- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02465567
Undersøgelse for at vurdere effektiviteten og sikkerheden af PT010 i forhold til PT003 og PT009 hos forsøgspersoner med moderat til meget svær KOL (Ethos)
1. februar 2021 opdateret af: Pearl Therapeutics, Inc.
Et randomiseret, dobbeltblindt, multicenter, parallelgruppestudie for at vurdere effektiviteten og sikkerheden af PT010 i forhold til PT003 og PT009 om KOL-eksacerbationer over en 52-ugers behandlingsperiode hos forsøgspersoner med moderat til meget svær KOL (etos)
Dette er et randomiseret, dobbeltblindt, multicenter, parallelgruppestudie til at vurdere effektiviteten og sikkerheden af PT010 i forhold til PT003 og PT009 på KOL-eksacerbationspersoner med moderat til meget svær KOL.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Et randomiseret, dobbeltblindt, multicenter, parallelgruppestudie til vurdering af effektiviteten og sikkerheden af PT010 i forhold til PT003 og PT009 på KOL-eksacerbationer over en 52-ugers behandlingsperiode hos forsøgspersoner med moderat til meget svær KOL.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
8588
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Buenos Aires, Argentina, C1414AIF
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Buenos Aires, Argentina, C1121ABE
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Buenos Aires, Argentina, C1425BEN
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Buenos Aires, Argentina, 1015
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Caba, Argentina, C1056ABJ
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Capital Federal, Argentina, C1122AAK
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Ciudad Autonoma de Buenos Aire, Argentina, C1120AAC
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Ciudad Autonoma de Buenos Aire, Argentina, C1028AAP
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Ciudad Autonomade Buenos Aires, Argentina, 1426
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Ciudad Autónoma de Bs. As., Argentina, 1426
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Ciudad Capital, Argentina, 5500
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Ciudad de Buenos Aire, Argentina, C1425BEN
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Cordoba, Argentina, X5008HHW
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Córdoba, Argentina, X5003DCE
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Florencio Varela, Argentina, 1888
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Florida, Argentina, B1602DQD
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La Plata, Argentina, 1900
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Lanus, Argentina, B1824KAJ
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Mar del Plata, Argentina, 7600
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Mar del Plata, Argentina, B7600FZN
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Mendoza, Argentina, 5500
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Mendoza, Argentina, M5500GIP
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Mendoza, Argentina, M5500GPD
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Monte Grande, Argentina, 1842
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Paraná, Argentina, E3100XAI
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Quilmes, Argentina, B1878FNR
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Rosario, Argentina, 2000
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Rosario, Argentina, S2000DEJ
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Rosario, Argentina, 2002
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San Fernando, Argentina, 1646
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San Miguel de Tucuman, Argentina, 4000
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San Miguel de Tucumán, Argentina, T4000IAR
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Santa Fe, Argentina, S3000FWO
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Santa Fe, Argentina, S3000ASF
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Santa Rosa, Argentina, L6300EAN
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Adelaide, Australien, 5000
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Bedford Park, Australien, 5042
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Box Hill, Australien, 3128
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Cairns, Australien, 4870
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Concord, Australien, 2139
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Everton Park, Australien, 4053
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Kent Town, Australien, 5067
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Murdoch, Australien, 6150
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Nedlands, Australien, 6009
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South Brisbane, Australien, 4101
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Westmead, Australien, 2145
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Bruxelles, Belgien, 1200
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Erpent, Belgien, 5101
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Genk, Belgien, 03600
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Gilly, Belgien, 6060
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Halen, Belgien, 03545
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Ham, Belgien, 03945
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Lebbeke, Belgien
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Montigny Le Tilleul, Belgien, BE-6110
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Wetteren, Belgien, 9230
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Quebec, Canada, G1G 3Y8
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Quebec, Canada, G1V 4G5
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Alberta
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Edmonton, Alberta, Canada, T5A 4L8
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Sherwood Park, Alberta, Canada, T8L 0N2
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British Columbia
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Vancouver, British Columbia, Canada, V5X04
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CA
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Vancouver, CA, Canada, V5Z 4E1
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Manitoba
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Winnipeg, Manitoba, Canada, R2K 3S8
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Nova Scotia
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Truro, Nova Scotia, Canada, B2N 1L2
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Ontario
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Ajax, Ontario, Canada, L1S 2J5
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Burlington, Ontario, Canada, L7N 3V2
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Hamilton, Ontario, Canada, L8N 4A6
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Mississauga, Ontario, Canada, L4V 1P1
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Sarnia, Ontario, Canada, N7T4X3
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Sudbury, Ontario, Canada, P3A 1W8
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Windsor, Ontario, Canada, N8X 1T3
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Quebec
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Gatineau, Quebec, Canada, J8Y 6S8
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Levis, Quebec, Canada, G6W 0M5
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Mirabel, Quebec, Canada, J7J 2K8
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Montreal, Quebec, Canada, H1M 1B1
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Montreal, Quebec, Canada, H2X 1P1
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Pointe-Claire, Quebec, Canada, H9R 3J1
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Saint-Jerome, Quebec, Canada, J7Z 5T3
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St Charles Borromee, Quebec, Canada, J6E 2B4
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 0W8
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Concepción, Chile, 4070038
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Curico, Chile, 3341643
