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NCT05624450PHASE3Recruiting

Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen

AstraZeneca

Start Date

12/13/2022

Completion Date

11/4/2027

Summary

The purpose of this study is to evaluate the effect of tozorakimab, as an add-on to SoC in patients with viral lung infection requiring supplemental oxygen, on the prevention of death or progression to IMV/ECMO.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Adult participants ≥ 18 years old at the time of signing the informed consent form. * Patients hospitalised with viral lung infection. * Hypoxaemia requiring treatment with supplemental O2. Hypoxaemia is defined as: SpO2 ≤ 90% OR SpO2 ≤ 92% AND one or both of the following: Radiographic infiltrates by CXR/CT compatible with viral lung infection per investigator judgement. Use of accessory muscles of respiration or RR (respiratory rate) \> 22. \- Patient remains hypoxaemic at randomisation requiring treatment with supplemental oxygen. Exclusion Criteria: * Known fungal or parasitic lung infection, aspiration lung infection, lung abscess, or evidence of septic shock. Bacterial co-infection is allowed, unless, in the opinion of the investigator, bacterial infection defines the severity of the participant's condition. * Hypoxaemia caused primarily by extrapulmonary insult or by lung injury of non-infective aetiology. * Ongoing IMV/ECMO at randomisation.

Interventions

DRUG

Tozorakimab

DRUG

Placebo

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Conditions

Viral Lung Infection and Acute Respiratory Failure

Locations

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Mobile, Alabama 36608

United States

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Phoenix, Arizona 85008

United States

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Phoenix, Arizona 85013

United States

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Tucson, Arizona 85719

United States

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Chula Vista, California 91911

United States

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Fresno, California 93701

United States

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La Mesa, California 91942

United States

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Los Angeles, California 90027

United States

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Newport Beach, California 92663

United States

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Torrance, California 90505

United States

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Colorado Springs, Colorado 80909

United States

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Denver, Colorado 80206

United States

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Washington D.C., District of Columbia 20037

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Bradenton, Florida 34209

United States

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Bradenton, Florida 34209

United States

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Gainesville, Florida 32611

United States

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Jacksonville, Florida 32224

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Lakeland, Florida 33805

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Miami, Florida 33144

United States

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South Pasadena, Florida 33707

United States

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St. Petersburg, Florida 33709

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Tampa, Florida 33617

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Atlanta, Georgia 30322

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Boise, Idaho 83702

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Chicago, Illinois 60612

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Elmhurst, Illinois 60126

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Evanston, Illinois 60201

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Fort Wayne, Indiana 46804

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Iowa City, Iowa 52242

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Kansas City, Kansas 66160

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Louisville, Kentucky 40202

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Baton Rouge, Louisiana 70808

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New Orleans, Louisiana 70121

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Shreveport, Louisiana 71103

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Annapolis, Maryland 21401

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Silver Spring, Maryland 20910

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Springfield, Massachusetts 01199

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Worcester, Massachusetts 01655

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Detroit, Michigan 48202

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Detroit, Michigan 48202

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Royal Oak, Michigan 48073

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Saint Paul, Minnesota 55101

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Columbia, Missouri 65212

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Kansas City, Missouri 64108

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St Louis, Missouri 63110

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Brooklyn, New York 11203

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Buffalo, New York 14203

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New York, New York 10016

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New York, New York 10039

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Potsdam, New York 13676

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Chapel Hill, North Carolina 27514

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Durham, North Carolina 27705

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Greenville, North Carolina 27834

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Winston-Salem, North Carolina 27157

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Cleveland, Ohio 44195

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Columbus, Ohio 43210

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Toledo, Ohio 43614

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Oklahoma City, Oklahoma 73104

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Corvallis, Oregon 97330

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Portland, Oregon 97239

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Philadelphia, Pennsylvania 19107

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Providence, Rhode Island 02903

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Greenville, South Carolina 29605

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Sioux Falls, South Dakota 57105

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Amarillo, Texas 79106

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Dallas, Texas 75203

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Dallas, Texas 75204

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El Paso, Texas 79905

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Houston, Texas 77030

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Houston, Texas 77090

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Salt Lake City, Utah 84107

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Charlottesville, Virginia 22908

