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Efficacy and Safety Study of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.
Sponsor: Novartis Pharmaceuticals
Summary
This study aimed to determine the efficacy and safety of QAW039 150 mg and QAW039 450 mg, compared with placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2016) in the following two populations: * patient with inadequately controlled severe asthma and high eosinophil counts at baseline (eosinophil count at Visit 1 ≥250 cells/ µl) (sub-population) * patients with inadequately controlled severe asthma (overall study population) Inadequate control is defined as partly controlled or uncontrolled asthma (GINA 2016).
Official title: A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Existing Asthma Therapy in Patients With Uncontrolled Severe Asthma.
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
894
Start Date
2015-12-11
Completion Date
2019-11-04
Last Updated
2026-10-07
Healthy Volunteers
No
Conditions
Interventions
QAW039
QAW039 150 mg once daily
QAW039
QAW039 450 mg once daily
Placebo
Placebo once daily
Locations (234)
Novartis Investigative Site
Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Gilbert, Arizona, United States
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Litchfield Park, Arizona, United States
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Peoria, Arizona, United States
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Little Rock, Arkansas, United States
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Hawaiian Gardens, California, United States
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Newport Beach, California, United States
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Redondo Beach, California, United States
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Riverside, California, United States
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Torrance, California, United States
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Westminster, California, United States
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New Haven, Connecticut, United States
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Brandon, Florida, United States
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New Smyrna Beach, Florida, United States
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Orlando, Florida, United States
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Orlando, Florida, United States
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Ormond Beach, Florida, United States
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Sebring, Florida, United States
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Winter Park, Florida, United States
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Gainesville, Georgia, United States
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Marietta, Georgia, United States
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Crowley, Louisiana, United States
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Zachary, Louisiana, United States
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Bangor, Maine, United States
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Gaithersburg, Maryland, United States
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White Marsh, Maryland, United States
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Livonia, Michigan, United States
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Ypsilanti, Michigan, United States
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Picayune, Mississippi, United States
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Bellevue, Nebraska, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Corning, New York, United States
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New York, New York, United States
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Charlotte, North Carolina, United States
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Gastonia, North Carolina, United States
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Monroe, North Carolina, United States
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New Bern, North Carolina, United States
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Whiteville, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Maumee, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Jefferson Hills, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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East Providence, Rhode Island, United States
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Boerne, Texas, United States
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McKinney, Texas, United States
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Plano, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Fairfax, Virginia, United States
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CABA, Buenos Aires, Argentina
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Ciudad Autonoma de Bs As, Ciudad Autonoma de Bs As, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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Buenos Aires, Argentina
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Bedford Park, South Australia, Australia
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Clayton, Victoria, Australia
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Footscray, Victoria, Australia
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Heidelberg, Victoria, Australia
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Melbourne, Victoria, Australia
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Amstetten, Austria, Austria
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Feldkirch, Austria, Austria
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Graz, Austria, Austria
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Thalheim bei Wels, Austria, Austria
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Vienna, State of Vienna, Austria
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Innsbruck, Tyrol, Austria
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Vienna, Austria
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Vienna, Austria
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Brussels, Belgium, Belgium
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Liège, Belgium, Belgium
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Genk, Limburg, Belgium
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Aalst, Belgium
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Brussels, Belgium
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Brussels, Belgium
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Erpent, Belgium
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Éghezée, Belgium
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Herentals, Belgium
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Kortrijk, Belgium
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Ottignies, Belgium
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Porto Alegre, Porto Alegre RS, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Blumenau, Santa Catarina, Brazil
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Florianópolis, Santa Catarina, Brazil
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São Bernardo do Campo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Guangzhou, Guangdong, China
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Haikou, Hainan, China
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Shijiazhuang, Hebei, China
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Wuhan, Hubei, China
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Nanjing, Jiangsu, China
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Nanjing, Jiangsu, China
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Nanchang, Jiangxi, China
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Changchun, Jilin, China
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Shenyang, Liaoning, China
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Shenyang, Liaoning, China
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Xian, Shanxi, China
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Chengdu, Sichuan, China
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Hangzhou, Zhejiang, China
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Beijing, China
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Chengdu, China
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Chongqing, China
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Shanghai, China
