A Master Protocol to Investigate Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without T2DM
Start Date
6/29/2026
Completion Date
7/30/2029
Summary
This master study protocol, Study D7260C00015, covers 2 independent, pivotal studies, Study 1 and Study 2. Each study is a global, randomized, double-blind, parallel-group, multicenter, Phase III study to assess the efficacy and safety of elecoglipron compared with placebo adjunct to diet and exercise for weight management, in adults living with obesity or overweight with at least one weight-related comorbidity, and without T2DM (Study 1) or with T2DM (Study 2).
Detailed Description
This is a Phase III, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of 2 doses of elecoglipron compared with placebo, given once daily as oral tablets. This protocol covers two independent pivotal studies in adults aged 18 years and above, who are living with obesity (BMI ≥ 30 kg/m2), or overweight (BMI ≥ 25 kg/m2) and have at least 1 weight-related comorbidity (Hypertension, Prediabetes, Dyslipidemia, CV disease and/or Obstructive sleep apnea) without T2DM (Study 1) and as well as those who are living with obesity or overweight with T2DM (Study 2). Approximately 3000 participants will be randomized in the study 1 and 1500 participants in the study 2. The primary endpoint is percent change in body weight from baseline at 72 weeks.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Elecoglipron
Placebo
Conditions
Locations
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Birmingham, Alabama 35205
United States
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Dothan, Alabama 36305
United States
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Chandler, Arizona 85225
United States
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Peoria, Arizona 85382
United States
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Little Rock, Arkansas 72205
United States
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Lynwood, California 90262
United States
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Rolling Hills Estates, California 90274
United States
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Sacramento, California 95821
United States
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Arvada, Colorado 80002
United States
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New Haven, Connecticut 06511
United States
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Clearwater, Florida 33765
United States
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Plantation, Florida 33324
United States
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Woodstock, Georgia 30189
United States
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Ammon, Idaho 83406
United States
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Melrose Park, Illinois 60160
United States
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Indianapolis, Indiana 46254
United States
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Wichita, Kansas 67218
United States
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Louisville, Kentucky 40213
United States
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Alexandria, Louisiana 71303
United States
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Baltimore, Maryland 21229
United States
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Potomac, Maryland 20854
United States
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White Marsh, Maryland 21162
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Ypsilanti, Michigan 48197
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Ridgeland, Mississippi 39157
United States
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Kansas City, Missouri 64114
United States
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St Louis, Missouri 63123
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Reno, Nevada 89511
United States
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Albuquerque, New Mexico 87106
United States
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Albany, New York 12205
United States
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Laurelton, New York 11413
United States
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Long Island City, New York 11106
United States
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Greensboro, North Carolina 27408
United States
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Raleigh, North Carolina 27609
United States
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Rocky Mount, North Carolina 27804
United States
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Statesville, North Carolina 28625
United States
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Columbus, Ohio 43228
United States
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Dayton, Ohio 45424
United States
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Edmond, Oklahoma 73013
United States
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Tulsa, Oklahoma 74133
United States
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Portland, Oregon 97223
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DuBois, Pennsylvania 15801
United States
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Newport, Pennsylvania 17074
United States
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Philadelphia, Pennsylvania 19104
United States
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East Providence, Rhode Island 02914
United States
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Charleston, South Carolina 29407
United States
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Gaffney, South Carolina 29340
United States
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Rapid City, South Dakota 57701
United States
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Franklin, Tennessee 37067
United States
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Knoxville, Tennessee 37912
United States
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Dallas, Texas 75254
United States
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Houston, Texas 77081
United States
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Humble, Texas 77346
United States
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Irving, Texas 75063
United States
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Sandy City, Utah 84070
United States
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Midlothian, Virginia 23112
United States
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Morgantown, West Virginia 26501
United States
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Buenos Aires, 1061
Argentina
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Buenos Aires, C1425AGC
Argentina
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CABA, 1056
Argentina
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CABA, C1120AAC
Argentina
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Caba, C1128AAF
Argentina
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Capital Federal, C1014A
Argentina
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Granadero Baigorria, S2152BOF
Argentina
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Lanus, B1824KAJ
Argentina
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Rosario, 2000
Argentina
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Rosario, S2000CVD
Argentina
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San Nicolás, B2900DMH
Argentina
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San Vicente, 5006
Argentina
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Botany, 2019
Australia
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Camberwell, 3124
Australia
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Kotara, 2289
Australia
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Maroubra, 2035
Australia
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St Albans, 3021
Australia
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St Leonards, 2065
Australia
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Belém, 66073-005
Brazil
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Brasília, 72145-450
Brazil
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Campinas, 13060-080
Brazil
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Campinas, 13092133
Brazil
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Curitiba, 80045-170
Brazil
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Fortaleza, 60430-350
Brazil
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Porto Alegre, 90430-001
Brazil
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São José dos Campos, 12230-001
Brazil
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São Paulo, 01228-000
Brazil
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São Paulo, 01236-030
Brazil
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São Paulo, 04012-180
Brazil
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Calgary, Alberta T2V 4J2
Canada
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Calgary, Alberta T3R 1W9
Canada
