A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00006)
Start Date
3/18/2025
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
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Foley, Alabama 36535
United States
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Mobile, Alabama 36609
United States
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Sheffield, Alabama 35660
United States
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Phoenix, Arizona 85012
United States
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Phoenix, Arizona 85027
United States
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Tucson, Arizona 85704
United States
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Garden Grove, California 92844
United States
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Newport Beach, California 92663
United States
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Torrance, California 90502
United States
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Clearwater, Florida 33765
United States
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Cutler Bay, Florida 33157
United States
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Cutler Bay, Florida 33189
United States
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DeBary, Florida 32713
United States
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Gainesville, Florida 32608
United States
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Homestead, Florida 33032
United States
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Miami, Florida 33125
United States
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Miami, Florida 33125
United States
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Miami, Florida 33155
United States
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Miami, Florida 33175
United States
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Orlando, Florida 32807
United States
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Tampa, Florida 33606
United States
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Tampa, Florida 33607
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Atlanta, Georgia 30344
United States
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Lithonia, Georgia 30038
United States
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Rincon, Georgia 31326
United States
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Chicago, Illinois 60611
United States
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Palos Hills, Illinois 60465
United States
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Winfield, Illinois 60190
United States
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Munster, Indiana 46321
United States
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Baltimore, Maryland 21201
United States
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Columbia, Maryland 21045
United States
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North Dartmouth, Massachusetts 02747
United States
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Farmington Hills, Michigan 48336
United States
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Saint Cloud, Minnesota 56303
United States
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St Louis, Missouri 63103
United States
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Missoula, Montana 59808
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Papillion, Nebraska 68046
United States
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Las Vegas, Nevada 89106
United States
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Sewell, New Jersey 08080
United States
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Toms River, New Jersey 08755
United States
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Buffalo, New York 14203
United States
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Buffalo, New York 14215
United States
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Cortland, New York 13045
United States
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Horseheads, New York 14845
United States
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High Point, North Carolina 27260
United States
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Kings Mountain, North Carolina 28086
United States
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New Bern, North Carolina 28562
United States
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Wilmington, North Carolina 28412
United States
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Winston-Salem, North Carolina 27103
United States
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Columbus, Ohio 43213
United States
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Oklahoma City, Oklahoma 73120
United States
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DuBois, Pennsylvania 15801
United States
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Philadelphia, Pennsylvania 19140
United States
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Rock Hill, South Carolina 29732
United States
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Franklin, Tennessee 37067
United States
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Johnson City, Tennessee 37604
United States
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Dallas, Texas 75254
United States
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Fort Worth, Texas 76104
United States
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Houston, Texas 77084
United States
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Houston, Texas 77090
United States
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Humble, Texas 77338
United States
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Kerrville, Texas 78028
United States
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Mansfield, Texas 76063
United States
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Clearfield, Utah 84015
United States
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Morgantown, West Virginia 26501
United States
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Cudahy, Wisconsin 53110
United States
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Milwaukee, Wisconsin 53295
United States
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Bragança Paulista, 12916-542
Brazil
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Brasília, 70200-730
Brazil
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Campinas, 13060-080
Brazil
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Chapecó, 89812-210
Brazil
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Curitiba, 80030-110
Brazil
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Jaú, 17201-130
Brazil
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Mossoró, 59603-020
Brazil
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Porto Alegre, 90035-903
Brazil
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Porto Alegre, 90480-000
Brazil
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Porto Alegre, 90560-003
Brazil
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Porto Alegre, 9061-000
Brazil
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Porto Alegre, 91350-200
Brazil
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Salvador, 40050-410
Brazil
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São José do Rio Preto, 15090-000
Brazil
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Vitória, 29062-110
Brazil
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Calgary, Alberta T3R 1W7
Canada
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Vancouver, British Columbia V5Z 1M9
Canada
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Ajax, Ontario L1S 2J5
Canada
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Burlington, Ontario L7N 3V2
Canada
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Scarborough Village, Ontario M1P 2V5
Canada
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Toronto, Ontario M5T 3A9
Canada
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Winchester, Ontario K0C 2K0
Canada
