
  - Manitowoc, Wisconsin, Forenede Stater, 54220
    - Investigational Site Number 840300
Frankrig
- - Besancon, Frankrig, 25000
    - Investigational Site Number 250003
  - Brest Cedex, Frankrig, 29609
    - Investigational Site Number 250007
  - Cambrai Cedex, Frankrig, 59409
    - Investigational Site Number 250010
  - Clermont-Ferrand Cedex 1, Frankrig, 63003
    - Investigational Site Number 250018
  - Compiegne, Frankrig, 60321
    - Investigational Site Number 250021
  - Dijon, Frankrig, 21000
    - Investigational Site Number 250002
  - Grenoble, Frankrig, 38043
    - Investigational Site Number 250001
  - Limoges Cedex 1, Frankrig, 87042
    - Investigational Site Number 250009
  - Marseille, Frankrig, 13015
    - Investigational Site Number 250019
  - Massy, Frankrig, 91300
    - Investigational Site Number 250008
  - Montfermeil, Frankrig, 93370
    - Investigational Site Number 250005
  - Montpellier Cedex 5, Frankrig, 34295
    - Investigational Site Number 250023
  - Nantes, Frankrig, 44093
    - Investigational Site Number 250025
  - Nice Cedex 01, Frankrig, 06002
    - Investigational Site Number 250017
  - Paris, Frankrig, 75013
    - Investigational Site Number 250020
  - Paris, Frankrig, 75015
    - Investigational Site Number 250012
  - Paris, Frankrig, 75018
    - Investigational Site Number 250004
  - Paris Cedex 12, Frankrig, 75571
    - Investigational Site Number 250015
  - Pau, Frankrig, 64000
    - Investigational Site Number 250011
  - Pessac, Frankrig, 33600
    - Investigational Site Number 250016
  - Rouen, Frankrig, 76000
    - Investigational Site Number 250026
  - Strasbourg Cedex, Frankrig, 67091
    - Investigational Site Number 250022
Georgien
- - Batumi, Georgien, 6010
    - Investigational Site Number 268004
  - Kutaisi, Georgien, 4600
    - Investigational Site Number 268001
  - Tbilisi, Georgien, 102
    - Investigational Site Number 268005
  - Tbilisi, Georgien, 159
    - Investigational Site Number 268002
  - Tbilisi, Georgien, 159
    - Investigational Site Number 268003
  - Tbilisi, Georgien, 159
    - Investigational Site Number 268008
  - Tbilisi, Georgien, 159
    - Investigational Site Number 268009
Grækenland
- - Athens, Grækenland, 11527
    - Investigational Site Number 300002
  - Athens, Grækenland, 11521
    - Investigational Site Number 300001
  - Athens, Grækenland, 16673
    - Investigational Site Number 300007
  - Chios, Grækenland
    - Investigational Site Number 300008
  - Haidari, Grækenland, 12462
    - Investigational Site Number 300013
  - Heraklion, Grækenland, 70013
    - Investigational Site Number 300010
  - Ioannina, Grækenland, 45500
    - Investigational Site Number 300005
  - Marousi, Grækenland, 151 26
    - Investigational Site Number 300003
  - N. Ionia, Grækenland, 14233
    - Investigational Site Number 300006
  - Patra, Grækenland, 26500
    - Investigational Site Number 300004
  - Thessaloniki, Grækenland, 546 36
    - Investigational Site Number 300011
  - Thessaloniki, Grækenland, 54642
    - Investigational Site Number 300009
Guatemala
- - Guatemala, Guatemala, 01001
    - Investigational Site Number 320003
  - Guatemala, Guatemala, 01014
    - Investigational Site Number 320001
  - Guatemala, Guatemala
    - Investigational Site Number 320002
  - Guatemala, Guatemala
    - Investigational Site Number 320004
Holland
- - Alkmaar, Holland, 1815 JD
    - Investigational Site Number 528006
  - Amsterdam, Holland, 1061 AE
    - Investigational Site Number 528022
  - Amsterdam, Holland, 1091 AC
    - Investigational Site Number 528026
  - Apeldoorn, Holland, 7314 ET
    - Investigational Site Number 528021
  - Arnhem, Holland, 6815 AD
    - Investigational Site Number 528029
  - Breda, Holland, 4818 CK
    - Investigational Site Number 528004
  - Delft, Holland, 2625 AD
    - Investigational Site Number 528002
  - Eindhoven, Holland, 5602 ZA
    - Investigational Site Number 528007
  - Goes, Holland, 4462 RA
    - Investigational Site Number 528032
  - Gouda, Holland, 2803 HH
    - Investigational Site Number 528012
  - Groningen, Holland, 9728 NT
    - Investigational Site Number 528001
  - Haarlem, Holland, 2035 RC
    - Investigational Site Number 528025
  - Hardenberg, Holland, 7702 SE
    - Investigational Site Number 528023
  - Heerenveen, Holland, 8441PW
    - Investigational Site Number 528024
  - Hoorn, Holland, 1624 NP
    - Investigational Site Number 528016
  - Leeuwarden, Holland, 8934 AD
    - Investigational Site Number 528019
  - Leiden, Holland, 2333 ZA
    - Investigational Site Number 528008
  - Meppel, Holland, 7943 KA
    - Investigational Site Number 528017
  - Nieuwegein, Holland, 3435 CM
    - Investigational Site Number 528030
  - Nijmegen, Holland, 6500 HB
    - Investigational Site Number 528011
  - Purmerend, Holland, 1441RN
    - Investigational Site Number 528015
  - Roosendaal, Holland, 4708 AE
    - Investigational Site Number 528018
  - Rotterdam, Holland, 3045 PM
    - Investigational Site Number 528014
  - Rotterdam, Holland, 3079
    - Investigational Site Number 528027
  - Sneek, Holland, 8601
    - Investigational Site Number 528005
  - Tiel, Holland, 4002 WP
    - Investigational Site Number 528034
  - Tilburg, Holland, 5022 GC
    - Investigational Site Number 528013
  - Uden, Holland, 5406 PT
    - Investigational Site Number 528028
  - Venlo, Holland, 5912 BL
    - Investigational Site Number 528009
  - Zaandam, Holland, 1502 DV
    - Investigational Site Number 528033
  - Zutphen, Holland, 7207 AE
    - Investigational Site Number 528031
  - Zwolle, Holland, 8011 JW
    - Investigational Site Number 528020
Hong Kong
- - Hong Kong, Hong Kong
    - Investigational Site Number 344003
  - Shatin, Nt, Hong Kong
    - Investigational Site Number 344001
Indien
- - Ahmedabad, Indien, 380008
    - Investigational Site Number 356060
  - Aurangabad, Indien, 431005
    - Investigational Site Number 356056
  - Bangalore, Indien, 560017
    - Investigational Site Number 356025
  - Bangalore, Indien, 560034
    - Investigational Site Number 356028
  - Bangalore, Indien, 560038
    - Investigational Site Number 356083
  - Bangalore, Indien, 560052
    - Investigational Site Number 356018
  - Bangalore, Indien, 560054
    - Investigational Site Number 356026
  - Bangalore, Indien, 560102
    - Investigational Site Number 356084
  - Belgaum, Indien, 590010
    - Investigational Site Number 356103
  - Bikaner, Indien
    - Investigational Site Number 356019
  - Chennai, Indien, 600 037
    - Investigational Site Number 356013
  - Chennai, Indien, 600006
    - Investigational Site Number 356012
  - Chennai, Indien, 603203
    - Investigational Site Number 356081
  - Delhi, Indien, 110060
    - Investigational Site Number 356093
  - Delhi, Indien, 110088
    - Investigational Site Number 356038
  - Gurgaon, Indien, 122001
    - Investigational Site Number 356101
  - Gurgaon, Indien, 122002
    - Investigational Site Number 356100
  - Hyderabad, Indien, 500004
    - Investigational Site Number 356035
  - Hyderabad, Indien, 50063
    - Investigational Site Number 356082
  - Jaipur, Indien, 302001
    - Investigational Site Number 356015
  - Karad, Indien, 415110
    - Investigational Site Number 356053
  - Karamsad, Indien, 388325
    - Investigational Site Number 356102
  - Kochi, Indien, 682018
    - Investigational Site Number 356022
  - Kolhapur, Indien, 416012
    - Investigational Site Number 356106
  - Kolkata, Indien, 700020
    - Investigational Site Number 356067
  - Kolkata, Indien, 700027
    - Investigational Site Number 356079
  - Kolkata, Indien
    - Investigational Site Number 356069
  - Ludhiana, Indien, 141003
    - Investigational Site Number 356089
  - Mangalore, Indien, 575002
    - Investigational Site Number 356095
  - Mumbai, Indien, 400022
    - Investigational Site Number 356071
  - Mumbai, Indien
    - Investigational Site Number 356057
  - Mysore, Indien, 570001
    - Investigational Site Number 356007
  - Nagpur, Indien, 440010
    - Investigational Site Number 356087
  - Nagpur, Indien, 440012
    - Investigational Site Number 356098
  - Nagpur, Indien
    - Investigational Site Number 356097
  - Nashik, Indien, 422005
    - Investigational Site Number 356096
  - New Delhi, Indien, 110017
    - Investigational Site Number 356055
  - New Delhi, Indien, 122001
    - Investigational Site Number 356031
  - Panaji, Indien, 403001
    - Investigational Site Number 356041
  - Pune, Indien, 411001
    - Investigational Site Number 356077
  - Pune, Indien, 411001
    - Investigational Site Number 356099
  - Pune, Indien, 411004
    - Investigational Site Number 356048
  - Pune, Indien, 411004
    - Investigational Site Number 356049
  - Pune, Indien, 411004
    - Investigational Site Number 356050
  - Pune, Indien, 411011
