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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 (OBERON)
Key Details
Gender
All
Age Range
40 Years - 130 Years
Study Type
INTERVENTIONAL
Enrollment
1132
Start Date
2022-01-03
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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Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Montgomery, Alabama, United States
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Tempe, Arizona, United States
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Bakersfield, California, United States
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Sacramento, California, United States
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Boynton Beach, Florida, United States
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Ormond Beach, Florida, United States
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Plantation, Florida, United States
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Meridian, Idaho, United States
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Evergreen Park, Illinois, United States
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Normal, Illinois, United States
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Iowa City, Iowa, United States
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Kansas City, Kansas, United States
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Baton Rouge, Louisiana, United States
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Zachary, Louisiana, United States
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Baltimore, Maryland, United States
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Rochester, Minnesota, United States
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St Louis, Missouri, United States
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Missoula, Montana, United States
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Brick, New Jersey, United States
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New York, New York, United States
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The Bronx, New York, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Gastonia, North Carolina, United States
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Fargo, North Dakota, United States
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DuBois, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Sayre, Pennsylvania, United States
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Rapid City, South Dakota, United States
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Franklin, Tennessee, United States
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Houston, Texas, United States
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Kingwood, Texas, United States
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Salt Lake City, Utah, United States
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Burlington, Vermont, United States
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Buenos Aires, Argentina
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CABA, Argentina
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Ciudad de Buenos Aires, Argentina
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Córdoba, Argentina
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Mar del Plata, Argentina
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Mar del Plata, Argentina
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Mendoza, Argentina
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Quilmes, Argentina
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San Fernando, Argentina
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San Juan Bautista, Argentina
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San Miguel de Tucumán, Argentina
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Brussels, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Liège, Belgium
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Namur, Belgium
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Dupnitsa, Bulgaria
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Haskovo, Bulgaria
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Kozloduy, Bulgaria
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Lovech, Bulgaria
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Petrich, Bulgaria
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Pleven, Bulgaria
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Rousse, Bulgaria
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Sliven, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Troyan Municipality, Bulgaria
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Vratsa, Bulgaria
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Sherwood Park, Alberta, Canada
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Kamloops, British Columbia, Canada
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Kelowna, British Columbia, Canada
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Ajax, Ontario, Canada
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Guelph, Ontario, Canada
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Markham, Ontario, Canada
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Stouffville, Ontario, Canada
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Winchester, Ontario, Canada
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Montreal, PQ, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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Terrebonne, Quebec, Canada
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Brno, Czechia
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Broumov, Czechia
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Jindřichův Hradec, Czechia
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Liberec, Czechia
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Olomouc, Czechia
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Rokycany, Czechia
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Aalborg, Denmark
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Hvidovre, Denmark
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København NV, Denmark
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Næstved, Denmark
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Roskilde, Denmark
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Vejle, Denmark
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Hämeenlinna, Finland
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Helsinki, Finland
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Kuopio, Finland
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Tampere, Finland
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Turku, Finland
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Turku, Finland
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Budapest, Hungary
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Debrecen, Hungary
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Edelény, Hungary
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Encs, Hungary
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Mosonmagyaróvár, Hungary
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Nyíregyháza-Sóstóhegy, Hungary
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Százhalombatta, Hungary
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Ahmedabad, India
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Belagavi, India
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Coimbatore, India
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Dehradun, India
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Hyderabad, India
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Jaipur, India
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Mohali, India
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Nagpur, India
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Nashik, India
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New Delhi, India
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Surat, India
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Thane, India
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Asahikawa-shi, Japan
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Chikushino-shi, Japan
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Chūōku, Japan
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Fujieda-shi, Japan
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Fukuoka, Japan
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Hamamatsu, Japan
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Hamamatsu, Japan
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Hiroshima, Japan
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Iizuka-shi, Japan
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Itabashi-ku, Japan
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Iwata-shi, Japan
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Joyo-shi, Japan
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Kagoshima, Japan
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Kanazawa, Japan
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Kawachinagano-shi, Japan
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Kitakyusyu-shi, Japan
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Kobe, Japan
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Koga-shi, Japan
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Kokubunji-shi, Japan
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Matsusaka-shi, Japan
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Mizunami-shi, Japan
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Nagaoka-shi, Japan
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Nagoya, Japan
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Obihiro, Japan
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Okayama, Japan
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Osaka, Japan
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Osaka, Japan
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Osaka, Japan
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Sakaishi, Japan
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Shinjuku-ku, Japan
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Shizuoka, Japan
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Toshima-ku, Japan
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Toyonaka-shi, Japan
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Yanagawa-shi, Japan
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Yokohama, Japan
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Yokohama, Japan
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Yokohama, Japan
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Benito Juárez, Mexico
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Chihuahua City, Mexico
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Guadalajara, Mexico
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Guadalajara, Mexico
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Mexico City, Mexico
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Mérida, Mexico
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Monterrey, Mexico
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Morelia, Mexico
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Oaxaca City, Mexico
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Veracruz, Mexico
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Alkmaar, Netherlands
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Eindhoven, Netherlands
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Groningen, Netherlands
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Harderwijk, Netherlands
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Heerlen, Netherlands
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Zutphen, Netherlands
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Zwolle, Netherlands
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Ålesund, Norway
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Bergen, Norway
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Bodø, Norway
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Levanger, Norway
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Lørenskog, Norway
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Oslo, Norway
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Tønsberg, Norway
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Guimarães, Portugal
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Lisbon, Portugal
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Lisbon, Portugal
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Matosinhos Municipality, Portugal
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Vila Franca de Xira, Portugal
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Vila Nova de Gaia, Portugal
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Guaynabo, Puerto Rico
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Daegu, South Korea
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Incheon, South Korea
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Jeonju, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Galdakao, Spain
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Madrid, Spain
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Málaga, Spain
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Mérida, Spain
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Pozuelo de Alarcón, Spain
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Santander, Spain
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Valencia, Spain
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Zaragoza, Spain
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Gothenburg, Sweden
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Gothenburg, Sweden
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Lund, Sweden
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Malmo, Sweden
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Stockholm, Sweden
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Ankara, Turkey (Türkiye)
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Aydin, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Mersin, Turkey (Türkiye)
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Hanoi, Vietnam
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Ho Chi Minh City, Vietnam