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NCT06129864PHASE3Recruiting

A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy

AstraZeneca

Start Date

12/14/2023

Completion Date

2/28/2031

Summary

The main purpose of this study is to assess the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not progressed after receiving definitive concurrent chemoradiotherapy (cCRT).

Eligibility Criteria

Age Range: 18 years to 130 years

Inclusion Criteria: * Histologically or cytologically documented locally advanced squamous cell carcinoma of the oropharynx, hypopharynx, oral cavity, or larynx with no evidence of metastatic disease (i.e. M0). * Confirmed unresected Stage III, Stage IVA or IVB according to the eighth edition of the American Joint Committee on Cancer (AJCC) staging manual (tumor, node, metastasis (TNM) staging system). * Participants will have completed definitive concurrent chemoradiotherapy (cCRT) with curative intent prior to randomization. Exclusion Criteria: * Histologically/cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including participants with squamous cell carcinoma of unknown primary or non-squamous histologies (eg, nasopharynx or salivary gland). Participants with \>1 primary tumors are not eligible for the study. * Participants with any of the following: 1. LA-HNSCC that was resected before definitive cCRT 2. LA-HNSCC that was treated and is recurrent at the time of screening * Participants who have received radiotherapy (RT) alone as definitive local therapy for LA-HNSCC.

Interventions

DRUG

volrustomig

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Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma

Locations

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Birmingham, Alabama 35233

United States

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Phoenix, Arizona 85028

United States

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Prescott Valley, Arizona 86314

United States

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Springdale, Arkansas 72762

United States

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Fountain Valley, California 92708

United States

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Los Angeles, California 90024

United States

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Orange, California 92868

United States

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San Francisco, California 94143

United States

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Santa Rosa, California 95403

United States

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Whittier, California 90602

United States

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Aurora, Colorado 80045

United States

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Colorado Springs, Colorado 80909

United States

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Lone Tree, Colorado 80124

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Washington D.C., District of Columbia 20037

United States

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Fort Myers, Florida 33901

United States

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Gainesville, Florida 32610

United States

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Miami, Florida 33125

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Palm Bay, Florida 32909

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West Palm Beach, Florida 33401

United States

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Niles, Illinois 60714

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Des Moines, Iowa 50309

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Kansas City, Kansas 66160

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Louisville, Kentucky 40202

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Baton Rouge, Louisiana 70817

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Shreveport, Louisiana 71101

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Baltimore, Maryland 21231

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Bethesda, Maryland 20817

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Hyattsville, Maryland 20782

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Towson, Maryland 21204

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Upper Marlboro, Maryland 20774

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Boston, Massachusetts 02215

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Fairhaven, Massachusetts 02719

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Ann Arbor, Michigan 48105

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Ann Arbor, Michigan 48109

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Minneapolis, Minnesota 55417

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Columbia, Missouri 65211

United States

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St Louis, Missouri 63110

United States

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St Louis, Missouri 63110

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East Brunswick, New Jersey 08816

United States

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Hackensack, New Jersey 07601

United States

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New Brunswick, New Jersey 08901

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Albuquerque, New Mexico 87108

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New York, New York 10065

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New York, New York 10075

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Stony Brook, New York 11794

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Charlotte, North Carolina 28204

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Winston-Salem, North Carolina 27157

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Cleveland, Ohio 44106

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Portland, Oregon 97213

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Portland, Oregon 97239

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Philadelphia, Pennsylvania 19107

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Pittsburgh, Pennsylvania 15261

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York, Pennsylvania 17403

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Sioux Falls, South Dakota 57104

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Sioux Falls, South Dakota 57105