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Vancouver, British Columbia V5Y 3W2
Canada
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Victoria, British Columbia V8V 4A1
Canada
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Moncton, New Brunswick E1G 1A7
Canada
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Truro, Nova Scotia B2N 1L2
Canada
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Brampton, Ontario L6T 0G1
Canada
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Hamilton, Ontario L8L 5G8
Canada
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Niagara Falls, Ontario L2H 1H5
Canada
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North York, Ontario M6B 3H7
Canada
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Sarnia, Ontario N7T 4X3
Canada
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Scarborough Village, Ontario M1R 0B1
Canada
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Stouffville, Ontario L4A1H2
Canada
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Toronto, Ontario M3J 0K2
Canada
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Toronto, Ontario M6G 1M2
Canada
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Toronto, Ontario M9V 4B4
Canada
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Joliette, Quebec J6E 6A9
Canada
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Montreal, Quebec H4N 2W2
Canada
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Saint-Lambert, Quebec J4P 2H4
Canada
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Terrebonne, Quebec J6X 4P7
Canada
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Araucania, 4781151
Chile
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Concepción, 4070196
Chile
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Las Condes, 7560908
Chile
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Osorno, 5311092
Chile
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Providencia, 7500504
Chile
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Santiago, 7510187
Chile
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Santiago, 7691236
Chile
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Santiago, 8330034
Chile
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Santiago, 8331143
Chile
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Temuco, 4810345
Chile
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Binzhou, 256603
China
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Chengdu, 610078
China
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Chengdu, 610081
China
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Deyang, 618000
China
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Ganzhou, 341099
China
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Guangzhou, 510220
China
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Guangzhou, 510280
China
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Haikou, 570208
China
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Hangzhou, 310006
China
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Hangzhou, 311200
China
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Huaian, 223300
China
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Huzhou, 313003
China
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Jinan, 250001
China
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Jinzhou, 121002
China
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Kunming, CN-650034
China
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Lanzhou, 730000
China
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Linhai, 317000
China
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Liuzhou, 545006
China
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Luoyang, 471001
China
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Nanchang, 330006
China
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Nanjing, 210006
China
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Nanjing, 211100
China
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Nantong, 226001
China
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Ningbo, 315000
China
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Panjin, 124000
China
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Pingxiang, 337055
China
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Qingdao, 266035
China
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Shanghai, 200025
China
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Shanghai, 201200
China
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Shenyang, 110016
China
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Shenzhen, 518036
China
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Siping, 136000
China
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Suining, 629000
China
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Suzhou, 215006
China
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Ürümqi, 831118
China
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Wanzhou, 404000
China
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Wenzhou, 325000
China
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Wuhan, 430030
China
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Wuxi, 214023
China
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Xiangfan, 441021
China
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Xuancheng, 242000
China
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Yibin, 644000
China
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Yichang, 443003
China
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Zhengzhou, 450002
China
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Zhenjiang, 212002
China
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Zunyi, 563100
China
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Bad Oeynhausen, 32545
Germany
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Bochum, 44789
Germany
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Cologne, 50937
Germany
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Cologne, 51069
Germany
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Dresden, 01307
Germany
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Falkensee, 14612
Germany
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Gera, 07548
Germany
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Hamburg, 22607
Germany
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Leipzig, 04103
Germany
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Leipzig, 04107
Germany
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Lübeck, 23562
Germany
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Mainz, 55131
Germany
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Mannheim, 68167
Germany
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München, 80809
Germany
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Münster, 48145
Germany
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Nuremberg, 90443
Germany
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Obertshausen, 63179
Germany
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Oldenburg, 23758
Germany
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Stuttgart, 70199
Germany
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Ulm, 89073
Germany
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Wangen, 88239
Germany
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Würzburg, 97080
Germany
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Bangalore, 560 092
India
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Belagavi, 590006
India
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Bikaner, 334001
India
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Delhi, 110029
India
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Guntur, 522001
India
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Hyderabad, 500034
India
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Jodhpur, 342005
India
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Kolkata, 700014
India
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Kolkata, 700020
India
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Madurai, 625020
India
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Mumbai, 400008
India
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Mumbai, 400012
India
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Mysore, 570001
India
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Nagpur, 440010
India
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New Delhi, 110002
India
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Siliguri, 734012
India
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Bologna, 40138
Italy
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Catania, 95123
Italy
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Chieti, 66100
Italy
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Florence, 50134
Italy
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Latina, 04100
Italy
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Milan, 20154
Italy
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Pisa, 56100
