A Study on The Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients With Stable Cardiovascular Disease and Glucose Abnormalities | NCT01715818 | Trialant

A Study on The Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients With Stable Cardiovascular Disease and Glucose Abnormalities | NCT01715818 | Trialant

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

Male and female patients with established evidence of stable cardiovascular disease (CVD) defined as at least one of the following groups of criteria (A or B) A. Age >/= 40 years with history with prior CV event of prior myocardial infarction or prior ischemic stroke (confirmed by brain imaging study), with onset >/= 3 months prior to randomization and stable in the Investigator's judgment B. Age >/= 55 years with evidence of CVD (stable in the Investigator's judgment), defined as at least one of the following: Coronary disease, cerebrovascular disease or peripheral arterial disease as defined by protocol

Patients with glucose abnormalities based on one of the following A-B criteria:

A. Established Type 2 diabetes mellitus (T2D) according to 2010 ADA criteria; treatment may include diet alone, or any glucose-lowering therapies except for thiazolidinediones (TDZs) B. No fulfillment of criterion A) but evidence of glucose abnormalities

Optimal management of CV risk factors including hypertension and dyslipidemia as informed by the best evidence and clinical practice guidelines

Exclusion Criteria:

Current treatment with a thiazolidinedione (TDZ) or fibrate

Prior intolerance to a TDZ or fibrate

Previous participation in a trial with aleglitazar

Other types of diabetes

Inadequate liver, hematologic or renal function

Symptomatic heart failure classified as NYHA class II-IV

Hospitalization for a primary diagnosis of heart failure in the 12-month period preceding randomization

Peripheral edema which in the judgment of the Investigator in believed to be severe and of cardiac origin

History of surgical coronary revascularization (CABG) less than 5 years prior to screening, except in cases of subsequent myocardial infarction

Currently scheduled for arterial revascularization procedures

Systemic corticosteroid therapy for > 2 weeks within 3 months prior to screening

Diagnosed or treated malignancy (except for treated basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years

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Muscle Shoals, Alabama 35662, United States

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Gilbert, Arizona 85295, United States

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Phoenix, Arizona 85018, United States

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Tucson, Arizona 85724, United States

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Cudahy, California 90201, United States

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Encino, California 91436, United States

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Fresno, California 93720, United States

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Fresno, California 93721, United States

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Hawaiian Gardens, California 90716, United States

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Huntington Beach, California 92646, United States

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Lomita, California 90717, United States

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Long Beach, California 90807, United States

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Los Angeles, California 90017, United States

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Los Angeles, California 90036, United States

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Los Angeles, California 90057, United States

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Los Gatos, California 95032, United States

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North Hollywood, California 91606, United States

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Northridge, California 91325, United States

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Roseville, California 95661, United States

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Sacramento, California 95821, United States

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San Diego, California 92103, United States

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Stockton, California 95207, United States

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Thousand Oaks, California 91360, United States

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Torrance, California 90502, United States

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Tustin, California 92780, United States

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Ventura, California 90265, United States

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Denver, Colorado 80209, United States

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Atlantis, Florida 33462, United States

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Bradenton, Florida 34208, United States

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Brooksville, Florida 34601, United States

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Clearwater, Florida 33755, United States

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Clearwater, Florida 33756, United States

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DeLand, Florida 32720, United States

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Fort Lauderdale, Florida 33316, United States

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Hialeah, Florida 33012, United States

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Hialeah, Florida 33013, United States

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Kissimmee, Florida 34741, United States

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Miami, Florida 33135, United States

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Miami, Florida 33144, United States

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Miami Beach, Florida 33140, United States

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New Port Richey, Florida 34652, United States

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Orlando, Florida 32822, United States

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Panama City, Florida 32401, United States

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Pinellas Park, Florida 33781, United States

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Port Charlotte, Florida 33952, United States

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Sarasota, Florida 34239, United States

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St. Petersburg, Florida 33709, United States