United States

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Nashville, Tennessee 37212

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Austin, Texas 78745

United States

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Dallas, Texas 75251

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Flower Mound, Texas 75028

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Houston, Texas 77030

United States

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Odessa, Texas 79761

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Tyler, Texas 75702

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Salt Lake City, Utah 84112

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West Jordan, Utah 84088

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Fairfax, Virginia 22031

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Norfolk, Virginia 23502

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Richmond, Virginia 23230

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Spokane, Washington 99204

United States

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Tacoma, Washington 98405

United States

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Tacoma, Washington 98415

United States

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Graz, 8036

Austria

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Innsbruck, 6020

Austria

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Linz, 4010

Austria

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Salzburg, 5020

Austria

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Vienna, 1080

Austria

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Charleroi, 6060

Belgium

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Edegem, 2650

Belgium

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Jette, 1090

Belgium

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La Louvière, 7100

Belgium

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Namur, 5000

Belgium

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Barretos, 14784-400

Brazil

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Florianópolis, 88034-000

Brazil

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Fortaleza, 60336-045

Brazil

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Ijuí, 98700-000

Brazil

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Ipatinga, 35162-189

Brazil

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Londrina, 86015-520

Brazil

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Natal, 59075-740

Brazil

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Porto Alegre, 91350200

Brazil

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Ribeirão Preto, 14051-140

Brazil

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Rio de Janeiro, 20231-050

Brazil

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São Paulo, 01509-900

Brazil

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São Paulo, 04538-132

Brazil

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Teresina, 64049-200

Brazil

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Calgary, Alberta T2N 5G2

Canada

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Edmonton, Alberta T6G 1Z2

Canada

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Kelowna, British Columbia V1Y 5L3

