Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer | NCT02200614 | Trialant

Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer | NCT02200614 | Trialant

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

Histologically or cytologically confirmed adenocarcinoma of prostate without neuroendocrine differentiation or small cell features.

Castration-resistant prostate cancer (CRPC) with castrate level of serum testosterone.

Prostate-specific Antigen (PSA) doubling time of ≤ 10 months and PSA > 2ng/ml.

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Blood counts at screening: haemoglobin ≥ 9.0 g/dl,absolute neutrophil count ≥ 1500/µl, platelet count ≥ 100,000/µl.

Screening values of serum alanine aminotransferase (ALT) and/or aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN), total bilirubin ≤ 1.5 x ULN, creatinine ≤ 2.0 x ULN.

Sexually active patients, unless surgically sterile, must agree to use condoms as an effective barrier method and refrain from sperm donation during the study treatment and for 3 months after the end of the study treatment.

Exclusion Criteria:

History of metastatic disease at any time or presence of detectable metastases.

Acute toxicities of prior treatments and procedures not resolved to grade ≤ 1 or baseline before randomisation.

Prior treatment with: second generation androgen receptor (AR) inhibitors, other investigational AR inhibitors, or CYP17 enzyme inhibitor.

Use of estrogens or 5-α reductase inhibitors or AR inhibitors.

Prior chemotherapy or immunotherapy for prostate cancer.

Use of systemic corticosteroid.

Radiation therapy within 12 weeks before randomisation.

Severe or uncontrolled concurrent disease, infection or co-morbidity.

Treatment with bisphosphonate or denosumab within 12 weeks before randomisation.

Known hypersensitivity to the study treatment or any of its ingredients.

Major surgery within 28 days before randomisation.

Any of the following within 6 months before randomisation: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure New York Heart Association (NYHA) Class III or IV.

Uncontrolled hypertension.

Prior malignancy.

Gastrointestinal disorder or procedure which expects to interfere significantly with absorption of study treatment.

Active viral hepatitis, active human immunodeficiency virus (HIV) or chronic liver disease.

Treatment with any investigational drug within 28 days before randomisation.

Any condition that in the opinion of the investigator would impair the patients' ability to comply with the study procedures.

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Homewood, Alabama 35209, United States

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Anchorage, Alaska 99503, United States

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Tucson, Arizona 85704, United States

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Fountain Valley, California 92708, United States

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La Jolla, California 92093, United States

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Laguna Hills, California 92653, United States

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Los Angeles, California 90048, United States

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Los Angeles, California 90073-1003, United States

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San Diego, California 92120, United States

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Whittier, California 90603, United States

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Denver, Colorado 80211, United States

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Denver, Colorado 80220, United States

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Parker, Colorado 80134, United States

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Boca Raton, Florida 33486, United States

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Orlando, Florida 32803, United States

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Port Saint Lucie, Florida 34952, United States

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Coeur d'Alene, Idaho 83814, United States

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Chicago, Illinois 60612, United States

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Evanston, Illinois 60201-1613, United States

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Springfield, Illinois 62702, United States

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Greenwood, Indiana 46143, United States

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Indianapolis, Indiana 46202, United States

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Jeffersonville, Indiana 47130, United States

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West Des Moines, Iowa 50266, United States

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Wichita, Kansas 67226, United States

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New Orleans, Louisiana 70121, United States

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Annapolis, Maryland 21401, United States

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Baltimore, Maryland 21204, United States

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Salisbury, Maryland 21801, United States

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Boston, Massachusetts 02114, United States

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Grand Rapids, Michigan 49546, United States

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Royal Oak, Michigan 48073, United States

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Omaha, Nebraska 68114, United States

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Omaha, Nebraska 68130, United States

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Lebanon, New Hampshire 03756-1000, United States

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Voorhees Township, New Jersey 08043, United States

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Syracuse, New York 13210, United States

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The Bronx, New York 10461, United States

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The Bronx, New York 10469, United States

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Asheboro, North Carolina 27203, United States

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Charlotte, North Carolina 28277, United States

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Canton, Ohio 44718, United States

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Cincinnati, Ohio 45212, United States

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Cleveland, Ohio 44195, United States

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Gahanna, Ohio 43230, United States

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Middleburg Heights, Ohio 44130, United States

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Oklahoma City, Oklahoma 73104, United States

