Study Comparing Orteronel Plus Prednisone in Participants With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer | NCT01193244 | Trialant

Study Comparing Orteronel Plus Prednisone in Participants With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer | NCT01193244 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Each patient must meet all of the following inclusion criteria:

Voluntary written consent

Male patients 18 years or older

Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma

Radiograph-documented metastatic disease

Progressive disease

Prior surgical castration or concurrent use of an agent for medical castration

Either absence of pain or pain not requiring use of any opioid or narcotic analgesia in the 2 weeks prior to study entry

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Even if surgically sterilized, patients must practice effective barrier contraception during the entire study treatment and for 4 months after the last dose of study drug, OR abstain from heterosexual intercourse

Meet screening laboratory values as specified in protocol

Stable medical condition

Exclusion Criteria:

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

Known hypersensitivity to orteronel, prednisone or gonadotropin-releasing hormone (GnRH) analogue

Received prior therapy with orteronel, aminoglutethimide, ketoconazole or abiraterone

Received antiandrogen therapy within 6 weeks for bicalutamide and 4 weeks for all others prior to first dose of study drug

Continuous daily use of oral prednisone or oral dexamethasone for more than 14 days within 3 months prior to study

Received prior chemotherapy for prostate cancer with exception of neoadjuvant/adjuvant therapy as part of initial primary treatment for local disease that was completed 2 or more years prior to screening

Exposure to radioisotope therapy within 4 weeks of receiving first dose of study drug; exposure to external beam radiation within 2 weeks of start of screening until receiving the first dose of study drug

Documented central nervous system metastases

Treatment with any investigational compound within 30 days prior to first dose of study drug

Current spinal cord compression, bilateral hydronephrosis or current bladder neck outlet obstruction

Diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected

Uncontrolled cardiovascular condition as specified in study protocol

Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C

Unwilling or unable to comply with protocol

Uncontrolled nausea, vomiting or diarrhea

Known gastrointestinal disease or procedure that could interfere with oral absorption or tolerance of orteronel

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Anchorage, Alaska, United States

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Tucson, Arizona, United States

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Duarte, California, United States

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Highland, California, United States

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Orange, California, United States

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Sacramento, 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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Deerfield Beach, Florida, United States

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Fort Myers, Florida, United States

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Jacksonville, Florida, United States

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Orlando, Florida, United States

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Port Saint Lucie, Florida, United States

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Jeffersonville, Indiana, United States

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Kansas City, Kansas, United States

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New Orleans, Louisiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Lansing, Michigan, United States

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Duluth, Minnesota, United States

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Corinth, Mississippi, United States

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Columbia, Missouri, United States

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Jefferson City, Missouri, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Hackensack, New Jersey, United States

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East Syracuse, New York, United States

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New York, New York, United States

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Durham, North Carolina, United States

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Raleigh, North Carolina, United States

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Kettering, Ohio, United States

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Tualatin, Oregon, United States

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Hershey, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Piitsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Chattanooga, Tennessee, United States

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Nashville, Tennessee, United States

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Amarillo, Texas, United States

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Bedford, Texas, United States

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Dallas, Texas, United States

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Denton, Texas, United States

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Tyler, Texas, United States

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Salt Lake City, Utah, United States

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Norfolk, Virginia, United States

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Garran, Australia

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Hobart, Australia

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Kurralta Park, Australia

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Nedlands, Australia

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Perth, Australia

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Redcliffe, Australia

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Wodonga, Australia

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Graz, Austria

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Linz, Austria

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Vienna, Austria

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Minsk, Belarus

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Edegem, Belgium

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Hasselt, Belgium

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Kortrijk, Belgium

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Leuven, Belgium

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Namur, Belgium

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Bairro Nazare - Salvador, Brazil

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Barretos/sp, Brazil

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Belo Horizonte, Brazil

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Campinas, Brazil

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Caxias do Sul, Brazil

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Curitiba, Brazil

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Fortaleza/ce, Brazil

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Ijuí, Brazil

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Joinville, Brazil

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Lajeado - Rs, Brazil

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Piracicaba - Sp, Brazil

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Porto Alegre- Rs, Brazil

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Porto Alegre/rs, Brazil

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Ribeirao Preto - Sp, Brazil

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Rio de Janeiro, Brazil

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Rio de Janeiro Rj, Brazil

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Santo André, Brazil

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São José do Rio Preto, Brazil