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Windsor, Ontario N8X-5A6
Canada
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Montreal, Quebec H1T 2M4
Canada
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Montreal, Quebec H3T 1E2
Canada
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Québec, Quebec G1G 3Y8
Canada
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Québec, Quebec G1V 4G5
Canada
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Saint-Charles-Borromée, Quebec J6E 2B4
Canada
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Saint-Laurent, Quebec H4R3C8
Canada
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Trois-Rivières, Quebec G8T 7A1
Canada
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Saskatoon, Saskatchewan S7N 0W8
Canada
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Concepción, 4070094
Chile
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Curicó, 3341643
Chile
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Quillota, 2260000
Chile
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Santiago, 7500010
Chile
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Santiago, 7500657
Chile
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Santiago, 7501126
Chile
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Santiago, 7750495
Chile
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Santiago, 8380453
Chile
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Talca, 3481349
Chile
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Anyang, 455099
China
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Beijing, 100020
China
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Beijing, 100191
China
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Changchun, 130021
China
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Changsha, 410008
China
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Changsha, 410015
China
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Changsha, 430033
China
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Chengdu, 610072
China
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Chengdu, 611130
China
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Chongqing, 400042
China
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Chongqing, 401320
China
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Fuzhou, 350031
China
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Guangzhou, 510000
China
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Guangzhou, 510150
China
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Guangzhou, 510163
China
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Guangzhou, 510515
China
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Haikou, 570311
China
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Hangzhou, 310005
China
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Hefei, 230061
China
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Hengyang, 421001
China
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Heze, 274099
China
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Hohhot, 750306
China
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Huizhou, 516002
China
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Jinan, 250013
China
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Jinan, 250021
China
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Jinhua, 321000
China
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Linhai, 317000
China
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Loudi, 417099
China
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Nanchang, 330006
China
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Nanchong, 637000
China
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Nanjing, 2100008
China
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Nanjing, 211100
China
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Nanning, 530000
China
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Nanning, 530021
China
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Pingxiang, 337055
China
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Qingdao, 266011
China
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Qingyuan, 511518
China
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Sanya, 572000
China
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Shanghai, 200040
China
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Shanghai, 200120
China
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Shanghai, 201199
China
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Shanghai, 310000
China
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Shantou, 515041
China
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Shenyang, 110004
China
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Shenzhen, 518020
China
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Shijiazhuang, 50051
China
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Suining Shi, 629000
China
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Taiyuan, 030001
China
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Taiyuan, 030032
China
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Taizhou, 318000
China
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Tianjin, 300050
China
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Wenzhou, 325027
China
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Wuhan, 430022
China
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Wuhan, 430030
China
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Xinxiang, 453100
China
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Xuzhou, 221000
China
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Xuzhou, 221009
China
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Yangzhou, 225001
China
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Yichang, 443003
China
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Yinchuan, 750001
China
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Yinchuan, 750004
China
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Zhangzhou, 363099
China
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Brandýs nad Labem, 250 01
Czechia
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Brno, 625 00
Czechia
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Jindřichův Hradec, 377 01
Czechia
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Lovosice, 410 02
Czechia
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Ostrava, 700 30
Czechia
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Pilsen, 301 00
Czechia
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Prague, 110 00
Czechia
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Prague, 15300
Czechia
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Teplice, 415 01
Czechia
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Varnsdorf, 407 47
Czechia
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København NV, 2400
Denmark
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Bendorf, 56170
Germany
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Berlin, 10787
Germany
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Haltern am See, 45721
Germany
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Hanover, D-30173
Germany
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Immenhausen, 34376
Germany
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Lübeck, 23552
Germany
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Marburg, 35037
Germany
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Rosenheim, 83022
Germany
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Wiesbaden, 65183
Germany
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Ahmedabad, 380053
India
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Ahmedabad, 380054
India
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Belagavi, 590010
India
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Coimbatore, 641028
India
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Dehradun, 248001
India
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Delhi, 110029
India