Canada

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Kingston, Ontario K7L 2V7

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London, Ontario N6A 5W9

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Toronto, Ontario M4N 3M5

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Chicoutimi, Quebec G7H 5H6

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Montreal, Quebec H2X 0C1

Canada

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Montreal, Quebec H3T 1E2

Canada

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Montreal, Quebec H4A 3J1

Canada

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Regina, S4T 7T1

Canada

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Beijing, 100142

China

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Beijing, 100210

China

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Bengbu, 233004

China

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Changchun, 130000

China

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Changsha, 410008

China

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Changsha, 410013

China

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Chengdu, 610000

China

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Chengdu, 610042

China

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Chengdu, 610072

China

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Chongqing, 400016

China

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Chongqing, 400030

China

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Dongwan, 523058

China

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Fuzhou, 350014

China

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Guangzhou, 510060

China

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Guangzhou, 510080

China

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Guangzhou, 510095

China

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Guangzhou, 510700

China

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Guiyang, 550002

China

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Hangzhou, 310022

China

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Harbin, 150049

China

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Hefei, 230001

China

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Huizhou, 516001

China

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Jinan, 250117

China

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Kunming, 650118

China

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Lanzhou, 730000

China

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Nanchang, 330029

China

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Nanning, 530021

China

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Shanghai, 20032

China

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Shenyang, 110004

China

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Shijiazhuang, 050000

China

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Tianjin, 300060

China

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Tianjin, 300060

China

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Ürümqi, 830000

China

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Wuhan, 430030

China

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Wuhan, 430060

China

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Wuxi, 214122

China

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Xi'an, 710061

China

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Xiamen, 361003

China

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Zhengzhou, 450008

China

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Zhuhai, 519000

China

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Avignon, 84918

France

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Bordeaux, 33075

France

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Le Mans, 72000

France

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Lyon, 69373

France

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Nice, 06100

France

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Saint-Herblain, 44805

France

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Toulouse, 31059

France

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Villejuif, 94805

France

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Berlin, 12200

Germany

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Erlangen, 91054

Germany

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Essen, 45122

Germany

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Freiburg im Breisgau, 79106

Germany

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Greifswald, 17475

Germany

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Hamburg, 20246

Germany

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Hanover, 30625

Germany

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Leipzig, 04103

Germany

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Lübeck, 23538

Germany

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München, 81675

Germany

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Rostock, 18059

Germany

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Tübingen, 72076

Germany

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Ulm, 89075

Germany

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Würzburg, 97070

Germany

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Budapest, 1062

Hungary

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Budapest, 1083

Hungary

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Budapest, 1122

Hungary

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Budapest, 1145

Hungary

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Győr, 9024

Hungary

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Gyula, 5700

Hungary

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Kecskemét, 6000

Hungary

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Miskolc, 3526

Hungary

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Nyíregyháza, 4400

Hungary

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Pécs, 7624

Hungary

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Szekszárd, 7100

Hungary

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Bengaluru, 560027

India

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Hyderabad, 500032

India

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Jaipur, 302022

India

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Kanpur, 208005

India

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Kochi, 682027

India

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Kolkata, 700099

India

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Lucknow, 226003

India

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Madurai, 625107

India

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Mohali, 160055

India

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Nashik, 422002

India

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New Delhi, 110076

India

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Thiruvananthapuram, 695011

India

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Vadodara, 391760

India

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Varanasi, 221005

India

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Aviano, 33081

Italy

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Florence, 50139

Italy

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Milan, 20133

Italy

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Modena, 41124

Italy

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Naples, 80131

Italy

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Padova, 35128

Italy

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Pavia, 27100

Italy

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Rozzano, 20089

Italy

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Bunkyō City, 113-8431

Japan

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Bunkyō City, 113-8519

Japan

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Chiba, 260-8677

Japan

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Chiba, 260-8717

Japan

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Chūōku, 104-0045

Japan

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Fukuoka, 811-1395

Japan

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Hidaka-shi, 350-1298

Japan

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Hiroshima, 734-8551

Japan

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Kashiwa, 277-8577

Japan

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Kobe, 650-0017

Japan

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Kōtoku, 135-8550

Japan

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Kyoto, 606-8507

Japan

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Nagoya, 464-8681

Japan

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Nagoya, 466-8560

Japan

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Niigata, 951-8520

Japan

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Okayama, 700-8558

Japan

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Osaka, 541-8567

Japan

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Osakasayama-shi, 589-8511

Japan

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Sagamihara-shi, 252-0375

Japan

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Sapporo, 060-8638

Japan

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Sendai, 980-8574

Japan

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Shinjuku-ku, 160-0023

Japan

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Shiwa-gun, 028-3695

Japan

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Sunto-gun, 411-8777

Japan

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Yokohama, 236-0004

Japan

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Yokohama, 241-8515

Japan

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George Town, 10450

Malaysia

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Johor Bahru, 81100

Malaysia

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Kuala Lumpur, 50586

Malaysia

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Kuala Lumpur, 59100

Malaysia

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Kuala Selangor, 62250

Malaysia

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Kuching, 93586

Malaysia

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Cebu City, 6000

Philippines

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General Santos, 9500

Philippines

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Iloilo City, 5000

Philippines

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Manila, 1008

Philippines

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Pasig, 1605

Philippines

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Quezon City, 1112

Philippines

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West San Juan City, 1502

Philippines

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Bialystok, 15-027

Poland

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Bielsko-Biala, 43-300

Poland

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Bydgoszcz, 85-796

Poland

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Gliwice, 44-102

Poland

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Olsztyn, 10-228

Poland

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Piotrkow Trybunalski, 97-300

Poland

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Siedlce, 08-110

Poland

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Tomaszów Mazowiecki, 97-200

Poland

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Warsaw, 02-781

Poland

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San Juan, 00927

Puerto Rico

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Goyang-si, 410-769

South Korea

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Gyeonggi-do, 13620

South Korea

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Incheon, 21565

South Korea

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Seoul, 06351

South Korea

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Seoul, 3722

South Korea

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Seoul, 5505

South Korea

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Suwon, 16247

South Korea

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Badalona, 08916

Spain

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Barcelona, 08035

Spain

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Barcelona, 08036

Spain

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Jaén, 23007

Spain

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Madrid, 28007

Spain

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Madrid, 28034

Spain

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Madrid, 28040

Spain

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Valencia, 46014

Spain

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Valencia, 46026

Spain

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Changhua, 500

Taiwan

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Kaohsiung City, 80756

Taiwan

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Kaohsiung City, 833401

Taiwan

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Taichung, 404

Taiwan

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Taichung, 40705

Taiwan

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Taipei, 10002

Taiwan

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Taipei, 11217

Taiwan

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Taoyuan, 333

Taiwan

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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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Chaing Mai, 50200

Thailand

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Hat Yai, 90110

Thailand

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Khon Kaen, 40002

Thailand

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Lampang, 52000

Thailand

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Muang, 22000

Thailand

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Mueang, 20000

Thailand

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Ankara, 06230

Turkey (Türkiye)

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Ankara, 6200

Turkey (Türkiye)

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Antalya, 07059

Turkey (Türkiye)

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Cordaleo, 35575

Turkey (Türkiye)

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Eskişehir, 26040

Turkey (Türkiye)

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Istanbul, 34722

Turkey (Türkiye)

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Yenimahalle, 06170

Turkey (Türkiye)

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Aberdeen, AB25 2ZN

United Kingdom

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Cambridge, CB2 0XY

United Kingdom

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Hampshire, SO16 6YD

United Kingdom

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Leeds, LS9 7TF

United Kingdom

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London, EC1A 7BE

United Kingdom

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London, SE1 9RT

United Kingdom

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London, SW3 6JJ

United Kingdom

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Manchester, M20 4BX

United Kingdom

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Metropolitan Borough of Wirral, CH63 4JY

United Kingdom

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Northwood, HA6 2RN

United Kingdom

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Sutton, SM2 5PT

United Kingdom

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Taunton, TA1 5DA

United Kingdom

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Da Nang, 550000

Vietnam

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Hanoi, 100000

Vietnam

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Hà Nội, 100000

Vietnam

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Ho Chi Minh City, 700000

Vietnam

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Huế, 530000

Vietnam

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Vinh, 460000

Vietnam