A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
A Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Effect of Inclisiran on Preventing Major Adverse Cardiovascular Events in High-risk Primary Prevention Patients (VICTORION-1 PREVENT)
1 other identifier
interventional
14,012
40 countries
917
Brief Summary
CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic cardiovascular disease (ASCVD) event will significantly reduce the risk of 4-Point-Major Adverse Cardiovascular Events (4P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI), non-fatal ischemic stroke, and urgent coronary revascularization, compared to placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2023
Longer than P75 for phase_3
917 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2023
CompletedFirst Posted
Study publicly available on registry
February 22, 2023
CompletedStudy Start
First participant enrolled
March 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 16, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 16, 2029
April 14, 2026
April 1, 2026
6.1 years
February 13, 2023
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to the first occurrence of 4P-MACE
4-Point-Major Adverse Cardiovascular Events (4P-MACE): composite of cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, and urgent coronary revascularization.
Time to the first occurrence of 4P-MACE (up to approximately 75 months)
Secondary Outcomes (5)
Time to the first occurrence of 3P-MACE
Time to the first occurrence of 3P-MACE (up to approximately 75 months)
Total number of first or repeated CV events (4P MACE)
up to 75 months
Total number of first or repeated CV events (3P MACE)
up to 75 months
Time to occurrence of Cardiovascular death
Time to Cardiovascular death (up to 75 months)
Time to occurrence of death due to any reason
Time to all-cause mortality (up to 75 months)
Study Arms (2)
Inclisiran sodium 300mg
EXPERIMENTALInclisiran sodium 300 mg in 1.5 mL solution for injection (subcutaneous) in pre-filled syringe. Randomized in a 1:1 ratio with matching placebo
Placebo
PLACEBO COMPARATORMatching placebo in 1.5ml pre-filled syringe. Randomized in a 1:1 ratio with Inclisiran.
Interventions
Subcutaneous injection in pre-filled syringe.
Eligibility Criteria
You may qualify if:
- At an increased risk for a first MACE (i.e., no prior major ASCVD event), defined as any one of the following:
- Evidence of atherosclerotic coronary artery disease (CAD) on computer tomography (CT) or invasive coronary angiogram defined as a coronary artery stenosis ≥20% but \<50% in the left main coronary artery or stenosis ≥20% but \<70% in any other major epicardial coronary artery, or
- Coronary artery calcium (CAC) score obtained by CT-scan ≥100 Agatston units, or
- High 10-year ASCVD risk ≥20%, or
- Intermediate 10-year ASCVD risk 7.5% - \<20% with at least 2 risk-enhancing factors.
- LDL-C ≥70 mg/dL (≥1.81 mmol/L) but \<190 mg/dL (\<4.91 mmol/L) at the screening visit. If on a background lipid lowering therapy, the dose should be stable for at least 4 weeks prior to the screening visit and the participant should be willing to remain on this background therapy for the entire duration of the study.
You may not qualify if:
- History of major ASCVD event.
- History of, or planned, ischemia-driven revascularization in a coronary or extracoronary arterial bed prior to randomization
- Absence of coronary atherosclerosis on a CT angiogram or an invasive coronary angiogram in the 2 years prior to randomization
- Coronary artery calcium (CAC) score of 0 obtained in the 2 years prior to randomization
- Active liver disease or hepatic dysfunction
- Previous, current, or planned treatment with a monoclonal antibody (mAb) directed toward proprotein convertase subtilisin/kexin type 9 (PCSK9) (e.g., evolocumab, alirocumab)
- Pregnant or nursing (lactating) women
- Women of childbearing potential unless they are using effective methods of contraception while taking study treatment which includes for 6 months after last study drug administration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (985)
Central Alabama Research
Birmingham, Alabama, 35209, United States
UAB St Vincents
Birmingham, Alabama, 35211, United States
Eastern Shore Research Institute
Fairhope, Alabama, 36532, United States
G and L Research LLC
Foley, Alabama, 36535, United States
Longwood Research
Huntsville, Alabama, 35801, United States
CB Flock Corporation
Mobile, Alabama, 36608, United States
Mobile Heart Specialists
Mobile, Alabama, 36608, United States
The Center for Clinical Trials
Saraland, Alabama, 36571, United States
Synexus
Glendale, Arizona, 85306, United States
Lenzmeier Family Practice
Glendale, Arizona, 85308, United States
Clinical Research Inst of Arizona
Sun City West, Arizona, 85375, United States
Clinical Research Advantage Fiel Family and Sports Med, PC
Tempe, Arizona, 85283, United States
Synexus Clinical Research US Inc
Tucson, Arizona, 85741, United States
Cardiovascular Res Found
Beverly Hills, California, 90210, United States
National Heart Institute
Beverly Hills, California, 90211, United States
Alliance Clinical
Canoga Park, California, 91303, United States
Inland Psychiatric Medical Group
Chino, California, 91710, United States
Valley Clinical Trials Inc
Covina, California, 91723, United States
Keck Medical Center USC
Los Angeles, California, 90033, United States
Charles R Drew University of Medicine and Science
Los Angeles, California, 90059, United States
C for Endo Diabetes and MD
Newhall, California, 91321, United States
California Medical Research Associates Inc
Northridge, California, 91324, United States
Valley Clinical Trials
Northridge, California, 91325, United States
Stanford University Medical Center
Palo Alto, California, 94304, United States
Clinical Trials Research Sacramento
Sacramento, California, 95821-2134, United States
Cordova Clinical Research
Sacramento, California, 95841, United States
University of California San Diego
San Diego, California, 92103, United States
Kaiser Permanente San Diego
San Diego, California, 92108, United States
Acclaim Clinical Research
San Diego, California, 92120, United States
San Diego Cardiac Center
San Diego, California, 92123, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
Harbor UCLA Medical Center
Torrance, California, 90502, United States
Cardiology Associates Medical Group
Ventura, California, 93003, United States
Blue Coast Research Center LLC
Vista, California, 92081, United States
Interv Cardiology Med Grp
West Hills, California, 91307, United States
South Denver Cardiology Associates PC
Littleton, Colorado, 80120, United States
Cardiology Ass of Fairfield County
Stamford, Connecticut, 06905, United States
Chase Medical Research LLC
Waterbury, Connecticut, 06708, United States
Excel Medical Clinical Trials LLC
Boca Raton, Florida, 33434, United States
Nova Clinical Research LLC
Bradenton, Florida, 34209, United States
Bay Care Medical Group
Clearwater, Florida, 33756, United States
Clearwater Cardiovascular and Interventional Consultants
Clearwater, Florida, 33756, United States
Tampa Bay Medical Research
Clearwater, Florida, 33761, United States
Cardiology Research Associates
Daytona Beach, Florida, 32117, United States
Hillcrest Medical Research
DeLand, Florida, 32720, United States
Personal Physicians Care
Delray Beach, Florida, 33445, United States
Fleming Island Ctr Clinical Res.