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Delhi, 110029
India
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Dwārka, 110075
India
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Faridabad, 121012
India
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Gurgaon, 122001
India
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Kochi, 682027
India
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Kolkata, 700053
India
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Kozhikode, 673008
India
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Lucknow, 226003
India
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Madurai, 625107
India
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Mysuru, 570002
India
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Nagpur, 440012
India
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Nagpur, 441108
India
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Pune, 411 018
India
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Telangana, 500004
India
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Vadodara, 391760
India
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Cona, 44124
Italy
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Florence, 50134
Italy
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Milan, 20122
Italy
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Montebelluna, 31044
Italy
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Naples, 80131
Italy
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Pavia, 27100
Italy
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Roma, 00128
Italy
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Sassari, 07100
Italy
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Telese Terme, 82037
Italy
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Tradate, 21049
Italy
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Alor Star, 5460
Malaysia
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Kajang, 43000
Malaysia
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Kota Kinabalu, 88200
Malaysia
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Kuala Lumpur, 50603
Malaysia
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Kuala Terengganu, 20400
Malaysia
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Kuantan, 25100
Malaysia
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Kuching, 93586
Malaysia
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Benito Juárez, 03650
Mexico
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Chihuahua City, 31000
Mexico
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Cuauhtémoc, 06700
Mexico
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Cuernavaca, 62290
Mexico
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Guadalajara, 44130
Mexico
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Mérida, 97130
Mexico
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Monterrey, 64310
Mexico
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Monterrey, 64460
Mexico
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Monterrey, 64465
Mexico
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Morelia, 58000
Mexico
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Oaxaca City, 68020
Mexico
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San Juan del Río, 76800
Mexico
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Tijuna, 22010
Mexico
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Veracruz, 91900
Mexico
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Zapopan, 45070
Mexico
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Zapopan, 45138
Mexico
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Iloilo City, 5000
Philippines
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Las Piñas, 1742
Philippines
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Manadaluyong City, 1552
Philippines
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Manila, 1000
Philippines
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Marilao, 3019
Philippines
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Quezon City, 1100
Philippines
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Quezon City, 1100
Philippines
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Tondo, 1012
Philippines
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Bialystok, 15-044
Poland
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Bydgoszcz, 85-231
Poland
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Bydgoszcz, 85-796
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Chrzanów, 32-500
Poland
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Karczew, 05-480
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Katowice, 40-648
Poland
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Kielce, 25-426
Poland
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Krakow, 31-513
Poland
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Lodz, 91-211
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Lublin, 20-011
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Ostróda, 14-100
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Piaseczno, 05-500
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Poznan, 60-693
Poland
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Pruszków, 05-800
Poland
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Płock, 09-407
Poland
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Humenné, 066 01
Slovakia
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Košice, 04011
Slovakia
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Levice, 93401
Slovakia
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Martin, 03659
Slovakia
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Trnava, 91701
Slovakia
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Anyang-si, 14068
South Korea
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Daegu, 42415
South Korea
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Iksan-si, 54538
South Korea
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Jeonju, 54907
South Korea
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Seoul, 06591
South Korea
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Seoul, 06973
South Korea
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Seoul, 08308
South Korea
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Seoul, 135-710
South Korea
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Seoul, 143-729
South Korea
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Seoul, 150-713
South Korea
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Uijeongbu-si, 11765
South Korea
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Wŏnju, 26426
South Korea
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Barakaldo, 48903
Spain
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Barcelona, 08036
Spain
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Granada, 18014
Spain
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Madrid, 28007
Spain
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Málaga, 29010
Spain
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Palma de Mallorca, 07010
Spain
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Pamplona, 31008
Spain
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Seville, 41013
Spain
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Valencia, 46010
Spain
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Bradford, BD9 6RJ
United Kingdom
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Brighton, BN2 1ES
United Kingdom
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Cottingham, HU16 5JQ
United Kingdom
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Glasgow, G12 0YN
United Kingdom
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Halifax, HX3 0PW
United Kingdom
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Leeds, LS9 7TF
United Kingdom
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Portsmouth, PO6 3LY
United Kingdom
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Tyne and Wear, NE29 8NH
United Kingdom
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Wakefield, WF1 4DG
United Kingdom