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NCT07088926PHASE2Recruiting

A Study to Evaluate the Efficacy, Safety, and PK of AZD0292 Administered IV in Participants 12 Years of Age and Older With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization

AstraZeneca

Start Date

11/6/2025

Completion Date

6/14/2028

Summary

AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.

Detailed Description

AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA. This Phase IIb study aims to assess the efficacy, safety, and PK of 2 dosage regimens of AZD0292 administered IV, as compared to placebo in participants 12 years of age and older. The primary population of this study will be PsA-colonized NCFBE patients, a bronchiectasis group with frequent pulmonary exacerbations due to chronic PsA airway colonization. These PsA associated pulmonary exacerbations contribute to a decline in lung function, impair quality of life and increase mortality, highlighting the urgent need for effective therapeutic options. To investigate the broader applicability of AZD0292, bronchiectasis patients with CF who are colonized with PsA will be also included as a non-powered exploratory group in this Phase IIb study.

Eligibility Criteria

Age Range: 12 years to No maximum

Inclusion Criteria: 1. Participant must be ≥ 12 years of age at the time of signing the informed consent/assent 2. Weight ≥ 35 kg 3. Bronchiectasis diagnosed by a physician and confirmed by CT demonstrating abnormal bronchial dilation in ≥ 1 lobe. Note: A historical CT scan within the past 5 years is acceptable. If not available, a CT scan should be conducted at screening to confirm eligibility. 4. Participants who are receiving appropriate standard of care therapy per local guidelines and have a documented history of ≥ 2 moderate exacerbations or ≥ 1 severe exacerbation in the preceding 12 months requiring antibiotics 5. Participants who are clinically stable and free from an exacerbation of bronchiectasis for 4 weeks prior to randomization 6. Participants with pre- or post-bronchodilator FEV1 ≥ 25% predicted value at screening. 7. Presence of positive (PCR or culture) PsA in an airway sample at least once in the last 24 months prior to screening 8. Presence of culture positive PsA in sputum at least within 5 weeks of randomization. Participants who have previously received PsA eradication therapy, as determined appropriate by their treating provider, but remain colonized with PsA are eligible for the study. 9. Capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol Exclusion Criteria: 1. Primary lung diagnosis other than bronchiectasis 2. Evidence of active tuberculosis or active nontuberculous mycobacteria being treated or requiring treatment. Participants currently receiving treatment for active TB or nontuberculous mycobacteria may be considered after completion of an appropriate course of therapy 3. Evidence of an active allergic bronchopulmonary aspergillosis being treated or requiring treatment 4. Need for long term supplemental oxygen. Oxygen use for ambulation and relief of breathlessness after exercise is allowed 5. Malignancy, current or within the previous 5 years, except for stable prostate cancer, adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma in situ treated with apparent success more than one year prior to enrolment 6. AIDS or Advanced human immunodeficiency virus disease (CD4 count of \< 200 cells/mm3) 7. History of severe adverse reaction associated with a mAb, and/or history of severe allergic reaction (eg, anaphylaxis that required the use of epinephrine/adrenaline or hospitalization), and/or history of immune complex disease (Type III hypersensitivity reactions) to monoclonal antibody administration 8. Treatment with long term anti-PsA antibiotics, macrolides, or DPP-1 inhibitors, which are newly initiated within the 3 months prior to screening 9. Chronic immunosuppressive therapy (including prednisolone \> 5 mg or equivalent) newly initiated within the last 3 months 10. Receipt of investigational products indicated for the treatment or prevention of bronchiectasis exacerbations or expected receipt during the study 11. Participants with CF on CFTR modulator therapies which are newly initiated within the previous 3 months prior to screening 12. Female participants who are pregnant, lactating, or WOCBP and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration

Interventions

BIOLOGICAL

AZD0292

OTHER

Placebo

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Conditions

Bronchiectasis With Pseudomonas Aeruginosa Colonization

Locations

Research Site

Orange, California 92868

United States

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San Francisco, California 94143

United States

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Denver, Colorado 80206

United States

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Washington D.C., District of Columbia 20007

United States

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Jacksonville, Florida 32209

United States

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Miami Lakes, Florida 33014

United States

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Naples, Florida 34102

United States

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Ormond Beach, Florida 32174

United States

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Plantation, Florida 33324

United States

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Rincon, Georgia 31326

United States

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Kansas City, Kansas 66160

United States

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Ann Arbor, Michigan 48109

United States

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Detroit, Michigan 48202

United States

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Rochester, Minnesota 55905

United States

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St Louis, Missouri 63130

United States

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New York, New York 10016

United States

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New Bern, North Carolina 28562

United States

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Winston-Salem, North Carolina 27104

United States

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Tulsa, Oklahoma 74133

United States

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DuBois, Pennsylvania 15801

United States

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Philadelphia, Pennsylvania 19104

United States

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Charleston, South Carolina 29425

United States

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Rock Hill, South Carolina 29732

United States

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Austin, Texas 78705

United States

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Mansfield, Texas 76063

United States

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Ciudad de Buenos Aires, C1180AAX

Argentina

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Florida, B1602DQD

Argentina

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Rosario, 2000

Argentina

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San Miguel de Tucumán, 4000

Argentina

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Birtinya, 4575

Australia

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Macquarie University, 2109

Australia

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South Brisbane, 4101

Australia

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Ghent, 9000

Belgium

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Leuven, 3000

Belgium

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Liège, 4000

Belgium

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Sint-Niklaas, 9100

Belgium

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Blumenau, 89030-101

Brazil

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Campinas, 13060-080

Brazil

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Curitiba, 80030-110

Brazil

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Curitiba, 80230-130

Brazil

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Porto Alegre, 9061-000

Brazil

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Porto Alegre, 90630-165

Brazil

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Porto Alegre, 91350-200

Brazil

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Salvador, 40050-410

Brazil

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São José dos Campos, 12230-001