Fleming Island, Florida, 32003, United States
Proactive Clinical Research
Fort Lauderdale, Florida, 33308, United States
Qway Research
Hialeah, Florida, 33010, United States
Indago Research and Health Ctr Inc
Hialeah, Florida, 33012, United States
Sister Life Research Inc
Hialeah, Florida, 33013, United States
Center for Diabetes and Endocrine Care
Hollywood, Florida, 33021, United States
South Florida Rsrch Solutions LLC
Hollywood, Florida, 33021, United States
Zenith Clinical Research
Hollywood, Florida, 33021, United States
Encore Medical Research
Hollywood, Florida, 33024, United States
UF Health Science Center
Jacksonville, Florida, 32209, United States
East Coast Institute for Research
Jacksonville, Florida, 32216, United States
Columbus Clinical Services LLC
Miami, Florida, 33125, United States
Finlay Medical Research
Miami, Florida, 33126, United States
Infinite Clinical Research
Miami, Florida, 33133, United States
Springs Medical And Research
Miami, Florida, 33135, United States
L and C Professional Medical Institute
Miami, Florida, 33144, United States
Regenerate Clinical Trial
Miami, Florida, 33155, United States
International Research Associates, LLC
Miami, Florida, 33156, United States
A&A Research Group Inc
Miami, Florida, 33186, United States
Meridian International Research
Miami Gardens, Florida, 33014, United States
Inpatient Research Clinical LLC
Miami Lakes, Florida, 33014, United States
RM Medical Research Inc
Miami Lakes, Florida, 33014, United States
FXM Clin Res Miramar LLC
Miramar, Florida, 33027, United States
Advent Health Orlando
Orlando, Florida, 32803, United States
CTMD Research
Palm Springs, Florida, 33406, United States
DBC Research USA
Pembroke Pines, Florida, 33029, United States
Fam Medical Specialists Of Fl Plc
Plant City, Florida, 33563, United States
St Johns Center
Ponte Vedra, Florida, 32801, United States
Peace River Cardiovascular Center
Port Charlotte, Florida, 33952, United States
East Coast Inst for Research LLC
Saint Augustine, Florida, 32086, United States
Cardiovascular Center Of Sarasota
Sarasota, Florida, 34239, United States
Advanced Medical Research Center
St. Petersburg, Florida, 33713, United States
James A Haley Veterans Hospital
Tampa, Florida, 33612, United States
BayCare Health System
Tampa, Florida, 33705, United States
Cardiology Partners Clinical Research Institute
Wellington, Florida, 33449, United States
East Coast Research
Canton, Georgia, 30114, United States
Javara Research
Fayetteville, Georgia, 30214, United States
The Jones Center For Diabetes And Endocrine Wellness
Macon, Georgia, 31210, United States
Atlanta Heart Specialists LLC
Tucker, Georgia, 30084, United States
East West Research Institute
Honolulu, Hawaii, 96814, United States
Kootenai Heart Clinic-Sandpoint
Sandpoint, Idaho, 83864, United States
Endeavor Health Clinical Op- NCH
Arlington Heights, Illinois, 60005, United States
Chicago Clinical Research Inst
Chicago, Illinois, 60607, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Flourish Research
Grandwood Park, Illinois, 60031, United States
Cardiovascular Services
Peoria, Illinois, 61602, United States
Beacon Health System
Elkhart, Indiana, 46514, United States
Franciscan Health Services Research Center
Indianapolis, Indiana, 46237, United States
Buynak Clinical Research PC
Valparaiso, Indiana, 46383, United States
West Broadway Clinic
Council Bluffs, Iowa, 51501, United States
Hutchinson Clinic
Hutchinson, Kansas, 67502, United States
Cotton O Neil Clinical Res Center
Topeka, Kansas, 66606, United States
Kansas Heart Hospital
Wichita, Kansas, 67226, United States
Graves Gilbert Clinic
Bowling Green, Kentucky, 42101, United States
The Research Group
Lexington, Kentucky, 40503, United States
Research Integrity LLC
Owensboro, Kentucky, 42303, United States
Cardiovascular Associates Research
Covington, Louisiana, 70433, United States
Louisiana Heart Center Research
Covington, Louisiana, 70433, United States
Avant Research Associates LLC
Crowley, Louisiana, 70526, United States
North Shore Heart and Vascular
Mandeville, Louisiana, 70448, United States
Bethesda Medical Clinic
Marrero, Louisiana, 70072, United States
NOLA Care Clinical Research
Metairie, Louisiana, 70006, United States
Omega Clinical Research
Metairie, Louisiana, 70006, United States
CV Ins of the South
