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NCT06932263PHASE2Recruiting

Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids

AstraZeneca

Start Date

3/26/2025

Completion Date

2/28/2028

Summary

This is a dose-range finding, double-blind, placebo-controlled, phase IIb study designed to assess efficacy and safety of tozorakimab administered subcutaneously in adult participants with uncontrolled asthma receiving medium-to-high dose inhaled corticosteroids.

Eligibility Criteria

Age Range: 18 years to 75 years

Inclusion Criteria: 1. Provision of signed and dated written informed consent prior to any study-specific procedures. 2. Adults aged 18-75, inclusive when signing the informed consent. 3. Documented physician-diagnosis of asthma for at least 12 months. 4. Treated with medium or high dose ICS in combination with LABA. 5. Demonstration of uncontrolled asthma through ACQ-6 score ≥ 1.5 . 6. Pre-bronchodilator FEV1 ≥ 40% to ≤ 90% of predicted normal. 7. Documented exacerbation history in the last 12 months and biomarker requirements of: 1. 2 severe exacerbations OR 2. 1 severe exacerbation and: (i) Eosinophils ≥ 150 cells/µl or (ii) FeNo ≥ 25 ppb 8. Participants need to demonstrate a ≥70% compliance for Asthma Daily Diary. 9. Women of Child Bearing Potential (WOCBP) must have a negative pregnancy test. 10. Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Exclusion Criteria: 1. Completed treatment for respiratory infection with antibiotics in the 4 weeks prior to Visit 1. 2. Clinically significant pulmonary disease other than asthma . 3. Current smokers, former smokers with \>10 pack-years history. 4. Clinically significant aortic stenosis or pulmonary arterial hypertension. 5. Active tuberculosis, hepatitis, HIV, or current diagnosis of cancer or immune complex disease. 6. Unstable cardiovascular disorders.

Interventions

DRUG

Tozorakimab

DRUG

Placebo

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Conditions

Asthma

Locations

Research Site

Bakersfield, California 93301

United States

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Huntington Beach, California 92647

United States

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La Mesa, California 91942

United States

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Loma Linda, California 92350

United States

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Long Beach, California 90815

United States

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Newport Beach, California 92663

United States

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San Jose, California 95117

United States

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Wilmington, Delaware 19805

United States

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Cutler Bay, Florida 33189

United States

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Hialeah, Florida 33015

United States

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Leesburg, Florida 34748

United States

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Miami, Florida 33155

United States

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Miami, Florida 33175

United States

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Miami Lakes, Florida 33016

United States

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Orlando, Florida 32819

United States

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Palmetto Bay, Florida 33157

United States

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Tampa, Florida 33607

United States

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Winter Park, Florida 32789

United States

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Boise, Idaho 83706

United States

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Noblesville, Indiana 46060

United States

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West Des Moines, Iowa 50266

United States

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Hutchinson, Kansas 67502

United States

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Kansas City, Kansas 66160

United States

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Louisville, Kentucky 40218

United States

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White Marsh, Maryland 21162

United States

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Farmington Hills, Michigan 48336

United States

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Warren, Michigan 48088

United States

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St Louis, Missouri 63141

United States

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Bellevue, Nebraska 68123

United States

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Grand Island, Nebraska 68803

United States

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Omaha, Nebraska 68134

United States

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Toms River, New Jersey 08755

United States

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Horseheads, New York 14845

United States

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Maspeth, New York 11378

United States

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Asheville, North Carolina 28803

United States

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Huntersville, North Carolina 28078

United States

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Kings Mountain, North Carolina 28086

United States

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Pinehurst, North Carolina 28374

United States

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Toledo, Ohio 43617

United States

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Edmond, Oklahoma 73034

United States

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Grants Pass, Oregon 97527

United States

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Medford, Oregon 97504

United States

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Portland, Oregon 97202

United States

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DuBois, Pennsylvania 15801

United States

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Philadelphia, Pennsylvania 19140

United States

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Smithfield, Pennsylvania 15478

United States

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Rock Hill, South Carolina 29732

United States

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Knoxville, Tennessee 37919

United States

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Austin, Texas 78759

United States

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Boerne, Texas 78006

United States

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Dallas, Texas 75254

United States

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El Paso, Texas 79912

United States

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Forney, Texas 75126

United States

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Greenville, Texas 75401

United States

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Kingwood, Texas 77339

United States

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McKinney, Texas 75069

United States

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Sugar Land, Texas 77478

United States

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Tyler, Texas 75708

United States

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Victoria, Texas 77901

United States

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Roy, Utah 84067

United States

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Bellingham, Washington 98225

United States

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Kingwood, West Virginia 26537

United States

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Milwaukee, Wisconsin 53228

United States

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CABA, C1425BEN

Argentina

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Ciudad de Buenos Aires, 1128

Argentina

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Ciudad de Buenos Aires, 1425

Argentina

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La Plata, B1900

Argentina

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Mendoza, 5500

Argentina

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Rosario, 2000

Argentina

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San Miguel de Tucumán, 4000

Argentina

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Caxias do Sul, 95070-560

Brazil

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Criciúma, 88811-000

Brazil

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Porto Alegre, 9061-000

Brazil

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Porto Alegre, 91350-200

Brazil

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Salvador, 40050 410

Brazil

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Santo André, 09080-110

Brazil

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São José do Rio Preto, 15090-000