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Quillota, Chile, 2260877
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Santiago, Chile, 7500698
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Santiago, Chile, 8910131
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Santiago, Chile, 8207257
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Santiago, Chile, 7750495
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Santiago, Chile, 8053095
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Santiago, Chile, 7500588
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Santiago, Chile, 7500692
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Talca, Chile, 3465584
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Valparaiso, Chile, 2341131
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Viña del Mar, Chile, 2520024
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Arkhangelsk, Den Russiske Føderation, 163001
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Ekaterinburg, Den Russiske Føderation, 620039
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Gatchina, Den Russiske Føderation, 188300
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Moscow, Den Russiske Føderation, 119991
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Moscow, Den Russiske Føderation, 125315
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Moscow, Den Russiske Føderation, 129090
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Moscow, Den Russiske Føderation, 117997
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Moscow, Den Russiske Føderation, 105229
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Moscow, Den Russiske Føderation, 115682
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Moscow, Den Russiske Føderation, 121309
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Moscow, Den Russiske Føderation, 119002
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Saint Petersburg, Den Russiske Føderation
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St. Petersburg, Den Russiske Føderation, 197022
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St. Petersburg, Den Russiske Føderation, 194356
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Belfast, Det Forenede Kongerige, BT7 2EB
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Birmingham, Det Forenede Kongerige, B9 5SS
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Birmingham, Det Forenede Kongerige, B15 2WB
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Blackpool, Det Forenede Kongerige, FY3 7EN
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Blackpool, Det Forenede Kongerige, FY4 3AD
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Bradford, Det Forenede Kongerige, BND9 6RJ
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Chesterfield, Det Forenede Kongerige, S40 4AA
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Corby, Det Forenede Kongerige, NN17 2UR
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Edinburgh, Det Forenede Kongerige, EH16 4SA
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Glasgow, Det Forenede Kongerige, G69 7AD
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Kenilworth, Det Forenede Kongerige, CV8 1JD
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Liverpool, Det Forenede Kongerige, L14 3PE
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London, Det Forenede Kongerige, EC1M 6BQ
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London, Det Forenede Kongerige, NW3 2PF
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Middlesex, Det Forenede Kongerige, HA2 2RN
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Norwich, Det Forenede Kongerige, NR4 7TJ
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Peterborough, Det Forenede Kongerige, PE8 6PL
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Romford, Det Forenede Kongerige, RM1 3PJ
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Shipley, Det Forenede Kongerige, BD18 3SA
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Sidcup, Det Forenede Kongerige, DA14 6LT
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Wokingham, Det Forenede Kongerige, RG40 1XS
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Alabama
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Andalusia, Alabama, Forenede Stater, 36420
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Athens, Alabama, Forenede Stater, 35611
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Birmingham, Alabama, Forenede Stater, 35209
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Birmingham, Alabama, Forenede Stater, 35243
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Birmingham, Alabama, Forenede Stater, 35235
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Dothan, Alabama, Forenede Stater, 36303
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Florence, Alabama, Forenede Stater, 35630
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Foley, Alabama, Forenede Stater, 36535
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Gulf Shores, Alabama, Forenede Stater, 36542
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Jasper, Alabama, Forenede Stater, 35501
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Mobile, Alabama, Forenede Stater, 36608
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Montgomery, Alabama, Forenede Stater, 36106
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Scottsboro, Alabama, Forenede Stater, 35768
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Sheffield, Alabama, Forenede Stater, 35660
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Arizona
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Peoria, Arizona, Forenede Stater, 85381
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Phoenix, Arizona, Forenede Stater, 85018
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Phoenix, Arizona, Forenede Stater, 85020
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Phoenix, Arizona, Forenede Stater, 85012
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Scottsdale, Arizona, Forenede Stater, 85258
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Arkansas
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Conway, Arkansas, Forenede Stater, 72032
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Little Rock, Arkansas, Forenede Stater, 72209
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Little Rock, Arkansas, Forenede Stater, 72205
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North Little Rock, Arkansas, Forenede Stater, 72117
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California
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Bakersfield, California, Forenede Stater, 93301
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Beverly Hills, California, Forenede Stater, 90212
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Cerritos, California, Forenede Stater, 90703
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El Cajon, California, Forenede Stater, 92020
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Escondido, California, Forenede Stater, 92025
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Fresno, California, Forenede Stater, 93702
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Gold River, California, Forenede Stater, 95670
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Hawaiian Gardens, California, Forenede Stater, 90716
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Huntington Beach, California, Forenede Stater, 92647
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Huntington Park, California, Forenede Stater, 90255-6046
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La Mirada, California, Forenede Stater, 90638
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Lakewood, California, Forenede Stater, 90712
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Los Angeles, California, Forenede Stater, 90025
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Los Angeles, California, Forenede Stater, 90017
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Los Angeles, California, Forenede Stater, 90036
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Los Angeles, California, Forenede Stater, 90048
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Newport Beach, California, Forenede Stater, 92663