Opelousas, Louisiana, 70570, United States
Cardiovascular Solutions LLC
Shreveport, Louisiana, 71103, United States
Louisiana Heart Center Research
Slidell, Louisiana, 70458, United States
Monroe Research Llc
West Monroe, Louisiana, 71291, United States
Southern Clinical Research
Zachary, Louisiana, 70791, United States
Northeast Cardiology Associates
Bangor, Maine, 04401, United States
Ascension Saint Agnes Heart Care
Baltimore, Maryland, 21229, United States
Metropolitan Cardiovascular Consultants Llc
Beltsville, Maryland, 20705, United States
Johns Hopkins University
Columbia, Maryland, 21044, United States
Anderson Medical Research
Ft. Washington, Maryland, 20744, United States
Capitol Cardiology Associates
Lanham, Maryland, 20706, United States
MGH
Boston, Massachusetts, 02114 2696, United States
Umass Memorial Medical Center
Worcester, Massachusetts, 01655, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
AA Medical Research Center
Flint, Michigan, 48504, United States
MyMichigan Medical Center Midland
Midland, Michigan, 48670, United States
Central Michigan University
Saginaw, Michigan, 48601, United States
Troy Internal Medicine Research
Troy, Michigan, 48098, United States
Trinity Health Michigan Heart
Ypsilanti, Michigan, 48197, United States
Essentia Health
Duluth, Minnesota, 55805, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407-3799, United States
Synexus Clinical Research US Inc
Richfield, Minnesota, 55432, United States
Park Nicollet Institute
Saint Louis Park, Minnesota, 55416, United States
Fairview Health Services
Saint Paul, Minnesota, 55103, United States
Elite Clinical Research LLC
Jackson, Mississippi, 39202, United States
Jackson Heart Clinic
Jackson, Mississippi, 39216, United States
VAMC Research-G V Sonny Montgomery Clinic
Jackson, Mississippi, 39216, United States
David M Headley Clinic
Port Gibson, Mississippi, 39150, United States
Cardiology Associates of North MS
Tupelo, Mississippi, 38801, United States
StudyMetrix Research
City of Saint Peters, Missouri, 63303, United States
Kansas City VA Medical Center
Kansas City, Missouri, 64128, United States
Barnes Jewish Hosp-Washington Univ
St Louis, Missouri, 63110, United States
St Louis V A Medical Center
St Louis, Missouri, 63125-4181, United States
St Louis Heart and Vascular
St Louis, Missouri, 63136, United States
Synexus Clinical Research US Inc
St Louis, Missouri, 63141, United States
Mercury Street Medical
Butte, Montana, 59701, United States
Nebraska Heart Institute
Lincoln, Nebraska, 68510, United States
Lincoln Internal Medicine Associates
Lincoln, Nebraska, 68516, United States
University of Nebraska Med Center
Omaha, Nebraska, 68198, United States
Las Vegas Endocrinology
Henderson, Nevada, 89074, United States
AB Clinical Trials
Las Vegas, Nevada, 89119, United States
Clinical Research of South Nevada
Las Vegas, Nevada, 89121, United States
Advanced Heart Care
Bridgewater, New Jersey, 08807, United States
Cardiovas Assoc of Delaware Valley
Elmer, New Jersey, 08318, United States
New Jersey Heart
Linden, New Jersey, 07036, United States
Albany Medical College
Albany, New York, 12206, United States
Capital Cardiology Associates
Albany, New York, 12211, United States
New York Presbyterian Queens
Flushing, New York, 11355, United States
Mid Hudson Medical Research PLLC
New Windsor, New York, 12553, United States
Hudson Valley Urology
Poughkeepsie, New York, 12601, United States
Rochester Clinical Research
Rochester, New York, 14609, United States
Clinical Research Advantage
The Bronx, New York, 10468, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
Great Lakes Medical Research
Westfield, New York, 14787, United States
Cary Research Group
Cary, North Carolina, 27511, United States
Moses Cone Hospital
Greensboro, North Carolina, 27401, United States
Medication Management LLC
Greensboro, North Carolina, 27405, United States
IMA Research
Mount Airy, North Carolina, 27030, United States
Multispecialty Research Ass Of NC
Raleigh, North Carolina, 27609, United States
Accellacare
Statesville, North Carolina, 28625, United States
Adv Imaging Prev and Clin Research
Wilmington, North Carolina, 28401, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Lillestol Research LLC
Fargo, North Dakota, 58103, United States
Altru Health Research Dept.