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Green Bay, Wisconsin 54311

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Milwaukee, Wisconsin 53295

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Buenos Aires, C1046

Argentina

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Buenos Aires, C1120AAF

Argentina

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Buenos Aires, C1180AAV

Argentina

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CABA, C1221ADC

Argentina

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CABA, C1425EOE

Argentina

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La Plata, B1900AVG

Argentina

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Mar del Plata, B7600GWV

Argentina

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Munro, B1605FRE

Argentina

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Rosario, S2000CVB

Argentina

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Adelaide, 5000

Australia

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Bedford Park, 5042

Australia

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New Lambton Heights, 2305

Australia

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Port Macquarie, 2444

Australia

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South Brisbane, 4101

Australia

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Kortrijk, 8500

Belgium

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Ottignies, 1340

Belgium

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Roeselare, 8800

Belgium

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Yvoir, 5530

Belgium

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Belo Horizonte, 30150-221

Brazil

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Campinas, 13060-904

Brazil

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Caxias do Sul, 95070-560

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Curitiba, 80215-901

Brazil

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Curitiba, 80730-150

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Indaiatuba, 13331-501

Brazil

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Jaú, 17201-130

Brazil

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Natal, 59025-050

Brazil

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Niterói, 24020-096

Brazil

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Passo Fundo, 99010-260

Brazil

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Porto Alegre, 90020-090

Brazil

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Porto Alegre, 9061-000

Brazil

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Recife, 50070-070

Brazil

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Ribeirão Preto, 14049-901

Brazil

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Rio de Janeiro, 21040-900

Brazil

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Salvador, 40170-130

Brazil

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São Caetano do Sul, 09521-160

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São José do Rio Preto, 15090-000

Brazil

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São Paulo, 04004-030

Brazil

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São Paulo, 09323-900

Brazil

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Montana, 3400

Bulgaria

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Pernik, 2300

Bulgaria

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Pleven, 5800

Bulgaria

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Rousse, 7002

Bulgaria

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Sofia, 1000

Bulgaria

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Sofia, 1154

Bulgaria

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Sofia, 1407

Bulgaria

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Sofia, 1431

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Sofia, 1606

Bulgaria

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Varna, 9010

Bulgaria

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Calgary, Alberta T2N 1N4

Canada

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New Westminster, British Columbia V3L 3W7

Canada

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Winnipeg, Manitoba R2H 2A6

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Winnipeg, Manitoba R3A 1R9

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Winnipeg, Manitoba R3J 3M7

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Brampton, Ontario L6R 3J9

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Ottawa, Ontario K1H 8L6

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Ottawa, Ontario K1Y 4E9

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Toronto, Ontario M4N 3M5

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Lévis, Quebec G6V 3Z1

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Montreal, Quebec H1T 2M4

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Montreal, Quebec H2W 1S6

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Montreal, Quebec H2X 3E4

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Québec, Quebec G1V 4G5

Canada

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Saskatoon, Saskatchewan S7N 0W8

