GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound | NCT01813422 | Trialant

GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound | NCT01813422 | Trialant

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

Clinical indication for coronary angiography

Subjects already taking statin therapy, niacin or ezetimibe at screening must have been on a stable dose for at least 4 weeks prior to screening LDL-C. Subjects not taking lipid-regulating therapy must enter the study via a lipid stabilization period. Subjects who are intolerant to statins must meet statin intolerance entry criteria

Fasting LDL-C ≥ 80 mg/dL (2.07 mmol/L) with or without additional risk factors, or, LDL-C ≥ 60 -< 80 mg/dL (1.55-2.07 mmol/L) in the presence of one major or three minor risk factors

Subjects must meet the following criteria at the qualifying coronary catheterization procedure:

Evidence of coronary heart disease (at least one lesion in a native coronary artery that has > 20% reduction in lumen diameter) or prior percutaneous intervention (PCI)

Left main coronary artery < 50% reduction in lumen diameter by visual estimation

Target coronary artery for IVUS must be accessible to the IVUS catheter, must not have a > 50% reduction in lumen diameter within the target segment (and at least 40 mm in length); cannot have undergone prior PCI or coronary artery bypass graft (CABG) and is not a candidate for intervention over the next 18 months. It may not be a bypass graft, bypassed vessel or culprit vessel for previous myocardial infarction (MI).

Exclusion Criteria:

Coronary artery bypass graft surgery < 6 weeks prior to the qualifying IVUS

New York Heart Association (NYHA) III or IV heart failure, or last known left ventricular ejection fraction less than 30%

Uncontrolled cardiac arrhythmia that is not controlled by medications in the 3 months prior to randomization

Known hemorrhagic stroke

Uncontrolled hypertension at randomization

Fasting Triglycerides ≥ 400 mg/dL (4.5 mmol/L) at screening

Type 1 diabetes or poorly controlled type 2 diabetes (hemoglobin A1c [HbA1c] > 9%) at screening.

Moderate to severe renal dysfunction (estimated glomerular filtration rate [eGFR] < 30 ml/min/1.73m²) at screening.

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Huntsville, Alabama 35801, United States

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Mobile, Alabama 36608, United States

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Little Rock, Arkansas 72211, United States

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La Jolla, California 92037, United States

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La Jolla, California 92093-0960, United States

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Long Beach, California 90822, United States

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Newport Beach, California 92663, United States

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Orange, California 92868, United States

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San Diego, California 92161, United States

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Santa Monica, California 90404, United States

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Torrance, California 90502, United States

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Washington D.C., District of Columbia 20010, United States

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Atlantis, Florida 33462, United States

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Clearwater, Florida 33756, United States

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Jacksonville, Florida 32209, United States

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Jacksonville, Florida 32216, United States

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Melbourne, Florida 32901, United States

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Safety Harbor, Florida 34695, United States

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Atlanta, Georgia 30342, United States

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Hammond, Indiana 46320, United States

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Valparaiso, Indiana 46383, United States

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Lexington, Kentucky 40536, United States

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Louisville, Kentucky 40205, United States

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Covington, Louisiana 70433, United States

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Bethesda, Maryland 20814, United States

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Columbia, Maryland 21044, United States

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Ann Arbor, Michigan 48109, United States

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Bay City, Michigan 48708, United States

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Grand Rapids, Michigan 49503, United States

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Marquette, Michigan 49855, United States

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Midland, Michigan 48670, United States

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Petoskey, Michigan 49770, United States

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Saginaw, Michigan 48601, United States

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Duluth, Minnesota 55805, United States

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Minneapolis, Minnesota 55407, United States

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Saint Cloud, Minnesota 56303, United States

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Saint Paul, Minnesota 55102, United States

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Columbia, Missouri 65212, United States

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Missoula, Montana 59802, United States

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Omaha, Nebraska 68198, United States

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Ridgewood, New Jersey 07450, United States

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Buffalo, New York 14215, United States

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Johnson City, New York 13790, United States

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Charlotte, North Carolina 28204, United States

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Fargo, North Dakota 58122, United States

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Canton, Ohio 44710, United States

