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Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease
Sponsor: Alnylam Pharmaceuticals
Summary
The purpose of this study is to evaluate whether zilebesiran versus placebo reduces the risk of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, or heart failure (HF) events. This is an event-driven study that will continue until the targeted number of positively adjudicated primary endpoint clinical outcome events (COEs) have been reached.
Official title: ZENITH: A Phase 3 Global, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Zilebesiran in Addition to Standard of Care in Reducing Major Adverse Cardiovascular Events in Adult Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
11000
Start Date
2025-09-22
Completion Date
2030-09-30
Last Updated
2026-03-31
Healthy Volunteers
No
Interventions
Zilebesiran
Zilebesiran will be administered SC
Placebo
Placebo will be administered SC
Locations (229)
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Huntsville, Alabama, United States
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Huntsville, Alabama, United States
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Sheffield, Alabama, United States
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Chandler, Arizona, United States
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Gilbert, Arizona, United States
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Glendale, Arizona, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Sun City West, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Little Rock, Arkansas, United States
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Beverly Hills, California, United States
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Chula Vista, California, United States
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Escondido, California, United States
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Glendale, California, United States
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Lancaster, California, United States
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Long Beach, California, United States
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Lynwood, California, United States
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Newhall, California, United States
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Northridge, California, United States
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Pasadena, California, United States
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San Diego, California, United States
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San Dimas, California, United States
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Tarzana, California, United States
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Toluca Lake, California, United States
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Vista, California, United States
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Walnut Creek, California, United States
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Boca Raton, Florida, United States
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Brandon, Florida, United States
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Fleming Island, Florida, United States
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Hialeah, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Leesburg, Florida, United States
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Melbourne, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Palm Springs, Florida, United States
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Tampa, Florida, United States
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Wellington, Florida, United States
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Brunswick, Georgia, United States
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Columbus, Georgia, United States
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Conyers, Georgia, United States
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Conyers, Georgia, United States
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Fayetteville, Georgia, United States
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Johns Creek, Georgia, United States
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Lawrenceville, Georgia, United States
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Suwanee, Georgia, United States
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Thomasville, Georgia, United States
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Hazel Crest, Illinois, United States
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Oak Brook, Illinois, United States
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Orland Park, Illinois, United States
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Tinley Park, Illinois, United States
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Avon, Indiana, United States
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Evansville, Indiana, United States
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Greenfield, Indiana, United States
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South Bend, Indiana, United States
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Valparaiso, Indiana, United States
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Hutchinson, Kansas, United States
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Topeka, Kansas, United States
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Wichita, Kansas, United States
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Wichita, Kansas, United States
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Lexington, Kentucky, United States
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Hammond, Louisiana, United States
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Lafayette, Louisiana, United States
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Opelousas, Louisiana, United States
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Shreveport, Louisiana, United States
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Zachary, Louisiana, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Beltsville, Maryland, United States
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Bowie, Maryland, United States
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Lanham, Maryland, United States
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Rockville, Maryland, United States
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Flint, Michigan, United States
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Southfield, Michigan, United States
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Troy, Michigan, United States
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Troy, Michigan, United States
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Richfield, Minnesota, United States
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Jackson, Mississippi, United States
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Olive Branch, Mississippi, United States
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Port Gibson, Mississippi, United States
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Kansas City, Missouri, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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Fremont, Nebraska, United States
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Bridgewater, New Jersey, United States
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Albuquerque, New Mexico, United States
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New Windsor, New York, United States
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North Massapequa, New York, United States
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Rosedale, New York, United States
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The Bronx, New York, United States
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West Seneca, New York, United States
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Westfield, New York, United States
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Durham, North Carolina, United States
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Greenville, North Carolina, United States
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High Point, North Carolina, United States
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Fargo, North Dakota, United States
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Beavercreek, Ohio, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Lima, Ohio, United States
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Maumee, Ohio, United States
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Edmond, Oklahoma, United States
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Moore, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Camp Hill, Pennsylvania, United States
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Horsham, Pennsylvania, United States
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Media, Pennsylvania, United States
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Uniontown, Pennsylvania, United States
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Columbia, South Carolina, United States
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Greenville, South Carolina, United States
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Chattanooga, Tennessee, United States
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Chattanooga, Tennessee, United States
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Knoxville, Tennessee, United States
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Knoxville, Tennessee, United States
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Amarillo, Texas, United States
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Arlington, Texas, United States
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Arlington, Texas, United States
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Austin, Texas, United States
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Beaumont, Texas, United States
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Carrollton, Texas, United States
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Dallas, Texas, United States
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Duncanville, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Humble, Texas, United States
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Katy, Texas, United States
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Kingwood, Texas, United States
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Laredo, Texas, United States
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McAllen, Texas, United States
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McKinney, Texas, United States
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McKinney, Texas, United States
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Mesquite, Texas, United States
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Missouri City, Texas, United States
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Paris, Texas, United States
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Plano, Texas, United States
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Port Arthur, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Sherman, Texas, United States
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Sugar Land, Texas, United States
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Tomball, Texas, United States
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Waco, Texas, United States
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Bountiful, Utah, United States
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Bountiful, Utah, United States
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Layton, Utah, United States
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Arlington, Virginia, United States
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Danville, Virginia, United States
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Newport News, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Suffolk, Virginia, United States
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Suffolk, Virginia, United States
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Winchester, Virginia, United States
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Bellevue, Washington, United States
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Castle Hill, Australia
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Gosford, Australia
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Merewether, Australia
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Southport, Australia
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Waitara, Australia
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Brampton, Canada
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Cambridge, Canada
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Etobicoke, Canada
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Greenfield Park, Canada
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Lévis, Canada
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Mirabel, Canada
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Mississauga, Canada
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Moncton, Canada
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Scarborough, Canada
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Toronto, Canada
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Chikushino-shi, Japan
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Chūōku, Japan
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Chūōku, Japan
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Fukuoka, Japan
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Fukuoka, Japan
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Hachiōji, Japan
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Hakodate-Shi, Japan
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Himeji, Japan
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Izumi, Japan
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Kasuga, Japan
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Kita-ku, Japan
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Kusatsu, Japan
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Minamiku, Japan
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Minato, Japan
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Nagasaki, Japan
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Osaka, Japan
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Osaka, Japan
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Saku, Japan
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Sapporo, Japan
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Shinagawa-Ku, Japan
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Tamanashi, Japan
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Yokosuka, Japan
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Ebdentown, New Zealand
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Hamilton, New Zealand
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Silverdale, New Zealand
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Birmingham, United Kingdom
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Birmingham, United Kingdom
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Bury St Edmunds, United Kingdom
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Cardiff, United Kingdom
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Chichester, United Kingdom
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Corby, United Kingdom
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Glasgow, United Kingdom
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Ilford, United Kingdom
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Leeds, United Kingdom
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Liverpool, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Penzance, United Kingdom
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Poole, United Kingdom
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Teeside, United Kingdom