A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)
Start Date
3/25/2025
Completion Date
6/5/2029
Summary
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
Detailed Description
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (COPD) receiving inhaled maintenance therapy and having had at least 2 moderate, or 1 severe, COPD exacerbations in the 12 months prior to Visit 1. Subjects will receive monthly subcutaneous injection of one of two different doses of tezepelumab, or placebo, with a maximum treatment duration of 76 weeks and a minimum of 52 weeks. The study also includes a off-treatment safety follow-up period of 12 weeks.
Eligibility Criteria
Age Range: 40 years to 80 years
Interventions
Tezepelumab
Placebo
Conditions
Locations
Research Site
Cullman, Alabama 35055
United States
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Phoenix, Arizona 85044
United States
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Scottsdale, Arizona 85258
United States
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Inglewood, California 90301
United States
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Los Angeles, California 90048
United States
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Palo Alto, California 94304
United States
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Redding, California 96001
United States
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San Diego, California 92108
United States
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New Britain, Connecticut 06051
United States
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Wilmington, Delaware 19803
United States
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Bay Pines, Florida 33744
United States
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Boynton Beach, Florida 33435
United States
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Clearwater, Florida 33765
United States
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Fleming Island, Florida 32003
United States
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Jacksonville, Florida 32209
United States
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Leesburg, Florida 34748
United States
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Margate, Florida 33063
United States
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Miami, Florida 33126
United States
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Miami, Florida 33155
United States
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Miami Lakes, Florida 33014
United States
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Ocala, Florida 34470
United States
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Palmetto Bay, Florida 33157
United States
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Winter Park, Florida 32789
United States
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Adairsville, Georgia 30103
United States
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Atlanta, Georgia 30349
United States
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Cordele, Georgia 31015
United States
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Decatur, Georgia 30033
United States
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Fort Eisenhower, Georgia 30905
United States
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Savannah, Georgia 31406
United States
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Evanston, Illinois 60201
United States
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Evansville, Indiana 47725
United States
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Indianapolis, Indiana 46202
United States
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Indianapolis, Indiana 46268
United States
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Kansas City, Kansas 66160
United States
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Bowling Green, Kentucky 42101
United States
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Owensboro, Kentucky 42301
United States
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Baltimore, Maryland 21224
United States
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Potomac, Maryland 20854
United States
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Ann Arbor, Michigan 48109
United States
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Minneapolis, Minnesota 55425
United States
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Hannibal, Missouri 63401
United States
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Staten Island, New York 10309
United States
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Syracuse, New York 13203
United States
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Charlotte, North Carolina 28277
United States
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Fayetteville, North Carolina 28303
United States
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Oklahoma City, Oklahoma 73102
United States
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Tulsa, Oklahoma 74133
United States
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Grants Pass, Oregon 97527
United States
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Sayre, Pennsylvania 18840
United States
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Anderson, South Carolina 29621
United States
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Columbia, South Carolina 29204
United States
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Gaffney, South Carolina 29340
United States
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Spartanburg, South Carolina 29303
United States
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Union, South Carolina 29379
United States
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Rapid City, South Dakota 57702
United States
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Knoxville, Tennessee 37919
United States
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Boerne, Texas 78006
United States
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El Paso, Texas 79902
United States
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Houston, Texas 77008
United States
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Houston, Texas 77074
United States
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Houston, Texas 77094
United States
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Lewisville, Texas 75067
United States
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McKinney, Texas 75069
United States
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Mesquite, Texas 75149
United States
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San Antonio, Texas 78258
United States
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Colchester, Vermont 05446
United States
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Williamsburg, Virginia 23188
United States
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Everett, Washington 98208
United States
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Alberdi, X5033DCE
Argentina
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Buenos Aires, C1425BEN
Argentina
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Ciudad de Buenos Aires, C1414AIF
Argentina
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Florida, B1602DQD
Argentina
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La Plata, B1900
Argentina
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La Plata, B1904
Argentina