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Elyria, Ohio 44035, United States

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Toledo, Ohio 43614, United States

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Oklahoma City, Oklahoma 73104, United States

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Tulsa, Oklahoma 74104, United States

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Hillsboro, Oregon 97123, United States

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Springfield, Oregon 97477, United States

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Doylestown, Pennsylvania 18901, United States

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Hershey, Pennsylvania 17033, United States

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Oak Ridge, Tennessee 37830, United States

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Amarillo, Texas 79106, United States

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Dallas, Texas 75216, United States

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San Antonio, Texas 78229, United States

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Wichita Falls, Texas 76301, United States

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Ciudad Autonoma de Buenos Aires, Buenos Aires C1199ABB, Argentina

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Ciudad Autonoma de Buenos Aires, Buenos Aires C1428DCO, Argentina

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La Plata, Buenos Aires 1900, Argentina

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Córdoba, Córdoba Province X5000JHQ, Argentina

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Córdoba, Córdoba Province X5016KEH, Argentina

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Rosario, Santa Fe Province 2000, Argentina

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Buenos Aires, C1280AEB, Argentina

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Corrientes, W3400AMZ, Argentina

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Córdoba, X5003DCE, 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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Liverpool, New South Wales 2170, Australia

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New Lambton Heights, New South Wales 2305, Australia

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Chermside, Queensland 4032, Australia

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Herston, Queensland 4029, Australia

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Adelaide, South Australia 5000, Australia

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Bedford Park, South Australia 5042, Australia

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Epping, Victoria 3076, Australia

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Footscray, Victoria 3011, Australia

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Heidelberg, Victoria 3084, Australia

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Melbourne, Victoria 3004, Australia

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Nedlands, Western Australia 6009, Australia

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Antwerp, 2020, Belgium

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Brussels, 1090, Belgium

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Brussels, 1200, Belgium

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Edegem, 2650, Belgium

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Genk, 3600, Belgium

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Ghent, 9000, Belgium

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Hasselt, 3500, Belgium

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Lodelinsart, 6042, Belgium

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Cariacica, Espírito Santo 29156-580, Brazil

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Goiânia, Goiás 74223-130, Brazil

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Curitiba, Paraná 80320-320, Brazil

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Porto Alegre, Rio Grande do Sul 90020-090, Brazil

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

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Porto Alegre, Rio Grande do Sul 90620-001, Brazil

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São Paulo, São Paulo 04012-909, Brazil

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São Paulo, 05403-000, Brazil

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Calgary, Alberta T2N 4Z6, Canada

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Edmonton, Alberta T5H 3V9, Canada

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Edmonton, Alberta T6G 2B7, Canada

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Victoria, British Columbia V8R 4R2, Canada

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Winnipeg, Manitoba R2H 2A6, Canada

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Saint John, New Brunswick E2L 4L2, Canada

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St. John's, Newfoundland and Labrador A1B 3V6, Canada

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Halifax, Nova Scotia B3H 3A7, Canada

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London, Ontario N6A 5A5, Canada

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Toronto, Ontario M5B 1W8, Canada

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Toronto, Ontario M5G 2C4, Canada

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Laval, Quebec H7M 3L9, Canada

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Montreal, Quebec H1T 2M4, Canada

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Montreal, Quebec H3A 1A1, Canada

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Montreal, Quebec H4J 1C5, Canada

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Québec, Quebec G1V 4G5, Canada

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Temuco, Cautín 4781156, Chile

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Santiago, 7650018, Chile

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Santiago, 8207257, Chile

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Santiago, 8330032, Chile

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Brno, 625 00, Czechia

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Hradec Králové, 500 05, Czechia

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Prague, 128 08, Czechia

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Prague, 140 21, Czechia

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Ústí nad Labem, 401 13, Czechia

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Zlín, 762 75, Czechia

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Aarhus N, 8200, Denmark

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Odense C, 5000, Denmark

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Besançon, 25030, France

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Chambray-lès-Tours, 37170, France

