A Phase III Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With CKD Stage 3b and 4 (BalanceD-CKD)
Start Date
9/1/2026
Completion Date
7/1/2030
Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of balcinrenone in fixed combination with dapagliflozin, compared with dapagliflozin, in patients with CKD Stage 3b and 4 (eGFR ≥ 15 to \< 45 mL/min/1.73 m2) administered orally once daily in addition to SoC. This is a population with high unmet medical need and an increased risk of CKD progression, who are frequently excluded from interventional trials.
Detailed Description
This is a Phase III, multicentre, randomised, double-blind, double-dummy, parallel-group, active-controlled, event-driven study in participants with CKD Stage 3b and 4. The purpose of this study is to determine if balcinrenone/dapagliflozin, compared with dapagliflozin, administered as a capsule once daily on a background of standard of care (SoC) therapy, reduces the risk of CV death, death from kidney failure, kidney failure, sustained ≥ 50% decline from baseline in eGFR, and HF events in adults with CKD Stage 3b and 4. The study will also assess safety and tolerability of balcinrenone/dapagliflozin. Eligible patients will randomly be assigned with a 1:1 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments: 1. Balcinrenone/dapagliflozin 15 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 2. Dapagliflozin 10 mg tablet and matching placebo for balcinrenone/dapagliflozin capsule The study will be conducted at approximately 550 sites in approximately 30 countries, globally.
Eligibility Criteria
Age Range: 18 years to 99 years
Interventions
Balcinrenone/dapagliflozin
Dapagliflozin
Placebo matching Dapagliflozin
Placebo matching balcinrenone/dapagliflozin
Conditions
Locations
Research Site
Huntsville, Alabama 35805
United States
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Surprise, Arizona 85374
United States
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Tempe, Arizona 85284
United States
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Little Rock, Arkansas 72205
United States
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Concord, California 94520
United States
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Daly City, California 94015
United States
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Fremont, California 94538
United States
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Huntington Park, California 90255
United States
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Lancaster, California 93534
United States
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Lynwood, California 90262
United States
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Northridge, California 91324
United States
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Palo Alto, California 94304
United States
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Pomona, California 91768
United States
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Riverside, California 92506
United States
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San Dimas, California 91773
United States
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Tarzana, California 91356
United States
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Washington D.C., District of Columbia 20422
United States
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Boca Raton, Florida 33487
United States
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Fort Lauderdale, Florida 33316
United States
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Gainesville, Florida 32608
United States
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Hollywood, Florida 33021
United States
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Jacksonville Beach, Florida 32250
United States
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Lakeland, Florida 33813
United States
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Melbourne, Florida 32901
United States
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Orlando, Florida 32806
United States
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Port Charlotte, Florida 33952
United States
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Riverview, Florida 33578
United States
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Weston, Florida 33331
United States
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Brunswick, Georgia 31520
United States
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East Point, Georgia 30344
United States
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Macon, Georgia 31210
United States
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Savannah, Georgia 31406
United States
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Oak Brook, Illinois 60523
United States
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Rockford, Illinois 61107
United States
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Iowa City, Iowa 52246
United States
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Wichita, Kansas 67214
United States
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Louisville, Kentucky 40205
United States
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Ann Arbor, Michigan 48105
United States
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Saint Joseph, Michigan 49085
United States
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Mankato, Minnesota 56001
United States
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Kansas City, Missouri 64111
United States
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Albuquerque, New Mexico 87108
United States
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Albany, New York 12209
United States
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Long Island City, New York 11106
United States
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The Bronx, New York 10468
United States
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Asheville, North Carolina 28805
United States
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Charlotte, North Carolina 28287
United States
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Cincinnati, Ohio 45212
United States
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Cincinnati, Ohio 45220
United States
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Media, Pennsylvania 19063
United States
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Columbia, South Carolina 29209
United States
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Greenville, South Carolina 29607
United States
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Chattanooga, Tennessee 37404
United States
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Fort Worth, Texas 76104
United States
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Houston, Texas 77043
United States
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Irving, Texas 75063
United States
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Lufkin, Texas 75904
United States
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McKinney, Texas 75069
United States
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Pasadena, Texas 77504
United States
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San Antonio, Texas 78204
United States
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San Antonio, Texas 78212
United States
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Sherman, Texas 75092
United States
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Stephenville, Texas 76401
United States
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Sugar Land, Texas 77478
United States
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Sugar Land, Texas 77478
United States
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Arlington, Virginia 22205
United States
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Richmond, Virginia 23249