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Northridge, California, Forenede Stater, 91324
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Palm Springs, California, Forenede Stater, 92262
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Poway, California, Forenede Stater, 92064
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Quartz Hill, California, Forenede Stater, 93536
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Rancho Mirage, California, Forenede Stater, 92270
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Riverside, California, Forenede Stater, 92506
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Rolling Hills Estates, California, Forenede Stater, 90274
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Sacramento, California, Forenede Stater, 95821
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Sacramento, California, Forenede Stater, 95823
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Sacramento, California, Forenede Stater, 95831
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San Diego, California, Forenede Stater, 92120
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San Diego, California, Forenede Stater, 92117
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Santa Ana, California, Forenede Stater, 92705
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Santa Ana, California, Forenede Stater, 92704
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Santa Monica, California, Forenede Stater, 90404
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Stockton, California, Forenede Stater, 95207
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Torrance, California, Forenede Stater, 90503
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Tustin, California, Forenede Stater, 92780
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Upland, California, Forenede Stater, 91786
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Westminster, California, Forenede Stater, 92683
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Wildomar, California, Forenede Stater, 92595
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Colorado
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Colorado Springs, Colorado, Forenede Stater, 80922
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Colorado Springs, Colorado, Forenede Stater, 80910
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Fort Collins, Colorado, Forenede Stater, 80525
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Lafayette, Colorado, Forenede Stater, 80026
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Florida
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Boynton Beach, Florida, Forenede Stater, 33435
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Brandon, Florida, Forenede Stater, 33511
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Clearwater, Florida, Forenede Stater, 33765
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Clearwater, Florida, Forenede Stater, 33756
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Clermont, Florida, Forenede Stater, 34711
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Coral Gables, Florida, Forenede Stater, 33134
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Daytona Beach, Florida, Forenede Stater, 32117
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Fort Lauderdale, Florida, Forenede Stater, 33308
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Gainesville, Florida, Forenede Stater, 32607
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Hialeah, Florida, Forenede Stater, 33012
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Hialeah, Florida, Forenede Stater, 33029
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Hollywood, Florida, Forenede Stater, 33024
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Homestead, Florida, Forenede Stater, 33030
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Kissimmee, Florida, Forenede Stater, 34741
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Kissimmee, Florida, Forenede Stater, 34744
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Leesburg, Florida, Forenede Stater, 34748
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Loxahatchee Groves, Florida, Forenede Stater, 33470
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Miami, Florida, Forenede Stater, 33126
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Miami, Florida, Forenede Stater, 33186
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Miami, Florida, Forenede Stater, 33165
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Miami, Florida, Forenede Stater, 33175
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Miami, Florida, Forenede Stater, 33144
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Miami, Florida, Forenede Stater, 33125
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Miami, Florida, Forenede Stater, 33155
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Miami, Florida, Forenede Stater, 33174
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Miami, Florida, Forenede Stater, 33012
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Miami Lakes, Florida, Forenede Stater, 33014
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Ormond Beach, Florida, Forenede Stater, 32174
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Panama City, Florida, Forenede Stater, 32405
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Pembroke Pines, Florida, Forenede Stater, 33029
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Pensacola, Florida, Forenede Stater, 32503
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Port Charlotte, Florida, Forenede Stater, 33952
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Saint Petersburg, Florida, Forenede Stater, 33704
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Saint Petersburg, Florida, Forenede Stater, 33710
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Saint Petersburg, Florida, Forenede Stater, 33707
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Sarasota, Florida, Forenede Stater, 34239
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Tampa, Florida, Forenede Stater, 33603
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Tampa, Florida, Forenede Stater, 33607
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Winter Park, Florida, Forenede Stater, 32789
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Georgia
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Atlanta, Georgia, Forenede Stater, 30328
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Atlanta, Georgia, Forenede Stater, 30308
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Atlanta, Georgia, Forenede Stater, 30345
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Atlanta, Georgia, Forenede Stater, 30331
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Blue Ridge, Georgia, Forenede Stater, 30513
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Columbus, Georgia, Forenede Stater, 31904
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Dacula, Georgia, Forenede Stater, 30019
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Duluth, Georgia, Forenede Stater, 30096
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Lawrenceville, Georgia, Forenede Stater, 30046
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Norcross, Georgia, Forenede Stater, 30071
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Rincon, Georgia, Forenede Stater, 31326
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Riverdale, Georgia, Forenede Stater, 30274
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Savannah, Georgia, Forenede Stater, 31406
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Woodstock, Georgia, Forenede Stater, 30189
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Illinois
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Belleville, Illinois, Forenede Stater, 62220
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Champaign, Illinois, Forenede Stater, 61820
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Chicago, Illinois, Forenede Stater, 60607
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O'Fallon, Illinois, Forenede Stater, 62269
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Skokie, Illinois, Forenede Stater, 60076
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Indiana
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Michigan City, Indiana, Forenede Stater, 46360
