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NCT06307652PHASE3Recruiting

Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function

AstraZeneca

Start Date

4/12/2024

Completion Date

6/11/2027

Summary

This is a Phase III, international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events.

Detailed Description

The purpose of this study is to investigate the effect of balcinrenone/dapagliflozin compared with dapagliflozin, on the risk of CV death, HF event with and without hospitalisation, in patients with chronic HF, impaired kidney function, and who have had a recent HF event. Eligible patients will randomly be assigned with a 1:1:1 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. Balcinrenone/dapagliflozin 40 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 3. Dapagliflozin 10 mg tablet and matching placebo for balcinrenone/dapagliflozin capsule The study is event driven, and the average study duration for a participant is estimated to be 22 months including screening period, 20 months blinded treatment period and a one-month follow-up period on open-label dapagliflozin. The study will be conducted at approximately 700 sites in approximately 40 countries globally.

Eligibility Criteria

Age Range: 18 years to 130 years

Inclusion Criteria: * Age ≥ 18 years * Documented diagnosis of symptomatic HF (NYHA functional class II-IV) * Having had a recent HF event within 6 months (hospitalization or urgent visit) * Have a LVEF value from an assessment within the last 12 months * Managed with SoC therapy for HF and renal impairment according to local guidelines * NT-proBNP must be \>300 pg/mL (\>600 pg/mL if concomitant atrial fibrillation or atrial flutter) * Not taking an MRA * An eGFR ≥ 20 to \< 60 mL/min/1.73 m2 * Serum/plasma potassium ≤ 5.0 mmol/L Exclusion Criteria: * Acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the previous 3 months prior to enrolment or during the screening period * Major cardiac surgery, coronary revascularisation or valvular repair or replacement, or implantation of a Cardiac resynchronisation therapy device within 3 months prior to enrolment or during the screening period, or planned to undergo any of these operations * History of hypertrophic obstructive cardiomyopathy * Complex congenital heart disease or severe uncorrected primary valvular disease * Symptomatic bradycardia or second- or third-degree heart block without a pacemaker * Systolic BP \< 90 mmHg, or symptomatic hypotension within the past 24 hours * Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD or exacerbation of COPD requiring invasive mechanical ventilation assistance within 12 months prior to enrolment * Type 1 diabetes mellitus * Kidney replacement therapy in the past 4 weeks, currently requiring kidney replacement or imminent plan to start kidney replacement therapy * Acute or chronic liver disease with severe impairment of liver function, eg, ascites, oesophageal varices, coagulopathy, and encephalopathy * Suspected or confirmed COVID-19 infection within the last 4 weeks or hospitalisation for COVID-19 within the last 12 weeks * Treatment with strong or moderate CYP3A4 inhibitor or inducer

Interventions

DRUG

balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg

DRUG

balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg

DRUG

dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin

Interested in This Trial?

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Conditions

Heart Failure and Impaired Kidney Function

Locations

Research Site

Alexander City, Alabama 35010

United States

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Birmingham, Alabama 35209

United States

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Fairhope, Alabama 36532

United States

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Huntsville, Alabama 35801

United States

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Phoenix, Arizona 85016

United States

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Phoenix, Arizona 85044

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Little Rock, Arkansas 72205

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Beverly Hills, California 90211

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Covina, California 91723

United States

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Encinitas, California 92024

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Los Angeles, California 90073

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Los Angeles, California 90089

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Newport Beach, California 92663

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Orange, California 92868

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Redding, California 96001

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San Diego, California 92123

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San Francisco, California 94110

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San Francisco, California 94121

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Santa Ana, California 92704

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Thousand Oaks, California 91360

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Vista, California 92081

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West Hills, California 91307

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Aurora, Colorado 80045

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Wheat Ridge, Colorado 80033

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Altamonte Springs, Florida 32701

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Boca Raton, Florida 33486

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Bradenton, Florida 34209

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Clearwater, Florida 33756

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Delray Beach, Florida 33484

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Fort Lauderdale, Florida 33308

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Gainesville, Florida 32610

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Jacksonville, Florida 32209

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Miami, Florida 33133

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Miami, Florida 33176

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Miami Lakes, Florida 33014

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Palm Beach Gardens, Florida 33410