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Créteil, 94010, France

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Marseille, 13385, France

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Paris, 75015, France

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Pessac, 33604, France

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Aachen, 52074, Germany

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Essen, 45122, Germany

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München, 81737, Germany

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Neuss, 41464, Germany

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Regensburg, 93053, Germany

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Ulm, 89081, Germany

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Alexandroupoli, 68100, Greece

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Athens, 11527, Greece

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Athens, 14561, Greece

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Athens, 17674, Greece

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Heraklion, 71110, Greece

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Budapest, 1023, Hungary

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Budapest, 1106, Hungary

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Budapest, 1122, Hungary

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Budapest, 1134, Hungary

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Debrecen, 4032, Hungary

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Pécs, 7624, Hungary

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Szeged, 6725, Hungary

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Reykjavik, 101, Iceland

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Dublin, 8, Ireland

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Galway, Ireland

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Hadera, 38100, Israel

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Jerusalem, 91031, Israel

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Rehovot, 76100, Israel

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Novara, 28100, Italy

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Roma, 00168, Italy

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Rozzano MI, 20089, Italy

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Sesto San Giovanni (MI), 20099, Italy

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Torino, 10154, Italy

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Kuantan, Pahang 25100, Malaysia

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George Town, 10050, Malaysia

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Guadalajara, Jalisco 44670, Mexico

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Querétaro City, Querétaro 76000, Mexico

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San Luis Potosí City, San Luis Potosí 78240, Mexico

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Culiacán, Sinaloa 80020, Mexico

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Aguascalientes, 20230, Mexico

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Puebla City, 72490, Mexico

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Alkmaar, 1815 JD, Netherlands

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Amsterdam, 1081 HV, Netherlands

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Amsterdam, 1091 AC, Netherlands

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Eindhoven, 5623 EJ, Netherlands

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Leeuwarden, 8934 AD, Netherlands

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Nieuwegein, 3435 CM, Netherlands

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Nijmegen, 6532 SZ, Netherlands

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Rotterdam, 3079 DZ, Netherlands

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Tilburg, 5042 AD, Netherlands

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Utrecht, 3584 CX, Netherlands

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Venlo, 5912 BL, Netherlands

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Zwolle, 8025 AB, Netherlands

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Oslo, 0424, Norway

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Tromsø, 9038, Norway

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Pasig, 1600, Philippines

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Quezon City, 1100, Philippines

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Quezon City, 1102, Philippines

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Chrzanów, 32-500, Poland

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Kędzierzyn-Koźle, 47-200, Poland

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Krakow, 31-202, Poland

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Krakow, 31-501, Poland

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Lodz, 90-549, Poland

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Warsaw, 04-628, Poland

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Kemerovo, 650002, Russia

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Moscow, 101990, Russia

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Moscow, 119991, Russia

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Moscow, 121552, Russia

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Singapore, 169609, Singapore

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Boksburg, Gauteng 1470, South Africa

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Centurion, Gauteng 0157, South Africa

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Johannesburg, Gauteng 2157, South Africa

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Kuils River, Western Cape 7580, South Africa

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Pinelands, Cape Town, Western Cape 7405, South Africa

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Somerset West, Western Cape 7130, South Africa

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Daejeon, 301-723, South Korea

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Seongnam-si, 463-707, South Korea

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Seoul, 130-872, South Korea

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Seoul, 156-707, South Korea

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Málaga, Andalusia 29010, Spain

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Barcelona, Catalonia 08035, Spain

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L'Hospitalet de Llobregat, Catalonia 08907, Spain

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Santiago de Compostela, Galicia 15706, Spain

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Gijón, Principality of Asturias 33394, Spain

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Madrid, 28034, Spain

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Madrid, 28046, Spain

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Gothenburg, 413 45, Sweden

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Helsingborg, 251 87, Sweden

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Lund, 221 85, Sweden

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Örebro, 701 85, Sweden

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Solna, 171 76, Sweden

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Stockholm, 118 83, Sweden

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Geneva, 1211, Switzerland

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Sankt Gallen, 9007, Switzerland

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Kaohsiung City, 83301, Taiwan

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New Taipei City, 251, Taiwan

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Taichung, 402, Taiwan

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Taipei, 11217, Taiwan

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Newcastle upon Tyne, NE7 7DN, United Kingdom