    - Investigational Site Number 356045
  - Pune, Indien, 411013
    - Investigational Site Number 356046
  - Pune, Indien, 411019
    - Investigational Site Number 356094
  - Secunderabad, Indien, 500 003
    - Investigational Site Number 356009
  - Secunderabad, Indien, 500003
    - Investigational Site Number 356032
  - Secunderabad, Hyderabad, Indien, 500003
    - Investigational Site Number 356042
  - Surat, Indien, 395002
    - Investigational Site Number 356091
  - Vijayawada, Indien, 520008
    - Investigational Site Number 356002
  - Vijaywada, Indien, 520002
    - Investigational Site Number 356105
  - Visakhapatnam, Indien, 530002
    - Investigational Site Number 356033
  - Vishkhapattanam, Indien, 530013
    - Investigational Site Number 356039
  - Wardha, Indien, 442004
    - Investigational Site Number 356104
Israel
- - Afula, Israel, 18101
    - Investigational Site Number 376006
  - Afula, Israel, 18101
    - Investigational Site Number 376024
  - Ashkelon, Israel, 78278
    - Investigational Site Number 376009
  - Beer Sheva, Israel, 84101
    - Investigational Site Number 376012
  - Haifa, Israel, 31048
    - Investigational Site Number 376011
  - Haifa, Israel, 31048
    - Investigational Site Number 376017
  - Haifa, Israel, 31048
    - Investigational Site Number 376025
  - Haifa, Israel, 31096
    - Investigational Site Number 376018
  - Holon, Israel, 58100
    - Investigational Site Number 376007
  - Holon, Israel, 58100
    - Investigational Site Number 376021
  - Jerusalem, Israel, 91031
    - Investigational Site Number 376016
  - Jerusalem, Israel, 91120
    - Investigational Site Number 376005
  - Jerusalem, Israel, 91120
    - Investigational Site Number 376027
  - Kfar Saba, Israel, 44281
    - Investigational Site Number 376002
  - Kfar Saba, Israel, 44281
    - Investigational Site Number 376013
  - Nahariya, Israel, 22100
    - Investigational Site Number 376004
  - Nazareth, Israel, 16100
    - Investigational Site Number 376015
  - Petah-Tikva, Israel, 49100
    - Investigational Site Number 376001
  - Petah-Tikva, Israel, 49100
    - Investigational Site Number 376019
  - Rehovot, Israel, 76100
    - Investigational Site Number 376020
  - Safed, Israel, 13100
    - Investigational Site Number 376003
  - Safed, Israel, 13100
    - Investigational Site Number 376008
  - Tel Aviv, Israel, 64239
    - Investigational Site Number 376010
  - Tel Aviv, Israel, 64239
    - Investigational Site Number 376014
  - Tel Hashomer, Israel, 52621
    - Investigational Site Number 376022
  - Tiberias, Israel, 15208
    - Investigational Site Number 376023
  - Tzrifin, Israel, 70300
    - Investigational Site Number 376026
Italien
- - Augusta, Italien, 96100
    - Investigational Site Number 380019
  - Bergamo, Italien, 24127
    - Investigational Site Number 380017
  - Brescia, Italien, 25123
    - Investigational Site Number 380026
  - Brescia, Italien, 25124
    - Investigational Site Number 380008
  - Ferrara, Italien, 44100
    - Investigational Site Number 380012
  - Forlì, Italien, 47100
    - Investigational Site Number 380027
  - Livorno, Italien, 57125
    - Investigational Site Number 380015
  - Massa, Italien, 54100
    - Investigational Site Number 380033
  - Milano, Italien, 20132
    - Investigational Site Number 380030
  - Milano, Italien, 20138
    - Investigational Site Number 380005
  - Milano, Italien, 20148
    - Investigational Site Number 380003
  - Monza, Italien, 20900
    - Investigational Site Number 380025
  - Napoli, Italien, 80100
    - Investigational Site Number 380001
  - Napoli, Italien, 80131
    - Investigational Site Number 380002
  - Novara, Italien, 28100
    - Investigational Site Number 380021
  - Osio Sotto, Italien, 24040
    - Investigational Site Number 380009
  - Palermo, Italien, 90127
    - Investigational Site Number 380007
  - Perugia, Italien, 06132
    - Investigational Site Number 380013
  - Rho, Italien, 20017
    - Investigational Site Number 380031
  - Rimini, Italien, 47900
    - Investigational Site Number 380014
  - Roma, Italien, 00152
    - Investigational Site Number 380024
  - Seriate, Italien, 24068
    - Investigational Site Number 380028
  - Treviso, Italien, 31100
    - Investigational Site Number 380032
  - Vittorio Veneto, Italien, 31029
    - Investigational Site Number 380020
Japan
- - Amagasaki-Shi, Japan
    - Investigational Site Number 392013
  - Amagasaki-Shi, Japan
    - Investigational Site Number 392041
  - Fukuoka-Shi, Japan
    - Investigational Site Number 392029
  - Hachioji-Shi, Japan
    - Investigational Site Number 392019
  - Higashihiroshima-Shi, Japan
    - Investigational Site Number 392026
  - Higashiibaraki-Gun, Japan
    - Investigational Site Number 392024
  - Hiroshima-Shi, Japan
    - Investigational Site Number 392003
  - Itabashi-Ku, Japan
    - Investigational Site Number 392002
  - Itabashi-Ku, Japan
    - Investigational Site Number 392014
  - Izumisano-Shi, Japan
    - Investigational Site Number 392033
  - Kanazawa-Shi, Japan
    - Investigational Site Number 392020
  - Kitakyushu-Shi, Japan
    - Investigational Site Number 392015
  - Kobe-Shi, Japan
    - Investigational Site Number 392017
  - Kobe-Shi, Japan
    - Investigational Site Number 392028
  - Kobe-Shi, Japan
    - Investigational Site Number 392037
  - Koga-Shi, Japan
    - Investigational Site Number 392025
  - Komatsu-Shi, Japan
    - Investigational Site Number 392010
  - Komatsushima-Shi, Japan
    - Investigational Site Number 392035
  - Kumamoto-Shi, Japan
    - Investigational Site Number 392023
  - Kumamoto-Shi, Japan
    - Investigational Site Number 392031
  - Kure-Shi, Japan
    - Investigational Site Number 392039
  - Kurume-Shi, Japan
    - Investigational Site Number 392012
  - Kusatsu-Shi, Japan
    - Investigational Site Number 392032
  - Kyoto City, Japan
    - Investigational Site Number 392001
  - Minato-Ku, Japan
    - Investigational Site Number 392027
  - Morioka-Shi, Japan
    - Investigational Site Number 392016
  - Nagoya-Shi, Japan
    - Investigational Site Number 392005
  - Nerima-Ku, Japan
    - Investigational Site Number 392022
  - Osaka-Shi, Japan
    - Investigational Site Number 392009
  - Osaka-Shi, Japan
    - Investigational Site Number 392011
  - Osaka-Shi, Japan
    - Investigational Site Number 392040
  - Sagamihara-Shi, Japan
    - Investigational Site Number 392004
  - Sapporo-Shi, Japan
    - Investigational Site Number 392036
  - Shinagawa-Ku, Japan
    - Investigational Site Number 392034
  - Suita-Shi, Japan
    - Investigational Site Number 392018
  - Tokushima-Shi, Japan
    - Investigational Site Number 392030
  - Urasoe-Shi, Japan
    - Investigational Site Number 392008
  - Yokohama-Shi, Japan
    - Investigational Site Number 392006
  - Yokohama-Shi, Japan
    - Investigational Site Number 392021
Kalkun
- - Adana, Kalkun, 01339
    - Investigational Site Number 792007
  - Ankara, Kalkun, 06018
    - Investigational Site Number 792009
  - Bursa, Kalkun, 16509
    - Investigational Site Number 792006
  - Eskisehir, Kalkun, 26480
    - Investigational Site Number 792016
  - Istanbul, Kalkun, 34034
    - Investigational Site Number 792014
  - Istanbul, Kalkun, 34098
    - Investigational Site Number 792005
  - Istanbul, Kalkun, 34846
    - Investigational Site Number 792011
  - Istanbul, Kalkun, 34896
    - Investigational Site Number 792013
  - Izmir, Kalkun, 35100
    - Investigational Site Number 792004
  - Izmir, Kalkun, 35340
    - Investigational Site Number 792003
  - Kocaeli, Kalkun, 41300
    - Investigational Site Number 792015
  - Mersin, Kalkun, 33169
    - Investigational Site Number 792010
Kina
- - Baotou, Kina, 014010
    - Investigational Site Number 156022
  - Beijing, Kina, 100730
    - Investigational Site Number 156003
  - Beijing, Kina, 100853
    - Investigational Site Number 156002
  - Beijing, Kina, 100020
    - Investigational Site Number 156004
  - Beijing, Kina, 100029
    - Investigational Site Number 156005
  - Beijing, Kina, 100029
    - Investigational Site Number 156006
  - Beijing, Kina, 100034
    - Investigational Site Number 156001
  - Beijing, Kina, 100048
    - Investigational Site Number 156082
  - Beijing, Kina, 100049
    - Investigational Site Number 156009
  - Changchun, Kina, 130021
    - Investigational Site Number 156013
  - Changchun, Kina, 130021
    - Investigational Site Number 156064
  - Changsha, Kina, 410005
    - Investigational Site Number 156052
  - Changsha, Kina, 410011
    - Investigational Site Number 156053
  - Changsha, Kina, 410013
    - Investigational Site Number 156088
  - Chongqing, Kina, 400037
    - Investigational Site Number 156057
  - Fuzhou, Kina, 350005
    - Investigational Site Number 156070
  - Fuzhou, Kina, 354200
    - Investigational Site Number 156079
