Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD) | NCT00637377 | Trialant

Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD) | NCT00637377 | Trialant

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

Signed informed consent.

Men and women >/=50 years of age.

Active primary or recurrent subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by Fluorescein angiography (FA) in the study eye.

ETDRS Best-Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye at 4 meters.

Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.

Able to read, (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member) understand and willing to sign the informed consent form.

Exclusion Criteria:

Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD, except dietary supplements or vitamins.

Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye.

Any prior treatment with anti-VEGF agents in the study eye.

Total lesion size >12 disc areas (30.5 mm, including blood, scars and neovascularization) as assessed by FA in the study eye.

Subretinal hemorrhages that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye (if the blood is under the fovea, then the fovea must be surrounded by 270 degrees by visible CNV).

Scar or fibrosis making up >50% of the total lesion in the study eye.

Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.

Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.

History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.

Presence of other causes of CNV in the study eye.

Prior vitrectomy in the study eye.

History of retinal detachment or treatment or surgery for retinal detachment in the study eye.

Any history of macular hole of stage 2 and above in the study eye.

Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of Day 1, as long as it is unlikely to interfere with the injection.

History or clinical evidence of diabetic retinopathy, diabetic macular edema or any retinal vascular disease other than AMD in either eye.

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Buenos Aires, Ciudad Auton. de Buenos Aires C1015ABO, Argentina

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Buenos Aires, Ciudad Auton. de Buenos Aires C1023AAQ, Argentina

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Buenos Aires, Ciudad Auton. de Buenos Aires C1122AAI, Argentina

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

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Córdoba, Córdoba Province X5000IIT, Argentina

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Rosario, Santa Fe Province S2000ANJ, Argentina

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Chatswood, New South Wales 2067, Australia

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Sydney, New South Wales 2000, Australia

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Westmead, New South Wales 2145, Australia

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East Melbourne, Victoria 3002, Australia

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Parkville, Victoria 3050, Australia

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Nedlands, Western Australia 6009, Australia

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Parramatta, 2150, Australia

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Innsbruck, 6020, Austria

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Linz, 4021, Austria

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Vienna, 1090, Austria

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Liège, 4000, Belgium

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Ribeirão Preto, São Paulo 14048-900, Brazil

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São Paulo, São Paulo 04023-062, Brazil

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São Paulo, São Paulo 05651-901, Brazil

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Minas Gerais, 30150-270, Brazil

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Medellín, Antioquia, Colombia

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Bogotá, Bogota D.C., Colombia

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Cali, Cauca Department, Colombia

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Brno, 63400, Czechia

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Olomouc, 77520, Czechia

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Prague, 10034, Czechia

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Prague, 14000, Czechia

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Ústí nad Labem, 401 13, Czechia

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Paris, Cedex 12 75557, France

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Nantes, Cedex 1 44093, France

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Besançon, 25030, France

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Bordeaux, 33000, France

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Dijon, 21079, France

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Lyon, 69003, France

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Lyon, 69006, France

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Marseille, 13008, France

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Paris, 75010, France

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Paris, 75015, France

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Freiburg im Breisgau, Baden-Wurttemberg 79106, Germany

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Heidelberg, Baden-Wurttemberg 69120, Germany

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Tübingen, Baden-Wurttemberg 72076, Germany

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München, Bavaria 81675, Germany

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Regensburg, Bavaria 93053, Germany

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Hamburg, Free and Hanseatic City of Hamburg 20251, Germany

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Darmstadt, Hesse 64297, Germany

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Aachen, North Rhine-Westphalia 52074, Germany

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Bonn, North Rhine-Westphalia 53105, Germany

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Cologne, North Rhine-Westphalia 50924, Germany

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Essen, North Rhine-Westphalia 45122, Germany

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Münster, North Rhine-Westphalia 48145, Germany

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Ludwigshafen am Rhein, Rhineland-Palatinate 67063, Germany

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Mainz, Rhineland-Palatinate 55131, Germany

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Homburg, Saarland 66421, Germany

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Dresden, Saxony 01307, Germany

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Dresden, Saxony 06067, Germany

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Leipzig, Saxony 04103, Germany

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Kiel, Schleswig-Holstein 24105, Germany

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Lübeck, Schleswig-Holstein 23538, Germany

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Berlin, State of Berlin 12200, Germany

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Budapest, 1083, Hungary

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Budapest, 1106, Hungary

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Budapest, 1133, Hungary

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Veszprém, 8200, Hungary

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Ahemedabad - 4, Gujarat 380009, India

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Wadala, Mumbai, Maharashtra 400031, India

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Chennai, Tamil Nadu 600 006, India

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Coimbatore, Tamil Nadu 641014, India

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Madurai, Tamil Nadu 625 020, India

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Pondicherry, Tamil Nadu 600007, India

