Sorafenib as Adjuvant Treatment in the Prevention Of Recurrence of Hepatocellular Carcinoma (STORM) | NCT00692770 | Trialant

Sorafenib as Adjuvant Treatment in the Prevention Of Recurrence of Hepatocellular Carcinoma (STORM) | NCT00692770 | Trialant

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

Subjects who have undergone surgical resection or local ablation (PEI or percutaneous or intraoperative RFA) for treatment of HCC with curative intent within 4 months from staging to potentially curative treatment. A maximum of 2 local ablation courses may be administered during this time period.

At least 3 weeks (21 days) but no more than 7 weeks (49 days), from resection or last local ablation course, to CT/MRI scan date

Male or female subjects >/= 18 years of age

Confirmation of CR (absence of residual tumor after curative treatment), on the eligibility scan by independent radiological review.

For subjects undergoing surgical resection pathology proven complete removal of tumor.

Intermediate or High Risk of recurrence as assessed by tumor characteristics.

Child-Pugh score 5 -7 points. A Child-Pugh score of 7 points is allowed only in the absence of ascites.

ECOG Performance Status of 0.

Adequate bone marrow, liver and renal function

Exclusion Criteria:

Recurrent HCC

Child-Pugh score 7 points with presence of ascites.

Low risk of recurrence after curative treatment

History of cardiovascular disease

History of HIV infection

Active clinically serious infections (> grade 2 NCI-CTCAE version 3.0)

Subjects with seizure disorder requiring medication (such as steroids or anti-epileptics)

Subjects with evidence or history of bleeding diathesis

Subjects undergoing renal dialysis

Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry as defined by the signing of informed consent..

Uncontrolled ascites (defined as not easily controlled with diuretic treatment)

Encephalopathy

History of GI bleeding within 30 days of randomization.

Subjects with a history of esophageal varices bleeding which has not been followed by effective therapy and/or treatment to prevent bleeding recurrence.

Prior anti cancer therapy for treatment of HCC (including sorafenib or any other molecular therapy) is excluded.

Major surgery within 4 weeks of start of study as defined by the signing of informed consent, except for surgical resection or local ablation of HCC.

Investigational drug therapy outside of this trial during or within 4 weeks of study entry, as defined by the signing of informed consent.

Liver transplantation, this includes patients on a transplant list with the intention to transplant

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Birmingham, Alabama 35294-3300, United States

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Phoenix, Arizona 85054, United States

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Los Angeles, California 90033, United States

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Los Angeles, California 90095-7077, United States

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San Francisco, California 94115, United States

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

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Miami, Florida 33136, United States

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Atlanta, Georgia 30322, United States

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Indianapolis, Indiana 46202, United States

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Louisville, Kentucky 40202, United States

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New Orleans, Louisiana 70112, United States

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Baltimore, Maryland 21287, United States

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Boston, Massachusetts 02114, United States

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Boston, Massachusetts 02215, United States

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Burlington, Massachusetts 01805, United States

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Ann Arbor, Michigan 48109, United States

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Minneapolis, Minnesota 55407, United States

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Minneapolis, Minnesota 55455, United States

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New York, New York 10029, 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

Providence Portland Medical Center

Portland, Oregon 97213, United States

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Portland, Oregon 97239, United States

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Pittsburgh, Pennsylvania 15213, United States

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Houston, Texas 77030, United States

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Richmond, Virginia 23249, United States

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Seattle, Washington 98101, United States

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Seattle, Washington 98109, United States

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Pilar, Buenos Aires B1629ODT, Argentina

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Buenos Aires, Ciudad Auton. de Buenos Aires C1181ACH, Argentina

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Rosario, Santa Fe Province S2002KDS, Argentina

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Camperdown, New South Wales 2050, Australia

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Randwick, New South Wales 2031, Australia

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Brisbane, Queensland 4120, Australia

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Heidelberg, Victoria 3084, Australia

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Melbourne, Victoria 3004, Australia

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Innsbruck, 6020, Austria

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Linz, 4020, Austria

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Vienna, 1090, Austria

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Bruxelles - Brussel, 1200, Belgium

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Ghent, 9000, Belgium

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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Porto Alegre, Rio Grande do Sul 90035-903, Brazil

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Porto Alegre, Rio Grande do Sul 90470 340, Brazil

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

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São Paulo, São Paulo 01323-001, Brazil

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São Paulo, 01246-903, Brazil

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Plovdiv, 4002, Bulgaria

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Varna, 2010, Bulgaria

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Calgary, Alberta T2N 4N1, Canada

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Edmonton, Alberta T6G 1Z2, Canada

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Vancouver, British Columbia V5Z 4E6, Canada

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Ottawa, Ontario K1H 8L6, Canada

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Toronto, Ontario M5G 2M9, Canada

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Santiago, Santiago Metropolitan 833-0024, Chile

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Reñaca, Valparaiso, Chile

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Guangzhou, Guangdong 510060, China

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Guangzhou, Guangdong 510080, China

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Guangzhou, Guangdong 510515, China

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Nanning, Guangxi 530021, China

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Wuhan, Hubei 430022, China

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Changsha, Hunan 410008, China

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Changsha, Hunan 410013, China

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Nanjing, Jiangsu 210002, China

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Xi’an, Shanxi 710038, China

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Xi’an, Shanxi 710061, China

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Xi’an, Shanxi 710068, China

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Chengdu, Sichuan 610041, China

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Chengdu, Sichuan 610072, China