United States
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Salem, Virginia 24153
United States
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Woodbridge, Virginia 22192
United States
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CABA, C1431FWO
Argentina
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Capital Federal, C1014A
Argentina
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Ciudad de Buenos Aires, C1425AGC
Argentina
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La Plata, B1900AVG
Argentina
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Lanús Este, B1824KAJ
Argentina
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Mar del Plata, 7600
Argentina
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Rosario, 2000
Argentina
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Rosario, S2000CVD
Argentina
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Rosario, S2000PBJ
Argentina
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San Nicolás, B2900DMH
Argentina
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Santa Fe, S3000FWO
Argentina
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Santa Fe, S3000
Argentina
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Feldkirch, 6807
Austria
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Innsbruck, 6020
Austria
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Linz, 4020
Austria
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Sankt Pölten, 3100
Austria
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Vienna, 1030
Austria
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Vienna, 1130
Austria
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Vienna, 1190
Austria
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Vienna, A-1090
Austria
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Wels, 4600
Austria
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Wiener Neustadt, 2700
Austria
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Barretos, 14784-400
Brazil
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Belém, 66073-005
Brazil
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Belo Horizonte, 30140-085
Brazil
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Belo Horizonte, 30455-610
Brazil
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Campinas, 13060-080
Brazil
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Goiânia, 74605-020
Brazil
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Natal, 59020-500
Brazil
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Recife, 50720-110
Brazil
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São Caetano do Sul, 09521-160
Brazil
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São José do Rio Preto, 15015-750
Brazil
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São José dos Campos, 12243-280
Brazil
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São Paulo, 01139-000
Brazil
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São Paulo, 03164-000
Brazil
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São Paulo, 04039-004
Brazil
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São Paulo, 05651-002
Brazil
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Blagoevgrad, 2700
Bulgaria
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Nova Zagora, 8900
Bulgaria
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Pleven, 5800
Bulgaria
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Plovdiv, 4000
Bulgaria
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Sandanski, 2800
Bulgaria
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Sevlievo, 5403
Bulgaria
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Sofia, 1000
Bulgaria
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Sofia, 1407
Bulgaria
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Sofia, 1527
Bulgaria
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Stara Zagora, 6000
Bulgaria
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Varna, 9010
Bulgaria
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Calgary, Alberta T2R0X7
Canada
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Edmonton, Alberta T6G 2P4
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Winnipeg, Manitoba R2V 3M3
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Halifax, Nova Scotia B3H 2Y9
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Brampton, Ontario L6T 0H9
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Greater Sudbury, Ontario P3E 5J1
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London, Ontario N6A 5A5
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Mississauga, Ontario L5M 2S6
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Oakville, Ontario L6M 0L8
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Toronto, Ontario M4G 3E8
Canada
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Toronto, Ontario M5G 2C4
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Waterloo, Ontario N2T 0C1
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Montreal, Quebec H1T 2M4
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Montreal, Quebec H2X 0A9
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Montreal, Quebec H3G 1A4
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Montreal, Quebec H4J 1C5
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Québec, Quebec G1R 2J6
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Baotou, 014010
China
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Beijing, 100029
China
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Beijing, 100044
China
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Beijing, 100053
China
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Beijing, 102218
China
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Changchun, 130041
China
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Changsha, 410015
China
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Changzhou, 213000
China
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Changzhou, 213100
China
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Chengdu, 610041
China
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Chengdu, 611130
China
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Chongqing, 400010
China
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Dongguan, 523009
China
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Dongyang, 322100
China
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Ganzhou, 341000
China
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Guangzhou, 510280
China
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Guangzhou, 510800
China
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Guiyang, 550044
China
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Hebei, 050071
China
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Hohhot, 750306
China
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Huaian, 223300
China
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Jinan, 250014
China
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Jining, 272006
China
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Jiujiang, 332000
China
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Linhai, 317000
China
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Nanchang, 330006
China
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Nanjing, 210011
China
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Nanjing, 210029
China
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Nanning, 530000
China
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Nanning, 530022
China
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Ningbo, 315000
China
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Ningbo, 315010
China
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Ningbo, 315100
China
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Ningbo, 315800
China