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Valparaiso, Indiana, Forenede Stater, 46383
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Iowa
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Council Bluffs, Iowa, Forenede Stater, 51503
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West Des Moines, Iowa, Forenede Stater, 50266
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Kentucky
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Fort Mitchell, Kentucky, Forenede Stater, 41017
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Owensboro, Kentucky, Forenede Stater, 42303
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Paducah, Kentucky, Forenede Stater, 42003
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Louisiana
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Crowley, Louisiana, Forenede Stater, 70526
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Lafayette, Louisiana, Forenede Stater, 70508
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Lake Charles, Louisiana, Forenede Stater, 70601
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New Orleans, Louisiana, Forenede Stater, 70115
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Opelousas, Louisiana, Forenede Stater, 70570
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Sunset, Louisiana, Forenede Stater, 70584
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Zachary, Louisiana, Forenede Stater, 70791
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Maine
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Bangor, Maine, Forenede Stater, 04401
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Maryland
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Baltimore, Maryland, Forenede Stater, 21237
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Baltimore, Maryland, Forenede Stater, 21224
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Baltimore, Maryland, Forenede Stater, 21236
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Columbia, Maryland, Forenede Stater, 21044
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White Marsh, Maryland, Forenede Stater, 21162
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Massachusetts
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Marlborough, Massachusetts, Forenede Stater, 01752
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Methuen, Massachusetts, Forenede Stater, 01844
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North Dartmouth, Massachusetts, Forenede Stater, 02747
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Michigan
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Buckley, Michigan, Forenede Stater, 49620
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Cadillac, Michigan, Forenede Stater, 49601
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Canton, Michigan, Forenede Stater, 48187
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Caro, Michigan, Forenede Stater, 48723
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Farmington Hills, Michigan, Forenede Stater, 48336
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Flint, Michigan, Forenede Stater, 48504
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Port Huron, Michigan, Forenede Stater, 48060
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Rochester, Michigan, Forenede Stater, 48307
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Southfield, Michigan, Forenede Stater, 48034
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Troy, Michigan, Forenede Stater, 48085
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Minnesota
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Edina, Minnesota, Forenede Stater, 55435
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Fridley, Minnesota, Forenede Stater, 55432
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Minneapolis, Minnesota, Forenede Stater, 55407
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Woodbury, Minnesota, Forenede Stater, 55125
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Mississippi
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Biloxi, Mississippi, Forenede Stater, 39531
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Missouri
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Belton, Missouri, Forenede Stater, 64012
- Research Site
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Chesterfield, Missouri, Forenede Stater, 63017
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Saint Charles, Missouri, Forenede Stater, 63301
- Research Site
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Saint Louis, Missouri, Forenede Stater, 63141
- Research Site
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Saint Louis, Missouri, Forenede Stater, 63143
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Montana
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Billings, Montana, Forenede Stater, 59102
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Nebraska
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Bellevue, Nebraska, Forenede Stater, 68005
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Bellevue, Nebraska, Forenede Stater, 68123
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89106
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Reno, Nevada, Forenede Stater, 89519
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New Hampshire
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Portsmouth, New Hampshire, Forenede Stater, 03801
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New Jersey
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Marlton, New Jersey, Forenede Stater, 08053
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Toms River, New Jersey, Forenede Stater, 08755
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New York
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Bronx, New York, Forenede Stater, 10459
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Bronx, New York, Forenede Stater, 10457
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Bronx, New York, Forenede Stater, 10461
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Bronx, New York, Forenede Stater, 10455
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Bronx, New York, Forenede Stater, 10468
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Bronxville, New York, Forenede Stater, 10708
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Brooklyn, New York, Forenede Stater, 11229
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Jamaica, New York, Forenede Stater, 11435
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New Windsor, New York, Forenede Stater, 12553
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New York, New York, Forenede Stater, 10016
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North Carolina
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Asheville, North Carolina, Forenede Stater, 28801
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Burlington, North Carolina, Forenede Stater, 27215
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Charlotte, North Carolina, Forenede Stater, 28277
- Research Site
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Charlotte, North Carolina, Forenede Stater, 28207
- Research Site
-
Charlotte, North Carolina, Forenede Stater, 28210
- Research Site
-
Elizabeth City, North Carolina, Forenede Stater, 27909
- Research Site
-
Gastonia, North Carolina, Forenede Stater, 28054
- Research Site
-
Greensboro, North Carolina, Forenede Stater, 27408
- Research Site
-
Hendersonville, North Carolina, Forenede Stater, 28739
- Research Site
-
Hickory, North Carolina, Forenede Stater, 28601
- Research Site
-
Huntersville, North Carolina, Forenede Stater, 28078
- Research Site
-
Lenoir, North Carolina, Forenede Stater, 28645
- Research Site
-
Monroe, North Carolina, Forenede Stater, 28112
- Research Site
-
Mooresville, North Carolina, Forenede Stater, 28117
- Research Site
-
Morganton, North Carolina, Forenede Stater, 28655
- Research Site
-
Mount Airy, North Carolina, Forenede Stater, 27030
- Research Site
-
New Bern, North Carolina, Forenede Stater, 28562
- Research Site
-
Raleigh, North Carolina, Forenede Stater, 27612
- Research Site
-
Shelby, North Carolina, Forenede Stater, 28150
- Research Site
-
Whiteville, North Carolina, Forenede Stater, 28472
