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NCT07624305PHASE3Recruiting

A Phase III Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With CKD Stage 3b and 4 (BalanceD-CKD)

AstraZeneca

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

Inclusion Criteria: * Age ≥ 18 years * Diagnosis of CKD and at least one of the following: 1. eGFR ≥ 15 to \< 45 mL/min/1.73 m2 AND: UACR ≥ 30 mg/g (central laboratory) or UACR ≥ 100 mg/g (local laboratory ) or UPCR ≥ 200 mg/g (local laboratory). 2. eGFR ≥ 15 to \< 30 mL/min/1.73 m2 and UACR \< 30 mg/g (local or central laboratory UACR value). * Serum/plasma K+ ≤ 5.0 mmol/L * Maximum tolerated dose of an ACEi or an ARB, unless contraindicated or not tolerated. The dose should be stable for at least 4 weeks before screening. Exclusion Criteria: * Recent (within 90 days prior to screening) or ongoing dialysis, or likely to require dialysis within 3 months following randomisation * UACR ≥ 5000 mg/g or UPCR ≥ 7000 mg/g at screening. * SBP \> 180 mmHg or DBP \> 110 mmHg at screening. * SBP \< 90 mmHg at screening. * HbA1c \> 9% at screening * T1DM, except: 1. For US only: patients with T1DM treated with SGLT2i for at least 4 months prior to screening, without DKA during that period, and who have experience with ketone monitoring are eligible. 2. For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at least 4 months prior to Screening, without DKA during the period of dapagliflozin treatment are eligible for inclusion. * Autosomal dominant polycystic kidney disease. * Major cardiac or valvular surgery, acute coronary syndrome (myocardial infarction or unstable angina), stroke, transient ischaemic attack within 12 weeks prior to screening. * Severe hepatic impairment (Child-Pugh Class C). * Adrenal insufficiency. * Clinically significant acute kidney injury within 12 weeks prior to the screening. * New York Heart Association functional HF class IV at screening, or hospitalisation for heart failure within 4 weeks prior to screening. * Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months) prior to screening. * Solid organ or bone marrow transplant or a plan for transplant within 6 months following randomisation. * Any use of the following medications and supplements: 1. MRAs 2. Aldosterone analogues 3. Aldosterone synthase inhibitors 4. Any use of potassium binders within 2 weeks prior to screening. Use is allowed after randomisation. 5. Strong or moderate inducers or inhibitors of CYP3A4, prohibited at least one week prior to randomisation

Interventions

DRUG

Balcinrenone/dapagliflozin

DRUG

Dapagliflozin

DRUG

Placebo matching Dapagliflozin

DRUG

Placebo matching balcinrenone/dapagliflozin

Interested in This Trial?

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Conditions

Renal Insufficiency, Chronic

Locations

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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

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Concord, California 94520

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Daly City, California 94015

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Fremont, California 94538

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Huntington Park, California 90255

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Lancaster, California 93534

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Lynwood, California 90262

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Northridge, California 91324

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Palo Alto, California 94304

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Pomona, California 91768

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Riverside, California 92506

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San Dimas, California 91773

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Tarzana, California 91356

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Washington D.C., District of Columbia 20422

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Boca Raton, Florida 33487

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Fort Lauderdale, Florida 33316

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Gainesville, Florida 32608

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Hollywood, Florida 33021

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Jacksonville Beach, Florida 32250

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Lakeland, Florida 33813

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Melbourne, Florida 32901

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Orlando, Florida 32806

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Port Charlotte, Florida 33952

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Riverview, Florida 33578

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Weston, Florida 33331

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Brunswick, Georgia 31520

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East Point, Georgia 30344

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Macon, Georgia 31210

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Savannah, Georgia 31406

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Oak Brook, Illinois 60523

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Rockford, Illinois 61107

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Iowa City, Iowa 52246

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Wichita, Kansas 67214

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Louisville, Kentucky 40205

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Ann Arbor, Michigan 48105

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Saint Joseph, Michigan 49085

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Mankato, Minnesota 56001

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Kansas City, Missouri 64111

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Albuquerque, New Mexico 87108

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Albany, New York 12209

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Long Island City, New York 11106

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The Bronx, New York 10468

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Asheville, North Carolina 28805

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Charlotte, North Carolina 28287

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Cincinnati, Ohio 45212

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Cincinnati, Ohio 45220

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Media, Pennsylvania 19063

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Columbia, South Carolina 29209

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Greenville, South Carolina 29607

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Chattanooga, Tennessee 37404