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Panjin, 124000
China
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Pingxiang, 337055
China
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Qingzhou, 262550
China
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Shanghai, 200032
China
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Shanghai, 200050
China
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Shanghai, 200090
China
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Shanghai, 200092
China
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Shanghai, 200233
China
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Shanghai, 200240
China
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Shanghai, 201199
China
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Shanghai, 201210
China
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Shantou, 515065
China
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Shenyang, 110004
China
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Shenzhen, 518036
China
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Shenzhen, 518053
China
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Suzhou, 215004
China
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Ürümqi, 831118
China
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Wuhan, 430010
China
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Wuhan, 430060
China
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Wuxi, 214023
China
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Xiamen, 361004
China
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Xiamen, 361101
China
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Xuzhou, 221000
China
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Yancheng, 224005
China
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Yangzhou, 225000
China
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Yangzhou, 225001
China
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Yantai, 264000
China
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Yibin, 644000
China
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Yinchuan, 750000
China
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Zhenjiang, 212002
China
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Zhuzhou, 412007
China
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Boulogne-sur-Mer, 62200
France
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Caen, 14000
France
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Cherbourg, 50102
France
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Colmar, 68024
France
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La Roche-sur-Yon, 85025
France
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Le Mans, 72037
France
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Marseille, 13385
France
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Nîmes, 30000
France
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Orléans, 45100
France
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Rouen, 76031
France
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Saint-Priez En Jarez, 42270
France
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Toulouse, 31059
France
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Tours, 37000
France
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Aachen, 52074
Germany
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Bad Nenndorf, 31542
Germany
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Berlin, 10787
Germany
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Berlin, 12203
Germany
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Berlin, 13509
Germany
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Bonn, 53127
Germany
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Brandenburg an der Havel, 14770
Germany
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Braunschweig, 38126
Germany
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Cloppenburg, 49661
Germany
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Essen, 45122
Germany
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Frankfurt am Main, 60590
Germany
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Fulda, 36037
Germany
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Gladbeck, 45968
Germany
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Goslar, 38642
Germany
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Hanover, 30625
Germany
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Heidelberg, 69120
Germany
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Leipzig, 04129
Germany
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Magdeburg, 39120
Germany
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München, 81377
Germany
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München, 81675
Germany
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Münster, 48153
Germany
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Nuremberg, 90443
Germany
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Nuremberg, 90471
Germany
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Obertshausen, 63179
Germany
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Riesa, 01589
Germany
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Rostock, 18057
Germany
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Rotenburg (Wümme), 27356
Germany
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Villingen-Schwenningen, 78052
Germany
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Würzburg, 97080
Germany
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Athens, 10676
Greece
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Athens, 11527
Greece
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Athens, 12462
Greece
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Heraklion, 71409
Greece
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Heraklion, 71500
Greece
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Ioannina, 455 00
Greece
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Larissa, 41110
Greece
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Marousi, 151 23
Greece
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Piraeus, 18454
Greece
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Rio, 265 04
Greece
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Thessaloniki, 54629
Greece
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Aligarh, 202002
India
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Belagavi, 590010
India
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Bhubaneswar, 751019
India
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Calicut, 673 008
India
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Coimbatore, 641018
India
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Dehli, 110075
India
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Dehradun, 248001
India
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Hyderabad, 500084
India
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Jaipur, 302017
India
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Jodhpur, 342005
India
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Kanpur, 208002
India
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Kochi, 682041
India
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Kolkata, 700014
India
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Mumbai, 400012
India
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Mumbai, 400026
India
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Mysore, 570001
India
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Nagpur, 440001
India
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New Delhi, 110001
India
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New Delhi, 110017
India
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New Delhi, 110029
India
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Pune, 411013