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Pensacola, Florida 32503

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Port Charlotte, Florida 33952

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Safety Harbor, Florida 34695

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Saint Augustine, Florida 32086

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St. Petersburg, Florida 33701

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Tampa, Florida 33617

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Atlanta, Georgia 30303

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Atlanta, Georgia 30309

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Peachtree City, Georgia 30269

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Thomasville, Georgia 31792

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Tucker, Georgia 30084

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Chicago, Illinois 60612

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Chicago, Illinois 60637

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Glenview, Illinois 60026

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Hazel Crest, Illinois 60429

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North Chicago, Illinois 60064

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Peoria, Illinois 61614

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Winfield, Illinois 60190

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Elkhart, Indiana 46514

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Evansville, Indiana 47710

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Hammond, Indiana 46324

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Indianapolis, Indiana 46237

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Muncie, Indiana 47303

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Munster, Indiana 46321

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Richmond, Indiana 47374

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Waterloo, Iowa 50701

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Wichita, Kansas 67218

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Wichita, Kansas 67226

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Louisville, Kentucky 40202

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Alexandria, Louisiana 71301

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New Orleans, Louisiana 70121

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Shreveport, Louisiana 71105

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West Monroe, Louisiana 71291

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Augusta, Maine 04330

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Rockville, Maryland 20850

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Boston, Massachusetts 02114

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Fall River, Massachusetts 02721

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Worcester, Massachusetts 01655

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Ann Arbor, Michigan 48109

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Bloomfield Hills, Michigan 48304

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Dearborn, Michigan 48126

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Farmington Hills, Michigan 48334

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Flint, Michigan 48504

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Troy, Michigan 48098

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Ypsilanti, Michigan 48197

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Minneapolis, Minnesota 55455

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Saint Paul, Minnesota 55109

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Jackson, Mississippi 39216

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Columbia, Missouri 65201

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Kansas City, Missouri 64111

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Kansas City, Missouri 64128

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Lincoln, Nebraska 68506

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Lincoln, Nebraska 68510

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Henderson, Nevada 89074

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North Las Vegas, Nevada 89086

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Bridgewater, New Jersey 08807

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Jersey City, New Jersey 07302

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Somerset, New Jersey 08873

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Albany, New York 12208

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Brooklyn, New York 11219

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Brooklyn, New York 11220

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Clifton Park, New York 12065

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Manhasset, New York 11030

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New Windsor, New York 12553

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New York, New York 10029

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Staten Island, New York 10310

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Stony Brook, New York 11794

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The Bronx, New York 10451

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The Bronx, New York 10455

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Asheville, North Carolina 28801

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Chapel Hill, North Carolina 27517

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Charlotte, North Carolina 28204

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Durham, North Carolina 27710

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Greensboro, North Carolina 27405

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Pinehurst, North Carolina 28374

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Statesville, North Carolina 28625

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Wilmington, North Carolina 28401

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Cincinnati, Ohio 45219

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Cincinnati, Ohio 45267

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Dayton, Ohio 45414

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Maumee, Ohio 43537

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Springfield, Ohio 45504

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Oklahoma City, Oklahoma 73102

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Portland, Oregon 97225

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Abington, Pennsylvania 19001

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Camp Hill, Pennsylvania 17011

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Hershey, Pennsylvania 17033

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Horsham, Pennsylvania 19044

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Philadelphia, Pennsylvania 19104

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Providence, Rhode Island 02908

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Anderson, South Carolina 29621

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Charleston, South Carolina 29401

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Charleston, South Carolina 29425

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Ladson, South Carolina 29456

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Lancaster, South Carolina 29720

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Rapid City, South Dakota 57701

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Jackson, Tennessee 38305

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Knoxville, Tennessee 37916

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Memphis, Tennessee 38120

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Memphis, Tennessee 38128

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Nashville, Tennessee 37212

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Tullahoma, Tennessee 37388

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Allen, Texas 75013

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Amarillo, Texas 79106

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Amarillo, Texas 79121

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Cypress, Texas 77429

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Dallas, Texas 75204

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Dallas, Texas 75216

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Dallas, Texas 75390

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El Paso, Texas 79905

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Houston, Texas 77002

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Houston, Texas 77025

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Katy, Texas 77493

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Mansfield, Texas 76063

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McKinney, Texas 75069

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McKinney, Texas 75071

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Odessa, Texas 79761

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Pearland, Texas 77584

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San Antonio, Texas 78229

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Sherman, Texas 75092

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Temple, Texas 76508

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Tyler, Texas 75701

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Tyler, Texas 75702

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Salt Lake City, Utah 84107

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Salt Lake City, Utah 84148

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Falls Church, Virginia 22042

