A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma | NCT01865747 | Trialant

A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma | NCT01865747 | Trialant

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

Documented histological or cytological diagnosis of renal cell cancer with a clear-cell component.

Measurable disease as determined by the investigator.

Must have received at least one VEGFR-targeting TKI (eg, sorafenib, sunitinib, axitinib, pazopanib or tivozanib).

Recovery from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.

Adequate organ and marrow function.

Sexually active fertile subjects(male and female)must agree to use medically accepted methods of contraception during the course of the study and for 4 months after the last dose of study treatment.

Female subjects of childbearing potential must not be pregnant at screening.

Select Exclusion Criteria:

Prior treatment with everolimus, or any other specific or selective TORC1/PI3K/AKT inhibitor (eg, temsirolimus), or cabozantinib.

Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before randomization.

Receipt of any type of anticancer antibody (including investigational antibody) within 4 weeks before randomization.

Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before randomization. Systemic treatment with radionuclides within 6 weeks before randomization. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.

Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before randomization.

Concomitant anticoagulation at therapeutic doses with oral anticoagulants or platelet inhibitors.

Chronic treatment with corticosteroids or other immunosuppressive agents.

Serious illness other than cancer.

Major surgery within 3 months before randomization. Complete wound healing from major surgery must have occurred 1 month before randomization and from minor surgery at least 10 days before randomization.

Pregnant or lactating females.

Diagnosis of another malignancy within 2 years before randomization, except for superficial skin cancers, or localized, low grade tumors.

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Birmingham, Alabama, United States

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Anchorage, Alaska 99503, United States

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Gilbert, Arizona 85234, United States

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Scottsdale, Arizona 85259, United States

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Tucson, Arizona 85724, United States

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Duarte, California 91010, United States

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La Jolla, California 92093, United States

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Los Angeles, California 90048, United States

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Los Angeles, California 90095, United States

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Vallejo, California 94589, United States

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Aurora, Colorado 80045, United States

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Denver, Colorado 80218, United States

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New Haven, Connecticut 06520, United States

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Washington D.C., District of Columbia 20007, United States

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Boca Raton, Florida 33486, United States

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Miami, Florida 33136, United States

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Miami, Florida 33176, United States

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Orlando, Florida 06520, United States

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Tampa, Florida 33612, United States

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Chicago, Illinois 60611, United States

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Chicago, Illinois 60612, United States

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Chicago, Illinois 60637, United States

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Iowa City, Iowa 52242, United States

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Westwood, Kansas 66205, United States

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Baltimore, Maryland 21201, United States

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Baltimore, Maryland 21287, United States

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Boston, Massachusetts 02215, United States

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Ann Arbor, Michigan 48109, United States

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Detroit, Michigan 48201, United States

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Detroit, Michigan 48202, United States

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Rochester, Minnesota 55905, United States

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St Louis, Missouri 63110, United States

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Las Vegas, Nevada 89148, United States

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Albany, New York 12206, United States

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New York, New York 10065, United States

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Durham, North Carolina 22710, United States

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Cleveland, Ohio 44106, United States

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Cleveland, Ohio 44195, United States

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Columbus, Ohio 43210, United States

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Portland, Oregon 97213, United States

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Portland, Oregon 97239, United States

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Philadelphia, Pennsylvania 19111, United States

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Pittsburgh, Pennsylvania 15232, United States

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Charleston, South Carolina 29425, United States

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Knoxville, Tennessee 37920, United States

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Memphis, Tennessee 38120, United States

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Nashville, Tennessee 37203, United States

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Nashville, Tennessee 37232, United States

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Austin, Texas 78731, United States

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Bedford, Texas 76022, United States

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Dallas, Texas 75246, United States

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Fort Worth, Texas 76104, United States

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Houston, Texas 77024, United States

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Houston, Texas 77030, United States

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San Antonio, Texas 78229, United States

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Salt Lake City, Utah 84112, United States

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Seattle, Washington 98109, United States

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Vancouver, Washington 98684, United States

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Yakima, Washington 98902, United States

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La Plata, Buenos Aires B1900BAJ, Argentina

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Mar del Plata, B7600LTO, Argentina

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Concord, New South Wales 2139, Australia

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Darlinghurst, New South Wales 2010, Australia

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Kogarah, New South Wales 2217, Australia

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Port Macquarie, New South Wales, Australia

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Randwick, New South Wales 2031, Australia

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Wahroonga, New South Wales 2076, Australia

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Westmead, New South Wales 2145, Australia

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Milton, Queensland 4064, Australia

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Wooloongabba, Queensland 4102, Australia

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Adelaide, South Australia 5000, Australia

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Hobart, Tasmania 7000, Australia

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Bentleight East, Victoria 3165, Australia

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Box Hill, Victoria 3128, Australia

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Wodonga, Victoria 3690, Australia

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Linz, Upper Austria 4010, Austria

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Vienna, 1090, Austria

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Vienna, 1100, Austria

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Bonheiden, Antwerpen 2820, Belgium

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Brasschaat, Antwerpen 2930, Belgium

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Brussels, Brussels Capital 1000, Belgium

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Leuven, Vlaams Brabant 3000, Belgium

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Roeselare, West-Vlaanderen 8800, Belgium

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Antwerp, 2020, Belgium

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Liège, 4000, Belgium

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Calgary, Alberta T2N 4N2, Canada

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Edmonton, Alberta T6G 1Z2, Canada

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Vancouver, British Columbia V5Z 4E6, Canada

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Winnepeg, Manitoba R3A 1R9, Canada

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Halifax, Nova Scotia B3H 1V7, Canada