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Tianjin, China
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Copenhagen NV, Denmark
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Tartu, Estonia, Estonia
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Tallinn, Estonia
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Tallinn, Estonia
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Helsinki, Finland
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HUS, Finland
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OYS, Finland
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Tampere, Finland
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Montpellier, Herault, France
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Dijon, France
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Le Kremlin-Bicêtre, France
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Lyon, France
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Marseille, France
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Nantes, France
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Reims, France
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Strasbourg, France
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Heidelberg, Baden-Wurttemberg, Germany
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Berlin, Germany, Germany
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Marburg, Germany, Germany
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Frankfurt, Germany
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Frankfurt, Germany
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Frankfurt, Germany
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Halle, Germany
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Hamburg, Germany
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Landsberg, Germany
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Leipzig, Germany
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Leipzig, Germany
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Magdeburg, Germany
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Mainz, Germany
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Neu-Isenburg, Germany
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Rosenheim, Germany
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Rostock, Germany
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Rüdersdorf, Germany
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Witten, Germany
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Thessaloniki, GR, Greece
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Guatemala City, Departamento de Guatemala, Guatemala
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Guatemala City, Departamento de Guatemala, Guatemala
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Ciudad, Gautemala, Guatemala
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Guatemala City, GTM, Guatemala
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Guatemala City, GTM, Guatemala
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Guatemala City, Guatemala
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Komárom, Hungary, Hungary
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Eger, HUN, Hungary
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Győr, HUN, Hungary
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Hajdúnánás, HUN, Hungary
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Makó, HUN, Hungary
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Százhalombatta, HUN, Hungary
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Törökbálint, Pest County, Hungary
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Pécs, Hungary
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Reykjavik, Iceland
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Dublin, Ireland
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Daugavpils, Latvia
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Daugavpils, Latvia
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Riga, Latvia
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Kaunas, LTU, Lithuania
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Klaipėda, LTU, Lithuania
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Vilnius, LTU, Lithuania
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Vilnius, LTU, Lithuania
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Vilnius, LTU, Lithuania
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Kaunas, LT, Lithuania
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Kaunas, Lithuania
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Klaipėda, Lithuania
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Bulacan, Philippines, Philippines
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Manila, Philippines, Philippines
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Quezon City, Philippines
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Biaystok, Poland, Poland
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Kielce, POL, Poland
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Bialystok, Poland
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Poznan, Poland
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Poznan, Poland
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Poznan, Poland
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Strzelce Opolskie, Poland
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Ploieşti, Prahova, Romania
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Brasov, Romania, Romania
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Cluj-Napoca, Romania, Romania
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Constanța, ROM, Romania
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Timișoara, Timiș County, Romania
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Arad, Romania
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Bragadiru, Romania
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Brasov, Romania
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Bucharest, Romania
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Cluj-Napoca, Romania
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Deva, Romania
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Oradea, Romania
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Sangiorgiu de Mures, Romania
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Singapore, SGP, Singapore
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Singapore, Singapore, Singapore
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Barcelona, Barcelona, Spain
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Basel, Switzerland, Switzerland
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Zurich, Switzerland, Switzerland
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Liestal, Switzerland
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Lugano, Switzerland
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Sankt Gallen, Switzerland
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Cambridge, Cambrigdeshire, United Kingdom
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Darlington, Durham, United Kingdom
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London, GBR, United Kingdom
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Sheffield, South Yorkshire, United Kingdom
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Bradford, West Yorkshire, United Kingdom
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Birmingham, United Kingdom
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Birmingham, United Kingdom
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Cardiff, United Kingdom
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Chertsey, United Kingdom
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East Yorkshire, United Kingdom
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Leicester, United Kingdom
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Nottingham, United Kingdom
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Plymouth, United Kingdom
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Tyne and Wear, United Kingdom
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Wakefield, United Kingdom
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Wishaw, United Kingdom
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Ho Chi Minh City, VNM, Vietnam
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Hanoi, Vietnam
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Ho Chi Minh City, Vietnam