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Newport News, Virginia 23606

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Puyallup, Washington 98372

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Seattle, Washington 98101

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Tacoma, Washington 98405

United States

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Buenos Aires, 1416

Argentina

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Buenos Aires, C1056ABJ

Argentina

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Buenos Aires, C1180AAX

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CABA, C1425HFA

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Ciudad de Buenos Aires, 1425DES

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Ciudad de Buenos Aires, C1419AHL

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Corrientes, W3400CDS

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Córdoba, X5003DCE

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Córdoba, X5006CBI

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Esperanza, S3080BQU

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Granadero Baigorria, S2152BOF

Argentina

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Mar del Plata, B7600GNY

Argentina

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Rosario, 2123

Argentina

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San Juan Bautista, 1888

Argentina

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San Miguel de Tucumán, 4000

Argentina

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San Miguel de Tucumán, 4000

Argentina

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San Miguel de Tucumán, T4000ICL

Argentina

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Santa Fe, S3000FWO

Argentina

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Blacktown, 2148

Australia

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Cairns, 4870

Australia

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Canberra, 2605

Australia

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Chermside, 4032

Australia

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Clayton, 3168

Australia

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Concord, 2139

Australia

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Frankston, 3199

Australia

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Geelong, 3220

Australia

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Murdoch, WA6150

Australia

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North Tamworth, 2340

Australia

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Westmead, 2145

Australia

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Bad Ischl, 4820

Austria

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Braunau am Inn, 5280

Austria

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Graz, 8036

Austria

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Linz, 4020

Austria

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Saint Stefan/Stainz, 8511

Austria

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Salzburg, 5020

Austria

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Sankt Pölten, 3100

Austria

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Vienna, 1090

Austria

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Vienna, 1100

Austria

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Vienna, 1160

Austria

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Vöcklabruck, 4840

Austria

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Aracaju, 49015-380

Brazil

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Blumenau, 89020-430

Brazil

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Brasília, 70200-730

Brazil

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Campina Grande do Sul, 83.430-000

Brazil

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Campinas, 13060-080

Brazil

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Curitiba, 80730-150

Brazil

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Goiânia, 74605-020

Brazil

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Niterói, 24033-900

Brazil

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Porto Alegre, 90035-903

Brazil

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Rio Branco, 69915-030

Brazil

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Rio de Janeiro, 20241-180

Brazil

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Rio de Janeiro, 20551-030

Brazil

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Rio de Janeiro, 22061-080

Brazil

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São José dos Campos, 12230-001

Brazil

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São Paulo, 04012-180

Brazil

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São Paulo, 05403-000

Brazil

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Teresina, 64049-550

Brazil

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Uberlândia, 38400-500

Brazil

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Botevgrad, 2140

Bulgaria

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Dupnitsa, 2600

Bulgaria

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Haskovo, 6300

Bulgaria

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Kozloduy, 3320

Bulgaria

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Pleven, 5800

Bulgaria

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Plovdiv, 4000

Bulgaria

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Plovdiv, 4003

Bulgaria

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Sliven, 8800

Bulgaria

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Sliven, 8800

Bulgaria

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Sofia, 1000

Bulgaria

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Sofia, 1309

Bulgaria

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Sofia, 1431

Bulgaria

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Sofia, 1606

Bulgaria

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Sofia, 1618

Bulgaria

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Sofia, 1756

Bulgaria

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Stara Zagora, 6000

Bulgaria

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New Westminster, British Columbia V3L 3W4

Canada

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North Vancouver, British Columbia V7M 2H4

Canada

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Vancouver, British Columbia V6Z 1Y6