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Tampa, Florida 33613, United States

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West Palm Beach, Florida 33401, United States

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Winter Park, Florida 32789, United States

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Augusta, Georgia 30909, United States

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Decatur, Georgia 30030, United States

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Dunwoody, Georgia 30338, United States

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Eagle, Idaho 83616, United States

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Idaho Falls, Idaho 83404, United States

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Melrose Park, Illinois 60160, United States

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Brownsburg, Indiana 46112, United States

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Evansville, Indiana 47714, United States

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Valparaiso, Indiana 46383, United States

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Council Bluffs, Iowa 51501, United States

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Iowa City, Iowa 52242, United States

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Wichita, Kansas 67203, United States

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Lexington, Kentucky 40504, United States

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Louisville, Kentucky 40213, United States

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Owensboro, Kentucky 42303, United States

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Alexandria, Louisiana 71301, United States

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Bangor, Maine 04401, United States

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Baltimore, Maryland 21201, United States

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Baltimore, Maryland 21209, United States

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Baltimore, Maryland 21215, United States

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Oxon Hill, Maryland 20745, United States

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Haverhill, Massachusetts 01830, United States

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Traverse City, Michigan 49684, United States

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Fall Rivers, Mississippi 02720, United States

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Kansas City, Missouri 64111, United States

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Bellevue, Nebraska 68005, United States

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Fremont, Nebraska 68025, United States

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Las Vegas, Nevada 89106, United States

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Las Vegas, Nevada 89121, United States

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Las Vegas, Nevada 89123, United States

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Elizabeth, New Jersey 07202, United States

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Albany, New York 12206-1098, United States

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North Massapequa, New York 11758, United States

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Smithtown, New York 11787, United States

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Syracuse, New York 13202, United States

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Westfield, New York 14787, United States

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Elizabeth City, North Carolina 27909, United States

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Morganton, North Carolina 28655, United States

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Raleigh, North Carolina 27609, United States

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Shelby, North Carolina 28150, United States

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Winston-Salem, North Carolina 27103, United States

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Fargo, North Dakota 58103, United States

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Akron, Ohio 44313, United States

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Gallipolis, Ohio 45631, United States

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Kettering, Ohio 45429, United States

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Zanesville, Ohio 43701, United States

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Oklahoma City, Oklahoma 73103, United States

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Tulsa, Oklahoma 74104, United States

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Portland, Oregon 97220, United States

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Beaver, Pennsylvania 15009, United States

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Doylestown, Pennsylvania 18901, United States

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Fleetwood, Pennsylvania 19522, United States

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Harleysville, Pennsylvania 19438, United States

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Jersey Shore, Pennsylvania 17740, United States

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Lansdale, Pennsylvania 19446, United States

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Philadelphia, Pennsylvania 19114, United States

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Pittsburgh, Pennsylvania 15202, United States

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Sellersville, Pennsylvania 18960, United States

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Uniontown, Pennsylvania 15401, United States

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Clinton, South Carolina 29325, United States

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Greer, South Carolina 29651, United States

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Murrells Inlet, South Carolina 29576, United States

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Varnville, South Carolina 29944, United States

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Dakota Dunes, South Dakota 57049, United States

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Chattanooga, Tennessee 37404-3230, United States

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Chattanooga, Tennessee 37411, United States

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Jackson, Tennessee 38305, United States

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Knoxville, Tennessee 27912, United States

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Nashville, Tennessee 37203, United States

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Arlington, Texas 76012, United States

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Corpus Christi, Texas 78404, United States

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Dallas, Texas 75230, United States

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El Paso, Texas 79925, United States

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Houston, Texas 77030, United States

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Houston, Texas 77036, United States

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Houston, Texas 77074, United States

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Kingwood, Texas 77339, United States

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McAllen, Texas 78501, United States

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New Braunfels, Texas 78130, United States

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North Richland Hills, Texas 76180, United States

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San Antonio, Texas 78224, United States