- Research Site
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Wilmington, North Carolina, Forenede Stater, 28401
- Research Site
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Winston-Salem, North Carolina, Forenede Stater, 27103
- Research Site
-
-
North Dakota
-
Fargo, North Dakota, Forenede Stater, 58104
- Research Site
-
-
Ohio
-
Blue Ash, Ohio, Forenede Stater, 45242
- Research Site
-
Cincinnati, Ohio, Forenede Stater, 45231
- Research Site
-
Cincinnati, Ohio, Forenede Stater, 45245
- Research Site
-
Columbus, Ohio, Forenede Stater, 43123
- Research Site
-
Dayton, Ohio, Forenede Stater, 45459
- Research Site
-
Dayton, Ohio, Forenede Stater, 45419
- Research Site
-
Dublin, Ohio, Forenede Stater, 43016
- Research Site
-
Kettering, Ohio, Forenede Stater, 45429
- Research Site
-
Maumee, Ohio, Forenede Stater, 43537
- Research Site
-
Toledo, Ohio, Forenede Stater, 43617
- Research Site
-
-
Oklahoma
-
Edmond, Oklahoma, Forenede Stater, 73034
- Research Site
-
Oklahoma City, Oklahoma, Forenede Stater, 73103
- Research Site
-
Tulsa, Oklahoma, Forenede Stater, 74136
- Research Site
-
-
Oregon
-
Medford, Oregon, Forenede Stater, 97504
- Research Site
-
Portland, Oregon, Forenede Stater, 97202
- Research Site
-
-
Pennsylvania
-
Altoona, Pennsylvania, Forenede Stater, 16602
- Research Site
-
Erie, Pennsylvania, Forenede Stater, 16508
- Research Site
-
Monroeville, Pennsylvania, Forenede Stater, 15665
- Research Site
-
Philadelphia, Pennsylvania, Forenede Stater, 19114
- Research Site
-
Phoenixville, Pennsylvania, Forenede Stater, 19460
- Research Site
-
Pittsburgh, Pennsylvania, Forenede Stater, 15241
- Research Site
-
Pittsburgh, Pennsylvania, Forenede Stater, 15243
- Research Site
-
Pittsburgh, Pennsylvania, Forenede Stater, 15236
- Research Site
-
Scottdale, Pennsylvania, Forenede Stater, 15683
- Research Site
-
Uniontown, Pennsylvania, Forenede Stater, 15401
- Research Site
-
-
Rhode Island
-
East Providence, Rhode Island, Forenede Stater, 02914
- Research Site
-
Providence, Rhode Island, Forenede Stater, 02908
- Research Site
-
-
South Carolina
-
Anderson, South Carolina, Forenede Stater, 29621
- Research Site
-
Charleston, South Carolina, Forenede Stater, 29406
- Research Site
-
Charleston, South Carolina, Forenede Stater, 29412
- Research Site
-
Columbia, South Carolina, Forenede Stater, 29201
- Research Site
-
Easley, South Carolina, Forenede Stater, 29640
- Research Site
-
Gaffney, South Carolina, Forenede Stater, 29340
- Research Site
-
Gaffney, South Carolina, Forenede Stater, 29341
- Research Site
-
Greenville, South Carolina, Forenede Stater, 29615
- Research Site
-
Greer, South Carolina, Forenede Stater, 29651
- Research Site
-
Greer, South Carolina, Forenede Stater, 29650
- Research Site
-
Hodges, South Carolina, Forenede Stater, 29653
- Research Site
-
Indian Land, South Carolina, Forenede Stater, 29707
- Research Site
-
Lancaster, South Carolina, Forenede Stater, 29720
- Research Site
-
Mount Pleasant, South Carolina, Forenede Stater, 29464
- Research Site
-
Rock Hill, South Carolina, Forenede Stater, 29732
- Research Site
-
Seneca, South Carolina, Forenede Stater, 29678
- Research Site
-
Spartanburg, South Carolina, Forenede Stater, 29303
- Research Site
-
Spartanburg, South Carolina, Forenede Stater, 29301
- Research Site
-
Union, South Carolina, Forenede Stater, 29379
- Research Site
-
-
South Dakota
-
Rapid City, South Dakota, Forenede Stater, 57702
- Research Site
-
-
Tennessee
-
Chattanooga, Tennessee, Forenede Stater, 37404
- Research Site
-
Hendersonville, Tennessee, Forenede Stater, 37075
- Research Site
-
Johnson City, Tennessee, Forenede Stater, 37601
- Research Site
-
Knoxville, Tennessee, Forenede Stater, 37912
- Research Site
-
-
Texas
-
Arlington, Texas, Forenede Stater, 76012
- Research Site
-
Arlington, Texas, Forenede Stater, 76014
- Research Site
-
Boerne, Texas, Forenede Stater, 78006
- Research Site
-
Carrollton, Texas, Forenede Stater, 75007
- Research Site
-
Corsicana, Texas, Forenede Stater, 75110
- Research Site
-
Cypress, Texas, Forenede Stater, 77429
- Research Site
-
Duncanville, Texas, Forenede Stater, 75116
- Research Site
-
El Paso, Texas, Forenede Stater, 79903
- Research Site
-
Fort Worth, Texas, Forenede Stater, 76109
- Research Site
-
Fort Worth, Texas, Forenede Stater, 76104
- Research Site
-
Houston, Texas, Forenede Stater, 77074
- Research Site
-
Houston, Texas, Forenede Stater, 77058
- Research Site
-
Houston, Texas, Forenede Stater, 77070
- Research Site
-
Houston, Texas, Forenede Stater, 77084
- Research Site
-
Houston, Texas, Forenede Stater, 77099
- Research Site
-
Houston, Texas, Forenede Stater, 77079
- Research Site
-
Houston, Texas, Forenede Stater, 77089
- Research Site
-
Houston, Texas, Forenede Stater, 77008
- Research Site
-
Houston, Texas, Forenede Stater, 77043
- Research Site
-
Huntsville, Texas, Forenede Stater, 77340
- Research Site
-
Katy, Texas, Forenede Stater, 77450
- Research Site
-
Kerrville, Texas, Forenede Stater, 78028
- Research Site
-
Killeen, Texas, Forenede Stater, 76543
- Research Site
-
Kingwood, Texas, Forenede Stater, 77339
- Research Site
-
Lampasas, Texas, Forenede Stater, 76550
- Research Site
-
Lewisville, Texas, Forenede Stater, 75067
- Research Site
-
Longview, Texas, Forenede Stater, 75605
- Research Site
-
Lufkin, Texas, Forenede Stater, 75904
- Research Site
-
McKinney, Texas, Forenede Stater, 75069
- Research Site
-
McKinney, Texas, Forenede Stater, 75071
- Research Site
-
Pearland, Texas, Forenede Stater, 77584
- Research Site
-
Pflugerville, Texas, Forenede Stater, 78660
- Research Site
-
Plano, Texas, Forenede Stater, 75093
- Research Site
-
San Antonio, Texas, Forenede Stater, 78229
- Research Site
-
San Antonio, Texas, Forenede Stater, 78258
- Research Site
-
Sealy, Texas, Forenede Stater, 77474
- Research Site
-
Sherman, Texas, Forenede Stater, 75092
- Research Site
-
Splendora, Texas, Forenede Stater, 77372
- Research Site
-
The Woodlands, Texas, Forenede Stater, 77380
- Research Site
-
Webster, Texas, Forenede Stater, 77598
- Research Site
-
-
Utah
-
Midvale, Utah, Forenede Stater, 84047
- Research Site
-
Salt Lake City, Utah, Forenede Stater, 84102
- Research Site
-
-
Virginia
-
Abingdon, Virginia, Forenede Stater, 24210
- Research Site
-
Burke, Virginia, Forenede Stater, 22015
- Research Site
-
Newport News, Virginia, Forenede Stater, 23606
- Research Site
-
Richmond, Virginia, Forenede Stater, 23225
- Research Site
-
Richmond, Virginia, Forenede Stater, 23220
- Research Site
-
Richmond, Virginia, Forenede Stater, 23235
- Research Site
-
Richmond, Virginia, Forenede Stater, 23230
- Research Site
-
Richmond, Virginia, Forenede Stater, 23219
- Research Site
-
Richmond, Virginia, Forenede Stater, 23114
- Research Site
-
Virginia Beach, Virginia, Forenede Stater, 23454
- Research Site
-
Williamsburg, Virginia, Forenede Stater, 23188
- Research Site
-
-
Washington
-
Bellevue, Washington, Forenede Stater, 98007
- Research Site
-
Richland, Washington, Forenede Stater, 99352
- Research Site
-
Spokane, Washington, Forenede Stater, 99202
- Research Site
-
Spokane, Washington, Forenede Stater, 99216
- Research Site
-
Tacoma, Washington, Forenede Stater, 98405
- Research Site
-
-
West Virginia
-
Morgantown, West Virginia, Forenede Stater, 26505
- Research Site
-
-
Wisconsin
-
Greenfield, Wisconsin, Forenede Stater, 53228
- Research Site
-
-
-
-
-
Lyon Cedex 4, Frankrig, 69317
- Research Site
-
Marseille, Frankrig, 13003
- Research Site
-
Nantes, Frankrig, 44277
- Research Site
-
Nimes Cedex 09, Frankrig, 30029
- Research Site
-
Vandoeuvre les Nancy, Frankrig, 54500
- Research Site
-
-
-
-
-
Almelo, Holland, 7609 PP
- Research Site
-
Almere, Holland, 1311 RL
- Research Site
-
Almere, Holland, 3562KX
- Research Site
-
Beek, Holland, 6191 JW
- Research Site
-
Breda, Holland, 4818 CK
- Research Site
-
Capelle aan den IJssel, Holland, 2906 ZC
- Research Site
-
Eindhoven, Holland, 5623EJ
- Research Site
-
Enschede, Holland, 7512 KZ
- Research Site
-
Harderwijk, Holland, 3844 DG
- Research Site
-
Heerlen, Holland, 6419 PC
- Research Site
-
Hoorn NH, Holland, 1624 NP
- Research Site
-
Voerendaal, Holland, 6367
- Research Site
-
Zutphen, Holland, 7207 AE
- Research Site
-
Zwolle, Holland, 8025 AB
- Research Site
-
-
-
-
-
Bologna, Italien, 40138
- Research Site
-
Foggia, Italien, 71100
- Research Site
-
Genova, Italien, 16132
- Research Site