Canada

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Winnipeg, Manitoba R2H 2A6

Canada

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Sydney, Nova Scotia B1P 1P3

Canada

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Cambridge, Ontario N1R 6V6

Canada

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Cambridge, Ontario N1R 7R1

Canada

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Hamilton, Ontario L8L 5G4

Canada

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London, Ontario N6A 5A5

Canada

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Newmarket, Ontario L3Y 2P6

Canada

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North York, Ontario M6B 3H7

Canada

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Oakville, Ontario L6K 3W7

Canada

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Oshawa, Ontario L1J 2K1

Canada

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Ottawa, Ontario K1Y 4W7

Canada

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Peterborough, Ontario K9J 0B2

Canada

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Thunder Bay, Ontario P7B 7C7

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Toronto, Ontario M6G 1M2

Canada

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Waterloo, Ontario N2T 0C1

Canada

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Chicoutimi, Quebec G7H 7K9

Canada

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Greenfield Park, Quebec J4V 2H1

Canada

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Montreal, Quebec H1T 1C8

Canada

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Montreal, Quebec H2X 0C1

Canada

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Montreal, Quebec H3G 1A4

Canada

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Montreal, Quebec H4J 1C5

Canada

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Saint-Charles-Borromée, Quebec J6E 2B4

Canada

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Saint-Jean-sur-Richelieu, Quebec J3A 1J2

Canada

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Trois-Rivières, Quebec G9A 4P3

Canada

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Antofagasta, 1240000

Chile

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Concepción, 4070196

Chile

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Independencia, 8380465

Chile

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Punta Arenas, 6200000

Chile

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Region Metropolitana, 7550000