Grand Forks, North Dakota, 58201, United States
Aultman Hospital
Canton, Ohio, 44710, United States
Synexus Clinical Research US Inc
Cincinnati, Ohio, 45236, United States
Synexus Clinical Research
Columbus, Ohio, 43212, United States
Primed Clinical Research
Dayton, Ohio, 45429, United States
Providence Medical Group
Dayton, Ohio, 45439, United States
NexGen Research
Lima, Ohio, 45801, United States
Rama Research LLC
Marion, Ohio, 43302, United States
Heart House Research Foundation
Springfield, Ohio, 45504, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
South Oklahoma Heart Research LLC
Oklahoma City, Oklahoma, 73135, United States
CCT Hatboro Medical Associates
Horsham, Pennsylvania, 19044, United States
Capital Area Research LLC
Newport, Pennsylvania, 17074, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Frontier Clinical Research LLC
Smithfield, Pennsylvania, 15478, United States
Care Access
Warwick, Rhode Island, 02886, United States
Columbia VA Health Care System
Columbia, South Carolina, 29209, United States
Bon Secours Medical Group
Greenville, South Carolina, 29607, United States
TRIBE Clinical Research
Greer, South Carolina, 29651, United States
Trident Cardiology
Ladson, South Carolina, 29465, United States
Main Street Physicians Care
Little River, South Carolina, 29566, United States
Care Access Rapid City
Rapid City, South Dakota, 57701, United States
Monument Health Clinical Research
Rapid City, South Dakota, 57701, United States
Wellmont CVA Heart Institute
Greenville, Tennessee, 37745, United States
Apex Cardiology Research Associates of Jackson
Jackson, Tennessee, 38301, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
New Phase Research And Development
Knoxville, Tennessee, 37909, United States
Accellacare
Knoxville, Tennessee, 37938, United States
Cardiovascular Res of Knoxville LLC
Powell, Tennessee, 37849, United States
Tennessee Center For Clinical Trials
Tullahoma, Tennessee, 37388, United States
Pharma Tex Research
Amarillo, Texas, 79106, United States
Amarillo Heart Clin Rsh Inst
Amarillo, Texas, 79124, United States
North Hills Medical Research Inc
Bedford, Texas, 76021, United States
Clinical Research Solution
Cypress, Texas, 77429, United States
VA North Texas Health Care System
Dallas, Texas, 75216, United States
Zenos Clinical Research
Dallas, Texas, 75230, United States
SW Family Medicine Associates
Dallas, Texas, 75235, United States
Doctors Hospital at Renaissance
Edinburg, Texas, 78539, United States
David Turbay MD PLLC
El Paso, Texas, 79905, United States
Texas Health Physicians Group
Fort Worth, Texas, 76107, United States
East Texas Cardiology PA
Houston, Texas, 77002, United States
Primecare Medical Group
Houston, Texas, 77024, United States
Northwest Houston Cardiology PA
Houston, Texas, 77070, United States
MedCare Pharma LLC
Houston, Texas, 77079, United States
Dallas Heart and Vascular Consultants PA
Houston, Texas, 77084, United States
Texas Cardiology Assocs Of Houston
Kingwood, Texas, 77339, United States
Epic Clinical Research
Lewisville, Texas, 75057, United States
East Texas Research Associates Inc.
Livingston, Texas, 77351, United States
Epic Medical Research
Red Oak, Texas, 75154, United States
Northeast Clinical Research of San Antonio LLC
San Antonio, Texas, 78233, United States
Consano Clinical Research LLC
Shavano Park, Texas, 78231, United States
Javara Research
Stephenville, Texas, 76401, United States
NRG Wellness Center
Sugarland, Texas, 77478, United States
Northwest Houston Clinical Research PLLC
Tomball, Texas, 77375, United States
Comprehensive Center
Weslaco, Texas, 78596, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
Diabetes And Endocrine Specialists
Sandy City, Utah, 84093, United States
Burke Internal Medicine and Research
Burke, Virginia, 22015, United States
Virginia Heart
Falls Church, Virginia, 22042, United States
Heart Care Associates P C
Hopewell, Virginia, 23860, United States
Carient Heart and Vascular
Manassas, Virginia, 20109, United States
Manassas Clinical Research Center
Manassas, Virginia, 20110, United States
Virginia Commonwealth University
Richmond, Virginia, 23298-0111, United States
Roanoke Heart Institute
Roanoke, Virginia, 24014, United States
Centricity Research Suffolk Fam Med
Suffolk, Virginia, 23435, United States
MultiCare Ins Research Innovation
Puyallup, Washington, 98372, United States
Universal Research Group LLC
Tacoma, Washington, 98405, United States
Confluence Health Hospital
Wenatchee, Washington, 98801, United States
West Virginia University Hospital
Morgantown, West Virginia, 26506, United States
Midwest Endocrinology Associates
Milwaukee, Wisconsin, 53215, United States
Cardiovascular Research and Education Foundation, Inc
Wausau, Wisconsin, 54401, United States
Novartis Investigative Site
CABA, Buenos Aires, 1280, Argentina
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CABA, Buenos Aires, 1407, Argentina
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CABA, Buenos Aires, 1425, Argentina
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CABA, Buenos Aires, 1426, Argentina
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Caba, Buenos Aires, C1119ACN, Argentina
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CABA, Buenos Aires, C1221ADC, Argentina
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CABA, Buenos Aires, C1405BCH, Argentina
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CABA, Buenos Aires, C1406BOA, Argentina
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CABA, Buenos Aires, C1414AIF, Argentina
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CABA, Buenos Aires, C1425AGC, Argentina
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Lanús, Buenos Aires, B8000XAV, Argentina
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Mar del Plata, Buenos Aires, 7600, Argentina
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Ramos Mejía, Buenos Aires, B1704ETD, Argentina
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San Martín, Buenos Aires, B1650CSQ, Argentina
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Córdoba, Córdoba Province, 5200, Argentina
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Córdoba, Córdoba Province, X5000, Argentina
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Córdoba, Córdoba Province, X5003DCE, Argentina
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Córdoba, Córdoba Province, X5003DCP, Argentina
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Córdoba, Córdoba Province, X5016KEH, Argentina
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Concepcion Uruguay, Entre Ríos Province, 3260, Argentina
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Paraná, Entre Ríos Province, 3100, Argentina
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Formosa, Formosa Province, P3600, Argentina
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Mendoza, Mendoza Province, 5500, Argentina
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Salta, Salta Province, A4406BPF, Argentina
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San Miguel de Tucumán, San Miguel de Tucuman, T4000ICL, Argentina
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Grandero Baigorria, Santa Fe Province, S2152, Argentina
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Rosario, Santa Fe Province, S2000DBS, Argentina
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Rosario, Santa Fe Province, S2000DSV, Argentina
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Rosario, Santa Fe Province, S200CVD, Argentina
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Santa Fe, Santa Fe Province, S3000FWO, Argentina
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San Miguel, Tucumán Province, 4400, Argentina
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San Miguel Tucuman, Tucumán Province, T4000IFL, Argentina
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Buenos Aires, C1114AAP, Argentina
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Buenos Aires, C1428DCO, Argentina
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Buenos Aires, W3400ABH, Argentina
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Caba, C1015ABO, Argentina
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Caba, C1426, Argentina
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Capital Federal, C1023AAB, Argentina
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Corrientes, 3400, Argentina
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Córdoba, X5000JHA, Argentina
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Córdoba, X5000JHQ, Argentina
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Córdoba, X5002, Argentina
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San Luis, D5702JRS, Argentina
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Santa Fe, S3000EOZ, Argentina
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Garran, Australian Capital Territory, 2605, Australia
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Camperdown, New South Wales, 2050, Australia
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Concord, New South Wales, 2139, Australia