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San Antonio, Texas 78229, United States

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Tyler, Texas 75701, United States

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Bountiful, Utah 84010, United States

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Draper, Utah 84020, United States

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Murray, Utah 84123, United States

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Salt Lake City, Utah 84124, United States

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Burke, Virginia 22015, United States

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Manassas, Virginia 20110, United States

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Suffolk, Virginia 23435, United States

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Port Orchard, Washington 98366, United States

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Spokane, Washington 99207, United States

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Madison, Wisconsin 53719, United States

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Caba, C1119ACN, Argentina

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Caba, C1428DCO, Argentina

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Camperdown, New South Wales 2050, Australia

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Gosford, New South Wales 2250, Australia

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Kogarah, New South Wales 2217, Australia

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Wollongong, New South Wales 2500, Australia

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South Brisbane, Queensland 4101, Australia

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Adelaide, South Australia 5000, Australia

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Woodville, South Australia 5011, Australia

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Launceston, Tasmania 7250, Australia

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Geelong, Victoria 3220, Australia

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Heidelberg, Victoria 3081, Australia

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Melbourne, Victoria 3004, Australia

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Armadale, Western Australia 6112, Australia

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Perth, Western Australia 6009, Australia

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Braunau am Inn, 5280, Austria

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Feldkirch, 6800, Austria

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Graz, 8036, Austria

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Vienna, 1130, Austria

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Kelowna, British Columbia V1Y 1E4, Canada

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Surrey, British Columbia V3V 1Z2, Canada

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Winnipeg, Manitoba R3E 3P4, Canada

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Bathurst, New Brunswick E2A 4X7, Canada

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Cambridge, Ontario N1R 6V6, Canada

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Collingwood, Ontario L9Y 1W3, Canada

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Greater Sudbury, Ontario P3C 5K7, Canada

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Hamilton, Ontario L8L 2X2, Canada

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London, Ontario N5W 6A2, Canada

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London, Ontario N6G 0J4, Canada

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Newmarket, Ontario L3Y 5G8, Canada

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Newmarket, Ontario L3Y 8C3, Canada

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Sarnia, Ontario N7T 4X3, Canada

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Toronto, Ontario M5G 2C4, Canada

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Toronto, Ontario M9V 4B4, Canada

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Quebec, Prince Edward Island G1V 4G2, Canada

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Chicoutimi, Quebec G7H 5H6, Canada

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Chicoutimi, Quebec G7H 7Y8, Canada

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Granby, Quebec J2G 8Z9, Canada

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Lachine, Quebec H8S 2E4, Canada

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Laval, Quebec H7M 3L9, Canada

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Longueuil, Quebec J4M 2X1, Canada

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Montreal, Quebec H1T 1C8, Canada

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Montreal, Quebec H1T 3Y7, Canada

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Montreal, Quebec H2P 2M1, Canada

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Montreal, Quebec H3G 1A4, Canada

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Montreal, Quebec H4N 2W2, Canada

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Québec, Quebec G3K 2P8, Canada

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Saint-Charles-Borromée, Quebec J6E 6J2, Canada

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Saint-Jérôme, Quebec J7Z 5T3, Canada

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Saint-Lambert, Quebec J4P 2H4, Canada

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Sherbrooke, Quebec J1H 5N4, Canada

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Ste-Foy, Quebec G1W 4R4, Canada

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Terrebonne, Quebec J6V 1S8, Canada

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Saskatoon, Saskatchewan S7K 3H3, Canada