India
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Thiruvananthapuram, 695011
India
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Vijayawada, 520 008
India
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Bari, 70124
Italy
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Bologna, 40138
Italy
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Cosenza, 87100
Italy
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Cremona, 26100
Italy
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Genoa, 16132
Italy
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Milan, 20122
Italy
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Modena, 41125
Italy
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Naples, 80138
Italy
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Palermo, 90127
Italy
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Pavia, 27100
Italy
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Ranica, 24020
Italy
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Verona, 37126
Italy
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Ageo, 362-8588
Japan
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Asahi-shi, 289-2511
Japan
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Chiba, 260-8712
Japan
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Fukaya, 366-0052
Japan
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Fukui-shi, 910-8526
Japan
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Izumisano, 598-8577
Japan
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Izunokuni-shi, 410-2295
Japan
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Kariya, 448-8505
Japan
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Kisarazu-shi, 292-8535
Japan
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Kita-ku, 144-0001
Japan
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Kitakyusyu-shi, 806-8501
Japan
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Kofu, 400-8506
Japan
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Koga-shi, 306-0232
Japan
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Komatsu-shi, 923-8560
Japan
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Koshigaya-shi, 343-8577
Japan
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Kumagaya-shi, 360-0197
Japan
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Kumamoto, 860-0008
Japan
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Kurashiki Shi, 701 0192
Japan
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Kuwana-shi, 511-0061
Japan
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Kyoto, 606-8507
Japan
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Kyoto, 607-8062
Japan
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Matsumoto-shi, 390-8621
Japan
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Minamiuonuma, 949-7302
Japan
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Minatoku, 105-8471
Japan
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Minokamo Shi, 505-8510
Japan
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Morioka, 020-0066
Japan
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Nagoya, 453-8511
Japan
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Nagoya, 457-8511
Japan
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Naka, 311-0113
Japan
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Nerima-ku, 177-8521
Japan
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Osaka, 530-0012
Japan
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Osaka, 553-0003
Japan
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Sendai, 982-8502
Japan
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Takatsuki-shi, 569-8686
Japan
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Toride-shi, 302-0022
Japan
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Tsu, 514-8507
Japan
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Urayasu, 279-0001
Japan
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Yokohama, 236-0004
Japan
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Cheras, 56000
Malaysia
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Ipoh, 30990
Malaysia
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Kajang, 43000
Malaysia
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Kota Kinabalu, 88200
Malaysia
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Kuala Lumpur, 50586
Malaysia
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Kuala Lumpur, 59100
Malaysia
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Kuantan, 25100
Malaysia
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Muar town, 84000
Malaysia
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Sarawak Miri, 98000
Malaysia
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Sungai Buloh, 47000
Malaysia
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Benito Juárez, 03330
Mexico
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Culiacán, 80000
Mexico
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Culiacán, 80230
Mexico
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Durango, 34200
Mexico
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Ecatepec de Morelos, 55000
Mexico
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Estado de México, 50090
Mexico
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Mexico City, 0 3100
Mexico
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México, 14080
Mexico
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Tuxpan, 92830
Mexico
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Veracruz, 91855
Mexico
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Villahermosa, 86000
Mexico
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Xalapa, 91020
Mexico
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Callao, Bellavista
Peru
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Chorrillos, Lima 9
Peru
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Cusco, CUSCO 01
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Lima, 14
Peru
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Lima, 15038
Peru
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Lima, 15072
Peru
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Lima, 15082
Peru
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Lima, 15088
Peru
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Lima, 15131
Peru
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Lima, LIMA 27
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Piura, 20001
Peru
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Trujillo, 130101
Peru
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Dasmariñas, 4114
Philippines
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Davao DEL SUR, 8000
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Iloilo City, 5000
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Las Piñas, 1742
Philippines
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Manila, 1000
Philippines
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Quezon City, 1101
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Quezon City, 1112
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West San Juan City, 1502
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Olsztyn, 10-561
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Warsaw, 02-507
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Warsaw, 04-141
Poland
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Węgrów, 07-100
Poland
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Wroclaw, 53-114
Poland
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Żywiec, 34-300
Poland
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Brasov, 500388
Romania
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Bucharest, 022328
Romania
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Bucharest, 031441
Romania
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Bucharest, 22328