  - Guangzhou, Kina, 510080
    - Investigational Site Number 156059
  - Guangzhou, Kina, 510080
    - Investigational Site Number 156060
  - Guangzhou, Kina, 510120
    - Investigational Site Number 156071
  - Guangzhou, Kina, 510515
    - Investigational Site Number 156061
  - Guiyang, Kina, 550002
    - Investigational Site Number 156072
  - Hangzhou, Kina, 310003
    - Investigational Site Number 156047
  - Hangzhou, Kina, 310006
    - Investigational Site Number 156077
  - Hangzhou, Kina, 310009
    - Investigational Site Number 156048
  - Hangzhou, Kina, 310013
    - Investigational Site Number 156068
  - Hangzhou, Kina, 310014
    - Investigational Site Number 156078
  - Hangzhou, Kina, 310016
    - Investigational Site Number 156046
  - Hohhot, Kina, 010017
    - Investigational Site Number 156020
  - Jinan, Kina, 250013
    - Investigational Site Number 156032
  - Jinan, Kina, 250033
    - Investigational Site Number 156031
  - Lanzhou, Kina, 730000
    - Investigational Site Number 156027
  - Lanzhou, Kina, 730030
    - Investigational Site Number 156074
  - Luzhou, Kina, 646000
    - Investigational Site Number 156081
  - Nanchang, Kina, 330006
    - Investigational Site Number 156054
  - Nanchang, Kina, 330006
    - Investigational Site Number 156055
  - Nanjing, Kina, 210008
    - Investigational Site Number 156034
  - Nanjing, Kina, 210009
    - Investigational Site Number 156035
  - Shanghai, Kina, 200025
    - Investigational Site Number 156039
  - Shanghai, Kina, 200030
    - Investigational Site Number 156076
  - Shanghai, Kina, 200032
    - Investigational Site Number 156044
  - Shanghai, Kina, 200080
    - Investigational Site Number 156043
  - Shanghai, Kina, 200120
    - Investigational Site Number 156038
  - Shanghai, Kina, 200233
    - Investigational Site Number 156040
  - Shenyang, Kina, 110001
    - Investigational Site Number 156016
  - Shenyang, Kina, 110004
    - Investigational Site Number 156017
  - Shenzhen, Kina, 518020
    - Investigational Site Number 156073
  - Shenzhen, Kina, 518036
    - Investigational Site Number 156084
  - Siping, Kina, 136000
    - Investigational Site Number 156063
  - Suzhou, Kina, 215006
    - Investigational Site Number 156037
  - Tianjin, Kina, 300052
    - Investigational Site Number 156066
  - Tianjin, Kina, 300121
    - Investigational Site Number 156067
  - Tianjin, Kina, 300140
    - Investigational Site Number 156083
  - Tianjin, Kina, 300457
    - Investigational Site Number 156025
  - Wenzhou, Kina, 325000
    - Investigational Site Number 156065
  - Wuhan, Kina, 430022
    - Investigational Site Number 156051
  - Wuhan, Kina, 430033
    - Investigational Site Number 156087
  - Xi'An, Kina, 710061
    - Investigational Site Number 156029
  - Xi'An, Kina, 710068
    - Investigational Site Number 156086
  - Xuzhou, Kina, 221002
    - Investigational Site Number 156062
  - Yanji, Kina, 133000
    - Investigational Site Number 156014
  - Yueyang, Kina, 414000
    - Investigational Site Number 156075
  - Zhanjiang, Kina, 524001
    - Investigational Site Number 156080
Korea, Republikken
- - Busan, Korea, Republikken, 602-715
    - Investigational Site Number 410013
  - Busan, Korea, Republikken, 602-739
    - Investigational Site Number 410003
  - Daegu, Korea, Republikken, 700-721
    - Investigational Site Number 410002
  - Goyang-Si, Korea, Republikken, 10326
    - Investigational Site Number 410012
  - Gwangju, Korea, Republikken, 501-757
    - Investigational Site Number 410001
  - Seongnam, Korea, Republikken, 463-707
    - Investigational Site Number 410008
  - Seoul, Korea, Republikken, 06591
    - Investigational Site Number 410004
  - Seoul, Korea, Republikken, 07061
    - Investigational Site Number 410007
  - Seoul, Korea, Republikken, 110-744
    - Investigational Site Number 410010
  - Seoul, Korea, Republikken, 134-727
    - Investigational Site Number 410011
  - Seoul, Korea, Republikken, 152-703
    - Investigational Site Number 410006
  - Suwon, Korea, Republikken, 443-721
    - Investigational Site Number 410009
  - Wonju, Korea, Republikken, 220-701
    - Investigational Site Number 410005
Kroatien
- - Dubrovnik, Kroatien, 20000
    - Investigational Site Number 191013
  - Krapinske Toplice, Kroatien, 49217
    - Investigational Site Number 191017
  - Opatija, Kroatien, 51410
    - Investigational Site Number 191009
  - Rijeka, Kroatien
    - Investigational Site Number 191006
  - Slavonski Brod, Kroatien, 35000
    - Investigational Site Number 191012
  - Varazdin, Kroatien, 42000
    - Investigational Site Number 191003
  - Zagreb, Kroatien, 10000
    - Investigational Site Number 191008
  - Zagreb, Kroatien, 10000
    - Investigational Site Number 191001
  - Zagreb, Kroatien, 10000
    - Investigational Site Number 191002
  - Zagreb, Kroatien, 10000
    - Investigational Site Number 191005
  - Zagreb, Kroatien, 10000
    - Investigational Site Number 191007
  - Zagreb, Kroatien, 10000
    - Investigational Site Number 191010
  - Zagreb, Kroatien, 10000
    - Investigational Site Number 191011
  - Zagreb, Kroatien, 10000
    - Investigational Site Number 191015
  - Zagreb, Kroatien, 10000
    - Investigational Site Number 191016
  - Zagreb, Kroatien, 10000
    - Investigational Site Number 191018
Letland
- - Daugavpils, Letland, LV-5417
    - Investigational Site Number 428004
  - Liepaja, Letland, LV-3414
    - Investigational Site Number 428002
  - Riga, Letland, LV-1002
    - Investigational Site Number 428006
  - Riga, Letland, LV-1011
    - Investigational Site Number 428001
  - Riga, Letland, LV-1038
    - Investigational Site Number 428005
  - Ventspils, Letland, LV-3601
    - Investigational Site Number 428003
Litauen
- - Kaunas, Litauen, 50009
    - Investigational Site Number 440004
  - Kaunas, Litauen, 50009
    - Investigational Site Number 440005
  - Kaunas, Litauen, 50128
    - Investigational Site Number 440009
  - Kaunas, Litauen, 50177
    - Investigational Site Number 440008
  - Klaipeda, Litauen, LT-92288
    - Investigational Site Number 440006
  - Klaipeda, Litauen, LT-91131
    - Investigational Site Number 440001
  - Vilnius, Litauen, 07157
    - Investigational Site Number 440002
  - Vilnius, Litauen, 10309
    - Investigational Site Number 440007
  - Vilnius, Litauen, LT-08661
    - Investigational Site Number 440003
Makedonien, Den Tidligere Jugoslaviske Republik
- - Bitola, Makedonien, Den Tidligere Jugoslaviske Republik, 7000
    - Investigational Site Number 807005
  - Shtip, Makedonien, Den Tidligere Jugoslaviske Republik, 2000
    - Investigational Site Number 807004
  - Skopje, Makedonien, Den Tidligere Jugoslaviske Republik, 1000
    - Investigational Site Number 807002
  - Skopje, Makedonien, Den Tidligere Jugoslaviske Republik, 1109
    - Investigational Site Number 807001
  - Tetovo, Makedonien, Den Tidligere Jugoslaviske Republik, 1200
    - Investigational Site Number 807003
Malaysia
- - Batu Caves, Malaysia, 68100
    - Investigational Site Number 458004
  - Kota Bharu, Malaysia, 16150
    - Investigational Site Number 458007
  - Kota Kinabalu, Malaysia, 88300
    - Investigational Site Number 458006
  - Kuala Lumpur, Malaysia, 50400
    - Investigational Site Number 458002
  - Kuala Lumpur, Malaysia, 56000
    - Investigational Site Number 458005
  - Kuching, Malaysia, 94300
    - Investigational Site Number 458003
  - Sungai Buloh, Malaysia, 47000
    - Investigational Site Number 458001
Mexico
- - Aguascalientes, Mexico, 20230
    - Investigational Site Number 484005
  - Aguascalientes, Mexico, 20230
    - Investigational Site Number 484015
  - Culiacan, Mexico, 80020
    - Investigational Site Number 484004
  - Durango, Mexico, 34000
    - Investigational Site Number 484003
  - Guadalajara, Mexico, 44100
    - Investigational Site Number 484010
  - Guadalajara, Mexico, 44210
    - Investigational Site Number 484006
  - Jalapa, Mexico, 91020
    - Investigational Site Number 484008
  - Mexico, Mexico, 06720
    - Investigational Site Number 484027
  - Mexico D.F., Mexico, 14080
    - Investigational Site Number 484019
  - Mexico Df, Mexico, 11850
    - Investigational Site Number 484023
  - Monterrey, Mexico, 64020
    - Investigational Site Number 484013
  - Monterrey, Mexico, 64060
    - Investigational Site Number 484018
  - Monterrey, Mexico, 64460
    - Investigational Site Number 484011
  - Monterrey, Mexico, 64710
    - Investigational Site Number 484007
  - Morelia, Mexico, 58260
    - Investigational Site Number 484017
  - Oaxaca, Mexico, 68000
    - Investigational Site Number 484012
  - Querétaro, Mexico, 76000
    - Investigational Site Number 484014
  - San Luis Potosi, Mexico, 72244
    - Investigational Site Number 484009
  - Tijuana, Mexico, 22500
    - Investigational Site Number 484002