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Mar del Plata, 7600
Argentina
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Mendoza, M5500CCG
Argentina
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Quilmes, B1878FNR
Argentina
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Rosario, 2000
Argentina
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San Fernando, B1646EBJ
Argentina
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San Juan Bautista, 1888
Argentina
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Coffs Harbour, 02450
Australia
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Frankston, 3199
Australia
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Garran, 2605
Australia
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Nedlands, 6009
Australia
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New Lambton, 2310
Australia
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Spearwood, 6163
Australia
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Wollongong, 2500
Australia
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Woodville South, 5011
Australia
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Genk, 3600
Belgium
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Ghent, 9000
Belgium
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Jette, 1090
Belgium
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Leuven, 3000
Belgium
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Mechelen, 2800
Belgium
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Namur, 5101
Belgium
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Dupnitsa, 2600
Bulgaria
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Haskovo, 6300
Bulgaria
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Lovech, 5500
Bulgaria
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Pleven, 5800
Bulgaria
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Plovdiv, 4003
Bulgaria
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Rousse, 7000
Bulgaria
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Rousse, 7000
Bulgaria
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Sofia, 1000
Bulgaria
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Sofia, 1202
Bulgaria
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Sofia, 1431
Bulgaria
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Sofia, 1756
Bulgaria
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Stara Zagora, 6003
Bulgaria
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Varna, 9000
Bulgaria
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Veliko Tanovo, 5000
Bulgaria
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Veliko Tarnovo, 5000
Bulgaria
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Vidin, 3700
Bulgaria
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Yambol, 8600
Bulgaria
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Armenia, 630004
Colombia
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Barranquilla, 080020
Colombia
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Bogotá, 110131
Colombia
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Cali, 760042
Colombia
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Ibague, 730006
Colombia
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Manizales, 170004
Colombia
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Medellín, 050022
Colombia
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Medellín, 050030
Colombia
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Aalborg, 9000
Denmark
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Hvidovre, 2650
Denmark
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Næstved, 4700
Denmark
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Odense C, 5000
Denmark
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Vejle, 7100
Denmark
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Brest, 29609
France
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Lyon, 69317
France
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Marseille, 13915
France
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Montpellier, 34295
France
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Paris, 75014
France
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Paris, 75877
France
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Pessac, 33604
France
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Saint-Herblain, 44800
France
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Athens, 11521
Greece
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Athens, 11527
Greece
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Athens, 17562
Greece
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Heraklion, 71110
Greece
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Ioannina, 45500
Greece
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Pátrai, 26332
Greece
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Thessaloniki, 57001
Greece
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Thessaloniki, 57010
Greece
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Hong Kong, 999077
Hong Kong
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Hong Kong,
Hong Kong
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Budapest, 1036
Hungary
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Debrecen, 4032
Hungary
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Edelény, 3780
Hungary
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Gödöllő, 2100
Hungary
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Hatvan, 3000
Hungary
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Mosonmagyaróvár, 9200
Hungary
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Nyíregyháza-Sóstóhegy, 4481
Hungary
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Törökbálint, 2045
Hungary
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Ashkelon, 78278
Israel
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Haifa, 34362
Israel
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Jerusalem, 00000
Israel
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Jerusalem, 90131
Israel
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Kfar Saba, 4428164
Israel
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Ramat Gan, 52621
Israel
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Rehovot, 76100
Israel
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Tel Aviv, 6423906
Israel
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Akashi-shi, 674-0063
Japan
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Chikushino-shi, 818-8502
Japan
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Chiyoda-ku, 1020074
Japan
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Fukui-shi, 910-8526
Japan
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Fukuoka, 811-1394
Japan
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Fukuoka, 819-8555
Japan
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Gifu, 502-8558
Japan
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Iruma-Gun, 350-0495
Japan
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Ishinomaki, 986-8522
Japan
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Kasuga-shi, 816-0864
Japan
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Kitakyushu-shi, 807-8555
Japan
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Kiyose-shi, 204-8522
Japan
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Kiyose-shi, 204-8585
Japan
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Kobe, 650-0047