-
Messina, Italien, 98125
- Research Site
-
Milan, Italien, 20122
- Research Site
-
Modena, Italien, 41124
- Research Site
-
Napoli, Italien, 80131
- Research Site
-
Palermo, Italien, 90127
- Research Site
-
Parma, Italien, 43100
- Research Site
-
Pisa, Italien, 56124
- Research Site
-
Pordenone, Italien, 33170
- Research Site
-
Roma, Italien, 00128
- Research Site
-
Roma, Italien, 00133
- Research Site
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Roma, Italien, 00185
- Research Site
-
Tradate, Italien, 21049
- Research Site
-
-
-
-
-
Osakasayama-shi, Japan, 589-8511
- Research Site
-
Sakaide-shi, Japan, 762-8550
- Research Site
-
Seto-shi, Japan, 489-8642
- Research Site
-
Shinagawa-ku, Japan, 142-8666
- Research Site
-
Yanagawa-shi, Japan, 832-0059
- Research Site
-
-
-
-
-
Baotou, Kina, 14010
- Research Site
-
Beijing, Kina, 100020
- Research Site
-
Beijing, Kina, 100034
- Research Site
-
Beijing, Kina, 100050
- Research Site
-
Beijing, Kina, CN-100029
- Research Site
-
Changsha, Kina, 410004
- Research Site
-
Changsha, Kina, 410005
- Research Site
-
Changsha, Kina, 410078
- Research Site
-
Chengdu, Kina, 610041
- Research Site
-
Guangzhou, Kina, 510150
- Research Site
-
Guangzhou, Kina, 510080
- Research Site
-
Guangzhou, Kina, 510220
- Research Site
-
Guiyang, Kina, 550004
- Research Site
-
Haikou, Kina, 570208
- Research Site
-
Hangzhou, Kina, 310006
- Research Site
-
Hangzhou, Kina, 310003
- Research Site
-
Hohhot, Kina, 010017
- Research Site
-
Hohhot, Kina, 610078
- Research Site
-
Huhehaote, Kina, 010050
- Research Site
-
Lanzhou, Kina, 730000
- Research Site
-
Linhai, Kina, 317000
- Research Site
-
Nanchang, Kina, 330006
- Research Site
-
Nanjing, Kina, 210006
- Research Site
-
Nanjing, Kina, CN-210000
- Research Site
-
Nanjing, Kina, 210000
- Research Site
-
Pingxiang, Kina, 337055
- Research Site
-
Shanghai, Kina, 201199
- Research Site
-
Shanghai, Kina, 200135
- Research Site
-
Shenyang, Kina, 110001
- Research Site
-
Shenzhen, Kina, 518020
- Research Site
-
Shenzhen, Kina, 518029
- Research Site
-
Shijiazhuang, Kina, 050051
- Research Site
-
Shijiazhuang, Kina, 50051
- Research Site
-
Wuhan, Kina, 430033
- Research Site
-
Xi'an, Kina, 710004
- Research Site
-
Xiangtan, Kina, 411100
- Research Site
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Xuzhou, Kina, 221006
- Research Site
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Yanji, Kina, 133000
- Research Site
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Zhanjiang, Kina, 524001
- Research Site
-
-
-
-
-
Cuautitlan Izcalli, Mexico, 54769
- Research Site
-
Guadalajara, Mexico, 44670
- Research Site
-
Guadalajara, Mexico, 44100
- Research Site
-
Mexico, Mexico, 14050
- Research Site
-
Monterrey, Mexico, 64060
- Research Site
-
Monterrey, Mexico, 64718
- Research Site
-
-
-
-
-
Auckland, New Zealand, 0626
- Research Site
-
Christchurch, New Zealand, 8024
- Research Site
-
Christchurch, New Zealand, 8140
- Research Site
-
Dunedin, New Zealand, 9016
- Research Site
-
Greenlane, New Zealand, 1051
- Research Site
-
Greenlane East, New Zealand, 1051
- Research Site
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Hamilton, New Zealand, 3240
- Research Site
-
Havelock North, New Zealand, 4130
- Research Site
-
Newtown, New Zealand, 6242
- Research Site
-
Papatoetoe, New Zealand, 2025
- Research Site
-
Tauranga, New Zealand, 3143
- Research Site
-
-
-
-
-
Cusco, Peru
- Research Site
-
Lima, Peru, 15033
- Research Site
-
Lima, Peru, LIMA 27
- Research Site
-
Lima, Peru, LIMA 41
- Research Site
-
Lima, Peru, Lima 18
- Research Site
-
Lima, Peru, Lima 32
- Research Site
-
Lima, Peru, 15102
- Research Site
-
Lima, Peru, LIMA 21
- Research Site
-
Lima, Peru, L 41
- Research Site
-
Lima, Peru, Lima-33
- Research Site
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Miraflores, Peru, 15046
- Research Site
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Piura, Peru, 51
- Research Site
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Santa Beatriz, Peru, LIMA 14
- Research Site
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-
-
-
-
Białystok, Polen, 15-003
- Research Site
-
Białystok, Polen, 15-044
- Research Site
-
Bydgoszcz, Polen, 85-863
- Research Site
-
Poznań, Polen, 60-823
- Research Site
-
Ruda Śląska, Polen, 41-707
- Research Site
-
Rzeszow, Polen, 35-301
- Research Site
-
Rzeszów, Polen, 35-205
- Research Site
-
Skarżysko-Kamienna, Polen, 26-110
- Research Site
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Szczecin, Polen, 70-111
- Research Site
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Tarnów, Polen, 33-100
- Research Site
-
Warszawa, Polen, 01-518
- Research Site
-
Wrocław, Polen, 54-239
- Research Site
-
Zabrze, Polen, 41-807
- Research Site
-
-
-
-
-
Belgrade, Serbien, 11000
- Research Site
-
Belgrade, Serbien, 11070
- Research Site
-
Kragujevac, Serbien, 34000
- Research Site
-
Nis, Serbien, 18000
- Research Site
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Sremska Kamenica, Serbien, 21204
- Research Site
-
Valjevo, Serbien, 14000
- Research Site
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-
-
-
-
Alcobendas, Spanien, 28100
- Research Site
-
Alicante, Spanien, 03004
- Research Site
-
Alzira, Spanien, 46410
- Research Site
-
Badalona(Barcelona), Spanien, 08916
- Research Site
-
Barcelona, Spanien, 08028
- Research Site
-
Barcelona, Spanien, 08041
- Research Site
-
Barcelona, Spanien, 08003
- Research Site
-
Barcelona, Spanien, 08006
- Research Site
-
Barcelona, Spanien, 08023
- Research Site
-
Barcelona, Spanien, 08550
- Research Site
-
Cartagena, Spanien, 30202
- Research Site
-
Coruna, Spanien, 15011A
- Research Site
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Girona, Spanien, 17005
- Research Site
-
Laredo, Spanien, 39770
- Research Site
-
Lleida, Spanien, 25198
- Research Site
-
Madrid, Spanien, 28040
- Research Site
-
Madrid, Spanien, 28007
- Research Site
-
Malaga, Spanien, 29010
- Research Site
-
Marbella (Málaga), Spanien, 29603
- Research Site
-
Mataro, Spanien, 08303
- Research Site
-
Mérida (Badajoz), Spanien, 06800
- Research Site
-
Pamplona, Spanien, 31008
- Research Site
-
Peralada, Spanien, 17491
- Research Site
-
Ponferrada, Spanien, 24411
- Research Site
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Sabadell, Spanien, 08208
- Research Site
-
Salamanca, Spanien, 37007
- Research Site
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Sant Boi de Llobregat, Spanien, 08830
- Research Site
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Valencia, Spanien, 46015
- Research Site
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Zaragoza, Spanien, 50009
- Research Site
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-
-
-
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Helsingborg, Sverige, 25220
- Research Site
-
Karlskrona, Sverige, 37171
- Research Site
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Lund, Sverige, 22222
- Research Site
-
Malmo, Sverige, 21152
- Research Site
-
Stockholm, Sverige, SE-181 58
- Research Site
-
Stockholm, Sverige, 114 46
- Research Site
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-
-
-
-
Benoni, Sydafrika, 1500
- Research Site
-
Bloemfontein, Sydafrika, 9301
- Research Site
-
Boksburg, Sydafrika, 1459
- Research Site
-
Boksburg, Sydafrika, 1460
- Research Site
-
Cape Town, Sydafrika, 7700
- Research Site
-
Cape Town, Sydafrika, 7764
- Research Site
-
Cape Town, Sydafrika, 7570
- Research Site
-
Cape Town, Sydafrika, 7500
- Research Site
-
Cape Town, Sydafrika, 7550
- Research Site
-
Cape Town, Sydafrika, 08000
- Research Site
-
Cape Town, Sydafrika, 7780
- Research Site
-
Durban, Sydafrika, 4001
- Research Site
-
Durban, Sydafrika, 4071
- Research Site
-
Johannesburg, Sydafrika, 1724
- Research Site
-
Johannesburg, Sydafrika, 2188
- Research Site
-
Port Elizabeth, Sydafrika, 6014
- Research Site
-
Pretoria, Sydafrika, 0002
- Research Site
-
Pretoria, Sydafrika, 0183
- Research Site
-
Pretoria, Sydafrika, 0014
- Research Site
-
Umhlanga, Sydafrika, 4319
- Research Site
-
-
-
-
-
Kaohsiung, Taiwan, 83301
- Research Site
-
Kaohsiung, Taiwan, 00807
- Research Site
-
Kaohsiung City, Taiwan, 82445
- Research Site
-
Keelung City, Taiwan, 20401
- Research Site
-
New-Taipei, Taiwan, 22056
- Research Site
-
Taichung, Taiwan, 40447
- Research Site
-
Taichung, Taiwan, 00407
- Research Site
-
Taipei, Taiwan, 10002