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Bala-Cynwyd, Pennsylvania 19004, United States

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Myrtle Beach, South Carolina 29572, United States

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Nashville, Tennessee 37209, United States

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Dallas, Texas 75231, United States

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Fairfax, Virginia 22031, United States

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Richmond, Virginia 23235, United States

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Virginia Beach, Virginia 23462, United States

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Wheeling, West Virginia 26003, United States

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Buenos Aires, Ciudad Auton. de Buenos Aires C1120AAT, Argentina

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Santa Fe, Santa Fe Province S3000FFV, Argentina

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San Miguel de Tucumán, Tucumán Province T4000HXU, Argentina

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Córdoba, X5000HXL, Argentina

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Córdoba, X5004FHP, Argentina

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Córdoba, X5016KEH, Argentina

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La Rioja, F5300COE, Argentina

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Randwick, New South Wales 2031, Australia

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St Leonards, New South Wales 2065, Australia

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Douglas, Queensland 4814, Australia

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South Brisbane, Queensland 4101, Australia

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Kurralta Park, South Australia 5037, Australia

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Fitzroy, Victoria 3065, Australia

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Vienna, 1020, Austria

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Vienna, 1090, Austria

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Lesnoy, 223040, Belarus

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Minsk, 220013, Belarus

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Bonheiden, 2820, Belgium

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Kortrijk, 8500, Belgium

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Libramont, 6800, Belgium

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Liège, 4000, Belgium

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Sint-Truiden, 3800, Belgium

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Fortaleza, Ceará 60430-230, Brazil

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Salvador, Estado de Bahia 40050-001, Brazil

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Goiânia, Goiás 74605-070, Brazil

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Belo Horizonte, Minas Gerais 30150-320, Brazil

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Juiz de Fora, Minas Gerais 36010-510, Brazil

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Uberlândia, Minas Gerais 38408-150, Brazil

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Curitiba, Paraná 81520-060, Brazil

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Recife, Pernambuco 50070-550, Brazil

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Passo Fundo, Rio Grande do Sul 99010-080, Brazil

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Porto Alegre, Rio Grande do Sul 90050 170, Brazil

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Porto Alegre, Rio Grande do Sul 90610-000, Brazil

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Itajaí, Santa Catarina 88301-220, Brazil

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Barretos, São Paulo 14784-400, Brazil

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Jaú, São Paulo 17210-080, Brazil

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Ribeirao Preto - SP, São Paulo 14048-900, Brazil

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São Paulo, São Paulo 01209-000, Brazil

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São Paulo, São Paulo 01236-030, Brazil

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São Paulo, São Paulo 01246-000, Brazil

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São Paulo, São Paulo 04014-002, Brazil

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São Paulo, São Paulo 04039-004, Brazil

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Sorocaba, São Paulo 18035-300, Brazil

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Sofia, 1680, Bulgaria

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Varna, 9000, Bulgaria

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Calgary, Alberta T2V 1P9, Canada

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Halifax, Nova Scotia B3H 2Y9, Canada

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Burlington, Ontario L7N 3V2, Canada

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Hamilton, Ontario L8N 4A6, Canada

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Kingston, Ontario K7L 3J7, Canada

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London, Ontario N6A 5W9, Canada

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Toronto, Ontario M4N 3M5, Canada

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Toronto, Ontario M5G 2M9, Canada

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Granby, Quebec J2G 8Z9, Canada

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Pointe-Claire, Quebec H9R 4S3, Canada

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Medellín, Antioquia 050034, Colombia

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Montería, Departamento de Córdoba 230002, Colombia

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Floridablanca, Santander Department 681004, Colombia

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Jablonec nad Nisou, 466 60, Czechia

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Kolín, 280 00, Czechia

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Olomouc, 775 20, Czechia

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Opava, 746 01, Czechia

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Prague, 120 00, Czechia

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Prague, 128 08, Czechia

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Prague, 160 00, Czechia

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Prague, 180 81, Czechia

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Tallinn, 13419, Estonia

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Helsinki, 00290, Finland

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Kuopio, 70210, Finland

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Seinäjoki, 60220, Finland

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Tampere, 33521, Finland

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Turku, FIN-20521, Finland

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Angers, 49100, France

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Bayonne, 64100, France

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Besançon, 25030, France

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Bordeaux, 33076, France

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Caen, 14076, France

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Cergy-Pontoise, 95303, France