Chile

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San Bernardo, 8070996

Chile

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Santiago, 7500587

Chile

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Santiago, 7500922

Chile

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Santiago, 7770086

Chile

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Santiago, 8330034

Chile

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Santiago, 8380453

Chile

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Santiago, 8910259

Chile

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Talcahuano, 4270918

Chile

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Temuco, 4781156

Chile

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Temuco, 4810345

Chile

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Valdivia, 5110683

Chile

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Victoria, 4720097

Chile

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Baotou, 14010

China

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Beijing, 100029

China

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Beijing, 100029

China

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Beijing, 100034

China

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Beijing, 100037

China

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Beijing, 100730

China

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Changchun, 130033

China

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Changsha, 410015

China

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Changsha, 430033

China

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Chengdu, 610041

China

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Chengdu, 610072

China

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Chifeng, 024000

China

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Chongqing, 404197

China

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Guangzhou, 510100

China

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Guangzhou, 510515

China

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Guangzhou, 510630

China

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Hangzhou, 310014

China

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Harbin, 150001

China

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Hengyang, 421001

China

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Heze, 274099

China

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Hohhot, 010017

China

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Jinan, 250013

China

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Jining, 272029

China

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Lanzhou, 730030

China

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Liaocheng, 252000

China

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Linhai, 317000

China

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Nanchang, 330009

China

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Nanchong, 637900

China

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Nanjing, 2100008

China

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Nanjing, 210009

China

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Nanjing, 210011

China

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Nanjing, 210029

China

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Ningbo, 315040

China

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Pingxiang, 337055

China

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Quzhou, 342000

China

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Sanya, 572000

China

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Shanghai, 200025

China

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Shanghai, 200062

China

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Shenyang, 110004

China

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Shenzhen, 518053

China

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Ürümqi, CN-830004

China

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Wuhan, 430022

China

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Wuhan, 430030

China

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Xi'an, 710061

China

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Xi'an, 710068

China

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Xianyang, 750004

China

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Xuzhou, 221000

China

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Xuzhou, 221009

China

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Yangzhou, 225001

China

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Zhangjiakou, 075061

China

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Zunyi, 563100

China

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Armenia, 630004

Colombia

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Barranquilla, 080020

Colombia

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Barranquilla, 80007

Colombia

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Bogotá, 110221

Colombia

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Bogotá, 111211

Colombia

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Cali, 760032

Colombia

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Cali, 760036

Colombia

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Cartagena, 130001

Colombia

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Cartagena, 130013

Colombia

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Manizales, 170004

Colombia

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Medellín, 050030

Colombia

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Medellín, 050034

Colombia

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Piedecuesta, 681017

Colombia

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Rionegro, 054047

Colombia

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Brno, 60200

Czechia

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Brno, 639 00

Czechia

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Broumov, 55001

Czechia

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Česká Lípa, 470 77

Czechia

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Jaroměř, 551 01

Czechia

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Louny, 440 01

Czechia

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Ostrava, 702 00

Czechia

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Ostrava, 702 00

Czechia

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Pilsen, 31001

Czechia

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Plzen - Bory, 305 99

Czechia

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Prague, 120 00

Czechia

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Přerov, 75152

Czechia

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Slaný, 274 01

Czechia

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Svitavy, 568 02

Czechia

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Ustí Nad Labem, 40011

Czechia

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Ústí nad Labem, 400 01

Czechia

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Zlín, 760 01

Czechia

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Helsinki, 00290

Finland

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Tampere, 33520

Finland

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Turku, 20520

Finland

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Béziers, 34500

France

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Bron, 69667

France

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Caen, 14033

France

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Cholet, 49300

France

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Créteil, 94010

France

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Dijon, 21079

France

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La Roche-sur-Yon, 85925

France

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La Tronche, 38043

France

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Le Coudray, 28630

France

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Limoges, 87000

France

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Meaux, 77104

France

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Montauban, 82017

France

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Montpellier, 34000

France

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Montpellier, 34295

France

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Nantes, 44093

France

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Orléans, 45100

France

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Paris, 75010

France

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Paris, 75015

France

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Poitiers, 86021

France

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Reims, 51092

France

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Rennes, 35033

France

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Rouen, 76031

France

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Saint-Quentin, 02100

France

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Strasbourg, 67091

France

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Toulon, 83100

France

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Toulouse, 31059

France

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Tours, 37044

France

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Valenciennes, 59300

France

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Bad Nauheim, 61231

Germany

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Bechhofen, 66894

Germany

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Berlin, 12203

Germany

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Berlin, 13405

Germany

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Bernau bei Berlin, 16321

Germany

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Chemnitz, 9113

Germany

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Coburg, 96450

Germany

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Dresden, 01099

Germany

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Dresden, 1307

Germany

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Elsterwerda, 04910

Germany

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Frankfurt, 60590

Germany

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Freiburg im Breisgau, 79106

Germany

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Goslar, 38642

Germany

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Göttingen, 37075

Germany

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Hagen, 58135

Germany

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Hamburg, 20246

Germany

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Hamburg, 22457

Germany

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Hamburg, 22459

Germany

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Heidelberg, 69120

Germany

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Kaiserslautern, 67655

Germany

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Langen, 63225

Germany

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Leipzig, 04103

Germany

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Leverkusen, 51375

Germany

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Mainz, 55122

Germany

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Mainz, 55131

Germany

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Mönchengladbach, 41063

Germany

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Münster, 48149

Germany

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Paderborn, 33098

Germany

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Papenburg, 26871

Germany

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Regensburg, 93053

Germany

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Rostock, 18059

Germany

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Germany

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Germany

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Athens, 11521

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Athens, 11526

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Athens, 11527

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Athens, 11528

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Athens, 12462

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Athens, 14233

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Athens, 15123

Greece

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Dragana, 68100

Greece

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Heraklio, 71110

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Thessaloniki, 54636

Greece

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Balatonfüred, 8230

Hungary

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Hungary

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Budapest, 1122

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Budapest, 1145

Hungary

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Gyula, 5700

Hungary

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Hódmezővásárhely, 6800

Hungary

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Kecskemét, 6000

Hungary

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Orosháza, 5900

Hungary

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Pécs, 7623

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Pécs, 7635

Hungary

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Székesfehérvár, 8000

Hungary

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Ahmedabad, 380054

India

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Ajmer, 305001

India

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Belagavi, 590010

India

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Coimbatore, 641018

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Dehradun, 248001

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Delhi, 110062

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Hyderabad, 500018

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Hyderabad, 500034

India

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Hyderabad, 500035

India

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Kanpur, 208001

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Karamsad, 388345

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Kolkata, 700014

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Kolkata, 700020

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Manipal, 576104

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Nagpur, 441108

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New Delhi, 110002

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New Delhi, 110017

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New Delhi, 110029

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Pune, 411001

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Afula, 1834111

Israel

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Israel

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Israel

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Israel

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Acquaviva delle Fonti, 70021