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Auchenflower, Queensland, 4066, Australia
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Sippy Downs, Queensland, 4556, Australia
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Woolloongabba, Queensland, 4102, Australia
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Adelaide, South Australia, 5000, Australia
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Leabrook, South Australia, 5068, Australia
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Hobart, Tasmania, 7000, Australia
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Clayton, Victoria, 3168, Australia
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Heidelberg, Victoria, 3084, Australia
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Malvern East, Victoria, 3145, Australia
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Joondalup, Western Australia, 6027, Australia
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Braunau am Inn, 5280, Austria
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Graz, 8036, Austria
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Linz, 4021, Austria
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Vienna, 1190, Austria
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Genk, Limburg, 3600, Belgium
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Hasselt, Limburg, 3500, Belgium
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Aalst, Oost Vlaanderen, 9300, Belgium
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Dendermonde, 9200, Belgium
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Mechelen, 2800, Belgium
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Maceió, Alagoas, 57051-160, Brazil
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Vitória, Espírito Santo, 29055-450, Brazil
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Salvador, Estado de Bahia, 40170-130, Brazil
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Salvador, Estado de Bahia, 41810-011, Brazil
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Brasília, Federal District, 70390-700, Brazil
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Brasília, Federal District, 70673-416, Brazil
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Brasília, Federal District, 71625-009, Brazil
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Belo Horizonte, Minas Gerais, 30140 062, Brazil
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Belo Horizonte, Minas Gerais, 30150-320, Brazil
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Uberlândia, Minas Gerais, 38400 500, Brazil
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Curitiba, Paraná, 80045-170, Brazil
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Curitiba, Paraná, 80730-150, Brazil
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Rio de Janeiro, Rio de Janeiro, 22061-080, Brazil
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Canoas, Rio Grande do Sul, 92425 900, Brazil
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Pelotas, Rio Grande do Sul, 96015-290, Brazil
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Porto Alegre, Rio Grande do Sul, 90160-093, Brazil
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Porto Alegre, Rio Grande do Sul, 90560-032, Brazil
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Porto Alegre, Rio Grande do Sul, 90880-480, Brazil
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Blumenau, Santa Catarina, 89020-430, Brazil
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Aracaju, Sergipe, 49055-530, Brazil
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Campinas, São Paulo, 13060 080, Brazil
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Ribeirão Preto, São Paulo, 14048-900, Brazil
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Santo André, São Paulo, 09030-010, Brazil
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Sao Jose Rio Preto, São Paulo, 15090 000, Brazil
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São José dos Campos, São Paulo, 12243-280, Brazil
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São Paulo, São Paulo, 01323 000, Brazil
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São Paulo, São Paulo, 01323001, Brazil
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São Paulo, São Paulo, 04012-909, Brazil
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São Paulo, São Paulo, 04266 010, Brazil
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Votuporanga, São Paulo, 15500-269, Brazil
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Campinas, 13092-133, Brazil
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Rio de Janeiro, 20241-180, Brazil
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Sofia, Bulgaria, 1202, Bulgaria
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Burgas, Burgas, 8000, Bulgaria
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Blagoevgrad, 270 0, Bulgaria
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Burgas, 8001, Bulgaria
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Gabrovo, 5300, Bulgaria
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Kyustendil, 2500, Bulgaria
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Pleven, 5800, Bulgaria
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Plovdiv, 4002, Bulgaria
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Sandanski, 2800, Bulgaria
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Sofia, 1233, Bulgaria
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Sofia, 1504, Bulgaria
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Sofia, 1510, Bulgaria
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Sofia, 1606, Bulgaria
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Sofia, 1750, Bulgaria
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Stara Zagora, 6000, Bulgaria
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Varna, 9010, Bulgaria
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Veliko Tarnovo, 5000, Bulgaria
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Calgary, Alberta, T2H 2G4, Canada
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Edmonton, Alberta, T6K 4C1, Canada
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Red Deer, Alberta, T4P 1K4, Canada
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Kelowna, British Columbia, V1Y 3J8, Canada
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Vancouver, British Columbia, V6Z 1Y6, Canada
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Moncton, New Brunswick, E1G 1A7, Canada
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Halifax, Nova Scotia, B3H 2Y9, Canada
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New Minas, Nova Scotia, B4N 3R7, Canada
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Barrie, Ontario, L4N 7L3, Canada
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Brampton, Ontario, L6S 0C6, Canada
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Etobicoke, Ontario, M9R 4E1, Canada
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Guelph, Ontario, N1H 1B1, Canada
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Hamilton, Ontario, L8L 5G4, Canada
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London, Ontario, N6A 5W9, Canada
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Napean, Ontario, K2J 0V2, Canada
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Newmarket, Ontario, L3Y 2P6, Canada
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North York, Ontario, M6B 3H7, Canada
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Oshawa, Ontario, L1J 2K9, Canada
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Scarborough Village, Ontario, M1B 5N1, Canada
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Thornhill, Ontario, L4J 8L7, Canada
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Toronto, Ontario, M4G 3E8, Canada
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Lévis, Quebec, G6W 5M6, Canada
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Mirabel, Quebec, J7J 2K8, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Québec, Quebec, G1V 4G5, Canada
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Québec, Quebec, G2J 0C4, Canada
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Terrebonne, Quebec, J6X 4P7, Canada
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Trois-Rivières, Quebec, G9A 4P3, Canada
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Victoriaville, Quebec, G6P 3Z8, Canada
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Guangzhou, Guangdong, 510000, China
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Guangzhou, Guangdong, 510080, China
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Nanning, Guangxi, 530022, China
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Cangzhou, Hebei, 061002, China
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Shijiazhuang, Hebei, 050000, China
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Tangshan, Hebei, 063000, China
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Xingtai, Hebei, 054000, China