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Clermont-Ferrand, 63011, France

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Créteil, 94010, France

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Dijon, 21000, France

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La Roche-sur-Yon, 85925, France

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Limoges, 87042, France

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Montpellier, 34295, France

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Montpellier, 34298, France

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Nancy, 54100, France

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Nantes, 44093, France

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Paris, 75010, France

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Paris, 75014, France

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Pierre-Bénite, 69495, France

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Poitiers, 86021, France

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Reims, 51726, France

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Rennes, 35033, France

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Rouen, 76031, France

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Saint-Mandé, 94160, France

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Strasbourg, 67000, France

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Suresnes, 92151, France

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Tours, 37044, France

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Villejuif, 94805, France

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Emmendingen, Baden-Wurttemberg 79312, Germany

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Kirchheim unter Teck, Baden-Wurttemberg 73230, Germany

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Mühlacker, Baden-Wurttemberg 75417, Germany

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Nürtingen, Baden-Wurttemberg 72622, Germany

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Reutlingen, Baden-Wurttemberg 72764, Germany

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Tübingen, Baden-Wurttemberg 72076, Germany

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Zirndorf, Bavaria 90513, Germany

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Frankfurt am Main, Hesse 60590, Germany

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Marburg, Hesse 35039, Germany

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Herzberg am Harz, Lower Saxony 37412, Germany

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Holzminden, Lower Saxony 37603, Germany

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Hagenow, Mecklenburg-Vorpommern 19230, Germany

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Cologne, North Rhine-Westphalia 50937, Germany

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Düsseldorf, North Rhine-Westphalia 40225, Germany

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Mülheim, North Rhine-Westphalia 45468, Germany

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Münster, North Rhine-Westphalia 48149, Germany

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Wuppertal, North Rhine-Westphalia 42103, Germany

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Mainz, Rhineland-Palatinate 55131, Germany

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Dresden, Saxony 01307, Germany

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Magdeburg, Saxony-Anhalt 39120, Germany

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Berlin, 12203, Germany

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Hamburg, 20246, Germany

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Hamburg, 22081, Germany

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Budapest, 1086, Hungary

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Budapest, 1145, Hungary

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Budapest, 1204, Hungary

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Debrecen, 4032, Hungary

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Győr, 9023, Hungary

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Nyíregyháza, 4400, Hungary

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Szeged, 6725, Hungary

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Szekszárd, 7100, Hungary

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Szolnok, 5000, Hungary

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Zalaegerszeg, 8900, Hungary

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Haifa, 35152, Israel

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Chieti, Abruzzo 66100, Italy

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Lecce, Apulia 73100, Italy

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Catanzaro, Calabria 88100, Italy

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Naples, Campania 80131, Italy

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Forlì Cesena, Emilia-Romagna 47014, Italy

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Modena, Emilia-Romagna 41124, Italy

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Parma, Emilia-Romagna 43126, Italy

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Rome, Lazio 00144, Italy

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Rome, Lazio 00189, Italy

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Turin, Piedmont 10043, Italy

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Turin, Piedmont 10060, Italy

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Messina, Sicily 98125, Italy

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Palermo, Sicily 90127, Italy

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Arezzo, Tuscany 52100, Italy

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Nagoya, Aichi-ken 466-8560, Japan

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Kashiwa, Chiba 277-8577, Japan

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Kurume, Fukuoka 839-0863, Japan

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Kōriyama, Fukushima 963-8052, Japan

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Maebashi, Gunma 371-8511, Japan

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Ōtake, Hiroshima 739-0696, Japan

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Sapporo, Hokkaido 060-8543, Japan

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Kobe, Hyōgo 650-0047, Japan

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Higashiibaraki, Ibaraki 311-3193, Japan

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Kanazawa, Ishikawa-ken 920-8530, Japan

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Sagamihara, Kanagawa 252-0375, Japan

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Yokohama, Kanagawa 232-0024, Japan

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Yokosuka, Kanagawa 238-8558, Japan

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Sendai, Miyagi 981-8563, Japan

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Ueda, Nagano 386-8610, Japan

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Kashihara, Nara 634-8522, Japan

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Yufu, Oita Prefecture 879-5593, Japan

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Sayama, Osaka 589-8511, Japan