  - Toluca, Mexico, 50130
    - Investigational Site Number 484020
New Zealand
- - Auckland, New Zealand, 1023
    - Investigational Site Number 554010
  - Christchurch, New Zealand
    - Investigational Site Number 554001
  - Dunedin, New Zealand
    - Investigational Site Number 554006
  - Hamilton, New Zealand, 3200
    - Investigational Site Number 554004
  - Lower Hutt, New Zealand, 5010
    - Investigational Site Number 554011
  - Nelson, New Zealand, 7010
    - Investigational Site Number 554005
  - New Plymouth, New Zealand
    - Investigational Site Number 554007
  - Otahuhu, New Zealand, 2025
    - Investigational Site Number 554002
  - Palmerston North, New Zealand, 4414
    - Investigational Site Number 554008
  - Rotorua, New Zealand, 3010
    - Investigational Site Number 554012
  - Takapuna, New Zealand, 1309
    - Investigational Site Number 554009
  - Wellington, New Zealand
    - Investigational Site Number 554003
Norge
- - Arendal, Norge, 4809
    - Investigational Site Number 578004
  - Bergen, Norge, 5021
    - Investigational Site Number 578013
  - Hamar, Norge
    - Investigational Site Number 578009
  - Kongsvinger, Norge, 2226
    - Investigational Site Number 578006
  - Oslo, Norge
    - Investigational Site Number 578003
  - Oslo, Norge
    - Investigational Site Number 578005
  - Stavanger, Norge, 4068
    - Investigational Site Number 578012
  - Svelvik, Norge, 3060
    - Investigational Site Number 578002
  - Tynset, Norge, 2500
    - Investigational Site Number 578011
Peru
- - Arequipa, Peru
    - Investigational Site Number 604018
  - Callao, Peru, CALLAO 02
    - Investigational Site Number 604004
  - Callao, Peru, Callao 02
    - Investigational Site Number 604025
  - Cuzco, Peru
    - Investigational Site Number 604022
  - Ica, Peru, 11001
    - Investigational Site Number 604013
  - Lima, Peru, LIMA 10
    - Investigational Site Number 604005
  - Lima, Peru, LIMA 11
    - Investigational Site Number 604006
  - Lima, Peru, 051
    - Investigational Site Number 604010
  - Lima, Peru, 27
    - Investigational Site Number 604008
  - Lima, Peru, LIMA 01
    - Investigational Site Number 604001
  - Lima, Peru, LIMA 01
    - Investigational Site Number 604007
  - Lima, Peru, LIMA 18
    - Investigational Site Number 604015
  - Lima, Peru, Lima 18
    - Investigational Site Number 604016
  - Lima, Peru, Lima 27
    - Investigational Site Number 604017
  - Lima, Peru, Lima 27
    - Investigational Site Number 604019
  - Lima, Peru, LIMA 29
    - Investigational Site Number 604003
  - Lima, Peru, LIMA 31
    - Investigational Site Number 604024
  - Lima, Peru, LIMA 32
    - Investigational Site Number 604012
  - Piura, Peru, 20001
    - Investigational Site Number 604020
  - Trujillo, Peru, 13001
    - Investigational Site Number 604023
Polen
- - Bydgoszcz, Polen, 85-094
    - Investigational Site Number 616026
  - Bydgoszcz, Polen, 85-681
    - Investigational Site Number 616029
  - Chrzanow, Polen, 40-635
    - Investigational Site Number 616010
  - Czeladz, Polen, 41-250
    - Investigational Site Number 616036
  - Gdansk, Polen, 80-462
    - Investigational Site Number 616034
  - Gdansk, Polen, 80-952
    - Investigational Site Number 616015
  - Gdynia, Polen, 81-394
    - Investigational Site Number 616035
  - Gdynia, Polen, 81-402
    - Investigational Site Number 616005
  - Gdynia, Polen, 81-472
    - Investigational Site Number 616033
  - Grodzisk Mazowiecki, Polen, 05-825
    - Investigational Site Number 616037
  - Jelenia Gora, Polen, 58-506
    - Investigational Site Number 616030
  - Krakow, Polen, 30-901
    - Investigational Site Number 616031
  - Krakow, Polen, 31-121
    - Investigational Site Number 616002
  - Leczna, Polen, 21-010
    - Investigational Site Number 616012
  - Legnica, Polen, 59-220
    - Investigational Site Number 616017
  - Lodz, Polen, 91-078
    - Investigational Site Number 616019
  - Lubin, Polen, 59-301
    - Investigational Site Number 616016
  - Olawa, Polen, 55-200
    - Investigational Site Number 616021
  - Olsztyn, Polen, 10-561
    - Investigational Site Number 616039
  - Plock, Polen, 09-402
    - Investigational Site Number 616003
  - Poznan, Polen, 61-289
    - Investigational Site Number 616011
  - Pulawy, Polen, 24-100
    - Investigational Site Number 616018
  - Skierniewice, Polen, 96-100
    - Investigational Site Number 616006
  - Sobotka, Polen, 55-050
    - Investigational Site Number 616027
  - Sokolka, Polen, 16-100
    - Investigational Site Number 616007
  - Swidnik, Polen, 21-040
    - Investigational Site Number 616022
  - Szczecin, Polen, 70-506
    - Investigational Site Number 616024
  - Torun, Polen, 87-100
    - Investigational Site Number 616013
  - Torun, Polen, 87-100
    - Investigational Site Number 616004
  - Torun, Polen, 87-100
    - Investigational Site Number 616025
  - W?Grów, Polen, 07-100
    - Investigational Site Number 616032
  - Warszawa, Polen, 00-444
    - Investigational Site Number 616040
  - Warszawa, Polen, 01-142
    - Investigational Site Number 616020
  - Warszawa, Polen, 02-672
    - Investigational Site Number 616038
  - Warszawa, Polen, 04-073
    - Investigational Site Number 616008
  - Wroclaw, Polen, 50-315
    - Investigational Site Number 616041
Portugal
- - Almada, Portugal, 2801-951
    - Investigational Site Number 620004
  - Aveiro, Portugal, 3814-501
    - Investigational Site Number 620005
  - Coimbra, Portugal, 3000-075
    - Investigational Site Number 620011
  - Coimbra, Portugal, 3041-801
    - Investigational Site Number 620008
  - Leiria, Portugal, 2410-197
    - Investigational Site Number 620001
  - Ponta Delgada, Portugal, 9500-370
    - Investigational Site Number 620003
  - Setubal, Portugal, 2910-446
    - Investigational Site Number 620002
  - Vila Franca De Xira, Portugal, 2600-009
    - Investigational Site Number 620010
  - Vila Nova Gaia, Portugal, 4434-502
    - Investigational Site Number 620006
Rumænien
- - Braila, Rumænien, 810249
    - Investigational Site Number 642001
  - Bucharest, Rumænien, 010242
    - Investigational Site Number 642003
  - Bucuresti, Rumænien, 011234
    - Investigational Site Number 642012
  - Bucuresti, Rumænien, 011461
    - Investigational Site Number 642021
  - Bucuresti, Rumænien, 014461
    - Investigational Site Number 642007
  - Bucuresti, Rumænien, 10416
    - Investigational Site Number 642008
  - Buzau, Rumænien, 120203
    - Investigational Site Number 642005
  - Codlea, Rumænien, 505100
    - Investigational Site Number 642013
  - Constanta, Rumænien, 900591
    - Investigational Site Number 642004
  - Craiova, Rumænien, 200147
    - Investigational Site Number 642002
  - Craiova, Rumænien, 200642
    - Investigational Site Number 642016
  - Focsani, Rumænien, 620034
    - Investigational Site Number 642010
  - Iasi, Rumænien, 700786
    - Investigational Site Number 642017
  - Targoviste, Rumænien, 130083
    - Investigational Site Number 642006
  - Targu Mures, Rumænien, 540136
    - Investigational Site Number 642019
  - Targu Mures, Rumænien, 540143
    - Investigational Site Number 642015
  - Timisoara, Rumænien, 300736
    - Investigational Site Number 642018
Schweiz
- - Basel, Schweiz, 4031
    - Investigational Site Number 756005
  - Geneve, Schweiz, 1205
    - Investigational Site Number 756003
  - Lugano, Schweiz, 6900
    - Investigational Site Number 756004
  - Zürich, Schweiz, 8091
    - Investigational Site Number 756002
Serbien
- - Belgrade, Serbien, 11000
    - Investigational Site Number 688003
  - Belgrade, Serbien, 11000
    - Investigational Site Number 688005
  - Belgrade, Serbien, 11000
    - Investigational Site Number 688006
  - Belgrade, Serbien, 11000
    - Investigational Site Number 688007
  - Belgrade, Serbien, 11000
    - Investigational Site Number 688008
  - Belgrade, Serbien, 11000
    - Investigational Site Number 688010
  - Belgrade, Serbien, 11000
    - Investigational Site Number 688011
  - Belgrade, Serbien, 11000
    - Investigational Site Number 688013
  - Belgrade, Serbien, 11050
    - Investigational Site Number 688015
  - Belgrade, Serbien, 11080
    - Investigational Site Number 688002
  - Kragujevac, Serbien, 34000
    - Investigational Site Number 688012
  - Leskovac, Serbien, 16000
    - Investigational Site Number 688016
  - Nis, Serbien, 18000
    - Investigational Site Number 688004
  - Niska Banja, Serbien, 18205
    - Investigational Site Number 688001
  - Pancevo, Serbien, 26 000
    - Investigational Site Number 688018
  - Sremska Kamenica, Serbien, 21204
    - Investigational Site Number 688009
  - Sremska Mitrovica, Serbien, 22000
    - Investigational Site Number 688017
  - Valjevo, Serbien, 14000
    - Investigational Site Number 688014
Singapore
- - Singapore, Singapore, 168752
    - Investigational Site Number 702001