Italy
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Ravenna, 48121
Italy
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Roma, 00128
Italy
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Roma, 161
Italy
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San Donato, 20097
Italy
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Amagasaki-shi, 660-0861
Japan
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Chūōku, 103-0002
Japan
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Chūōku, 1040031
Japan
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Kasugai-shi, 486-8510
Japan
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Koga-shi, 306-0232
Japan
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Maebashi, 371-8511
Japan
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Minatoku, 105-0004
Japan
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Minatoku, 108-0073
Japan
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Naka, 311-0113
Japan
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Shinjuku-ku, 169-0072
Japan
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Shizuoka, 424-0855
Japan
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Suita-shi, 564-8565
Japan
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Suita-shi, 565-0853
Japan
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Toshima-ku, 171-0014
Japan
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Yamato-shi, 242-0004
Japan
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Yokohama, 230-8765
Japan
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Yokohama, 232-0064
Japan
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Bialystok, 15-375
Poland
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Bialystok, 15-435
Poland
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Bydgoszcz, 85-796
Poland
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Kielce, 25-355
Poland
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Krakow, 30-727
Poland
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Krakow, 31-261
Poland
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Krakow, 31-271
Poland
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Lodz, 90-338
Poland
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Lublin, 20-064
Poland
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Lublin, 20-718
Poland
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Poznan, 60-354
Poland
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Poznan, 60-589
Poland
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Radom, 26-600
Poland
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Warsaw, 00-124
Poland
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Warsaw, 02-507
Poland
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Warsaw, 02-758
Poland
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Al-Ahsa, 36428
Saudi Arabia
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Dammam, 31444
Saudi Arabia
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Jeddah, 22384
Saudi Arabia
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Khobar, 31952
Saudi Arabia
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Riyadh, 11462
Saudi Arabia
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Riyadh, 12713
Saudi Arabia
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Bellville, 7530
South Africa
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Bloemfontein, 9301
South Africa
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Cape Town, 7500
South Africa
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Cape Town, 7764
South Africa
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Chatsworth, 4092
South Africa
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Claremont, 7708
South Africa
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Durban, 4091
South Africa
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eMkhomazi, 4170
South Africa
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Johannesburg, 1827
South Africa
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Johannesburg, 2113
South Africa
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Midrand, 1685
South Africa
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Wentworth, 4032
South Africa
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Busan, 49201
South Korea
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Busan, 49241
South Korea
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Daegu, 42415
South Korea
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Goyang-si, 13620
South Korea
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Gyeonggi-do, 13620
South Korea
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Incheon, 21565
South Korea
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Jongno-gu, 110-746
South Korea
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Seoul, 02447
South Korea
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Seoul, 120-752
South Korea
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Suwon, 443-721
South Korea
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A Coruña, 15006
Spain
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Almería, 04009
Spain
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Badalona, 08916
Spain
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Barcelona, 08036
Spain
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Barcelona, 08041
Spain
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Barcelona, 8035
Spain
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León, 24008
Spain
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Madrid, 28006
Spain
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Santander, 39008
Spain
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Santiago de Compostela, 15706
Spain
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Seville, 41003
Spain
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Seville, 41013
Spain
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Seville, 41950
Spain
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Tarragona, 43007
Spain
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Valencia, 46014
Spain
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Changhua, 500
Taiwan
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Kaohsiung City, 807
Taiwan
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Taichung, 402
Taiwan
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Taichung, 40447
Taiwan
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Taichung, 40705
Taiwan
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Taichung, 433004
Taiwan
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Tainan, 704
Taiwan
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Tainan County, 71044
Taiwan
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Taipei, 10002
Taiwan
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Taipei, 110
Taiwan
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Adana, 01060
Turkey (Türkiye)
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Adana, 01120
Turkey (Türkiye)
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Adapazarı, 54290
Turkey (Türkiye)
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Ankara, 06530
Turkey (Türkiye)
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Ankara, 5000
Turkey (Türkiye)
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Ankara, 6230
Turkey (Türkiye)
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Antalya, 07059
Turkey (Türkiye)
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Istanbul, 34098
Turkey (Türkiye)
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Istanbul, 34384
Turkey (Türkiye)
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Istanbul, 34722
Turkey (Türkiye)
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Ashton-under-Lyne, OL6 6EW
United Kingdom
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Blackpool, FY3 7EN
United Kingdom
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Chesterfield, S40 4AA
United Kingdom
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Corby, NN17 2UR
United Kingdom
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Ely, CB7 5JD
United Kingdom
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Glasgow, G51 4TF
United Kingdom
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Hounslow, TW3 3LN
United Kingdom
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Leicester, Le5 4PW
United Kingdom
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Metropolitan Borough of Wirral, CH48 5AA
United Kingdom
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Poole, BH16 5PW
United Kingdom
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Rotherham, S65 1DA
United Kingdom
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Stowmarket, IP142SY
United Kingdom
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Wansford, PE8 6PL
United Kingdom
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Witney, OX28 6JS
United Kingdom
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Yate, BS37 4AX
United Kingdom