Brazil

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São Paulo, 04014-002

Brazil

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São Paulo, 05403-000

Brazil

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Sorocaba, 18040-425

Brazil

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Curicó, 3341643

Chile

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Quillota, 2260000

Chile

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Santiago, 7500657

Chile

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Santiago, 7501126

Chile

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Santiago, 7750495

Chile

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Temuco, 4810345

Chile

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Viña del Mar, 2540488

Chile

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Baotou, 014010

China

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Changchun, 130021

China

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Chengdu, 610000

China

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Chongqing, 400010

China

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Guangzhou, 510163

China

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Haikou, 570311

China

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Hefei, 230061

China

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Hohhot, 10050

China

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Huizhou, 516001

China

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Qingdao, 266011

China

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Shanghai, 200025

China

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Shanghai, 200065

China

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Shanghai, 201114

China

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Shenzhen, 518020

China

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Wenzhou, 325027

China

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Xuzhou, 221000

China

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Brest, 29200

France

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Créteil, 94010

France

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Lyon, 69317

France

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Marseille, 13015

France

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Pessac, 33604

France

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Strasbourg, 67091

France

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Suresnes, 92150

France

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Athens, 11521

Greece

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Athens, 17562

Greece

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Ioannina, 45500

Greece

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Pátrai, 26500

Greece

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Thessaloniki, 57001

Greece

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Thessaloniki, 57010

Greece

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Balassagyarmat, 2660

Hungary

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Budapest, 1036

Hungary

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Budapest, 1121

Hungary

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Debrecen, 4032

Hungary

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Gödöllő, 2100

Hungary

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Pécs, 7635

Hungary

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Törökbálint, 2045

Hungary

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Belagavi, 590010

India

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Coimbatore, 641028

India

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Dehradun, 248001

India

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Delhi, 110029

India

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Faridabad, 121012

India

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Gurgaon, 122001

India

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Kochi, 682027

India

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Lucknow, 226003

India

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New Delhi, 110005

India

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Vadodara, 391760

India

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Haifa, 3109601

Israel

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Jerusalem, 91120

Israel

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Kfar Saba, 44281

Israel

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Ramat Gan, 52621

Israel

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Rehovot, 76100

Israel

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Catania, 95123

Italy

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Foggia, 71100

Italy

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Genoa, 16132

Italy

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Roma, 00168

Italy

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Fukuoka, 811-1394

Japan

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Ginowan-shi, 901-2214

Japan

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Hiroshima, 730-0013

Japan

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Ishinomaki, 986-8522

Japan

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Kawaguchi-shi, 332-8558

Japan

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Kiyose-shi, 204-8585

Japan

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Kobe, 650-0017

Japan

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Meguro-ku, 152-8902

Japan

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Miura, 238-0111

Japan

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Neyagawa, 572-8551

Japan

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Sapporo, 060-0033

Japan

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Sapporo, 064-0804

Japan

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Takamatsu, 761-8073

Japan

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Ube, 755-8505

Japan

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Yokohama, 232-0024

Japan

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Yokohama, 232-0066

Japan

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Yokohama, 245-8575

Japan

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Lima, 15046

Peru

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Lima, 15082

Peru

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Lima, 15088

Peru

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Lima, LIMA 1

Peru

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Lima, LIMA 21

Peru

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Lima, LIMA 33

Peru

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Iloilo City, 5000

Philippines

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Las Piñas, 1742

Philippines

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Lipa, 4217

Philippines

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Manadaluyong City, 1552

Philippines

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Quezon City, 1100

Philippines

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Roxas City, 5800

Philippines

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Bellville, 7530

South Africa

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Benoni, 1501

South Africa

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Brackenfell, 7560

South Africa

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Cape Town, 7700

South Africa

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Durban, 4093

South Africa

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eMkhomazi, 4170

South Africa

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Somerset West, 7130

South Africa

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Cheongju-si, 28644

South Korea

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Daegu, 42415

South Korea

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Seoul, 03080

South Korea

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Seoul, 03312

South Korea

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Seoul, 03722

South Korea

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Seoul, 05505

South Korea

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Seoul, 06591

South Korea

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Seoul, 08308

South Korea

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Barcelona, 08003

Spain

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Barcelona, 8025

Spain

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Madrid, 28041

Spain

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Málaga, 29010

Spain

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Mérida, 06800

Spain

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Patraix, 46017

Spain

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Santander, 39008

Spain

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Kaohsiung City, 80756

Taiwan

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New Taipei City, 231

Taiwan

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Taichung, 40705

Taiwan

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Taichung, 433004

Taiwan

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Taipei, 10002

Taiwan

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Taipei, 110

Taiwan

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Taipei, 11220

Taiwan

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Taipei, 11696

Taiwan

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Bangkok, 10700

Thailand

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Chanthaburi, 22000

Thailand

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Chiang Rai, 57000

Thailand

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Chon Buri, 20000

Thailand

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Khon Kaen, 40002

Thailand

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Nakhon Sri Thammarat, 80000

Thailand

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Adana, 01330

Turkey (Türkiye)

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Ankara, 06280

Turkey (Türkiye)

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Bursa, 16059

Turkey (Türkiye)

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Gaziantep, 27470

Turkey (Türkiye)

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Istanbul, 34890

Turkey (Türkiye)

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Kayseri, 38039

Turkey (Türkiye)

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Mersin, 33079

Turkey (Türkiye)

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Da Nang, 550000

Vietnam

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Haiphong, 180000

Vietnam

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Hanoi, 100000

Vietnam

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Ho Chi Minh City, 10000

Vietnam

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Ho Chi Minh City, 700000

Vietnam

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Ho Chi Minh City, 700000

Vietnam

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Huế, 530000

Vietnam