  - Singapore, Singapore, 119228
    - Investigational Site Number 702002
  - Singapore, Singapore, 159964
    - Investigational Site Number 702003
Slovakiet
- - Bardejov, Slovakiet, 085 01
    - Investigational Site Number 703001
  - Bratislava, Slovakiet, 821 01
    - Investigational Site Number 703008
  - Bratislava, Slovakiet, 821 01
    - Investigational Site Number 703020
  - Bratislava, Slovakiet, 826 06
    - Investigational Site Number 703014
  - Bratislava, Slovakiet, 841 08
    - Investigational Site Number 703013
  - Dolny Kubin, Slovakiet, 02601
    - Investigational Site Number 703023
  - Kosice, Slovakiet, 040 01
    - Investigational Site Number 703002
  - Kosice, Slovakiet, 040 01
    - Investigational Site Number 703009
  - Kosice, Slovakiet, 040 01
    - Investigational Site Number 703016
  - Kosice, Slovakiet, 04001
    - Investigational Site Number 703019
  - Kosice, Slovakiet
    - Investigational Site Number 703007
  - Kralovsky Chlmec, Slovakiet, 077 01
    - Investigational Site Number 703012
  - Lucenec, Slovakiet, 984 39
    - Investigational Site Number 703006
  - Lucenec, Slovakiet, 98401
    - Investigational Site Number 703010
  - Nitra, Slovakiet, 950 01
    - Investigational Site Number 703003
  - Presov, Slovakiet, 080 01
    - Investigational Site Number 703004
  - Svidnik, Slovakiet, 089 01
    - Investigational Site Number 703018
  - Trebisov, Slovakiet, 075 01
    - Investigational Site Number 703022
  - Zilina, Slovakiet, 01001
    - Investigational Site Number 703005
Slovenien
- - Celje, Slovenien, 3000
    - Investigational Site Number 705001
  - Izola, Slovenien, 6310
    - Investigational Site Number 705004
  - Jesenice, Slovenien, 4270
    - Investigational Site Number 705002
  - Ljubljana, Slovenien, 1525
    - Investigational Site Number 705005
  - Ljubljana, Slovenien, SI-1525
    - Investigational Site Number 705006
Spanien
- - Alcalá De Henares, Spanien, 28805
    - Investigational Site Number 724010
  - Almería, Spanien, 04120
    - Investigational Site Number 724007
  - Barcelona, Spanien, 08003
    - Investigational Site Number 724037
  - Barcelona, Spanien, 08025
    - Investigational Site Number 724041
  - Barcelona, Spanien, 08035
    - Investigational Site Number 724038
  - Barcelona, Spanien, 08036
    - Investigational Site Number 724008
  - Cáceres, Spanien, 10003
    - Investigational Site Number 724039
  - Córdoba, Spanien, 14004
    - Investigational Site Number 724042
  - Fuenlabrada, Spanien, 28942
    - Investigational Site Number 724027
  - Girona, Spanien, 17007
    - Investigational Site Number 724002
  - Granada, Spanien, 18014
    - Investigational Site Number 724013
  - Guadalajara, Spanien, 19002
    - Investigational Site Number 724032
  - Hospitalet De Llobregat, Spanien, 08907
    - Investigational Site Number 724025
  - Huelva, Spanien, 21005
    - Investigational Site Number 724003
  - León, Spanien, 24071
    - Investigational Site Number 724021
  - Lleida, Spanien, 25198
    - Investigational Site Number 724026
  - Lugo, Spanien, 27003
    - Investigational Site Number 724006
  - Madrid, Spanien, 28034
    - Investigational Site Number 724015
  - Madrid, Spanien, 28006
    - Investigational Site Number 724030
  - Madrid, Spanien, 28031
    - Investigational Site Number 724020
  - Madrid, Spanien, 28040
    - Investigational Site Number 724031
  - Madrid, Spanien, 28040
    - Investigational Site Number 724033
  - Madrid, Spanien, 28922
    - Investigational Site Number 724017
  - Majadahonda, Spanien, 28222
    - Investigational Site Number 724035
  - Murcia, Spanien, 30120
    - Investigational Site Number 724036
  - Málaga, Spanien, 29010
    - Investigational Site Number 724016
  - Málaga, Spanien, 29010
    - Investigational Site Number 724043
  - Oviedo, Spanien, 33011
    - Investigational Site Number 724001
  - Sabadell, Spanien, 08208
    - Investigational Site Number 724022
  - San Sebastian De Los Reyes, Spanien, 28702
    - Investigational Site Number 724029
  - Santander, Spanien, 39008
    - Investigational Site Number 724028
  - Santiago De Compostela, Spanien, 15706
    - Investigational Site Number 724034
  - Sevilla, Spanien, 41071
    - Investigational Site Number 724014
  - Tarragona, Spanien, 43007
    - Investigational Site Number 724024
  - Valencia, Spanien, 46010
    - Investigational Site Number 724019
  - Valencia, Spanien, 46015
    - Investigational Site Number 724009
  - Valencia, Spanien, 46017
    - Investigational Site Number 724011
  - Valladolid, Spanien, 47005
    - Investigational Site Number 724023
  - Vigo, Spanien, 36312
    - Investigational Site Number 724005
  - Zaragoza, Spanien, 50009
    - Investigational Site Number 724040
Sri Lanka
- - Colombo, Sri Lanka, 1000
    - Investigational Site Number 144003
  - Colombo, Sri Lanka, 1000
    - Investigational Site Number 144010
  - Colombo, Sri Lanka, 10250
    - Investigational Site Number 144005
  - Colombo, Sri Lanka, 10250
    - Investigational Site Number 144006
  - Colombo, Sri Lanka, 7000
    - Investigational Site Number 144001
  - Colombo 7, Sri Lanka, 1000
    - Investigational Site Number 144002
  - Colombo 8, Sri Lanka, 1000
    - Investigational Site Number 144004
  - Kandy, Sri Lanka, 20000
    - Investigational Site Number 144008
  - Kurunegala, Sri Lanka, 60000
    - Investigational Site Number 144009
  - Ragama, Sri Lanka, 11010
    - Investigational Site Number 144007
Sverige
- - Falun, Sverige, 791 82
    - Investigational Site Number 752001
  - Göteborg, Sverige, 41345
    - Investigational Site Number 752016
  - Halmstad, Sverige, 30185
    - Investigational Site Number 752011
  - Karlshamn, Sverige, 378 00
    - Investigational Site Number 752006
  - Karlskrona, Sverige, 371 85
    - Investigational Site Number 752008
  - Kristianstad, Sverige, 29185
    - Investigational Site Number 752004
  - Köping, Sverige, 721 51
    - Investigational Site Number 752013
  - Malmö, Sverige, S-20502
    - Investigational Site Number 752015
  - Mölndal, Sverige, 43180
    - Investigational Site Number 752012
  - Stockholm, Sverige, 11883
    - Investigational Site Number 752009
  - Stockholm, Sverige, 14186
    - Investigational Site Number 752002
  - Sundsvall, Sverige, 85186
    - Investigational Site Number 752014
  - Uppsala, Sverige, 75237
    - Investigational Site Number 752007
Sydafrika
- - Alberton, Sydafrika, 1450
    - Investigational Site Number 710017
  - Bellville, Sydafrika, 7530
    - Investigational Site Number 710007
  - Bloemfontein, Sydafrika, 9300
    - Investigational Site Number 710015
  - Cape Town, Sydafrika, 7405
    - Investigational Site Number 710009
  - Cape Town, Sydafrika, 7925
    - Investigational Site Number 710010
  - Chatsworth, Sydafrika, 4091
    - Investigational Site Number 710005
  - Durban, Sydafrika, 4001
    - Investigational Site Number 710006
  - Durban, Sydafrika, 4052
    - Investigational Site Number 710004
  - Durban, Sydafrika, 4320
    - Investigational Site Number 710002
  - Johannesburg, Sydafrika, 2193
    - Investigational Site Number 710012
  - Johannesburg, Sydafrika
    - Investigational Site Number 710014
  - Kempton Park, Sydafrika, 1619
    - Investigational Site Number 710019
  - Kimberley, Sydafrika, 8301
    - Investigational Site Number 710011
  - Kuils River, Sydafrika, 7580
    - Investigational Site Number 710021
  - Parow, Sydafrika, 7500
    - Investigational Site Number 710018
  - Pretoria, Sydafrika, 0040
    - Investigational Site Number 710008
  - Pretoria, Sydafrika, 0157
    - Investigational Site Number 710016
  - Stellenbosch, Sydafrika, 7600
    - Investigational Site Number 710020
  - Tongaat, Sydafrika, 4400
    - Investigational Site Number 710013
  - Western Cape, Sydafrika, 7500
    - Investigational Site Number 710022
  - Worcester, Sydafrika, 6850
    - Investigational Site Number 710003
Taiwan
- - Changhua, Taiwan, 500
    - Investigational Site Number 158003
  - Division Of Cardiology, Taiwan, 833
    - Investigational Site Number 158008
  - Hsinchu, Taiwan, 30071
    - Investigational Site Number 158014
  - Kaohsiung, Taiwan, 807
    - Investigational Site Number 158013
  - Taichung, Taiwan, 402
    - Investigational Site Number 158004
  - Tainan, Taiwan, 704
    - Investigational Site Number 158009
  - Tainan, Taiwan, 710
    - Investigational Site Number 158011
  - Taipei, Taiwan, 104
    - Investigational Site Number 158005
  - Taipei, Taiwan, 112
    - Investigational Site Number 158001
  - Taipei, Taiwan, 114
    - Investigational Site Number 158010
  - Taipei, Taiwan
    - Investigational Site Number 158007
  - Taoyuan Hsien, Taiwan
    - Investigational Site Number 158012
  - Yunlin, Taiwan
    - Investigational Site Number 158002
Thailand
- - Bangkok, Thailand, 10220