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Wako, Saitama 351-0102, Japan

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Hamamatsu, Shizuoka 431-3192, Japan

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Utsunomiya, Tochigi 321-0974, Japan

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Bunkyo-ku, Tokyo 113-8431, Japan

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Bunkyo-ku, Tokyo 113-8603, Japan

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Itabashi-ku, Tokyo 173-0015, Japan

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Minato-ku, Tokyo 105-8471, Japan

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Mitaka, Tokyo 181-8611, Japan

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Nakano-ku, Tokyo 164-8541, Japan

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Shinjuku-ku, Tokyo 160-8582, Japan

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Sumida-ku, Tokyo 130-8587, Japan

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Ube, Yamaguchi 755-8505, Japan

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Chiba, 260-8717, Japan

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Fukui, 910-8526, Japan

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Hiroshima, 730-8518, Japan

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Kyoto, 602-8566, Japan

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Nagasaki, 852-8501, Japan

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Nagasaki, 852-8511, Japan

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Okayama, 700-8558, Japan

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Osaka, 541-8567, Japan

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Osaka, 545-8586, Japan

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Osaka, 558-8558, Japan

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Toyama, 930-0194, Japan

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Daugavpils, LV5401, Latvia

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Jelgava, LV-3001, Latvia

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Leipaja, LV-3401, Latvia

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Riga, LV-1001, Latvia

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Riga, LV-1002, Latvia

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Riga, LV-1038, Latvia

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Kaunas, LT-45434, Lithuania

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Kaunas, LT-50009, Lithuania

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Klaipėda, LT-92288, Lithuania

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Vilnius, LT-08660, Lithuania

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Vilnius, LT-08661, Lithuania

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La Victoria, Arequipa 4001, Peru

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Lima, 15046, Peru

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Lima, 15073, Peru

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San Isidro, 15036, Peru

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Elblag, 82-300, Poland

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Gdansk, 80-952, Poland

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Lodz, 90-302, Poland

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Lublin, 20-718, Poland

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Otwock, 05-400, Poland

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Rzeszów, 35-021, Poland

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Siedlce, 08-110, Poland

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Warsaw, 02-616, Poland

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Warsaw, 02-781, Poland

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Warsaw, 04-125, Poland

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Wroclaw, 54-144, Poland

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Guimarães, Braga District 4835-044, Portugal

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Almada, Lisbon District 2801-951, Portugal

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Matosinhos Municipality, Porto District 4464-513, Portugal

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Braga, 4710-243, Portugal

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Lisbon, 1099-023, Portugal

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Lisbon, 1150-199, Portugal

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Lisbon, 1400-038, Portugal

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Lisbon, 1500-650, Portugal

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Porto, 4200-072, Portugal

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Porto, 4200-319, Portugal

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Bucharest, 22328, Romania

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Bucharest, 41345, Romania

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Bucharest, 50659, Romania

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Bucharest, 75000, Romania

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Cluj-Napoca, 400015, Romania

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Craiova, 200347, Romania

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Craiova, 200385, Romania

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Oradea, 410159, Romania

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Ploieşti, 100337, Romania

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Târgu Mureş, 540103, Romania

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Chelyabinsk, 454087, Russia

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Ivanovo, 153040, Russia

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Kazan', 420029, Russia

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Krasnoyarsk, 660133, Russia

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Moscow, 105425, Russia

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Moscow, 117997, Russia

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Moscow, 125284, Russia

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Moscow, 129301, Russia

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Nizhny Novgorod, 603006, Russia

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Novosibirsk, 630099, Russia

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Obninsk, 249036, Russia

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Omsk, 644013, Russia

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Orenburg, 460021, Russia

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Pyatigorsk, 357502, Russia

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Rostov-on-Don, 344022, Russia

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Saint Petersburg, 191014, Russia

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Saint Petersburg, 194017, Russia

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Saint Petersburg, 194354, Russia

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Saint Petersburg, 197022, Russia

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Saratov, 410054, Russia

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Tyumen, 625041, Russia

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Ufa, 450008, Russia

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Vladimir, 600009, Russia

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Belgrade, 11000, Serbia

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Belgrade, 11080, Serbia

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Niš, 18000, Serbia

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Bratislava, 851 01, Slovakia

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Bratislava, 851 05, Slovakia