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Hamilton, Ontario L8V 5C2, Canada

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Kingston, Ontario K7L 5P9, Canada

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London, Ontario N6A 4L6, Canada

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Oshawa, Ontario L1G 2B9, Canada

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Ottawa, Ontario K1H 8L6, Canada

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Toronto, Ontario M4N 3M5, Canada

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Toronto, Ontario M5G 2N2, Canada

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Montreal, Quebec H2L 4M1, Canada

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Saskatoon, Saskatchewan S7N 4H4, Canada

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Santiago, Chile

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Olomouc, Olomouc Region 775 20, Czechia

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Brno, 656 91, Czechia

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Prague, 128 08, Czechia

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Herlev, Capital Region DK-2730, Denmark

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Aarhus, Central Jutland DK-8000, Denmark

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Odense, Region Syddanmark DK-5000, Denmark

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Turku, Länsi-Suomen Lääni FI-20520, Finland

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Helsinki, 290, Finland

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Caen, Calvados 14076, France

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Besançon, Doubs 25030, France

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Bordeaux, Gironde 33075, France

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Toulouse, Haute-Garonne 31052, France

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Rennes, Ille-et-Vilaine 35042, France

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Nantes, Loire-Atlantique 44805, France

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Lyon, Rhône 96008, France

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Le Mans, Sarthe 72000, France

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Villejuif, Val-de-Marne 94805, France

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Marseille, 13273, France

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Paris, 75908, France

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Freiburg im Breisgau, Baden Wuttemberg 79106, Germany

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Tübingen, Baden-Wurttemberg 72076, Germany

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Ulm, Baden-Wurttemberg 89075, Germany

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Erlangen, Bavaria 91054, Germany

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Aachen, North Rhine-Westphalia 52074, Germany

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Essen, North Rhine-Westphalia 45122, Germany

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Mainz, Rhineland-Palatinate 55131, Germany

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Erfurt, Thuringia 99089, Germany

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Jena, Thuringia 99089, Germany

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Berlin, 12200, Germany

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Dresden, 01307, Germany

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Frankfurt am Main, 60590, Germany

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Gütersloh, 33332, Germany

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Hamburg, 20246, Germany

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Hanover, 30605, Germany

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Heidelberg, 69120, Germany

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Munich, 81377, Germany

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München, 81675, Germany

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Budapest, 1122, Hungary

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Szolnok, 5004, Hungary

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Dublin, 24, Ireland

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Dublin, 7, Ireland

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Bari, Apulia 70124, Italy

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Meldola, Emilia-Romagna 47014, Italy

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Modena, Emilia-Romagna 41124, Italy

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Ravenna, Emilia-Romagna 48100, Italy

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Rome, Lazio 00128, Italy

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Rome, Lazio 00152, Italy

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Genoa, Liguria 16132, Italy

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Cremona, Lombardy Lombardia, Italy

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Arezzo, Tuscany 52100, Italy

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Terni, Umbria 05100, Italy

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Maastricht, Limburg 6229 HX, Netherlands

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Amsterdam, North Holland 1066 CX, Netherlands

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Leiden, South Holland 2333 ZA, Netherlands

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Rotterdam, South Holland 3045 PM, Netherlands

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Poznan, Greater Poland Voivodeship 60-569, Poland

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Bialystok, Podlaskie Voivodeship 15-027, Poland

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Gdansk, Pomeranian Voivodeship 80-210, Poland

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Warsaw, 04-909, Poland

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Lisbon, 1500-650, Portugal

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Lisbon, 1649-035, Portugal

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Porto, 200-072, Portugal

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Moscow, 115478, Russia

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Omsk, 644013, Russia

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Saint Petersburg, 196247, Russia

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Yaroslavl, 150040, Russia

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Prešov, 08001, Slovakia

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Žilina, 01207, Slovakia

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Seoul, 110-744, South Korea

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Seoul, 120-752, South Korea

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Seoul, South Korea

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Badalona, Catalonia 08003, Spain

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Barcelona, Catalonia 08025, Spain

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L'Hospitalet de Llobregat, Catalonia 08907, Spain

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Pamplona, Navarre 31008, Spain

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Oviedo, Principality of Asturias 33006, Spain

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Barcelona, 08035, Spain

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Madrid, 28034, Spain

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Madrid, 28041, Spain

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Madrid, 28922, Spain

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Málaga, Málaga, Spain

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Santiago de Compostela, 15706, Spain

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Seville, 28050, Spain

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Valencia, 46010, Spain

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Lund, Skåne County SE-22185, Sweden

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Stockholm, Södermanland County, Sweden

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Umeå, Sweden

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Taichung, Taiwan

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Taipei, Taiwan

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Ankara, 6500, Turkey (Türkiye)

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Gaziantep, 27100, Turkey (Türkiye)

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Istanbul, 34365, Turkey (Türkiye)

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Izmir, 35100, Turkey (Türkiye)

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Birmingham, England B15 2TH, United Kingdom

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Derby, England DE22 3NE, United Kingdom

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Guildford, England GU2 7XX, United Kingdom

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London, England EC1A 7BE, United Kingdom

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London, England SE1 9ER, United Kingdom

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London, England, United Kingdom

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Manchester, England M20 4BX, United Kingdom

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Metropolitan Borough of Wirral, England CH63 4JY, United Kingdom

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Northwood, England HA6 2RN, United Kingdom

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Aberdeen, Scotland AB25 2ZN, United Kingdom

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Edinburgh, Scotland EH4 2XU, United Kingdom

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Glasgow, Scotland, United Kingdom