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A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus
Sponsor: AstraZeneca
Summary
This study aims to evaluate the efficacy and safety of subcutaneous (SC) anifrolumab versus placebo in adult participants with chronic and/or subacute cutaneous lupus erythematosus (CLE).
Official title: A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase III Study to Evaluate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus Who Are Refractory and/or Intolerant to Antimalarial Therapy.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
302
Start Date
2024-06-29
Completion Date
2027-08-20
Last Updated
2026-03-11
Healthy Volunteers
No
Conditions
Interventions
Anifrolumab
Anifrolumab will be provided as a solution for injection in accessorized pre-filled syringe (aPFS).
Placebo
Matching placebo solution for injection in aPFS.
Locations (272)
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Glendale, Arizona, United States
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Phoenix, Arizona, United States
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Covina, California, United States
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Fountain Valley, California, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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Orange, California, United States
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San Francisco, California, United States
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Aurora, Colorado, United States
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Denver, Colorado, United States
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New Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Fort Lauderdale, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Plantation, Florida, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Murray, Kentucky, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Ann Arbor, Michigan, United States
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Bloomfield Hills, Michigan, United States
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Rochester, Minnesota, United States
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Omaha, Nebraska, United States
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Midland Park, New Jersey, United States
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Brooklyn, New York, United States
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New York, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Statesville, North Carolina, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Providence, Rhode Island, United States
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Charleston, South Carolina, United States
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Summerville, South Carolina, United States
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Dallas, Texas, United States
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Galveston, Texas, United States
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Mesquite, Texas, United States
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Charlottesville, Virginia, United States
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Roanoke, Virginia, United States
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Seattle, Washington, United States
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Ciudad de Buenos Aires, Argentina
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Córdoba, Argentina
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Córdoba, Argentina
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Quilmes, Argentina
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Rosario, Argentina
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San Miguel, Argentina
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Clayton, Australia
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Kogarah, Australia
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Malvern, Australia
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Melbourne, Australia
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Mitcham, Australia
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Westmead, Australia
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Woolloongabba, Australia
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Graz, Austria
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Innsbruck, Austria
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Linz, Austria
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Sankt Pölten, Austria
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Vienna, Austria
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Brussels, Belgium
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Leuven, Belgium
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Liège, Belgium
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Belo Horizonte, Brazil
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Belo Horizonte, Brazil
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Porto Alegre, Brazil
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Rio de Janeiro, Brazil
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Salvador, Brazil
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São Paulo, Brazil
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Vancouver, British Columbia, Canada
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Hamilton, Ontario, Canada
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Newmarket, Ontario, Canada
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Toronto, Ontario, Canada
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Osorno, Chile
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Santiago, Chile
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Santiago, Chile
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Santiago, Chile
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Baotou, China
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Beijing, China
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Beijing, China
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Beijing, China
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Changchun, China
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Changsha, China
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Chengdu, China
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Chongqing, China
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Dongguan, China
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Guangzhou, China
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Hangzhou, China
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Heilongjiang, China
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Jinan, China
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Kunming, China
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Nanchang, China
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Nanjing, China
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Shanghai, China
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Shanghai, China
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Shenzhen, China
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Shenzhen, China
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Shenzhen, China
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Shijiazhuang, China
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Ürümqi, China
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Wuhan, China
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Zhuzhou, China
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Barranquilla, Colombia
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Barranquilla, Colombia
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Bogotá, Colombia
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Chía, Colombia
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Aarhus, Denmark
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Copenhagen, Denmark
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Bois-Guillaume, France
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Bordeaux, France
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Chambray-lès-Tours, France
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Dijon, France
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Lille, France
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Lyon, France
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Montivilliers, France
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Nantes, France
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Nice, France
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Paris, France
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Paris, France
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Paris, France
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Paris, France
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Poitiers, France
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Toulouse, France
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Berlin, Germany
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Bochum, Germany
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Dresden, Germany
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Erlangen, Germany
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Essen, Germany
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Freiburg im Breisgau, Germany
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Hamburg, Germany
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Hanover, Germany
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Kiel, Germany
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Leipzig, Germany
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Mainz, Germany
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Marburg, Germany
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Regensburg, Germany
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Wuppertal, Germany
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Athens, Greece
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Athens, Greece
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Athens, Greece
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Athens, Greece
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Athens, Greece
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Brescia, Italy
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Cona, Italy
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Florence, Italy
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Marche, Italy
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Milan, Italy
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Naples, Italy
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Reggio Emilia, Italy
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Roma, Italy
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Rome, Italy
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Bunkyō City, Japan
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Chūōku, Japan
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Fukuoka, Japan
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Kanazawa, Japan
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Kita-gun, Japan
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Nagasaki, Japan
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Nagoya, Japan
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Nagoya, Japan
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Okayama, Japan
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Omura-shi, Japan
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Ono, Japan
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Osaka, Japan
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Sapporo, Japan
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Suita, Japan
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tabashi City, Japan
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Wakayama, Japan
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Yokohama, Japan
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Yokohama, Japan
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Yotsukaido-shi, Japan
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Cuernavaca, Mexico
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Guadalajara, Mexico
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Guadalajara, Mexico
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Guadalajara, Mexico
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Guadalajara, Mexico
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Mexico City, Mexico
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San Luis Potosí City, Mexico
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Veracruz, Mexico
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Zapopan, Mexico
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Amsterdam, Netherlands
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Breda, Netherlands
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Nijmegen, Netherlands
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Rotterdam, Netherlands
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Hamilton, New Zealand
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Papatoetoe, New Zealand
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Iloilo City, Philippines
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Lipa, Philippines
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Manila, Philippines
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Gdynia, Poland
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Katowice, Poland
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Kielce, Poland
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Olsztyn, Poland
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Ossy, Poland
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Poznan, Poland
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Rzeszów, Poland
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Warsaw, Poland
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Warsaw, Poland
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Warsaw, Poland
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Braga, Portugal
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Coimbra, Portugal
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Lisbon, Portugal
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Porto, Portugal
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Bucharest, Romania
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Bucharest, Romania
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Craiova, Romania
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Iași, Romania
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Târgu Mureş, Romania
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Belgrade, Serbia
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Belgrade, Serbia
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Belgrade, Serbia
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Kragujevac, Serbia
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Košice, Slovakia
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Piešťany, Slovakia
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Piešťany, Slovakia
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Svidník, Slovakia
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Cape Town, South Africa
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Johannesburg, South Africa
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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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A Coruña, Spain
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Barcelona, Spain
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Barcelona, Spain
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Castellon, Spain
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Granada, Spain
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L'Hospitalet de Llobregat, Spain
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Las Palmas de Gran Canaria, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Majadahonda, Spain
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Salamanca, Spain
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Seville, Spain
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Valencia, Spain
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Valencia, Spain
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Vigo, Spain
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Bangkok, Thailand
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Bangkok, Thailand
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Hat Yai, Thailand
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Khlong Luang, Thailand
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Khon Kaen, Thailand
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Cordaleo, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Kayseri, Turkey (Türkiye)
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Samsun, Turkey (Türkiye)
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Cambridge, United Kingdom
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Leeds, United Kingdom
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London, United Kingdom
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London, United Kingdom
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London, United Kingdom
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London, United Kingdom
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Newcastle upon Tyne, United Kingdom