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Beppu-shi, 874-0011

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Bunkyō City, 113-8431

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Hakusan-shi, 924-8588

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Kobe, 654-0155

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Aguascalientes, 20230

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Mexico

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Mexico

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Amsterdam, 1091 AC

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Piura, 20001

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Angeles City, 2009

Philippines

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City of Taguig, 1634

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Davao City, 8000

Philippines

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Davao City, PH-8000

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Iloilo City, 5000

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Philippines

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Philippines

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Manadaluyong City, 1552

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Marikina City, 1800

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Pasig, 1605

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Quezon City, 1112

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Quezon City,

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West San Juan City, 1502

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Biała Podlaska, 21-500

Poland

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Poland

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Poland

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Afumaţi, 077010

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Cluj-Napoca, 400437

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Satu Mare, 440192

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Timișoara, 300254

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Dammam, 31463

Saudi Arabia

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Saudi Arabia

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Saudi Arabia

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Riyadh, 11481

Saudi Arabia

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Riyadh, 11525

Saudi Arabia

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Riyadh, 12713

Saudi Arabia

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Banská Bystrica, 974 01

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South Africa

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South Africa

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Panorama, 7500

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Parow, 7505

South Africa

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Pietermaritzburg, 3201

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Somerset West, 7130

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Soweto, 2013

South Africa

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Worcester, 6850

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South Korea

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Cheongju-si, 28644

South Korea

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Daegu, 42601

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South Korea

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South Korea

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South Korea

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South Korea

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Seoul, 04763

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Seoul, 05505

South Korea

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South Korea

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Seoul, 06591

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South Korea

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South Korea

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South Korea

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A Coruña, 15006

Spain

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Stockholm, 18288

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Changhua, 500

Taiwan

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Kaohsiung City, 80756

Taiwan

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Kaohsiung City, 81362

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New Taipei City, 220

Taiwan

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New Taipei City, 231

Taiwan

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New Taipei City, 25160

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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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Taipei, 0116

Taiwan

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Taipei, 10002

Taiwan

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Taipei, 10449

Taiwan

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Taipei, 110

Taiwan

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Taipei, 11101

Taiwan

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Taipei, 11217

Taiwan

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Taipei, TAIWAN

Taiwan

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Taoyuan, 333

Taiwan

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Yilan, 260

Taiwan

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Yung Kang City, 71044

Taiwan

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Bangkok, 10330

Thailand

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Bangkok, 10400

Thailand

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Bangkok, 10700

Thailand

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Chiang Mai, 50200

Thailand

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Hat Yai, 90110

Thailand

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Khon Kaen, 40002

Thailand

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Naimuang, 30000

Thailand

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Pathum Thani, 12120

Thailand

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Adana, 01060

Turkey (Türkiye)

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Ankara, 06

Turkey (Türkiye)

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Antalya, 07059

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Antalya, 07100

Turkey (Türkiye)

Research Site

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Turkey (Türkiye)

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Center, 78200

Turkey (Türkiye)

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Dinar, 03400

Turkey (Türkiye)

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Eskişehir, 26480

Turkey (Türkiye)

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Turkey (Türkiye)

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Turkey (Türkiye)

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Turkey (Türkiye)

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Ukraine

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Ivano-Frankivsk, 76018

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Ukraine

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Ukraine

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Uzhhorod, 88014

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Ukraine

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Zhytomyr, 100002

Ukraine

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Airdrie, ML6 0JS

United Kingdom

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United Kingdom

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United Kingdom

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United Kingdom

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United Kingdom

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United Kingdom

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United Kingdom

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United Kingdom

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United Kingdom

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Can Tho, 900000

Vietnam

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Vietnam

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Haiphong, 180000

Vietnam

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Hanoi, 100000

Vietnam

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Vietnam

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Vietnam

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Vietnam

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Ho Chi Minh City, 70000

Vietnam

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Ho Chi Minh City, 70000

Vietnam

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Hochiminh City, 700000

Vietnam

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Hochiminh, 70000

Vietnam

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Hồ Chí Minh, 700000

Vietnam

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Huế, 530000

Vietnam