Canada

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Anyang, 455099

China

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Beijing, 100015

China

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Beijing, 100029

China

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Beijing, 101199

China

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Beijing,

China

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Changchun, 130041

China

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Changsha, 410004

China

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Changsha, 410015

China

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Chengdu, 610000

China

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Chengdu, 610072

China

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Chongqing, 400010

China

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Fuyang, 236012

China

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Guangzhou, 510180

China

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Guangzhou, 510515

China

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Haikou, 570311

China

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Hangzhou, 310006

China

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Hangzhou, 310016

China

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Hefei, 230001

China

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Jinhua, 321099

China

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Jining, 272006

China

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Nanchang, 330006

China

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Nantong, 226001

China

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Ningbo, 315010

China

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Qingdao, 266011

China

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Shanghai, 200025

China

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Shanghai, 200032

China

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Shanghai, 200240

China

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Shanghai, 201199

China

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Shanghai, CN-200433

China

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Shenzhen, 518020

China

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Tianjin, 300050

China

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Weifang, 261041

China

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Wuhan, 430023

China

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Wuhan, 430030

China

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Xinxiang, 453100

China

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Yantai, 264000

China

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Yinchuan, 750004

China

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Yueyang, 414000

China

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Zhengzhou, 450000

China

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Bogota DC, 111121

Colombia

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Floridablanca, 681004

Colombia

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Medellín, 050021

Colombia

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Soledad, 083001

Colombia

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Villavicencio, 500001

Colombia

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Benešov, 256 01

Czechia

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Brno, 625 00

Czechia

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Hradec Králové, 500 05

Czechia

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Kolín, 280 02

Czechia

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Kyjov, 697 01

Czechia

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Mladá Boleslav, 293 01

Czechia

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Prague, 100 34

Czechia

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Prague, 150 30

Czechia

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Prague, 18000

Czechia

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Aalborg, 9000

Denmark

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Aarhus N, 8200

Denmark

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Copenhagen, 2400

Denmark

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Copenhagen Ø, 2100

Denmark

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Herning, 7400

Denmark

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Hillerød, 3400

Denmark

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Hvidovre, 2650

Denmark

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Kolding, 6000

Denmark

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Odense C, 5000

Denmark

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Vejle, 7100

Denmark

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Alexandria, 21131

Egypt

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Cairo, 11561

Egypt

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Cairo, 11566

Egypt

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New Cairo, 11566

Egypt

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Amiens, 80054

France

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Angers, 49033

France

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Brest, 29609

France

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Créteil, 94000

France

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Dijon, 21000

France

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La Tronche, 38700

France

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Le Coudray, 28630

France

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Montpellier, 34295

France

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Nantes, 44800

France

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Orléans, 45100

France

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Strasbourg, 67091

France

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Strasbourg, 67098

France

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Tours, 37000

France

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Augsburg, 86156

Germany

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Berlin, 10117

Germany

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Berlin, 12351

Germany

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Cologne, 51109

Germany

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Hamburg, 20246

Germany

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Hanover, 30625

Germany

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Kiel, 24105

Germany

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Leverkusen, 51375

Germany

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Marburg, 35043

Germany

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Regensburg, 93053

Germany

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Rosenheim, 83022

Germany

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Rostock, 18057

Germany

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Athens, 11527

Greece

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Athens, 12462

Greece

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Exohi Thessaloniki, 57010

Greece

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Heraklion, 71500