Brazil

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São Paulo, 05.403-010

Brazil

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São Paulo, 05403-000

Brazil

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Calgary, Alberta T2N4Z6

Canada

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Vancouver, British Columbia V5Z 1M9

Canada

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Ajax, Ontario L1S 2J5

Canada

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Stoney Creek, Ontario L8G 2V6

Canada

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Québec, Quebec G1V 4G5

Canada

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Saint-Charles-Borromée, Quebec J6E 2B4

Canada

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Trois-Rivières, Quebec G8T 7A1

Canada

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Concepción, 4070196

Chile

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Santiago, 8150000

Chile

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Santiago, 8380453

Chile

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Talca, 3481349

Chile

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Viña del Mar, 2540364

Chile

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Aalborg, 9000

Denmark

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Aarhus N, 8200

Denmark

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Hvidovre, 2650

Denmark

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Odense C, 5000

Denmark

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Roskilde, 4000

Denmark

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Brest, 29200

France

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Créteil, 94010

France

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Marseille, 13915

France

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Montpellier, 34295

France

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Paris, 75014

France

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Pessac, 33604

France

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Strasbourg, 67091

France

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Toulouse, 31100

France

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Berlin, 10117

Germany

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Darmstadt, 64283

Germany

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Essen, 45239

Germany

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Frankfurt, 60596

Germany

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Halle, 06108

Germany

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Hanover, 30625

Germany

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Konstanz, 78464

Germany

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München, 80336

Germany

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München-Pasing, 81241

Germany

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Athens, 11527

Greece

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Athens, 12462

Greece

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Athens, 15126

Greece

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Athens, 17562

Greece

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Ioannina, 45500

Greece

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Larissa, 41110

Greece

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Pátrai, 26500

Greece

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Thessaloniki, 57010

Greece

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Ashkelon, 7830604

Israel

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Haifa, 34362

Israel

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Jerusalem, 00000

Israel

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Jerusalem, 91031

Israel

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Ramat Gan, 52621

Israel

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Tel Aviv, 6423906

Israel

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Milan, 20122

Italy

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Palermo, 90127

Italy

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Pavia, 27100

Italy

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Perugia, 06129

Italy

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Roma, 00163

Italy

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Rozzano, 20089

Italy

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Torrette, 60126

Italy

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Bunkyō City, 113-8655

Japan

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Gifu, 500-8717

Japan

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Hiratsuka-shi, 254-8502

Japan

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Kamogawa-shi, 296-0041

Japan

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Kiyose-shi, 204-8522

Japan

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Kiyose-shi, 204-8585

Japan

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Kurashiki-shi, 710-8602

Japan

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Miyazaki, 889-1692

Japan

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Nagasaki, 852-8501

Japan

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Ogi, 845-0032

Japan

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Shinjuku-ku, 160-8582

Japan

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Shinjuku-ku, 162-8655

Japan

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Urayasu-shi, 279-0021

Japan

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Bandar Puncak Alam, 42300

Malaysia

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Kuala Lumpur, 59100

Malaysia

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Sibu, 96000

Malaysia

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Amsterdam, 1081 HV

Netherlands

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Rotterdam, 3015 GD

Netherlands

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Zutphens, 7207 AE

Netherlands

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Bellavista, CALLAO 2

Peru

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Callao, Bellavista

Peru

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Lima, 15023

Peru

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Lima, 15036

Peru

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Lima, 15038

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 29

Peru

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Iloilo City, 5000

Philippines

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Manila, 1000

Philippines

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Quezon City, 1100

Philippines

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Tondo, 1012

Philippines

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Anyang-si, 14068

South Korea

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Cheongju-si, 28644

South Korea

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Daegu, 42415

South Korea

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Seongnam-si, 13620

South Korea

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Seoul, 04763

South Korea

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Seoul, 05030

South Korea

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Seoul, 05505

South Korea

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Seoul, 07441

South Korea

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Ulsan, 44033

South Korea

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Barcelona, 08003

Spain

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Barcelona, 08036

Spain

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Benalmádena, 29631

Spain

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Madrid, 28040

Spain

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Madrid, 28046

Spain

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Mérida, 06800

Spain

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Patraix, 46017

Spain

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Valencia, 46009

Spain

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Kaohsiung City, 80756

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, 110

Taiwan

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Taoyuan, 333

Taiwan

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Bang Kra So, 11000

Thailand

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Bangkok, 10400

Thailand

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Muang, 40002

Thailand

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Muang, 50200

Thailand

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Pathum Thani, 12120

Thailand

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Adana, 1330

Turkey (Türkiye)

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Ankara, 6340

Turkey (Türkiye)

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Diyarbakır, 21280

Turkey (Türkiye)

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Istanbul, 34098

Turkey (Türkiye)

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Istanbul, 34890

Turkey (Türkiye)

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Mersin, 33343

Turkey (Türkiye)

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Zeytinburnu, 34020

Turkey (Türkiye)

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Belfast, BT9 7AB

United Kingdom

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Birmingham, B9 5SS

United Kingdom

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Brighton, BN2 1ES

United Kingdom

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Cambridge, CB2 0AY

United Kingdom

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Dundee, DD1 9SY

United Kingdom

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Edinburgh, EH16 4SA

United Kingdom

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Exeter, EX2 5DW

United Kingdom

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Liverpool, L14 3PE

United Kingdom

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Manchester, M23 9LT

United Kingdom

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Can Tho, 900000

Vietnam

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Haiphong, 180000

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