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São José dos Campos, Brazil

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São Paulo, Brazil

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Sorocaba - Sp, Brazil

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Plovdiv, Bulgaria

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Sofia, Bulgaria

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Varna, Bulgaria

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Kelowna, British Columbia, Canada

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Burlington, Ontario, Canada

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Hamilton, Ontario, Canada

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London, Ontario, Canada

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Owen Sound, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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Québec, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Las Condes, Chile

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Santiago, Chile

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Temuco, Chile

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Valparaíso, Chile

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Cali, Colombia

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Hradec Králové, Czechia

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Prague, Czechia

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Joensuu, Finland

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Oulu, Finland

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Seinäjoki, Finland

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Tampere, Finland

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Angers, France

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Bordeaux, France

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Caen, France

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Créteil, France

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La Roche-sur-Yon, France

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Lyon, France

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Marseille, France

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Nancy, France

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Nantes, France

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Paris, France

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Poitiers, France

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Saint-Etienne, France

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Villejuif, France

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Braunschweig, Germany

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Dresden, Germany

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Hamburg, Germany

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Hanover, Germany

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Kassel, Germany

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Kempen, Germany

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Nürtingen, Germany

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Tübingen, Germany

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Wuppertal, Germany

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Athens, Greece

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Heraklion Crete, Greece

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Larissa, Greece

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Pátrai, Greece

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Thessaloniki, Greece

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Kowloon, Hong Kong

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Shatin, Hong Kong

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Dublin, Ireland

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Galway, Ireland

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Haifa, Israel

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Holon, Israel

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Jerusalem, Israel

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Petah Tikva, Israel

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Ramat Gan, Israel

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Tel Aviv, Israel

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Ẕerifin, Israel

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Aviano, Italy

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Novara, Italy

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Roma, Italy

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Torino, Italy

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Chiba, Japan

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Fukuoka, Japan

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Hamamatsu, Japan

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Hokkaido, Japan

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Kanazawa, Japan

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Kita-gun, Japan

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Maebashi, Japan

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Mito, Japan

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Osaka, Japan

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Sakura, Japan

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Sayama, Japan

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Sendai, Japan

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Shimizucho Sunto-gun, Japan

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Suntou-gun, Japan

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Tokyo, Japan

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Yamagata, Japan

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Yokohama, Japan

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Yufu, Japan

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Riga, Latvia

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Kaunas, Lithuania

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Klaipėda, Lithuania

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Vilnius, Lithuania

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Durango Durango, Mexico

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Mexico City Distrito Federal, Mexico

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Zapopan Jalisco, Mexico

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Amsterdam, Netherlands

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Arnhem, Netherlands

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Breda, Netherlands

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Eindhoven, Netherlands

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Heerlen, Netherlands

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Nieuwegein, Netherlands

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Nijmegen, Netherlands

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Rotterdam, Netherlands

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Auckland, New Zealand

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Christchurch, New Zealand

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Dunedin, New Zealand

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Takapuna, New Zealand

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Tauranga, New Zealand

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Lima, Peru

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Bielsko-Biala, Poland

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Wroclaw, Poland

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Liepaja, Portugal

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Lisbon, Portugal

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Porto, Portugal

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San Juan, PR, Puerto Rico

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Bucharest, Romania

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Cluj-Napoca, Romania

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Moscow, Russia

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Saint Petersburg, Russia

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Singapore, Singapore

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Nitra, Slovakia

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Prešov, Slovakia

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Trenčín, Slovakia

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Žilina, Slovakia

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Cape Town, South Africa

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Durban, South Africa

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George, South Africa

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Port Elizabeth, South Africa

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A Coruña, Spain

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Barcelona, Spain

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Madrid, Spain

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Majadahonda, Spain

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Pamplona, Spain

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Seville, Spain

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Valencia, Spain

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Gothenburg, Sweden

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Stockholm, Sweden

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Uppsala, Sweden

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Aarau, Switzerland

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Lausanne, Switzerland

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Winterthur, Switzerland

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Zurich, Switzerland

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Taichung, Taiwan

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Taipei, Taiwan

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Dnipropetrovsk, Ukraine

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Donetsk, Ukraine

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Kyiv, Ukraine

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Zaporizhzhya, Ukraine

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Aberdeen, United Kingdom

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Belfast, United Kingdom

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Bristol, United Kingdom

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Cottingham, United Kingdom

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Coventry, United Kingdom

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Glasgow, United Kingdom

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London, United Kingdom

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Manchester, United Kingdom

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Northwood, United Kingdom

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Preston, United Kingdom

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Southampton, United Kingdom