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ACTIVE NOT RECRUITING
NCT05156281
PHASE3

Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS)

Official title: A Randomized, Double-blind, Double-dummy, Parallel-group Study, Comparing the Efficacy and Safety of Remibrutinib Versus Teriflunomide in Participants With Relapsing Multiple Sclerosis, Followed by Extended Treatment With Open-label Remibrutinib

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

1011

Start Date

2021-12-13

Completion Date

2030-10-30

Last Updated

2026-03-30

Healthy Volunteers

No

Interventions

DRUG

Remibrutinib

tablet taken orally

DRUG

Teriflunomide

capsule taken orally

Locations (225)

Ctr for Neurology and Spine

Phoenix, Arizona, United States

Vladimir Royter MD APMC

Hanford, California, United States

VA Greater LA Healthcare System

Los Angeles, California, United States

Regina Berkovich MD PhD Inc

West Hollywood, California, United States

CU Anschutz Med Campus

Aurora, Colorado, United States

Colorado Neurological Research PC

Denver, Colorado, United States

New England Institute for Clinical Research

Stamford, Connecticut, United States

Georgetown University Hospital Research

Washington D.C., District of Columbia, United States

Georgetown University Hospital

Washington D.C., District of Columbia, United States

Nova Clinical Research LLC

Bradenton, Florida, United States

University of Florida

Gainesville, Florida, United States

Memorial Healthcare System

Hollywood, Florida, United States

Neurology Associates PA

Maitland, Florida, United States

Gables Neurology

Miami, Florida, United States

UM Department Of Neurology

Miami, Florida, United States

Aqualane Clinical Research

Naples, Florida, United States

Advent Health Orlando

Orlando, Florida, United States

Humanity Clinical Research

Pembroke Pines, Florida, United States

Emerald Coast Neurology

Pensacola, Florida, United States

Brain and Spine Institute

Port Orange, Florida, United States

Vero Beach Neurology

Vero Beach, Florida, United States

Conquest Research

Winter Park, Florida, United States

Methodist Neuroscience Institute

Merrillville, Indiana, United States

University of Kansas Hospital

Kansas City, Kansas, United States

Baptist Physicians Lexington

Nicholasville, Kentucky, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Clinre Comprehensive Neurology

Frederick, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Kansas City VA Medical Center

Kansas City, Missouri, United States

South Shore Neurologic Associates

Patchogue, New York, United States

True North Neurology

Port Jefferson, New York, United States

University Of NC At Chapel Hill

Chapel Hill, North Carolina, United States

Piedmont HealthCare

Charlotte, North Carolina, United States

The Boster Ctr for MS

Columbus, Ohio, United States

Neurology Diagnostics Inc

Dayton, Ohio, United States

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Premier Neurology

Greenville, South Carolina, United States

Metrolina Neurological Associates PA

Old Point Station, South Carolina, United States

Sibyl Wray MD Neurology PC

Knoxville, Tennessee, United States

Neurology Consultants Of Dallas PA

Dallas, Texas, United States

Med Research Inc

El Paso, Texas, United States

Lone Star Neurology

Frisco, Texas, United States

UT Health MARC Medical Arts and Research Center

San Antonio, Texas, United States

Lonestar Neurology of San Antonio

San Antonio, Texas, United States

Texas Institute for Neurological Disorders

Sherman, Texas, United States

Baylor Scott and White

Temple, Texas, United States

Virginia Mason Medical Centre

Seattle, Washington, United States

University of Washington MS Clinic

Seattle, Washington, United States

Elligo Health Research

Crab Orchard, West Virginia, United States

Ascension St Francis Center

Milwaukee, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Novartis Investigative Site

Bombal, Mendoza Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Rosario, Santa Fe Province, Argentina

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San Miguel de, Tucumán Province, Argentina

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Buenos Aires, Argentina

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CABA, Argentina

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Córdoba, Argentina

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Vitória, Espírito Santo, Brazil

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Brasília, Federal District, Brazil

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Curitiba, Paraná, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Joinville, Santa Catarina, Brazil

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São Paulo, Brazil

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Plovdiv, Bulgaria

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Sofia, Bulgaria

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Sofia, Bulgaria

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Sofia, Bulgaria

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Edmonton, Alberta, Canada

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Burnaby, British Columbia, Canada

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Halifax, Nova Scotia, Canada

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Ottawa, Ontario, Canada

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Lévis, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Saint-Jérôme, Quebec, Canada

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Wuhan, Hubei, China

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Wuhan, Hubei, China

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Nanjing, Jiangsu, China

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Yinchuan, Ningxia, China

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Taiyuan, Shanxi, China

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Hangzhou, Zhejiang, China

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Hangzhou, Zhejiang, China

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Wenzhou, Zhejiang, China

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Beijing, China

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Shanghai, China

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Shanghai, China

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Split, HRV, Croatia

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Varaždin, HRV, Croatia

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Vukovar, Croatia

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Zagreb, Croatia

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Brno, Czechia

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Hradec Králové, Czechia

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Teplice, Czechia

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Tallinn, Estonia

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Tartu, Estonia

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Limoges, Haute Vienne, France