- Research Site
-
Taoyuan, Taiwan, 00333
- Research Site
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-
-
-
-
Benešov, Tjekkiet, 256 01
- Research Site
-
Beroun, Tjekkiet, 26601
- Research Site
-
Jindrichuv Hradec, Tjekkiet, 37701
- Research Site
-
Liberec, Tjekkiet, 525947
- Research Site
-
Liberec 1, Tjekkiet, 46063
- Research Site
-
Melnik, Tjekkiet, 250 63
- Research Site
-
Moravsky Krumlov, Tjekkiet, 67201
- Research Site
-
Praha 1, Tjekkiet, 110 00
- Research Site
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Praha 10, Tjekkiet, 10800
- Research Site
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Teplice, Tjekkiet, 415 01
- Research Site
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Zatec, Tjekkiet, 43801
- Research Site
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-
-
-
-
Aschaffenburg, Tyskland, 63739
- Research Site
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Augsburg, Tyskland, 86150
- Research Site
-
Bad Wörishofen, Tyskland, 86825
- Research Site
-
Bamberg, Tyskland, 96049
- Research Site
-
Bergisch Gladbach, Tyskland, 51429
- Research Site
-
Berlin, Tyskland, 14059
- Research Site
-
Berlin, Tyskland, 10117
- Research Site
-
Berlin, Tyskland, 10367
- Research Site
-
Berlin, Tyskland, 10717
- Research Site
-
Berlin, Tyskland, 10969
- Research Site
-
Berlin, Tyskland, 10119
- Research Site
-
Berlin, Tyskland, 10787
- Research Site
-
Berlin, Tyskland, 12157
- Research Site
-
Berlin, Tyskland, 12203
- Research Site
-
Berlin, Tyskland, 13187
- Research Site
-
Berlin, Tyskland, 12159
- Research Site
-
Bonn, Tyskland, 53123
- Research Site
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Bonn, Tyskland, 53119
- Research Site
-
Cottbus, Tyskland, 03044
- Research Site
-
Darmstadt, Tyskland, 64283
- Research Site
-
Deggendorf, Tyskland, 94469
- Research Site
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Deggingen, Tyskland, 73326
- Research Site
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Dortmund, Tyskland, 44263
- Research Site
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Düren, Tyskland, 52349
- Research Site
-
Erlangen, Tyskland, 91052
- Research Site
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Essen, Tyskland, 45355
- Research Site
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Essen, Tyskland, 45359
- Research Site
-
Frankfurt, Tyskland, 60596
- Research Site
-
Frankfurt am Main, Tyskland, 60596
- Research Site
-
Frankfurt am Main, Tyskland, 60389
- Research Site
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Gelsenkirchen, Tyskland, 45879
- Research Site
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Grosshansdof, Tyskland, 22927
- Research Site
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Halle, Tyskland, 06108
- Research Site
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Hamburg, Tyskland, 20354
- Research Site
-
Hamburg, Tyskland, 22299
- Research Site
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Hannover, Tyskland, 30625
- Research Site
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Hannover, Tyskland, D-30173
- Research Site
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Hannover, Tyskland, 30167
- Research Site
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Ibbenbüren, Tyskland, 49477
- Research Site
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Kiel, Tyskland, 24105
- Research Site
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Koblenz, Tyskland, 56068
- Research Site
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Köln, Tyskland, 51069
- Research Site
-
Landsberg, Tyskland, 86899
- Research Site
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Leipzig, Tyskland, 04357
- Research Site
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Leipzig, Tyskland, 04103
- Research Site
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Leipzig, Tyskland, 04207
- Research Site
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Leipzig, Tyskland, 04275
- Research Site
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Leipzig, Tyskland, 04107
- Research Site
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Leipzig, Tyskland, 04157
- Research Site
-
Lübeck, Tyskland, 23552
- Research Site
-
Magdeburg, Tyskland, 39120
- Research Site
-
Mainz, Tyskland, 55131
- Research Site
-
Marburg, Tyskland, 35037
- Research Site
-
München, Tyskland, 80339
- Research Site
-
München, Tyskland, 80539
- Research Site
-
Münster, Tyskland, 48145
- Research Site
-
Neu-Isenburg, Tyskland, 63263
- Research Site
-
Peine, Tyskland, 31224
- Research Site
-
Potsdam, Tyskland, 14469
- Research Site
-
Radebeul, Tyskland, 01445
- Research Site
-
Rosenheim, Tyskland, 83022
- Research Site
-
Ruesselsheim, Tyskland, D-65428
- Research Site
-
Rüdersdorf, Tyskland, 15562
- Research Site
-
Schleswig, Tyskland, 24837
- Research Site
-
Schwedt, Tyskland, 16303
- Research Site
-
Wardenburg, Tyskland, 26203
- Research Site
-
Weinheim, Tyskland, 69469
- Research Site
-
Wiesbaden, Tyskland, 65189
- Research Site
-
Wiesloch, Tyskland, 69168
- Research Site
-
Witten, Tyskland, 58452
- Research Site
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Zerbst, Tyskland, 39261
- Research Site
-
-
-
-
-
Balassagyarmat, Ungarn, 2660
- Research Site
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Budapest, Ungarn, 1134
- Research Site
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Csorna, Ungarn, 9300
- Research Site
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Debrecen, Ungarn, H-4031
- Research Site
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Gödöllő, Ungarn, 2100
- Research Site
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Kaposvár, Ungarn, H-7400
- Research Site
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Kapuvar, Ungarn, 09330
- Research Site
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Komarom, Ungarn, 2900
- Research Site
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Komló, Ungarn, 7300
- Research Site
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Miskolc, Ungarn, 3529
- Research Site
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Nyíregyháza, Ungarn, 4400
- Research Site
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Siófok, Ungarn, 08600
- Research Site
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Szigetszentmiklós, Ungarn, 2310
- Research Site
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Százhalombatta, Ungarn, 2440
- Research Site
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Törökbálint, Ungarn, 2045
- Research Site
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-
-
-
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Feldbach, Østrig, A-8330
- Research Site
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Grieskirchen, Østrig, 4710
- Research Site
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Hallein, Østrig, 5400
- Research Site
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Linz, Østrig, 04020
- Research Site
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Salzburg, Østrig, 5020
- Research Site
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Thalheim, Østrig, 4600
- Research Site
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Vienna, Østrig, 1190
- Research Site
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Wels, Østrig, 4600
- Research Site
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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 til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inklusionskriterier
- Ikke-fertilitetspotentiale (dvs. fysiologisk ude af stand til at blive gravid, inklusive enhver kvinde, der er 2 år efter overgangsalderen); eller i den fødedygtige alder, har en negativ serumgraviditetstest ved besøg 1 og accepterer acceptable præventionsmetoder, der anvendes konsekvent og korrekt i hele undersøgelsens varighed.
- Forsøgspersoner med en etableret klinisk historie med KOL som defineret af American Thoracic Society (ATS)/European Respiratory Society (ERS),
- Nuværende eller tidligere rygere med en historie på mindst 10 pakkeår med cigaretrygning.
- Forceret ekspiratorisk volumen på 1 sekund (FEV1)/Forced vital kapacitet (FVC)-forhold skal være <0,70, og FEV1 skal være <65 % af den forventede normalværdi beregnet ved hjælp af NHANES III-referenceligninger (eller referencenormer, der gælder for andre regioner).