    - Investigational Site Number 764001
  - Bangkok, Thailand, 10300
    - Investigational Site Number 764011
  - Bangkok, Thailand, 10400
    - Investigational Site Number 764007
  - Bangkok, Thailand, 10400
    - Investigational Site Number 764012
  - Bangkok-Noi, Thailand, 10700
    - Investigational Site Number 764009
  - Hat Yai, Thailand, 90110
    - Investigational Site Number 764005
  - Klong Luang, Thailand, 12120
    - Investigational Site Number 764008
  - Moung, Thailand, 30000
    - Investigational Site Number 764002
  - Muang, Thailand, 50200
    - Investigational Site Number 764003
  - Nonthaburi, Thailand, 11000
    - Investigational Site Number 764010
  - Pratumwan, Thailand, 10400
    - Investigational Site Number 764006
Tjekkiet
- - Brno, Tjekkiet, 62500
    - Investigational Site Number 203003
  - Ceska Lipa, Tjekkiet, 470 01
    - Investigational Site Number 203020
  - Cesky Krumlov, Tjekkiet, 38101
    - Investigational Site Number 203025
  - Hodonin, Tjekkiet, 695 01
    - Investigational Site Number 203023
  - Hradec Kralove, Tjekkiet, 50005
    - Investigational Site Number 203006
  - Kladno, Tjekkiet, 272 59
    - Investigational Site Number 203019
  - Kladno, Tjekkiet, 272 80
    - Investigational Site Number 203005
  - Kromeriz, Tjekkiet, 767 01
    - Investigational Site Number 203008
  - Liberec, Tjekkiet, 46063
    - Investigational Site Number 203015
  - Marianske Lazne, Tjekkiet, 353 01
    - Investigational Site Number 203024
  - Olomouc, Tjekkiet, 77520
    - Investigational Site Number 203013
  - Ostrava, Tjekkiet, 72880
    - Investigational Site Number 203016
  - Pardubice, Tjekkiet, 53203
    - Investigational Site Number 203014
  - Plzen, Tjekkiet, 30599
    - Investigational Site Number 203018
  - Praha 10, Tjekkiet, 10034
    - Investigational Site Number 203011
  - Praha 2, Tjekkiet, 12808
    - Investigational Site Number 203017
  - Praha 4, Tjekkiet, 14021
    - Investigational Site Number 203004
  - Praha 4, Tjekkiet, 14059
    - Investigational Site Number 203021
  - Praha 5, Tjekkiet, 15030
    - Investigational Site Number 203012
  - Praha 5 - Motol, Tjekkiet, 15006
    - Investigational Site Number 203007
  - Rakovnik, Tjekkiet, 269 01
    - Investigational Site Number 203009
  - Zlin, Tjekkiet, 76275
    - Investigational Site Number 203010
Tyskland
- - Aachen, Tyskland, 52074
    - Investigational Site Number 276013
  - Bad Krozingen, Tyskland, 79189
    - Investigational Site Number 276019
  - Berlin, Tyskland, 10789
    - Investigational Site Number 276008
  - Berlin, Tyskland, 12203
    - Investigational Site Number 276040
  - Berlin, Tyskland, 12559
    - Investigational Site Number 276051
  - Berlin, Tyskland, 13347
    - Investigational Site Number 276039
  - Berlin, Tyskland, 13509
    - Investigational Site Number 276025
  - Bernau, Tyskland, 16321
    - Investigational Site Number 276054
  - Bielefeld, Tyskland, 33604
    - Investigational Site Number 276037
  - Bonn, Tyskland, 53127
    - Investigational Site Number 276016
  - Bonn, Tyskland, 53225
    - Investigational Site Number 276009
  - Dortmund, Tyskland, 44137
    - Investigational Site Number 276001
  - Dortmund, Tyskland, 44137
    - Investigational Site Number 276006
  - Dortmund, Tyskland, 44137
    - Investigational Site Number 276031
  - Dresden, Tyskland, 01099
    - Investigational Site Number 276050
  - Eschweiler, Tyskland, 52249
    - Investigational Site Number 276024
  - Essen, Tyskland, 45219
    - Investigational Site Number 276028
  - Frankfurt Am Main, Tyskland, 60594
    - Investigational Site Number 276036
  - Freiburg, Tyskland, 79106
    - Investigational Site Number 276012
  - Halle/Saale, Tyskland, 06120
    - Investigational Site Number 276030
  - Hamburg, Tyskland, 20099
    - Investigational Site Number 276032
  - Hamburg, Tyskland, 20246
    - Investigational Site Number 276017
  - Hamburg, Tyskland, 22041
    - Investigational Site Number 276027
  - Hamm, Tyskland, 59071
    - Investigational Site Number 276029
  - Haßloch, Tyskland, 67454
    - Investigational Site Number 276052
  - Heidelberg, Tyskland, 69115
    - Investigational Site Number 276014
  - Homburg/Saar, Tyskland, 66421
    - Investigational Site Number 276023
  - Kassel, Tyskland, 34121
    - Investigational Site Number 276035
  - Leipzig, Tyskland, 04103
    - Investigational Site Number 276046
  - Limburg, Tyskland, 65549
    - Investigational Site Number 276020
  - Lippstadt, Tyskland, 59555
    - Investigational Site Number 276026
  - Lübeck, Tyskland, 23560
    - Investigational Site Number 276044
  - Magdeburg, Tyskland, 39120
    - Investigational Site Number 276021
  - Mainz, Tyskland, 55131
    - Investigational Site Number 276015
  - Marburg, Tyskland, 35043
    - Investigational Site Number 276010
  - Münster, Tyskland, 48149
    - Investigational Site Number 276018
  - Nürnberg, Tyskland, 90402
    - Investigational Site Number 276042
  - Peine, Tyskland, 31224
    - Investigational Site Number 276048
  - Rotenburg An Der Fulda, Tyskland, 36199
    - Investigational Site Number 276053
  - Rüdersdorf Bei Berlin, Tyskland, 15562
    - Investigational Site Number 276045
  - Stuttgart, Tyskland, 70376
    - Investigational Site Number 276002
  - Warendorf, Tyskland, 48231
    - Investigational Site Number 276033
Ukraine
- - Chernivtsi, Ukraine, 58013
    - Investigational Site Number 804015
  - Dnipropetrovsk, Ukraine
    - Investigational Site Number 804018
  - Donetsk, Ukraine, 83114
    - Investigational Site Number 804027
  - Donetsk, Ukraine
    - Investigational Site Number 804012
  - Ivano-Frankivsk, Ukraine, 76018
    - Investigational Site Number 804010
  - Kharkiv, Ukraine, 61002
    - Investigational Site Number 804006
  - Kharkiv, Ukraine, 61176
    - Investigational Site Number 804003
  - Kharkiv, Ukraine
    - Investigational Site Number 804009
  - Khmelnytskyi, Ukraine, 29000
    - Investigational Site Number 804020
  - Kiev, Ukraine, 02091
    - Investigational Site Number 804001
  - Kiev, Ukraine, 02660
    - Investigational Site Number 804002
  - Kyiv, Ukraine, 01601
    - Investigational Site Number 804011
  - Kyiv, Ukraine, 01601
    - Investigational Site Number 804014
  - Kyiv, Ukraine, 03049
    - Investigational Site Number 804025
  - Kyiv, Ukraine, 03110
    - Investigational Site Number 804034
  - Kyiv, Ukraine, 03115
    - Investigational Site Number 804036
  - Kyiv, Ukraine, 03680
    - Investigational Site Number 804016
  - Kyiv, Ukraine, 04050
    - Investigational Site Number 804030
  - Lutsk, Ukraine, 43024
    - Investigational Site Number 804028
  - Lviv, Ukraine, 79010
    - Investigational Site Number 804033
  - Lviv, Ukraine, 79059
    - Investigational Site Number 804031
  - Mykolaiv, Ukraine, 54003
    - Investigational Site Number 804029
  - Odesa, Ukraine, 65025
    - Investigational Site Number 804013
  - Odessa, Ukraine, 65014
    - Investigational Site Number 804004
  - Simferopol, Ukraine, 95026
    - Investigational Site Number 804017
  - Sumy, Ukraine, 40021
    - Investigational Site Number 804035
  - Uzhgorod, Ukraine, 88014
    - Investigational Site Number 804007
  - Vinnitsya, Ukraine, 21100
    - Investigational Site Number 804005
  - Vinnytsia, Ukraine, 21018
    - Investigational Site Number 804008
  - Zaporizhia, Ukraine, 69005
    - Investigational Site Number 804026
  - Zhytomyr, Ukraine, 10002
    - Investigational Site Number 804024
  - Zhytomyr, Ukraine, 10002
    - Investigational Site Number 804032
Ungarn
- - Balatonfüred, Ungarn, 8230
    - Investigational Site Number 348013
  - Budapest, Ungarn, 1023
    - Investigational Site Number 348002
  - Budapest, Ungarn, 1106
    - Investigational Site Number 348012
  - Budapest, Ungarn, 1122
    - Investigational Site Number 348005
  - Budapest, Ungarn, 1134
    - Investigational Site Number 348006
  - Debrecen, Ungarn, 4032
    - Investigational Site Number 348008
  - Eger, Ungarn, 3300
    - Investigational Site Number 348004
  - Gyula, Ungarn, 5700
    - Investigational Site Number 348003
  - Pécs, Ungarn, 7624
    - Investigational Site Number 348010
  - Szeged, Ungarn, 6725
    - Investigational Site Number 348009
  - Szekesfehervar, Ungarn, 8000
    - Investigational Site Number 348007
  - Szombathely, Ungarn, 9700
    - Investigational Site Number 348011
  - Zalaegerszeg, Ungarn, 8900
    - Investigational Site Number 348001
Østrig
- - Feldkirch, Østrig, 6800
    - Investigational Site Number 040004
  - Graz, Østrig, 8036
    - Investigational Site Number 040007
  - Salzburg, Østrig, 5020
    - Investigational Site Number 040001
  - Wien, Østrig, 1090
    - Investigational Site Number 040003
  - Wien, Østrig, 1030
    - Investigational Site Number 040006
  - Wien, Østrig, 1160
    - Investigational Site Number 040002