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Las Condes, 7500710, Chile

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Santiago, 7500010, Chile

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Santiago, 7500347, Chile

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Santiago, 7500710, Chile

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Temuco, 4781156, Chile

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Temuco, 4790869, Chile

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Temuco, 4813299, Chile

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Barranquila, Colombia

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Barranquilla, Colombia

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Bogotá, Colombia

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Cartagena, Colombia

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Floridablanca, Colombia

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Medellín, Colombia

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Beroun, 266 01, Czechia

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Brno, 601 77, Czechia

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Brno, 625 00, Czechia

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Jihlava, 586 33, Czechia

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Liberec, 460 63, Czechia

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Prague, 100 34, Czechia

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Prague, 128 08, Czechia

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Prague, 140 21, Czechia

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Prague, 140 59, Czechia

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Prague, 149 00, Czechia

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Prague, 150 06, Czechia

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Prague, 150 30, Czechia

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Prague, 158 00, Czechia

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Praha 4 - Krc, 140 59, Czechia

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Slaný, 274 51, Czechia

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Třebíč, 674 01, Czechia

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Narva, 20307, Estonia

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Tallinn, 10138, Estonia

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Tartu, 50410, Estonia

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Tartu, 51014, Estonia

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Berlin, 10117, Germany

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Berlin, 13125, Germany

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Bochum, 44787, Germany

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Charlottenburg, 14050, Germany

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Chemnitz, 09111, Germany

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Cologne, 50937, Germany

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Damme, 49401, Germany

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Dresden, 01067, Germany

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Frankfurt, 60596, Germany

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Frankfurt, 65929, Germany

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Hanover, 30159, Germany

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Homburg/Saar, 66421, Germany

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Kassel, 34121, Germany

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Köthen, 06366, Germany

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Leipzig, 04103, Germany

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Magdeburg, 39104, Germany

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Mönchengladbach, 41063, Germany

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Münster, 48145, Germany

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Neunkirchen, 66539, Germany

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Wangen, 88239, Germany

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Balatonfüred, 8230, Hungary

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Budapest, 1023, Hungary

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Budapest, 1027, Hungary

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Budapest, 1036, Hungary

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Budapest, 1085, Hungary

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Budapest, 1097, Hungary

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Budapest, 1125, Hungary

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Budapest, 1131, Hungary

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Debrecen, 4032, Hungary

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Gyöngyös, 3200, Hungary

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Mosonmagyaróvár, 9200, Hungary

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Nyíregyháza, 4400, Hungary

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Pápa, 8500, Hungary

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Szeged, 6720, Hungary

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Székesfehérvár, 8000, Hungary

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Szolnok, 5004, Hungary

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Zalaegerszeg, 8900, Hungary

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Giv‘atayim, 53583, Israel

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Naples, Campania 80122, Italy

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Naples, Campania 80131, Italy

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Bologna, Emilia-Romagna 40133, Italy

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Rome, Lazio 00128, Italy

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Rome, Lazio 00185, Italy

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Milan, Lombardy 20132, Italy

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Milan, Lombardy 20138, Italy

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Pavia, Lombardy 27100, Italy

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Catania, Sicily 95122, Italy

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Palermo, Sicily 90127, Italy

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Pesaro, The Marches 61121, Italy

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Massa, Tuscany 54100, Italy

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Tochigi, 329-0498, Japan

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Liepāja, 3400, Latvia

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Riga, LV-1002, Latvia

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Riga, LV-1012, Latvia

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Riga, LV-1024, Latvia

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Riga, LV-1058, Latvia

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Kaunas, 48259, Lithuania

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Kaunas, 50184, Lithuania

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Kaunas, LT-47144, Lithuania

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Vilnius, LT-02169, Lithuania

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Johor Bahru, 80100, Malaysia

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Kuala Lumpur, 59100, Malaysia

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Kuala Selangor, 68100, Malaysia

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Perak, 34000, Malaysia

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Sabak Bernam, 88300, Malaysia

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Sarawak, 94300, Malaysia

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Aguascalientes, 20234, Mexico