- Emner med historie med eksacerbationer.
Se venligst undersøgelsesprotokollen for den komplette liste over inklusionskriterier.
Eksklusionskriterier
- Væsentlige sygdomme eller tilstande ud over KOL, som efter Investigators vurdering kan bringe forsøgspersonen i fare på grund af deltagelse i undersøgelsen eller kan påvirke enten undersøgelsens resultater eller forsøgspersonens mulighed for at deltage i undersøgelsen.
- Kvinder, der er gravide eller ammer, eller planlægger at blive gravide i løbet af undersøgelsen, eller kvinder i den fødedygtige alder, som ikke bruger en acceptabel præventionsmetode.
- Forsøgspersoner, som efter efterforskerens opfattelse har en aktuel diagnose astma.
- Forsøgspersoner, der har været indlagt på grund af dårligt kontrolleret KOL inden for 3 måneder før besøg 1 (screening)
- Forsøgspersoner, der har dårligt kontrolleret KOL, defineret som akut forværring af KOL, der kræver behandling med orale kortikosteroider eller antibiotika inden for 6 uger før besøg 1 (screening)
- Immunsuppression eller alvorlige neurologiske lidelser, der påvirker kontrollen af de øvre luftveje eller andre risikofaktorer, som efter investigatorens mening ville sætte forsøgspersonen i betydelig risiko for lungebetændelse.
- Forsøgspersoner med diagnosen snævervinklet glaukom, som efter undersøgerens vurdering ikke er blevet tilstrækkeligt behandlet.
- Personer, der har en historie med overfølsomhed over for β2-agonister, budesonid eller andre kortikosteroidkomponenter, glycopyrronium eller andre muskarine antikolinergika eller enhver anden komponent i IMP'erne.
Se venligst undersøgelsesprotokollen for den komplette liste over inklusionskriterier.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: BGF (PT010) MDI 320/14,4/9,6 μg
BGF MDI 320/14,4/9,6 μg, Budesonid, Glycopyrronium, Formoterol Fumarate Aerosol (PT010, BGF afmålt dosis inhalator [MDI])
|
Budensonid, Glycopyrronium og Formoterol Fumarate
Andre navne:
|
|
Eksperimentel: BGF (PT010) MDI 160/14,4/9,6 μg
BGF MDI 160/14,4/9,6 μg, Budesonid, Glycopyrronium, Formoterol Fumarate Aerosol (PT010, BGF afmålt dosis inhalator [MDI])
|
Budensonid, Glycopyrronium og Formoterol Fumarate
Andre navne:
|
|
Eksperimentel: BFF (PT009) MDI 320/9,6 μg
BFF MDI 320/9,6 μg Budesonid, Formoterol Fumarate Aerosol Glycopyrronium og Formoterol Fumarate Inhalation Aerosol (PT009)
|
Budensonid og formoterolfumarat
Andre navne:
|
|
Eksperimentel: GFF (PT003) MDI 14,4/9,6 μg
GFF MDI 14,4/9,6 μg Glycopyrronium, Formoterol Fumarate Aerosol Budesonide og Formoterol Fumarate Inhalation Aerosol (PT003)
|
Glycopyrronium og formoterolfumarat
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Justeret forekomst af moderate eller svære eksacerbationer
Tidsramme: 52 ugers behandlingsperiode
|
Justeret forekomst af moderate eller svære eksacerbationer
|
52 ugers behandlingsperiode
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Tid til første moderat eller svær KOL-eksacerbation
Tidsramme: 52 uger
|
Tid til den første moderate eller svære KOL-eksacerbation (andel med hændelsen rapporteret som mediantid blev ikke nået, statistiske analyser er baseret på tid til hændelse)
|
52 uger
|
|
Ændring fra baseline i gennemsnitlig daglig brug af Ventolin HFA over 24 uger
Tidsramme: 24 uger
|
Ændring fra baseline i den gennemsnitlige daglige brug af Ventolin HFA i løbet af 24 uger
|
24 uger
|
|
Procentdel af forsøgspersoner, der opnår et MCID på 4 enheder eller mere i SGRQ Total Score
Tidsramme: i uge 24
|
Procentdel af forsøgspersoner, der opnår en minimal klinisk vigtig forskel (MCID) på 4 enheder eller mere i SGRQ (St.
George's Respiratory Questionnaire) samlet score i uge 24
|
i uge 24
|
|
Tid til døden (alle årsager)
Tidsramme: 52 uger
|
Emnedødsfald (alle årsager)
|
52 uger
|
|
Hyppighed af alvorlige KOL-eksacerbationer
Tidsramme: 52 uger
|
Hyppighed af alvorlige KOL-eksacerbationer
|
52 uger
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Paul M Dorinsky, MD, Pearl Therapeutics
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
- Singh D, Hurst JR, Martinez FJ, Rabe KF, Bafadhel M, Jenkins M, Salazar D, Dorinsky P, Darken P. Predictive modeling of COPD exacerbation rates using baseline risk factors. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221107314. doi: 10.1177/17534666221107314.
- Rhodes K, Jenkins M, de Nigris E, Aurivillius M, Ouwens M. Relationship between risk, cumulative burden of exacerbations and mortality in patients with COPD: modelling analysis using data from the ETHOS study. BMC Med Res Methodol. 2022 May 25;22(1):150. doi: 10.1186/s12874-022-01616-7.
- Rabe KF, Martinez FJ, Ferguson GT, Wang C, Singh D, Wedzicha JA, Trivedi R, St Rose E, Ballal S, McLaren J, Darken P, Aurivillius M, Reisner C, Dorinsky P; ETHOS Investigators. Triple Inhaled Therapy at Two Glucocorticoid Doses in Moderate-to-Very-Severe COPD. N Engl J Med. 2020 Jul 2;383(1):35-48. doi: 10.1056/NEJMoa1916046. Epub 2020 Jun 24.
- Rabe KF, Martinez FJ, Ferguson GT, Wang C, Singh D, Wedzicha JA, Trivedi R, St Rose E, Ballal S, McLaren J, Darken P, Reisner C, Dorinsky P. A phase III study of triple therapy with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler 320/18/9.6 mug and 160/18/9.6 mug using co-suspension delivery technology in moderate-to-very severe COPD: The ETHOS study protocol. Respir Med. 2019 Oct-Nov;158:59-66. doi: 10.1016/j.rmed.2019.08.010. Epub 2019 Aug 22.
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)
30. juni 2015
Primær færdiggørelse (Faktiske)
26. juli 2019
Studieafslutning (Faktiske)
26. juli 2019
Datoer for studieregistrering
Først indsendt
29. maj 2015
Først indsendt, der opfyldte QC-kriterier
5. juni 2015
Først opslået (Skøn)
8. juni 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. februar 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. februar 2021
Sidst verificeret
1. januar 2021
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- PT010005
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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 .