Romania
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Craiova, 200515
Romania
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Galati, 800183
Romania
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Oradea, 410469
Romania
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Timișoara, 300736
Romania
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Anyang, 14068
South Korea
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Cheonan-si, 31151
South Korea
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Seoul, 03181
South Korea
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Seoul, 03312
South Korea
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Seoul, 04401
South Korea
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Seoul, 05278
South Korea
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Seoul, 06351
South Korea
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Seoul, 07061
South Korea
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Seoul, 07345
South Korea
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Seoul, 08308
South Korea
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Seoul, 3722
South Korea
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Seoul, 4763
South Korea
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Wŏnju, 26426
South Korea
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Yangsan, 50612
South Korea
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Badajoz, 06080
Spain
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Barcelona, 08003
Spain
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Barcelona, 08035
Spain
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Barcelona, 08036
Spain
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Córdoba, 14004
Spain
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Girona, 17007
Spain
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Madrid, 28006
Spain
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Madrid, 28040
Spain
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Majadahonda, 28222
Spain
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Talavera de la Reina, 45600
Spain
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Valencia, 46010
Spain
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Valencia, 46026
Spain
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Changhua, 500
Taiwan
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Hualien City, 970473
Taiwan
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Kaohsiung City, 813
Taiwan
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Kaohsiung City, 833
Taiwan
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New Taipei City, 220216
Taiwan
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Taichung, 40201
Taiwan
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Taichung, 404
Taiwan
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Taichung, 40705
Taiwan
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Taichung, 433004
Taiwan
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Tainan, 70403
Taiwan
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Tainan, 710
Taiwan
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Taipei, 100
Taiwan
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Taipei, 110
Taiwan
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Taipei, 116
Taiwan
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Taoyuan, 333
Taiwan
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Zhubei, 302
Taiwan
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Bangkok, 10210
Thailand
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Bangkok, 10300
Thailand
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Bangkok, 10400
Thailand
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Bangkok, 10700
Thailand
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Banphaeo, 74120
Thailand
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Changwat Sara Buri, 18000
Thailand
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Chiang Mai, 50200
Thailand
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Hat Yai, 90110
Thailand
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Naimuang, 30000
Thailand
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Phitsanulok, 65000
Thailand
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Ubonratchathani, 34000
Thailand
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Adapazarı, 54290
Turkey (Türkiye)
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Ankara, 06800
Turkey (Türkiye)
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Antalya, 07059
Turkey (Türkiye)
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Dinar, 03400
Turkey (Türkiye)
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İzmit, 41380
Turkey (Türkiye)
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Kahramanmaraş, 46100
Turkey (Türkiye)
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Kayseri, 38039
Turkey (Türkiye)
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Kazımkarabekir, 01230
Turkey (Türkiye)
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Malatya, 44280
Turkey (Türkiye)
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Samsun, 55139
Turkey (Türkiye)
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Ivano-Frankivsk, 76018
Ukraine
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Kyiv, 01601
Ukraine
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Kyiv, 02002
Ukraine
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Kyiv, 03037
Ukraine
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Kyiv, 03049
Ukraine
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Kyiv, 03151
Ukraine
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Kyiv, 04050
Ukraine
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Kyiv, 04114
Ukraine
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Kyiv, 04210
Ukraine
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Lviv, 79016
Ukraine
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Vinnytsia, 21001
Ukraine
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Vinnytsia, 21009
Ukraine
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Vinnytsia, 21029
Ukraine
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Aberdeen, AB25 2ZN
United Kingdom
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Bristol, BS1 3NU
United Kingdom
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Cardiff, CF14 4XW
United Kingdom
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Dundee, DD1 9SY
United Kingdom
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Glasgow, G51 4TF
United Kingdom
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London, E1 1FR
United Kingdom
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London, NW3 2QG
United Kingdom
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London, SE5 9RS
United Kingdom
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London, SW170QT
United Kingdom
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Swansea, SN6 6NL
United Kingdom
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Can Tho, 900000
Vietnam
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Da Nang, 550000
Vietnam
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Da Nang, 55000
Vietnam
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Hanoi, 100000
Vietnam
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Hanoi, 10000
Vietnam
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Hà Nội, 100000
Vietnam
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Ho Chi Minh City, 7000000
Vietnam
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Ho Chi Minh City, 700000
Vietnam
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Hochiminh City, 700000
Vietnam
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Hochiminh, 70000
Vietnam
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Huế, 530000
Vietnam