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México, 03300, Mexico

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Monclova, 25750, Mexico

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Monterrey, 64460, Mexico

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Xalapa, 91020, Mexico

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Bialystok, 15-276, Poland

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Gdynia, 81-384, Poland

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Gdynia, 81-472, Poland

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Katowice, 40-748, Poland

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Katowice, 40-954, Poland

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Krakow, 30-015, Poland

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Krakow, 30-082, Poland

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Krakow, 31-202, Poland

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Krakow, 31-261, Poland

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Lodz, 90-242, Poland

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Lublin, 20-044, Poland

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Lublin, 20-093, Poland

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Nowy Sącz, 33-300, Poland

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Opole, 45-367, Poland

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Rzeszów, 35-055, Poland

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Warsaw, 01-192, Poland

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Wroclaw, 50-088, Poland

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Baia Mare, 430123, Romania

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Bucharest, 010507, Romania

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Bucharest, 010825, Romania

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Bucharest, 020359, Romania

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Bucharest, 050098, Romania

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Bucharest, 061119, Romania

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Bucharest, 800578, Romania

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Craiova, 200642, Romania

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Oradea, 410169, Romania

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Ploieşti, 100163, Romania

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Târgu Mureş, 540124, Romania

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Kemerovo, Russia

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Saint Petersburg, 199034, Russia

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Tomsk, 634012, Russia

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Pretoria, 0103, South Africa

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Pretoria West, 0183, South Africa

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Busan, 602-715, South Korea

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Busan, 602-739, South Korea

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Daejeon, 35015, South Korea

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Gwangju, 61469, South Korea

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Gyeonggi-do, 10380, South Korea

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Gyeonggi-do, 11765, South Korea

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Gyeonggi-do, 410-773, South Korea

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Gyeonggi-do, 431-070, South Korea

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Gyeonggi-do, 443-380, South Korea

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Incheon, 405-760, South Korea

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Seoul, 05030, South Korea

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Seoul, 06273, South Korea

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Seoul, 130-872, South Korea

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Seoul, 137-701, South Korea

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Seoul, 156-707, South Korea

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Suwon, 442-723, South Korea

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Wŏnju, 220-701, South Korea

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Albacete, Albacete 02006, Spain

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Sant Joan d'Alacant, Alicante 3550, Spain

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Almería, Almeria 04009, Spain

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Palma de Mallorca, Balearic Islands 07014, Spain

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Barcelona, Barcelona 08003, Spain

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Barcelona, Barcelona 08035, Spain

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Barcelona, Barcelona 08036, Spain

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Barcelona, Barcelona, Spain

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L'Hospitalet de Llobregat, Barcelona 08907, Spain

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Girona, Girona 17007, Spain

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Granada, Granada 18012, Spain

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Huelva, Huelva 21005, Spain

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Santiago de Compostela, La Coruña 15706, Spain

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Lleida, Lerida 25198, Spain

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Madrid, Madrid 41013, Spain

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Málaga, Malaga 29006, Spain

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Málaga, Malaga 29009, Spain

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Málaga, Malaga 29010, Spain

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Seville, Sevilla 41009, Spain

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Tarragona, Tarragona 43007, Spain

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Alzira, Valencia 46600, Spain

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Valencia, Valencia 46014, Spain

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Malmö, 205 02, Sweden

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Stockholm, 111 35, Sweden

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Stockholm, 113 61, Sweden

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Stockholm, 171 76, Sweden

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Bangkok, 10330, Thailand

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Khon Kaen, 40002, Thailand

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Birmingham, B15 2SQ, United Kingdom

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Cardiff, CF14 5GJ, United Kingdom

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Chorley, PR7 7NA, United Kingdom

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Edinburgh, EH16 4TJ, United Kingdom

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Glasgow, G12 8QQ, United Kingdom

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Glasgow, G20 0SP, United Kingdom

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Inverness, IV2 4AG, United Kingdom

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Liverpool, L22 0LG, United Kingdom

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Liverpool, L9 7AL, United Kingdom

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Manchester, M15 6SX, United Kingdom

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Mortimer, RG7 3SQ, United Kingdom

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Reading, RG2 0TG, United Kingdom

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Soham, Ely, CB7 5JD, United Kingdom