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Fort Worth, Texas 76104

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Houston, Texas 77043

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Irving, Texas 75063

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Lufkin, Texas 75904

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McKinney, Texas 75069

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Pasadena, Texas 77504

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San Antonio, Texas 78204

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San Antonio, Texas 78212

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Sherman, Texas 75092

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Stephenville, Texas 76401

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Sugar Land, Texas 77478

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Sugar Land, Texas 77478

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Arlington, Virginia 22205

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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

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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

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Vienna, 1030

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Vienna, 1130

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Vienna, 1190

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Vienna, A-1090

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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

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Campinas, 13060-080

Brazil

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Goiânia, 74605-020

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Natal, 59020-500

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Recife, 50720-110

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São Caetano do Sul, 09521-160

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São José do Rio Preto, 15015-750

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São José dos Campos, 12243-280

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São Paulo, 01139-000

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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

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Sofia, 1527

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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

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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

Canada

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Québec, Quebec G1R 2J6

Canada

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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

Peru

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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

Peru

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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

Philippines

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Iloilo City, 5000

Philippines

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Las Piñas, 1742

Philippines

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Manila, 1000

Philippines

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Quezon City, 1101

Philippines

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Quezon City, 1112

Philippines

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West San Juan City, 1502

Philippines

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Olsztyn, 10-561

Poland

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Warsaw, 02-507

Poland

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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

Research Site

Taoyuan, 333

Taiwan

Research Site

Zhubei, 302

Taiwan

Research Site

Bangkok, 10210

Thailand

Research Site

Bangkok, 10300

Thailand

Research Site

Bangkok, 10400

Thailand

Research Site

Bangkok, 10700

Thailand

Research Site

Banphaeo, 74120

Thailand

Research Site

Changwat Sara Buri, 18000

Thailand

Research Site

Chiang Mai, 50200

Thailand

Research Site

Hat Yai, 90110

Thailand

Research Site

Naimuang, 30000

Thailand

Research Site

Phitsanulok, 65000

Thailand

Research Site

Ubonratchathani, 34000

Thailand

Research Site

Adapazarı, 54290

Turkey (Türkiye)

Research Site

Ankara, 06800

Turkey (Türkiye)

Research Site

Antalya, 07059

Turkey (Türkiye)

Research Site

Dinar, 03400

Turkey (Türkiye)

Research Site

İzmit, 41380

Turkey (Türkiye)

Research Site

Kahramanmaraş, 46100

Turkey (Türkiye)

Research Site

Kayseri, 38039

Turkey (Türkiye)

Research Site

Kazımkarabekir, 01230

Turkey (Türkiye)

Research Site

Malatya, 44280

Turkey (Türkiye)

Research Site

Samsun, 55139

Turkey (Türkiye)

Research Site

Ivano-Frankivsk, 76018

Ukraine

Research Site

Kyiv, 01601

Ukraine

Research Site

Kyiv, 02002

Ukraine

Research Site

Kyiv, 03037

Ukraine

Research Site

Kyiv, 03049

Ukraine

Research Site

Kyiv, 03151

Ukraine

Research Site

Kyiv, 04050

Ukraine

Research Site

Kyiv, 04114

Ukraine

Research Site

Kyiv, 04210

Ukraine

Research Site

Lviv, 79016

Ukraine

Research Site

Vinnytsia, 21001

Ukraine

Research Site

Vinnytsia, 21009

Ukraine

Research Site

Vinnytsia, 21029

Ukraine

Research Site

Aberdeen, AB25 2ZN

United Kingdom

Research Site

Bristol, BS1 3NU

United Kingdom

Research Site

Cardiff, CF14 4XW

United Kingdom

Research Site

Dundee, DD1 9SY

United Kingdom

Research Site

Glasgow, G51 4TF

United Kingdom

Research Site

London, E1 1FR

United Kingdom

Research Site

London, NW3 2QG

United Kingdom

Research Site

London, SE5 9RS

United Kingdom

Research Site

London, SW170QT

United Kingdom

Research Site

Swansea, SN6 6NL

United Kingdom

Research Site

Can Tho, 900000

Vietnam

Research Site

Da Nang, 550000

Vietnam

Research Site

Da Nang, 55000

Vietnam

Research Site

Hanoi, 100000

Vietnam

Research Site

Hanoi, 10000

Vietnam

Research Site

Hà Nội, 100000

Vietnam

Research Site

Ho Chi Minh City, 7000000

Vietnam

Research Site

Ho Chi Minh City, 700000

Vietnam

Research Site

Hochiminh City, 700000

Vietnam

Research Site

Hochiminh, 70000

Vietnam

Research Site

Huế, 530000

Vietnam