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Martin, 036 59, Slovakia

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Trenčín, 91101, Slovakia

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George, Eastern Cape 6530, South Africa

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Port Elizabeth, Eastern Cape 6045, South Africa

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Pretoria, Gauteng 0002, South Africa

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Pretoria, Gauteng 0083, South Africa

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Paarl, Western Cape 7646, South Africa

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Rondebosch, Western Cape 7700, South Africa

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Cape Town, 7505, South Africa

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Cape Town, 7925, South Africa

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Gwangju, Gwangju Gwang''yeogsi 61469, South Korea

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Cheongju-si, North Chungcheong 28644, South Korea

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Seoul, Seoul Teugbyeolsi 03080, South Korea

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Seoul, Seoul Teugbyeolsi 06273, South Korea

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Daegu, 41404, South Korea

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Daegu, 42601, South Korea

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Incheon, 21565, South Korea

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Seoul, 03722, South Korea

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Seoul, 05505, South Korea

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Seoul, 06351, South Korea

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Seoul, 06591, South Korea

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Elche, Alicante 03203, Spain

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Cadiz, Andalusia 11009, Spain

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L'Hospitalet de Llobregat, Barcelona 08907, Spain

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Sabadell, Barcelona 08208, Spain

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Terrassa, Barcelona 08221, Spain

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Jerez de la Frontera, Cádiz 11407, Spain

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Manacor, Illes Baleares 07500, Spain

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Palma de Mallorca, Illes Baleares 07120, Spain

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Alcorcón, Madrid 28922, Spain

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Bilbao, Vizcaya 48013, Spain

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Barcelona, 08035, Spain

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Barcelona, 08036, Spain

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Córdoba, 14004, Spain

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Granada, 18012, Spain

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Lugo, 27003, Spain

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Madrid, 28007, Spain

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Madrid, 28040, Spain

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Madrid, 28041, Spain

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Madrid, 28046, Spain

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Málaga, 29010, Spain

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Salamanca, 37007, Spain

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Seville, 41009, Spain

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Seville, 41013, Spain

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Valencia, 46009, Spain

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Valencia, 46015, Spain

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Valencia, 46026, Spain

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Gothenburg, 413 45, Sweden

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Örebro, 701 85, Sweden

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Stockholm, 171 76, Sweden

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Uppsala, 751 85, Sweden

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Kaohsiung City, 807, Taiwan

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Kaoshiung, 81362, Taiwan

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Taichung, 40705, Taiwan

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Taipei, 100, Taiwan

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Taoyuan, 33305, Taiwan

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Ankara, 06500, Turkey (Türkiye)

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Istanbul, 34724, Turkey (Türkiye)

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Izmir, 35100, Turkey (Türkiye)

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Izmir, 35340, Turkey (Türkiye)

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Manisa, 45030, Turkey (Türkiye)

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Sivas, 58140, Turkey (Türkiye)

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Chernivtsi, 58002, Ukraine

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Dnipro, 49102, Ukraine

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Kharkiv, 61037, Ukraine

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Kryvyi Rih, 50048, Ukraine

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Kyiv, 04053, Ukraine

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Kyiv, 2660, Ukraine

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Uzhhorod, 88014, Ukraine

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Zaporizhzhya, 69600, Ukraine

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Reading, Berkshire RG1 5AN, United Kingdom

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Llanelli, Carmarthenshire SA14 8QF, United Kingdom

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Romford, Essex RM7 0AG, United Kingdom

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Stevenage, Hertfordshire SG1 4AB, United Kingdom

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Dartford, Kent DA2 8DA, United Kingdom

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Maidstone, Kent ME16 9QQ, United Kingdom

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Preston, Lancashire PR2 4HT, United Kingdom

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Bebington, Merseyside CH63 4JY, United Kingdom

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Scunthorpe, North East Lincolnshire DN15 7BH, United Kingdom

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Bath, Somerset BA1 3NG, United Kingdom

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Stoke-on-Trent, Staffordshire ST4 6QG, United Kingdom

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Dudley, West Midlands DY1 2HQ, United Kingdom

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Huddersfield, West Yorkshire HD3 3EA, United Kingdom

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Wakefield, West Yorkshire WF1 4DG, United Kingdom

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Cardiff, CF14 4XN, United Kingdom

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Glasgow, G12 0YN, United Kingdom

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London, SW17 0QT, United Kingdom