Greece

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Ioannina, 45500

Greece

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Thessaloniki, 57010

Greece

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Hong Kong, 999077

Hong Kong

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Shatin, 00000

Hong Kong

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Balassagyarmat, 2660

Hungary

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Budapest, 1082

Hungary

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Budapest, 1121

Hungary

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Debrecen, 4032

Hungary

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Győr, 9024

Hungary

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Kaposvár, 7400

Hungary

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Kistarcsa, 2143

Hungary

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Nyíregyháza, 4400

Hungary

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Pécs, 7624

Hungary

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Ahmedabad, 380054

India

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Ahmedabad, 382415

India

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Belagavi, 590010

India

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Chennai, 600113

India

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Dehradun, 248001

India

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Gurgaon, 122001

India

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Gurugram, 122001

India

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Hyderabad, 500035

India

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Hyderabad, 500068

India

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Kanpur, 208002

India

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Mumbai, 400008

India

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New Delhi, 110017

India

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New Delhi, 110029

India

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New Delhi, 110060

India

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Pune, 411043

India

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Thane, 401107

India

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Vijayawada, 520 008

India

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Afula, 18341

Israel

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Ashkelon, 7830604

Israel

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Beersheba, 8410101

Israel

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Haifa, 34362

Israel

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Holon, 58100

Israel

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Jerusalem, 91120

Israel

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Petah Tikva, 4941492

Israel

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Ramat Gan, 52621

Israel

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Rehovot, 76100

Israel

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Arezzo, 52100

Italy

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Brescia, 25123

Italy

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Naples, 80131

Italy

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Roma, 00128

Italy

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Roma, 00149

Italy

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Rozzano, 20089

Italy

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Torino, 10149

Italy

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Chiba, 260-0852

Japan

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Fukuoka, 814-0180

Japan

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Gifu, 502-8558

Japan

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Ginowan-shi, 901-2725

Japan

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Hanyu-shi, 348-8505

Japan

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Hiroshima, 734-8530

Japan

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Hiroshima, 734-8551

Japan

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Hitachi-shi, 317-0077

Japan

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Isehara-shi, 259-1193

Japan

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Izumisano, 598-8577

Japan

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Izumo-shi, 693-8501

Japan

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Kamakura-shi, 247-8533

Japan

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Kamogawa-shi, 296-8602

Japan

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Kanazawa, 920-8641

Japan

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Kanazawa, 920-8650

Japan

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Kasuga-shi, 816-0864

Japan

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Kawasaki-shi, 216-8511

Japan

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Koshigaya-shi, 343-8555

Japan

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Kumagaya-shi, 360-0197

Japan

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Kumamoto, 860-0008

Japan

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Kusatsu-shi, 525-8585

Japan

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Kyoto, 602-8566

Japan

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Kyoto, 612-8555

Japan

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Maebashi, 371-0811

Japan

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Meguro-ku, 152-8902

Japan

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Mitaka-shi, 181-8611

Japan

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Nagoya, 466-8560

Japan

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Nerima-ku, 179-0072

Japan

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Okayama, 702-8055

Japan

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Okazaki-shi, 444-0827

Japan

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Omuta-shi, 837-0911

Japan

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Osaka, 534-0021

Japan

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Osaka, 543-0035

Japan

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Osaka, 545-8586

Japan

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Sapporo, 062-0931

Japan

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Sapporo, 063-0005

Japan

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Shinagawa-ku, 142-8666

Japan

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Shinjuku-ku, 162-8655

Japan

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Suita-shi, 565-0871

Japan

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Tachikawa-shi, 190-8531

Japan

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Takamatsu, 760-0018

Japan

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Urasoe-shi, 901-2132

Japan

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Ureshino-shi, 843-0393

Japan

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Yokohama, 236-0004

Japan

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Yokohama, 241-0811

Japan

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Yokohama, 245-8575

Japan

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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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Kuala Terengganu, 20400