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Daqing, Heilongjiang, 163001, China
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Harbin, Heilongjiang, 150000, China
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Harbin, Heilongjiang, 150001, China
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Luoyang, Henan, 471002, China
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Pingdingshan, Henan, 467000, China
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Zhengzhou, Henan, 450003, China
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Huangshi, Hubei, 435000, China
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Wuhan, Hubei, 430081, China
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Changsha, Hunan, 410005, China
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Changsha, Hunan, 410011, China
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Hohhot, Inner Mongolia, 010017, China
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Changzhou, Jiangsu, 213004, China
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Xuzhou, Jiangsu, 221003, China
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Nanchang, Jiangxi, 330009, China
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Tonghua, Jilin, 134000, China
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Dalian, Liaoning, 116000, China
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Jinzhou, Liaoning, 121001, China
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Shenyang, Liaoning, 110016, China
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Yinchuan, Ningxia, 750004, China
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Xianyang, Shaanxi, 712000, China
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Jinan, Shandong, 250021, China
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Jining, Shandong, 272000, China
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Qingdao, Shandong, 266011, China
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Zibo, Shandong, 255000, China
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Xian, Shanxi, 710061, China
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Tianjin, Tianjin Municipality, 300121, China
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Hangzhou, Zhejiang, 310000, China
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Hangzhou, Zhejiang, 310006, China
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Lishui, Zhejiang, 323000, China
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Wenzhou, Zhejiang, 325000, China
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Beijing, 100083, China
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Beijing, 100730, China
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Jining, 272011, China
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Shanghai, 200120, China
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Tianjin, 300140, China
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Medellín, Antioquia, 050010, Colombia
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Medellín, Antioquia, 050021, Colombia
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Barranquilla, Atlántico, 080002, Colombia
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Barranquilla, Atlántico, 080012, Colombia
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Barranquilla, Atlántico, 080020, Colombia
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Barranquilla, Colombia, 080020, Colombia
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Chía, Cundinamarca, 250001, Colombia
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Bucaramanga, Santander Department, 681017, Colombia
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Floridablanca, Santander Department, 57-7, Colombia
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Ibagué, Tolima Department, 730006, Colombia
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Cali, Valle del Cauca Department, 760001, Colombia
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Bogotá, 110221, Colombia
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Cali, 760004, Colombia
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Manizales, 170008, Colombia
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Medellín, 050012, Colombia
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Medellín, 050034, Colombia
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Medellín, 050037, Colombia
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San Gil, 684031, Colombia
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Zagreb, City of Zagreb, 10000, Croatia
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Osijek, County of Osijek-Baranja, 31000, Croatia
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Krapinske Toplice, Croatia, 49 217, Croatia
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Krapinske Toplice, Croatia, 49217, Croatia
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Slavonski Brod, Croatia, 35000, Croatia
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Zagreb, Croatia, 10000, Croatia
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Rijeka, Primorje-Gorski Kotar County, 51000, Croatia
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Opatija, 51410, Croatia
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Osijek, 31000, Croatia
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Pula, 52100, Croatia
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Varaždin, 42000, Croatia
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Vinkovci, 32100, Croatia
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Zagreb, 10000, Croatia
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Chlumec nad Cidlinou, Chlumec Nad Cidlinou, 503 51, Czechia
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Louny, Czech Republic, 440 01, Czechia
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Ostrava, Czech Republic, 725 27, Czechia
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Ústí nad Labem, Czech Republic, 400 01, Czechia
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Ostrava, CZE, 728 80, Czechia
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Přerov, Olomoucký kraj, 750 02, Czechia
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Ostrava, Zabreh, 700 30, Czechia
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Brandýs nad Labem, 250 01, Czechia
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Brno, 602 00, Czechia
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Český Krumlov, 381 01, Czechia
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Hlučín, 748 01, Czechia
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Hodonín, 695 01, Czechia
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Jihlava, 586 01, Czechia
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Kolín, 280 20, Czechia
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Liberec, 46063, Czechia
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Mariánské Lázně, 353 01, Czechia
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Náchod, 547 01, Czechia
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Olomouc, 772 00, Czechia
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Ostrava, 710 00, Czechia
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Pardubice, 532 03, Czechia
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Plzen Bory, 301 00, Czechia
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Prague, 100 34, Czechia
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Prague, 104 00, Czechia
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Prague, 128 08, Czechia
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Prague, 148 00, Czechia
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Prague, 158 00, Czechia
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Trutnov, 460 63, Czechia
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Uherské Hradiště, 686 01, Czechia
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Ústí nad Labem, 400 01, Czechia
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Zlín, 760 01, Czechia
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Znojmo, 669 02, Czechia
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Aarhus N, 8200, Denmark
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Copenhagen S, 2300, Denmark
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Esbjerg, 6700, Denmark
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Gandrup, 9362, Denmark
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Herlev, 2730, Denmark
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Herlev, DK-2730, Denmark
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Herning, 7400, Denmark
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Kobenhavn N V, 2400, Denmark
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Roskilde, 4000, Denmark
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Svendborg, 5700, Denmark
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Vejle, 7100, Denmark