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Toulon, Val De Marne, France

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Caen, France

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Clermont-Ferrand, France

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Dijon, France

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Gonesse, France

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Grenoble, France

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Lille, France

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Lille, France

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Nice, France

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Nîmes, France

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Poissy, France

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Toulouse, France

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Freiburg im Breisgau, Baden-Wurttemberg, Germany

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Essen, Germany

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Hamburg, Germany

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Ulm, Germany

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Athens, Greece

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Athens, Greece

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Chaïdári, Greece

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Ioannina, Greece

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Larissa, Greece

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Thessaloniki, Greece

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Thessaloniki, Greece

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Kochi, Kerala, India

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Pune, Maharashtra, India

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New Delhi, National Capital Territory of Delhi, India

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Amritsar, Punjab, India

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Hyderabad, Telangana, India

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Lucknow, Uttar Pradesh, India

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Kolkata, West Bengal, India

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Brindisi, BR, Italy

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Foggia, FG, Italy

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Pozzilli, IS, Italy

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Messina, ME, Italy

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Modena, MO, Italy

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Pavia, PV, Italy

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Orbassano, TO, Italy

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Naples, Italy

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Nagoya, Aichi-ken, Japan

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Ichihara, Chiba, Japan

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Sapporo, Hokkaido, Japan

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Nishinomiya, Hyōgo, Japan

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Isehara, Kanagawa, Japan

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Sagamihara, Kanagawa, Japan

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Sendai, Miyagi, Japan

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Kashihara, Nara, Japan

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Moriguchi, Osaka, Japan

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Suita, Osaka, Japan

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Higashi-Matsuyama, Saitama, Japan

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Itabashi-ku, Tokyo, Japan

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Kodaira, Tokyo, Japan

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Shinjuku Ku, Tokyo, Japan

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Shinjuku Ku, Tokyo, Japan

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Shinjuku-ku, Tokyo, Japan

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Chiba, Japan

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Fukuoka, Japan

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Fukuoka, Japan

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Kobe, Japan

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Kyoto, Japan

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Niigata, Japan

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Mexico City, Mexico City, Mexico

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Chihuahua City, Mexico

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Mexico City, Mexico

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Querétaro, Mexico

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Plewiska, Poznan, Poland

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Bialystok, Poland

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Glogow Wielkopolski, Poland

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Katowice, Poland

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Katowice, Poland

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Katowice, Poland

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Katowice, Poland

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Lublin, Poland

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Wroclaw, Poland

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Zabrze, Poland

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Braga, Portugal

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Coimbra, Portugal

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Leiria, Portugal

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Lisbon, Portugal

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Lisbon, Portugal

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Matosinhos Municipality, Portugal

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Santa Maria da Feira, Portugal

Caribbean Center for Clinical Research, Inc

Guaynabo, Puerto Rico

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Brasov, ROM, Romania

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Constanța, ROM, Romania

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Campulung Muscel, Romania

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Constanța, Romania

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Banská Bystrica, Slovakia

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Banská Bystrica, Slovakia

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Bratislava, Slovakia

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Celje, Slovenia

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Ljubljana, Slovenia

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Maribor, Slovenia

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Bloemfontein, Free State, South Africa

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Pretoria, South Africa

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Rosebank, South Africa

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Santiago Compostela, A Coruna, Spain

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Vitoria-Gasteiz, Araba, Spain

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L'Hospitalet de Llobregat, Barcelona, Spain

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Albacete, Castille-La Mancha, Spain

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Barcelona, Catalonia, Spain

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Logroño, La Rioja, Spain

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Pozuelo de Alarcón, Madrid, Spain

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Torrejón de Ardoz, Madrid, Spain

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Gijón, Principality of Asturias, Spain

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Valencia, Valencia, Spain

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Barcelona, Spain

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Lleida, Spain

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Madrid, Spain

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Madrid, Spain

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Málaga, Spain

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Seville, Spain

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Valencia, Spain

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Stockholm, Sweden

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Samsun, Atakum, Turkey (Türkiye)

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Izmir, Balcova, Turkey (Türkiye)

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Istanbul, Fatih, Turkey (Türkiye)

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Istanbul, Fatih, Turkey (Türkiye)

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Izmir, Karabaglar, Turkey (Türkiye)

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Kayseri, Melikgazi, Turkey (Türkiye)

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Bursa, Nilufer, Turkey (Türkiye)

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Istanbul, Pendik, Turkey (Türkiye)

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Istanbul, Sancaktepe, Turkey (Türkiye)

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Kocaeli, Turkey (Türkiye)

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Konya, Turkey (Türkiye)

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Inverness, Invernesshire, United Kingdom

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Canterbury, Kent, United Kingdom