Malaysia

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Kuantan, 25200

Malaysia

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Kubang Kerian, 16150

Malaysia

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Malacca, 75400

Malaysia

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Petaling Jaya, 47500

Malaysia

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Pulau Pinang, 10450

Malaysia

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Sarawak Miri, 98000

Malaysia

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Selangor Darul Ehsan, 42300

Malaysia

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Shah Alam, 40000

Malaysia

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Aguascalientes, 20259

Mexico

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Guadalajara, 44280

Mexico

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Guadalajara, 44340

Mexico

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Mexico City, 06720

Mexico

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Mexico City, 06726

Mexico

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Monterrey, 64460

Mexico

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San Luis Potosí City, 78250

Mexico

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Tlalpan, 14050

Mexico

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Tlalpan, 14080

Mexico

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Xalapa, 91020

Mexico

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Cusco, CUSCO 01

Peru

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El Agustino, LIMA 10

Peru

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Lima, 15074

Peru

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Lima, 15088

Peru

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Lima, 15324

Peru

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Lima, LIMA 01

Peru

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Lima, LIMA 11

Peru

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Lima, LIMA 1

Peru

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Lima, LIMA 31

Peru

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Piura, 05

Peru

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Cebu, 6000

Philippines

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Iloilo City,

Philippines

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Manila, 1000

Philippines

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Quezon City, 1100

Philippines

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Quezon City, 1109

Philippines

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Chrzanów, 32-500

Poland

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Lodz, 91-347

Poland

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Rzeszów, 35-241

Poland

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Warsaw, 00-416

Poland

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Warsaw, 01-138

Poland

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Warsaw, 04-141

Poland

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Wroclaw, 51-149

Poland

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Łańcut, 37-100

Poland

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Łęczna, 21-010

Poland

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Bayamón, 00961

Puerto Rico

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Bucharest, 010825

Romania

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Bucharest, 21105

Romania

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Cluj-Napoca, 400000

Romania

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Constanța, 900709

Romania

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Iași, 700116

Romania

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Sibiu, 550245

Romania

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Timișoara, 300310

Romania

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Jeddah, 21423

Saudi Arabia

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Riyadh, 11426

Saudi Arabia

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Riyadh, 12231

Saudi Arabia

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Riyadh, 12372

Saudi Arabia

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Bratislava, 82606

Slovakia

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Johannesburg, Soweto, 2013

South Africa

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Observatory, 7925

South Africa

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Parktown, 2193

South Africa

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Westdene, 2092

South Africa

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Daegu, 42415

South Korea

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Jeonju, 54907

South Korea

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Seoul, 143-729

South Korea

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Barcelona, 08003

Spain

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Barcelona, 08036

Spain

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Madrid, 28034

Spain

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Majadahonda, 28222

Spain

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Málaga, 29010

Spain

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Ourense, 32005

Spain

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Palma de Mallorca, 07010

Spain

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Pamplona, 31008

Spain

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Santander, 39008

Spain

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Valencia, 46010

Spain

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Helsingborg, 25187

Sweden

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Huddinge, 14157

Sweden

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Lund, 22185

Sweden

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Malmö, 20502

Sweden

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Solna, 17176

Sweden

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Stockholm, 11861

Sweden

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Stockholm, 18288

Sweden

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Umeå, 90185

Sweden

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Västerås, 72189

Sweden

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Kaohsiung City, 80756

Taiwan

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Kaohsiung City, 81362

Taiwan

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Taichung, 40447

Taiwan

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Taichung, 40705

Taiwan

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Taipei, 0116

Taiwan

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Taipei, 10002

Taiwan

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Taipei, 112

Taiwan

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Taoyuan, 333

Taiwan

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Taoyuan City, 330

Taiwan

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Bangkok, 10210

Thailand

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Bangkok, 10400

Thailand

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Bangkok, 10700

Thailand

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Banphaeo, 74120

Thailand

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Chiang Mai, 50200

Thailand

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Khlong Luang, 12120

Thailand

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Khon Kaen, 40002

Thailand

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Phutthamonthon, 73170

Thailand

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Ubonratchathani, 34000

Thailand

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Ankara, 06800

Turkey (Türkiye)

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Diyarbakır, 21280

Turkey (Türkiye)

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Istanbul, 34010

Turkey (Türkiye)

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Istanbul, 34069

Turkey (Türkiye)

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Istanbul, 34303

Turkey (Türkiye)

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Istanbul, 34899

Turkey (Türkiye)

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Izmir, 35040

Turkey (Türkiye)

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Izmir, 35110

Turkey (Türkiye)

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İzmit, 41000

Turkey (Türkiye)

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Malatya, 44280

Turkey (Türkiye)

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Ortahisar, 61080

Turkey (Türkiye)

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Bristol, BS105NB

United Kingdom

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Dundee, DD1 9SY

United Kingdom

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Glasgow, G4 0SF

United Kingdom

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Glasgow, G51 4TF

United Kingdom

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Hampshire, SO16 6YD

United Kingdom

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Huddersfield, HD3 3EA

United Kingdom

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Leeds, LS9 7TF

United Kingdom

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Leicester, LE3 9QP

United Kingdom

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London, W1T 7HA

United Kingdom

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London, W2 1NY

United Kingdom

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London, W6 8RF

United Kingdom

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Oxford, OX3 9DU

United Kingdom

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Prescot, L35 5DR

United Kingdom

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Tyne and Wear, NE29 8NH

United Kingdom

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Wythenshawe, M23 9LT

United Kingdom

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Haiphong, 180000

Vietnam

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Haiphong, 180000

Vietnam

Research Site

Hanoi, 100000

Vietnam

Research Site

Hanoi, 10000

Vietnam

Research Site

Ho Chi Minh City, 700000

Vietnam

Research Site

Ho Chi Minh City, 700000

Vietnam

Research Site

Ho Chi Minh City, 700000

Vietnam

Research Site

Ho Chi Minh City,

Vietnam

Research Site

Hochiminh City, 700000

Vietnam

Research Site

Huế, 530000

Vietnam