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Tartu, Estonia, 50406, Estonia
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Pärnu, 80018, Estonia
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Tallinn, 10128, Estonia
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Tallinn, 10138, Estonia
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Tallinn, 13419, Estonia
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Tallinn, 13619, Estonia
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Tartu, 50708, Estonia
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Avignon, 84000, France
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Besançon, 25030, France
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Béziers, 34525, France
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Bobigny, 93009, France
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Bordeaux, 33075, France
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Caen, 14033, France
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Compiègne, 60321, France
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Dijon, 21000, France
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Marseille, 13005, France
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Montauban, 82017, France
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Montpellier, 34295, France
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Nantes, 44093, France
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Nice, 06202, France
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Orléans, 45100, France
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Paris, 75012, France
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Paris, 75013, France
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Paris, 75015, France
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Paris, 75018, France
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Poitiers, 86021, France
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Rouen, 76031, France
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Strasbourg, 67091, France
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Tourcoing, 59208, France
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Valenciennes, 59300, France
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Vandœuvre-lès-Nancy, 54511, France
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Villeneuve-d'Ascq, 59650, France
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Athens, 115 21, Greece
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Athens, 115 27, Greece
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Athens, 151 23, Greece
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Heraklion Crete., 715 00, Greece
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Ioannina, 455 00, Greece
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Thessaloniki, 546 42, Greece
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Thessaloniki, 564 03, Greece
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Thessaloniki, 570 01, Greece
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Hong Kong, Hong Kong, 999077, Hong Kong
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Hong Kong SAR, 999077, Hong Kong
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Kowloon, 999077, Hong Kong
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Shatin, 999077, Hong Kong
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Budapest, Pest County, 1132, Hungary
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Zalaegerszeg, Zala County, 8900, Hungary
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Balatonfüred, 8230, Hungary
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Budapest, 1036, Hungary
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Budapest, 1132, Hungary
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Budapest, 1146, Hungary
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Budapest, H-1083, Hungary
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Budapest, H-1097, Hungary
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Budapest, H-1145, Hungary
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Debrecen, 4027, Hungary
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Hatvan, 3000, Hungary
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Hosszúhetény, 7694, Hungary
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Mosanmagyarovar, 9200, Hungary
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Nyíregyháza, 4400, Hungary
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Pécs, 7623, Hungary
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Szeged, 6725, Hungary
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Szekszárd, 7100, Hungary
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Guntur, Andhrapradesh, 522001, India
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Ahmedabad, Gujarat, 380054, India
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Ahmedabad, Gujarat, 380060, India
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Bangalore, Karnataka, 560069, India
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Belagavi, Karnataka, 590010, India
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Mangalore, Karnataka, 575018, India
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Manipal, Karnataka, 576104, India
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Mysore, Karnataka, 570004, India
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Mysore, Karnataka, 570015, India
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Kochi, Kerala, 682018, India
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Kochi, Kerala, 682041, India
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Nagpur, Maharashtra, 440012, India
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Nagpur, Maharashtra, 441108, India
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Nashik, Maharashtra, 422005, India
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Pune, Maharashtra, 411004, India
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Pune, Maharashtra, 411045, India
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New Delhi, National Capital Territory of Delhi, 110002, India
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New Delhi, National Capital Territory of Delhi, 110060, India
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Ajmer, Rajasthan, 305001, India
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Bikaner, Rajasthan, 334003, India
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Jaipur, Rajasthan, 302001, India
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Jaipur, Rajasthan, 302020, India
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Chennai, Tamil Nadu, 600006, India
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Chennai, Tamil Nadu, 600116, India
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Coimbatore, Tamil Nadu, 641009, India
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Coimbatore, Tamil Nadu, 641037, India
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Madurai, Tamil Nadu, 625020, India
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Kanpur, Uttar Pradesh, 208002, India
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Lucknow, Uttar Pradesh, 226003, India
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Dehradun, Uttarakhand, 248001, India
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Dehradun, Uttrakhand, 248104, India
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Kolkata, West Bengal, 700 020, India
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Coimbatore, 641018, India
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New Delhi, 110029, India
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Uttarakhand, 263153, India
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Holon, Gush Dan, 5845997, Israel
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Beersheba, 8457108, Israel
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Haifa, 3104802, Israel
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Jerusalem, 9112001, Israel
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Nahariya, 2210001, Israel
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Poria – Neve Oved, 1528001, Israel
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Ramat Gan, 5265601, Israel
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Rehovot, 7661041, Israel
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Sefad, 1311300, Israel
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Tel Aviv, 6423906, Israel
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Ancona, AN, 60128, Italy
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Brescia, BS, 25123, Italy
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Caserta, CE, 81100, Italy
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Chieti, CH, 66100, Italy
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Catanzaro, CZ, 88100, Italy
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Florence, FI, 50134, Italy