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Beijing, 100021, China

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Beijing, 100071, China

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Beijing, 100142, China

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Beijing, 100853, China

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Beijng, 100142, China

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Chongqing, 400038, China

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Dalian, 116027, China

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Hefei, 230022, China

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Shanghai, 200001, China

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Shanghai, 200438, China

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Tianjin, 300060, China

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Angers, 49933, France

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Bondy, 93143, France

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Bordeaux, 33000, France

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Créteil, 94010, France

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Lille, 59037, France

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Lyon, 69004, France

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Marseille, 13005, France

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Nice, 06202, France

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Paris, 75020, France

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Paris, 75571, France

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Rennes, 35000, France

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Toulouse, 31059, France

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Vandœuvre-lès-Nancy, 54500, France

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Villejuif, 94800, France

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München, Bavaria 81377, Germany

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München, Bavaria 81675, Germany

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Regensburg, Bavaria 93042, Germany

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Göttingen, Lower Saxony 37075, Germany

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Hanover, Lower Saxony 30625, Germany

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Aachen, North Rhine-Westphalia 52074, 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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Essen, North Rhine-Westphalia 45147, Germany

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Mainz, Rhineland-Palatinate 55131, Germany

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Homburg/Saar, Saarland 66421, Germany

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Halle, Saxony-Anhalt 06120, Germany

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Magdeburg, Saxony-Anhalt 39120, Germany

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Berlin, 12200, Germany

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Hamburg, 20246, Germany

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Athens / Greece, 115 27, Greece

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Hong Kong, Hong Kong

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Kwun Tong, Hong Kong

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Shatin, Hong Kong

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Bari, Apulia 70124, Italy

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Benevento, Campania 82100, Italy

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Naples, Campania 80123, Italy

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Naples, Campania 80131, Italy

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Bologna, Emilia-Romagna 40138, Italy

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Modena, Emilia-Romagna 41124, Italy

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Rome, Lazio 00168, Italy

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Milan, Lombardy 20121, Italy

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Milan, Lombardy 20133, Italy

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Turin, Piedmont 10126, Italy

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Cagliari, Sardinia 09134, Italy

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Catania, Sicily 95122, Italy

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Palermo, Sicily 90127, Italy

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Padova, Veneto 35128, Italy

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Kashiwa-shi, Chiba 277-8577, Japan

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Kanazawa, Ishikawa-ken 920-8641, Japan

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Yokohama, Kanagawa 232-0024, Japan

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Osakasayama-shi, Osaka 589-8511, Japan

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Suita, Osaka 565-0871, Japan

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Bunkyo-ku, Tokyo 113-8655, Japan

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Chuo-ku, Tokyo 104-0045, Japan

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Itabashi-ku, Tokyo 173-8610, Japan

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Minato-ku, Tokyo 105-8470, Japan

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Shibuya-ku, Tokyo 150-8935, Japan

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Shinjuku-ku, Tokyo 162-8666, Japan

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Fukuoka, 812-8582, Japan

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Kumamoto, 860-8556, Japan

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Kyoto, 606-8507, Japan

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Okayama, 700-8558, Japan

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Osaka, 537-8511, Japan

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Tokushima, 770-8503, Japan

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México, D.F., Mexico City 14080, Mexico

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Monterrey, Nuevo León 64710, Mexico

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México, D.F., 14050, Mexico

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Auckland, 1023, New Zealand

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Coimbra, 3000-075, Portugal

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Bucharest, 022326, Romania

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Cluj-Napoca, 400015, Romania

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Iași, 700106, Romania

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Moscow, 115478, Russia

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Moscow, 119991, Russia

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Obninsk, 249036, Russia

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Saint Petersburg, 197758, Russia

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Singapore, 119228, Singapore

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Singapore, 169608, Singapore

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Goyang-si, Gyeonggido 410-769, South Korea

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Goyang-si, Gyeonggido 411-706, South Korea

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Seoul, Seoul Teugbyeolsi 135-720, South Korea

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Busan, 49241, South Korea

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Daegu, 700721, South Korea

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Jeollabuk-do, 561-712, South Korea

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Seoul, 05505, South Korea

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Seoul, 110-744, South Korea

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Seoul, 120-752, South Korea

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Seoul, 135-710, South Korea

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Sabadell, Barcelona 08208, Spain

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Cruces/Barakaldo, Bilbao 48903, Spain

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Barcelona, Catalonia 08035, Spain

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Majadahonda, Madrid 28222, Spain

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Oviedo, Principality of Asturias 33011, Spain

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Badajoz, 06080, Spain

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Barcelona, 08036, Spain

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Córdoba, 14004, Spain

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Madrid, 28007, Spain

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Madrid, 28040, Spain

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Valladolid, 47012, Spain

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Gothenburg, 413 45, Sweden

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Stockholm, 141 86, Sweden

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Bern, 3010, Switzerland

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Zurich, 8091, Switzerland

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Changhua, 500-06, Taiwan

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Kaohsiung City, 807, Taiwan

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Kaohsung, 833, Taiwan

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Tainan, 704, Taiwan

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Taipei, 100, Taiwan

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Taipei, 112, Taiwan

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Taoyuan, 333, Taiwan

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Southampton, Hampshire SO16 6YD, United Kingdom

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Birmingham, West Midlands B15 2TT, United Kingdom

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Leeds, West Yorkshire LS9 7TF, United Kingdom

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London, NW3 2QG, United Kingdom

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London, SE5 9RS, United Kingdom

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Manchester, M20 4BX, United Kingdom

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Newcastle upon Tyne, NE7 7DN, United Kingdom