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inklusionskriterier:

For nylig (< 52 uger) indlagt for ACS.

Ekskluderingskriterier:

Alder < 40 år.
ACS-hændelse, der forekommer mere end 52 uger før randomiseringsbesøg.
LDL-C er sandsynligvis <70 mg/dL (<1,81 mmo/L), og apolipoprotein B (ApoB) <80 mg/dL (<0,8 g/L) og non-high-density lipoprotein kolesterol (HDL-C) ) <100 mg/dL (<2,59 mmol/L) med evidensbaseret medicinsk og diætmæssig behandling af dyslipidæmi.

Ovenstående information er ikke beregnet til at indeholde alle overvejelser, der er relevante for en deltagers potentielle deltagelse i et klinisk forsøg.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Forebyggelse
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Dobbelt

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Placebo komparator: Placebo Placebo (til alirocumab) subkutan (SC) injektion hver 2. uge (Q2W) tilføjet til stabil lipid-modificerende terapi (LMT) i op til 64 måneder.	Medicin: Placebo Placebo matchet med alirocumab administreret som en SC-injektion på 1 ml i maven eller låret med en auto-injektor til engangsbrug. Medicin: LMT Statiner (atorvastatin eller rosuvastatin) ved stabil maksimal tolereret dosis af statin med eller uden anden LMT som klinisk indiceret.
Eksperimentel: Alirocumab 75 mg Q2W/Op til 150 mg Q2W Alirocumab 75 mg SC injektion Q2W tilføjet til stabil LMT i op til 64 måneder. Alirocumab-dosis blev optitreret til 150 mg Q2W fra måned 2, når Low-Density Lipoprotein Cholesterol (LDL-C) niveauer >=50 mg/dL (1,29 mmol/L) ved måned 1; eller hvis optitreringen blev overset på grund af manglende tilgængelighed af LDL-C-værdi, blev den optitreret ved måned 4 baseret på LDL-C-værdi ved måned 2. For deltagere, der fik 150 mg Q2W, blev alirocumab-dosis nedtitreret i en blindet måde til 75 mg Q2W, hvis to på hinanden følgende værdier af LDL-C var <25 mg/dL (0,65 mmol/L). For deltagere, der fik 75 mg Q2W, blev alirocumab-dosis skiftet til placebo på en blind måde, hvis to på hinanden følgende værdier af LDL-C var <15 mg/dL (0,39 mmol/L).	Medicin: LMT Statiner (atorvastatin eller rosuvastatin) ved stabil maksimal tolereret dosis af statin med eller uden anden LMT som klinisk indiceret. Medicin: Alirocumab Alirocumab administreret som SC-injektion på 1 ml i maven eller låret med en auto-injektor til engangsbrug. Andre navne: SAR236553 REGN727 Praluent®

Deltagergruppe / Arm

Intervention / Behandling

Placebo komparator: Placebo

Placebo (til alirocumab) subkutan (SC) injektion hver 2. uge (Q2W) tilføjet til stabil lipid-modificerende terapi (LMT) i op til 64 måneder.

Medicin: Placebo

Placebo matchet med alirocumab administreret som en SC-injektion på 1 ml i maven eller låret med en auto-injektor til engangsbrug.

Medicin: LMT

Statiner (atorvastatin eller rosuvastatin) ved stabil maksimal tolereret dosis af statin med eller uden anden LMT som klinisk indiceret.

Eksperimentel: Alirocumab 75 mg Q2W/Op til 150 mg Q2W

Alirocumab 75 mg SC injektion Q2W tilføjet til stabil LMT i op til 64 måneder. Alirocumab-dosis blev optitreret til 150 mg Q2W fra måned 2, når Low-Density Lipoprotein Cholesterol (LDL-C) niveauer >=50 mg/dL (1,29 mmol/L) ved måned 1; eller hvis optitreringen blev overset på grund af manglende tilgængelighed af LDL-C-værdi, blev den optitreret ved måned 4 baseret på LDL-C-værdi ved måned 2. For deltagere, der fik 150 mg Q2W, blev alirocumab-dosis nedtitreret i en blindet måde til 75 mg Q2W, hvis to på hinanden følgende værdier af LDL-C var <25 mg/dL (0,65 mmol/L). For deltagere, der fik 75 mg Q2W, blev alirocumab-dosis skiftet til placebo på en blind måde, hvis to på hinanden følgende værdier af LDL-C var <15 mg/dL (0,39 mmol/L).

Medicin: LMT

Statiner (atorvastatin eller rosuvastatin) ved stabil maksimal tolereret dosis af statin med eller uden anden LMT som klinisk indiceret.

Medicin: Alirocumab

Alirocumab administreret som SC-injektion på 1 ml i maven eller låret med en auto-injektor til engangsbrug.

Andre navne:

SAR236553
REGN727
Praluent®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Tid til første forekomst af større uønsket kardiovaskulær hændelse (MACE); Procentdel af observerede deltagere med udfaldsmålhændelser i løbet af undersøgelsen Tidsramme: Fra randomisering op til 64 måneder	Alle MACE positivt bedømt af Clinical Events Committee (CEC) på en blind måde, blev brugt i analysen af det sammensatte kardiovaskulære (CV) resultatmål bestående af koronar hjertesygdom (CHD) død, ikke-dødelig myokardieinfarkt (MI), fatal og ikke-dødelig iskæmisk slagtilfælde (IS) eller ustabil angina (UA), der kræver hospitalsindlæggelse. Kaplan Meier-plot af den kumulative incidensrate efter behandlingsgrupper blev brugt til at afbilde den første forekomst af MACE over tid. Procentdel af observerede deltagere med udfaldsmålsbegivenheder under undersøgelsen blev rapporteret.	Fra randomisering op til 64 måneder