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Chiavari, GE, 16043, Italy
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Genova, GE, 16132, Italy
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Pozzilli, IS, 86077, Italy
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Latina, LT, 04100, Italy
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Monza, MB, 20900, Italy
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Messina, ME, 98125, Italy
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Cinisello Balsamo, MI, 20092, Italy
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Milan, MI, 20100, Italy
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Milan, MI, 20122, Italy
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Milan, MI, 20132, Italy
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Milan, MI, 20138, Italy
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Milan, MI, 20157, Italy
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Milan, MI, 20162, Italy
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Modena, MO, 41126, Italy
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Perugia, PG, 06129, Italy
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Pisa, PI, 56124, Italy
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Pisa, PI, 56126, Italy
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Roma, RM, 00161, Italy
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Roma, RM, 00168, Italy
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Siena, SI, 53100, Italy
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Naples, 80131, Italy
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Naples, 80138, Italy
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Daugavpils, LV-5417, Latvia
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Kuldīga, LV-3300, Latvia
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Liepāja, LV 3401, Latvia
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Ogre, LV-5001, Latvia
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Riga, LV 1002, Latvia
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Riga, LV-1001, Latvia
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Riga, LV-1038, Latvia
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Kaunas, Kaunas County, 50161, Lithuania
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Kaunas, Kaunas County, LT-50177, Lithuania
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Klaipėda, Klaipėda County, 91131, Lithuania
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Klaipėda, Klaipėda County, 92288, Lithuania
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Alytus, LT-62386, Lithuania
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Kaunas, 49449, Lithuania
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Kaunas, LT-50009, Lithuania
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Panevezys, 35144, Lithuania
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Šiauliai, 76206, Lithuania
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Vilnius, LT-08406, Lithuania
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Alor Star, Kedah, 05460, Malaysia
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Kota Bharu, Kelantan, 16150, Malaysia
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Kuala Lumpur, Kuala Lumpur, 50586, Malaysia
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Seremban, Negeri Sembilan, 70300, Malaysia
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Ipoh, Perak, 30450, Malaysia
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Seri Manjung, Perak, 32040, Malaysia
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Taiping, Perak, 34000, Malaysia
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Timur Laut, Pulau Pinang, 11500, Malaysia
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Kuching, Sarawak, 93586, Malaysia
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Miri, Sarawak, 98000, Malaysia
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Sungai Buloh, Selangor, 47000, Malaysia
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Johor Bahru, 80100, Malaysia
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Kuala Lumpur, 50400, Malaysia
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León, Guanajuato, 37160, Mexico
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Actopan, Hidalgo, 42500, Mexico
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Guadalajara, Jalisco, 44260, Mexico
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Guadalajara, Jalisco, 44340, Mexico
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Guadalajara, Jalisco, 44670, Mexico
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Gustavo Adolfo Madero, Mexico City, 07020, Mexico
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Mexico City, Mexico City, 06700, Mexico
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Cuernavaca, Morelos, 62250, Mexico
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Monterrey, Nuevo León, 64020, Mexico
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Monterrey, Nuevo León, 64060, Mexico
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Monterrey, Nuevo León, 64440, Mexico
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Monterrey, Nuevo León, 64610, Mexico
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San Luis Potosí City, San Luis Potosí, 78200, Mexico
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Culiacán, Sinaloa, 80200, Mexico
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Culiacán, Sinaloa, 80230, Mexico
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Tampico, Tamaulipas, 89440, Mexico
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Mérida, Yucatán, 97070, Mexico
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Aguascalientes, 20116, Mexico
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Aguascalientes, 20230, Mexico
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Chihuahua City, 31238, Mexico
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Distrito Federal, 03100, Mexico
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Distrito Federal, 14080, Mexico
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Mexico City, 06760, Mexico
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Mexico D F, 06720, Mexico
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Oaxaca City, 68020, Mexico
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Veracruz, 91900, Mexico
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Arnhem, Gelderland, 6815 AD, Netherlands
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Doetinchem, Gelderland, 7009 BL, Netherlands
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Nijmegen, Gelderland, 6500HB, Netherlands
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Nijmegen, Gerlderland, 6532 SZ, Netherlands
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's-Hertogenbosch, North Brabant, 5223 GZ, Netherlands
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Tilburg, North Brabant, 5042 AD, Netherlands
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Amsterdam, North Holland, 1090 HM, Netherlands
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Amsterdam, North Holland, 1105 AZ, Netherlands
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Beverwijk, North Holland, 1942 LE, Netherlands
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Deventer, Overijssel, 7416 SE, Netherlands
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Leeuwarden, Provincie Friesland, 8934 AD, Netherlands
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Sneek, Provincie Friesland, 8601 ZK, Netherlands
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Delft, South Holland, 2625 AD, Netherlands
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Dirksland, South Holland, 3247 BW, Netherlands
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Dordrecht, South Holland, 3318 AT, Netherlands
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The Hague, South Holland, 2545 AA, Netherlands
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Ede, 6716 RP, Netherlands
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Eindhoven, 5623 EJ, Netherlands
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Enschede, 7512KZ, Netherlands
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Gouda, 2803 HH, Netherlands
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Hardenberg, 7770 SE, Netherlands
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Venlo, 5912 BL, Netherlands
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Iloilo City, Iloilo, 5000, Philippines
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Manila, National Capital Region, 1000, Philippines
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MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2023
First Posted
February 22, 2023
Study Start
March 9, 2023
Primary Completion (Estimated)
April 16, 2029
Study Completion (Estimated)
April 16, 2029
Last Updated
April 14, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com