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Bangalore, 560010, India

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Chandigarh, 160012, India

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Hyderabad, 500 034, India

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Kerala, 683572, India

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Kolkata, 700073, India

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Mumbai, 400 050, India

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New Delhi, 110002, India

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New Delhi, 110029, India

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Orissa, 751 024, India

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Haifa, Israel 34362, Israel

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Kfar Saba, Israel, Israel

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Petah Tikva, Israel 49100, Israel

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Zrifin, Israel 70300, Israel

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Afula, Israel

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Beersheba, Israel

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Jerusalem, 91120, Israel

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Rehovot, 76100, Israel

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Tel Aviv, 64239, Israel

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Tel Litwinsky, Israel

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Ancona, 60126, Italy

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Bari, 70124, Italy

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Catania, 95123, Italy

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Genova, 16132, Italy

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Milan, 20122, Italy

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Milan, 20132, Italy

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Milan, 20157, Italy

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Padova, 35128, Italy

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Roma, 00133, Italy

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Roma, 00168, Italy

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Roma, 00198, Italy

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Torino, 10122, Italy

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Udine, 33100, Italy

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Varese, 21100, Italy

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Verona, 37121, Italy

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Nagoya, Aichi-ken 466-8560, Japan

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Nagoya, Aichi-ken 467-8602, Japan

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Urayasu, Chiba 279-0021, Japan

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Fukuoka, Fukuoka 812-8582, Japan

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Fukushima, Fukushima 960-1295, Japan

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Maebashi, Gunma 371-8511, Japan

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Sapporo, Hokkaido 060-8604, Japan

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Kita, Kagawa-ken 761-0793, Japan

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Kagoshima, Kagoshima-ken 890-8520, Japan

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Kyoto, Kyoto 606-8507, Japan

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Hirakata, Osaka 573-1191, Japan

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Suita, Osaka 565-0871, Japan

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Ōtsu, Shiga 520-2192, Japan

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Chiyoda-ku, Tokyo 101-8309, Japan

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Shinjuku-ku, Tokyo 160-8582, Japan

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Riga, 1002, Latvia

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Riga, 1009, Latvia

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Riga, 1050, Latvia

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Chihuahua City, Chihuahua 31238, Mexico

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Zapopan, Jalisco 45060, Mexico

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Mexico City, Mexico City 06800, Mexico

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Monterrey, Nuevo León 64060, Mexico

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Monterrey, Nuevo León 64480, Mexico

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Metepec, State of Mexico 52140, Mexico

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Mexico City, 06030, Mexico

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México D.F., 04030, Mexico

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Leiden, ZA 2333, Netherlands

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Amsterdam, 1100 DD, Netherlands

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Groningen, 9713 GZ, Netherlands

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Nijmegen, 6525 EX, Netherlands

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Rotterdam, 3000 CA, Netherlands

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Bydgoszcz, 85-631, Poland

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Gdansk, 80-952, Poland

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Katowice, 40-760, Poland

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Poznan, 61-848, Poland

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Warsaw, 00-416, Poland

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Warszaa, 02-005, Poland

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Wroclaw, 50-368, Poland

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Coimbra, 3000-548, Portugal

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Porto, 4200-319, Portugal

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Singapore, 119074, Singapore

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Singapore, 159964, Singapore

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Singapore, 168751, Singapore

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Singapore, 308433, Singapore

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Banská Bystrica, 97517, Slovakia

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Bratislava, 81369, Slovakia

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Seongnam, Gyeonggido 463 707, South Korea

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Incheon, 405-760, South Korea

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Seoul, 110 744, South Korea

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Seoul, 137 701, South Korea

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Seoul, 138-736, South Korea

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Seoul, 152-703, South Korea

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Santiago de Compostela, A Coruña 15705, Spain

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Alicante, Alicante 03016, Spain

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Madrid, Madrid 28002, Spain

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Pamplona, Navarre 31008, Spain

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Oviedo, Principality of Asturias 33012, Spain

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Barcelona, 08017, Spain

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Barcelona, 08022, Spain

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Barcelona, 08035, Spain

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Barcelona, 08036, Spain

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Madrid, 28046, Spain

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Málaga, 29010, Spain

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Seville, 41009, Spain

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Seville, 41013, Spain

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Valencia, 46014, Spain

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Valencia, 46015, Spain

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Valladolid, 47005, Spain

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Linköping, 58185, Sweden

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Örebro, 70185, Sweden

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Stockholm, 11282, Sweden

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Basel, 4031, Switzerland

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Bern, 3010, Switzerland

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Geneva, 1211, Switzerland

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Zurich, 8091, Switzerland

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Southampton, Hampshire SO16 6YD, United Kingdom

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Camberley, Surrey GU16 5UJ, United Kingdom

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Aberdeen, AB25 2ZN, United Kingdom

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Belfast, BT12 6BA, United Kingdom

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Birmingham, B4 7ET, United Kingdom

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Liverpool, L7 8XP, United Kingdom

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London, NW1 5QH, United Kingdom

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London, SE5 9RS, United Kingdom

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Plymouth, PL4 6PL, United Kingdom

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Torquay, TQ2 7AA, United Kingdom