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Tid til første forekomst af enhver koronar hjertesygdomsbegivenhed; Procentdel af observerede deltagere med udfaldsmålhændelser i løbet af undersøgelsen Tidsramme: Fra randomisering op til 64 måneder	Alle CHD-hændelser positivt bedømt af CEC på en blindet måde blev brugt i analysen af det sammensatte CHD-endepunkt bestående af enhver CHD-død, ikke-fatal ikke-fatal MI, UA, der kræver hospitalsindlæggelse eller iskæmi-drevet koronar revaskulariseringsprocedure. Kaplan Meier-plot af den kumulative incidensrate efter behandlingsgrupper blev brugt til at afbilde den første forekomst af enhver CHD-hændelse over tid. Procentdel af observerede deltagere med udfaldsmålsbegivenheder under undersøgelsen blev rapporteret.	Fra randomisering op til 64 måneder
Tid til første forekomst af enhver større koronar hjertesygdomsbegivenhed; Procentdel af observerede deltagere med udfaldsmålhændelser i løbet af undersøgelsen Tidsramme: Fra randomisering op til 64 måneder	Alle større CHD-hændelser, positivt bedømt af CEC på en blindet måde, blev brugt i analysen af det sammensatte CHD-endepunkt bestående af enhver CHD-død og ikke-dødelig MI. Kaplan Meier-plot af den kumulative incidensrate efter behandlingsgrupper blev brugt til at afbilde den første forekomst af enhver større CHD-hændelse over tid. Procentdel af observerede deltagere med udfaldsmålsbegivenheder under undersøgelsen blev rapporteret.	Fra randomisering op til 64 måneder
Tid til første forekomst af enhver kardiovaskulær hændelse; Procentdel af observerede deltagere med udfaldsmålhændelser i løbet af undersøgelsen Tidsramme: Fra randomisering op til 64 måneder	Alle CV-hændelser positivt bedømt af CEC på en blindet måde blev brugt i analysen af det sammensatte CV-endepunkt bestående af enhver ikke-dødelig CHD-hændelse, enhver CV-død og ikke-dødelig IS. Kaplan Meier-plot af den kumulative incidensrate efter behandlingsgrupper blev brugt til at afbilde den første forekomst af enhver CV-hændelse over tid. Procentdel af observerede deltagere med udfaldsmålsbegivenheder under undersøgelsen blev rapporteret.	Fra randomisering op til 64 måneder
Tid til første forekomst af dødelighed af alle årsager, ikke-fatalt myokardieinfarkt, ikke-fatalt iskæmisk slagtilfælde; Procentdel af observerede deltagere med udfaldsmålhændelser i løbet af undersøgelsen Tidsramme: Fra randomisering op til 64 måneder	Mortalitet af alle årsager, ikke-dødelig MI og ikke-dødelig IS positivt bedømt af CEC på en blind måde, blev brugt i analysen af dette endepunkt. Kaplan Meier-plot af den kumulative incidensrate efter behandlingsgrupper blev brugt til at afbilde den første forekomst af dødelighed af alle årsager, ikke-dødelig MI og ikke-dødelig IS over tid. Procentdel af observerede deltagere med udfaldsmålsbegivenheder under undersøgelsen blev rapporteret.	Fra randomisering op til 64 måneder
Tid til koronar hjertesygdom død; Procentdel af observerede deltagere med udfaldsmålhændelser i løbet af undersøgelsen Tidsramme: Fra randomisering op til 64 måneder	Kaplan Meier-plot af den kumulative incidensrate efter behandlingsgrupper blev brugt til at skildre CHD-døden over tid. Procentdel af observerede deltagere med CHD-død (positivt bedømt af CEC på en blind måde) blev rapporteret.	Fra randomisering op til 64 måneder
Tid til kardiovaskulær død; Procentdel af observerede deltagere med udfaldsmålhændelser i løbet af undersøgelsen Tidsramme: Fra randomisering op til 64 måneder	Kaplan Meier-plot af den kumulative incidensrate efter behandlingsgrupper blev brugt til at skildre CV-døden over tid. Procentdel af observerede deltagere med CV-død (positivt bedømt af CEC på en blind måde) blev rapporteret.	Fra randomisering op til 64 måneder
Tid til alle årsager død; Procentdel af observerede deltagere med udfaldsmålhændelser i løbet af undersøgelsen Tidsramme: Fra randomisering op til 64 måneder	Kaplan Meier-plot af den kumulative incidensrate efter behandlingsgrupper blev brugt til at skildre dødsfaldet af alle årsager over tid. Procentdel af observerede deltagere med dødsfald af alle årsager (positivt bedømt af CEC på en blind måde) blev rapporteret.	Fra randomisering op til 64 måneder
Tid til første forekomst af enhver ikke-dødelig myokardieinfarkt; Procentdel af observerede deltagere med udfaldsmålhændelser i løbet af undersøgelsen Tidsramme: Fra randomisering op til 64 måneder	Kaplan Meier-plot af den kumulative incidensrate efter behandlingsgrupper blev brugt til at afbilde den første forekomst af enhver ikke-dødelig MI over tid. Procentdel af observerede deltagere med enhver ikke-dødelig MI (positivt bedømt af CEC på en blind måde) blev rapporteret.	Fra randomisering op til 64 måneder
Tid til første forekomst af fatalt eller ikke-fatalt iskæmisk slagtilfælde; Procentdel af observerede deltagere med udfaldsmålhændelser i løbet af undersøgelsen Tidsramme: Fra randomisering op til 64 måneder	Kaplan Meier-plot af den kumulative incidensrate efter behandlingsgrupper blev brugt til at afbilde den første forekomst af dødelig eller ikke-dødelig IS over tid. Procentdel af observerede deltagere med dødelig eller ikke-dødelig IS (positivt bedømt af CEC på en blind måde) blev rapporteret.	Fra randomisering op til 64 måneder
Tid til første forekomst af enhver ustabil angina, der kræver hospitalsindlæggelse; Procentdel af observerede deltagere med udfaldsmålhændelser i løbet af undersøgelsen Tidsramme: Fra randomisering op til 64 måneder	Kaplan Meier-plot af den kumulative incidensrate efter behandlingsgrupper blev brugt til at afbilde den første forekomst af enhver UA, der kræver hospitalsindlæggelse over tid. Procentdel af observerede deltagere med enhver UA, der kræver hospitalsindlæggelse (positivt bedømt af CEC på en blind måde) blev rapporteret.	Fra randomisering op til 64 måneder
Tid til første forekomst af enhver iskæmi-drevet koronar revaskulariseringsprocedure; Procentdel af observerede deltagere med udfaldsmålhændelser i løbet af undersøgelsen Tidsramme: Fra randomisering op til 64 måneder	Kaplan Meier-plot af den kumulative incidensrate efter behandlingsgrupper blev brugt til at afbilde den første forekomst af enhver iskæmi-drevet koronar revaskulariseringsprocedure over tid. Procentdel af observerede deltagere med en iskæmi-drevet koronar revaskulariseringsprocedure (positivt bedømt af CEC på en blind måde) blev rapporteret.	Fra randomisering op til 64 måneder
Tid til første forekomst af kongestiv hjertesvigt (CHF), der kræver hospitalsindlæggelse; Procentdel af observerede deltagere med udfaldsmålhændelser i løbet af undersøgelsen Tidsramme: Fra randomisering op til 64 måneder	Kaplan Meier-plot af den kumulative incidensrate efter behandlingsgrupper blev brugt til at afbilde den første forekomst af enhver CHF, der kræver indlæggelse over tid. Procentdel af observerede deltagere med en hvilken som helst CHF, der kræver hospitalsindlæggelse (positivt bedømt af CEC på en blind måde) blev rapporteret.	Fra randomisering op til 64 måneder

Andre resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Procentvis ændring fra baseline i beregnet LDL-C ved 4, 12 og 48 måneder: ITT-analyse Tidsramme: Baseline, måned 4, 12 og 48	Justerede gennemsnit og standardfejl i måned 4, 12 og 48 fra multipel imputationstilgang (for at tage højde for manglende data) efterfulgt af analyser af kovariansmodellen (ANCOVA) med den faste kategoriske effekt af behandlingsgruppen og den kontinuerlige faste kovariat af baseline LDL-C værdi, inklusive alle tilgængelige post-baseline-data fra måned 1 op til måned 48 uanset status til eller uden behandling.	Baseline, måned 4, 12 og 48
Procentvis ændring fra baseline i beregnet LDL-C ved 4, 12 og 48 måneder: Analyse under behandling Tidsramme: Baseline, måned 4, 12 og 48	Justerede mindste kvadraters (LS)-middelværdier og standardfejl i måned 4, 12 og 48 blev opnået fra en blandet-effekt-model med gentagne mål (MMRM) inklusive tilgængelige post-baseline on-treatment data fra måned 1 op til måned 48 (dvs. op til 21 dage efter sidste injektion).	Baseline, måned 4, 12 og 48

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sanofi

Samarbejdspartnere

Regeneron Pharmaceuticals

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. oktober 2012

Primær færdiggørelse (Faktiske)

23. januar 2018

Studieafslutning (Faktiske)

23. januar 2018

Datoer for studieregistrering

Først indsendt

8. august 2012

Først indsendt, der opfyldte QC-kriterier

10. august 2012

Først opslået (Skøn)

13. august 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. marts 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. marts 2019

Sidst verificeret

1. marts 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

EFC11570
2011-005698-21 (EudraCT nummer)
U1111-1127-4323 (Anden identifikator: UTN)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Aterosklerotisk kardiovaskulær sygdom

Ottawa Hospital Research Institute

Afsluttet

Virkningen af uventet død i simulering: Fastholdelse af færdigheder, stress og følelser

Stress | Crisis Resource Management (CRM) færdigheder | Advanced Cardiovascular Life Support (ACLS) færdigheder

Canada

Kliniske forsøg med Placebo

Galderma R&D

Afsluttet

Effekt af CD07805/47 Gel i Rosacea Flushing

Rosacea

Tyskland
SamA Pharmaceutical Co., Ltd

Ukendt

Kliniske forsøg for at vurdere effektiviteten og sikkerheden af HLIM

Akut bronkitis | Akut øvre luftvejsinfektion

Korea, Republikken
National Institute on Drug Abuse (NIDA)

Afsluttet

Virkninger af cannabisadministrationsveje på menneskelig ydeevne og farmakokinetik

Brug af cannabis

Forenede Stater
AstraZeneca
Parexel; Spandauer Damm 130; 14050; Berlin, Germany

Afsluttet

Vurdering af sikkerhed, tolerabilitet og farmakodynamik efter administration af én dosis AZD8601 til mandlige patienter med type II diabetes mellitus (T2DM)

Mandlige forsøgspersoner med type II-diabetes (T2DM)

Tyskland
Heptares Therapeutics Limited

Afsluttet

Farmakokinetik af oral kapsel hos raske japanske vs. kaukasiske forsøgspersoner (HTL0018318)

Farmakokinetik | Sikkerhedsproblemer

Det Forenede Kongerige
Texas A&M University
Nutrabolt

Afsluttet

Glycemic Response of a Commercial Food Bar (NB16)

Glucose and Insulin Response
Regado Biosciences, Inc.

Afsluttet

Safety, Tolerability and PK/PD of RB006 in a Healthy Volunteer SAD (SC101)

Sund frivillig

Forenede Stater
Longeveron Inc.

Afsluttet

Allogeneic hMSC Injection in Patients With Hypoplastic Left Heart Syndrome (ELPIS)

Hypoplastisk venstre hjerte syndrom

Forenede Stater
Italfarmaco

Afsluttet

Klinisk undersøgelse for at evaluere effektiviteten og sikkerheden af Givinostat hos ambulante patienter med Becker muskeldystrofi

Beckers muskeldystrofi

Holland, Italien
West Penn Allegheny Health System

Afsluttet

Sunovion vækstundersøgelse Pædiatriske forsøgspersoner med mild astma og allergisk rhinitis

Astma | Allergisk rhinitis

Forenede Stater

ODYSSEY-resultater: Evaluering af kardiovaskulære resultater efter et akut koronarsyndrom under behandling med Alirocumab

En randomiseret, dobbeltblind, placebokontrolleret, parallelgruppeundersøgelse til evaluering af effekten af ​​Alirocumab (SAR236553/REGN727) på forekomsten af ​​kardiovaskulære hændelser hos patienter, der for nylig har oplevet et akut koronarsyndrom

Studieoversigt

Status

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Undersøgelsestype

Tilmelding (Faktiske)

Fase

Kontakter og lokationer

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Andre resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Samarbejdspartnere

Publikationer og nyttige links

Generelle publikationer

Datoer for undersøgelser

Studer store datoer

Studiestart (Faktiske)

Primær færdiggørelse (Faktiske)

Studieafslutning (Faktiske)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Skøn)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Kliniske forsøg med Aterosklerotisk kardiovaskulær sygdom

Kliniske forsøg med Placebo

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in United Kingdom

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

En randomiseret, dobbeltblind, placebokontrolleret, parallelgruppeundersøgelse til evaluering af effekten af Alirocumab (SAR236553/REGN727) på forekomsten af kardiovaskulære hændelser hos patienter, der for nylig har oplevet et akut koronarsyndrom