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Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations.
Sponsor: AstraZeneca
Summary
The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab Dose 1 and Dose 2 administered subcutaneously (SC) in adult participants with symptomatic COPD and history of ≥ 2 moderate or ≥ 1 severe exacerbation of COPD in the previous 12 months. Participants should be receiving optimised treatment with maintenance inhaled therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) in stable doses throughout at least 3 months prior to enrolment.
Official title: A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of Tozorakimab in Participants With Symptomatic Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations (TITANIA)
Key Details
Gender
All
Age Range
40 Years - 130 Years
Study Type
INTERVENTIONAL
Enrollment
1172
Start Date
2022-02-07
Completion Date
2026-03-23
Last Updated
2026-01-16
Healthy Volunteers
No
Interventions
Tozorakimab
Administered subcutaneously tozorakimab Dose 1 and placebo through Week 52.
Tozorakimab
Administered subcutaneously tozorakimab Dose 2 through Week 52.
Placebo
Placebo administered subcutaneously, equivalent volume to tozorakimab through week 52.
Locations (212)
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Sheffield, Alabama, United States
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Lincoln, California, United States
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Newport Beach, California, United States
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Northridge, California, United States
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Colorado Springs, Colorado, United States
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Newark, Delaware, United States
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Bay Pines, Florida, United States
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Cape Coral, Florida, United States
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Pensacola, Florida, United States
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Tampa, Florida, United States
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Winter Park, Florida, United States
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Macon, Georgia, United States
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Greenwood, Indiana, United States
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Bowling Green, Kentucky, United States
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White Marsh, Maryland, United States
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North Dartmouth, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Farmington Hills, Michigan, United States
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Grand Rapids, Michigan, United States
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Buffalo, New York, United States
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The Bronx, New York, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Philadelphia, Pennsylvania, United States
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Rock Hill, South Carolina, United States
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Amarillo, Texas, United States
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Boerne, Texas, United States
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Fort Worth, Texas, United States
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McKinney, Texas, United States
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Tomball, Texas, United States
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Webster, Texas, United States
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Williamsburg, Virginia, United States
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Cudahy, Wisconsin, United States
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Campbelltown, Australia
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Frankstown, Australia
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Macquarie University, Australia
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Melbourne, Australia
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Nedlands, Australia
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Southport, Australia
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Spearwood, Australia
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Wollongong, Australia
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Woodville South, Australia
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Blumenau, Brazil
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Botucatu, Brazil
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Brasília, Brazil
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Curitiba, Brazil
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Porto Alegre, Brazil
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Porto Alegre, Brazil
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Porto Alegre, Brazil
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Rio de Janeiro, Brazil
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São Bernardo do Campo, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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Curicó, Chile
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Santiago, Chile
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Santiago, Chile
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Santiago, Chile
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Santiago, Chile
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Santiago, Chile
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Talca, Chile
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Baotou, China
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Beijing, China
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Beijing, China
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Changchun, China
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Changde, China
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Changsha, China
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Chengdu, China
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Chengdu, China
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Chengdu, China
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Chongqing, China
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Chongqing, China
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Guangzhou, China
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Guangzhou, China
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Guangzhou, China
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Haikou, China
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Hangzhou, China
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Hefei, China
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Hohhot, China
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Kunming, China
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Linhai, China
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Nanchang, China
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Nanjing, China
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Ningbo, China
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Shanghai, China
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Shanghai, China
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Shanghai, China
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Shengyang, China
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Shenyang, China
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Shenzhen, China
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Shenzhen, China
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Shijiazhuang, China
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Suzhou, China
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Taiyuan, China
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Tianjin, China
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Wuhan, China
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Wuxi, China
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Xiamen, China
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Xuzhou, China
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Xuzhou, China
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Yangzhou, China
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Yinchuan, China
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Zhanjiang, China
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Zunyi, China
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Barranquilla, Colombia
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Ibagué, Colombia
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Rionegro, Colombia
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Zipaquirá, Colombia
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Brest, France
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Dijon, France
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Grenoble, France
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Lyon, France
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Marseille, France
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Montivilliers, France
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Montpellier, France
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Pessac, France
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Saint-Herblain, France
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Toulouse, France
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Ahrensburg, Germany
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Bamberg, Germany
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Berlin, Germany
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Berlin, Germany
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Cologne, Germany
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Darmstadt, Germany
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Halle, Germany
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Marburg, Germany
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München, Germany
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München-Pasing, Germany
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Peine, Germany
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Alexandroupoli, Greece
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Athens, Greece
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Exohi Thessaloniki, Greece
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Ioannina, Greece
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Pátrai, Greece
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Thessaloniki, Greece
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Ashkelon, Israel
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Beersheba, Israel
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Jerusalem, Israel
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Kfar Saba, Israel
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Rehovot, Israel
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Tel Aviv, Israel
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Bari, Italy
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Massa, Italy
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Milan, Italy
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Milan, Italy
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Naples, Italy
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Roma, Italy
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Salerno, Italy
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San Donà di Piave, Italy
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Sassari, Italy
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Statte, Italy
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Telese Terme, Italy
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Tradate, Italy
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Vercelli, Italy
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Verona, Italy
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Lima, Peru
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Lima, Peru
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Lima, Peru
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Lima, Peru
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Baguio City, Philippines
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Cebu City, Philippines
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Iloilo City, Philippines
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Bialystok, Poland
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Bialystok, Poland
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Bychawa, Poland
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Bydgoszcz, Poland
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Katowice, Poland
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Krakow, Poland
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Lublin, Poland
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Ostrowiec Świętokrzyski, Poland
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Ostróda, Poland
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Poznan, Poland
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Poznan, Poland
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Rzeszów, Poland
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Skierniewice, Poland
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Sosnowiec, Poland
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Wroclaw, Poland
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Ponce, Puerto Rico
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Brasov, Romania
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Bucharest, Romania
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Cluj-Napoca, Romania
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Constanța, Romania
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Timișoara, Romania
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Penza, Russia
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Saratov, Russia
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Hsinchu, Taiwan
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Kaohsiung City, Taiwan
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Taichung, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Yunlin, Taiwan
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Bang Kra So, Thailand
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Bangkok, Thailand
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Hat Yai, Thailand
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Khon Kaen, Thailand
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Muang,, Thailand
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Muang, Thailand
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Mueang, Thailand
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Nakhon Ratchasima, Thailand
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Bradford, United Kingdom
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Corby, United Kingdom
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Corby, United Kingdom
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Enfield, United Kingdom
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Hampshire, United Kingdom
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High Wycombe, United Kingdom
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Northwood, United Kingdom
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Preston, United Kingdom
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Shipley, United Kingdom