Japan
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Komatsu-shi, 923-8560
Japan
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Kure-shi, 737-8505
Japan
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Kyoto, 612-8555
Japan
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Matsusaka-shi, 515-8544
Japan
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Meguro-ku, 153-0051
Japan
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Minatoku, 105-8470
Japan
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Minatoku, 108-0073
Japan
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Miyazaki, 889-1692
Japan
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Mizunami-shi, 509-6134
Japan
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Nagaoka-shi, 940-8621
Japan
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Nagasaki, 852-8501
Japan
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Nagoya, 457-0866
Japan
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Nagoya, 457-8511
Japan
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Nagoya, 466-8650
Japan
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Nerima-ku, 177-8521
Japan
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Ohta-ku, 143-0013
Japan
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Okayama, 700-8558
Japan
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Okayama, 701-1192
Japan
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Osaka, 540-0008
Japan
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Sapporo, 064-0804
Japan
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Sendai, 980-8574
Japan
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Sendai, 983-8520
Japan
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Shinjuku-ku, 160-8582
Japan
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Shinjuku-ku, 162-8655
Japan
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Shinjuku-ku, 162-8666
Japan
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Shiogama, 985-8506
Japan
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Takamatsu, 760-0018
Japan
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Takatsuiki-shi, 569-1096
Japan
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Tanabe-shi, 646-8558
Japan
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Toshima-ku, 171-0014
Japan
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Ube, 755-8505
Japan
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Yokohama, 236-0004
Japan
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Yokohama, 245-8575
Japan
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Eindhoven, 5623 EJ
Netherlands
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Maastricht, 6229 HX
Netherlands
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Rotterdam, 3045 PM
Netherlands
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Rotterdam, 3083 AN
Netherlands
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Zutphen, 7207 AE
Netherlands
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Auckland, 0626
New Zealand
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Auckland, 1051
New Zealand
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Auckland, 2025
New Zealand
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Hamilton West, 3204
New Zealand
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Tauranga, 3112
New Zealand
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Cusco, CUSCO 01
Peru
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Lima, 15036
Peru
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Lima, 15036
Peru
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Lima, 15046
Peru
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Lima, 15088
Peru
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Lima, LIMA 01
Peru
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Lima, LIMA 1
Peru
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Lima, LIMA 21
Peru
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Lima, LIMA 33
Peru
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Piura, 20001
Peru
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Bucharest, 011461
Romania
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Bucharest, 050159
Romania
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Cluj-Napoca, 400275
Romania
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Cluj-Napoca, 400332
Romania
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Oradea, 410176
Romania
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Timișoara, 300002
Romania
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Timișoara, 300310
Romania
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Bellville, 7530
South Africa
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Benoni, 1501
South Africa
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Cape Town, 7700
South Africa
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Durban, 4001
South Africa
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Durban, 4093
South Africa
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eMkhomazi, 4170
South Africa
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Kimberley, 8301
South Africa
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Somerset West, 7130
South Africa
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Gothenburg, 413 46
Sweden
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Karlskrona, 371 79
Sweden
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Lund, 22185
Sweden
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Örebro, 703 62
Sweden
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Stockholm, 11446
Sweden
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Stockholm, 171 64
Sweden
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Bang Kra So, 11000
Thailand
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Bangkok, 10330
Thailand
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Hat Yai, 90110
Thailand
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Muang, 22000
Thailand
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Muang, 40002
Thailand
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Mueang, 20000
Thailand
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Rayong, 21000
Thailand
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Adana, 1330
Turkey (Türkiye)
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Ankara, 6620
Turkey (Türkiye)
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Istanbul, 34020
Turkey (Türkiye)
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Kayseri, 38039
Turkey (Türkiye)
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Kocaeli, 41380
Turkey (Türkiye)
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Mersin, 33079
Turkey (Türkiye)
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Can Tho, 900000
Vietnam
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Da Nang, 550000
Vietnam
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Haiphong, 180000
Vietnam
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Hanoi, 100000
Vietnam
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Ho Chi Minh City, 700000
Vietnam
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Ho Chi Minh City, 700000
Vietnam
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Ho Chi Minh City,
Vietnam
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Hồ Chí Minh, 700000
Vietnam
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Huế, 530000
Vietnam