Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS
Start Date
10/3/2023
Completion Date
8/1/2027
Summary
This is a placebo-controlled, randomized, double-blind, parallel group, phase 3 multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are performed. A separate informed consent will be allowed for an initial pre-screening genetic testing. Subjects meeting the AA genotype will then consent to the full study and confirmatory genetic testing as required. Subject enrollment may begin in the hospital and will continue following release from the hospital or may begin following release from hospital. Screening procedures may be performed at the time of the index ACS event or anytime thereafter, with the condition that randomization must occur within the mandated window (up to12 weeks after the index event). Subjects will be assessed based on their medical history. Those who are likely to qualify will undergo Genotype Assay testing to evaluate genetic determination for the presence of AA genotype.
Detailed Description
This is an event-driven study and will last until approximately 200 subjects have experienced a primary event, unless the study is stopped at the planned interim analysis. Visits after randomization will be performed as virtual visits where permissible every 3 months or as clinic visits until the study is stopped. For any subject prematurely discontinuing study medication, assessments will be conducted every 3 months for the collection of study endpoints. Those who are likely to qualify will undergo Genotype Assay Testing to evaluate genetic determination or the presence of the AA genotype at variant rs 1967309 in the ADCY9 gene as determined by the investigational use only version of the cobas ADCY9 Genotype Test, conducted at a designated investigational testing site.
Eligibility Criteria
Age Range: 45 years to No maximum
Interventions
Dalcetrapib
Placebo
Conditions
Locations
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Alexander City, Alabama 35010
United States
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Birmingham, Alabama 35211
United States
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Fairhope, Alabama 36532
United States
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Huntsville, Alabama 35801
United States
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Mobile, Alabama 36608
United States
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Scottsdale, Arizona 85258
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Tucson, Arizona 85724
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Jonesboro, Arkansas 72405
United States
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North Little Rock, Arkansas 72117
United States
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Garden Grove, California 92844
United States
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Huntington Beach, California 92648
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La Jolla, California 92037
United States
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Long Beach, California 90813
United States
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Los Angeles, California 90025
United States
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Newport Beach, California 92648
United States
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Newport Beach, California 92658
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San Francisco, California 94143
United States
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Santa Barbara, California 93105
United States
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Stanford, California 94305
United States
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Torrance, California 90502
United States
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West Hills, California 91307
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Aurora, Colorado 80011
United States
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Golden, Colorado 80401
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Hartford, Connecticut 06102
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New Haven, Connecticut 06519
United States
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Newark, Delaware 19718
United States
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Washington D.C., District of Columbia 20010
United States
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Boca Raton, Florida 33434
United States
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Boca Raton, Florida 33486
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Clearwater, Florida 33756
United States
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Doral, Florida 33166
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Fort Lauderdale, Florida 33316
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Fort Myers, Florida 33908
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Gainesville, Florida 32608
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Hialeah, Florida 33013
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Homestead, Florida 33030
United States
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Jacksonville, Florida 32209
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Kissimmee, Florida 34741
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Largo, Florida 33777
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Miami, Florida 33032
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Miami, Florida 33033
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Miami, Florida 33136
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Miami, Florida 33145
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Miami, Florida 33175
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Miami Lakes, Florida 33014
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Miami Lakes, Florida 33016
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Ocala, Florida 34471
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Orlando, Florida 32803
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Pembroke Pines, Florida 33024
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Pensacola, Florida 32502
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Port Charlotte, Florida 33952
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Safety Harbor, Florida 34695
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Sarasota, Florida 34239
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South Miami, Florida 33143
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Tallahassee, Florida 32308
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Tampa, Florida 33606
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Tampa, Florida 33607
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The Villages, Florida 32162
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Winter Haven, Florida 33881
United States
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Acworth, Georgia 30101
United States
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Atlanta, Georgia 30310
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Atlanta, Georgia 30322
United States
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Augusta, Georgia 30912
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Gainesville, Georgia 30501
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McDonough, Georgia 30253
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Arlington Heights, Illinois 60005
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Bloomingdale, Illinois 60108
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Chicago, Illinois 60612
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Chicago, Illinois 60616
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Glenview, Illinois 60026
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Hazel Crest, Illinois 60429
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Park Ridge, Illinois 60068
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Springfield, Illinois 62702
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Fort Wayne, Indiana 46845
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Indianapolis, Indiana 46202
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Merrillville, Indiana 46410
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Munster, Indiana 46321
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Newburgh, Indiana 47630
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Richmond, Indiana 47374
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Davenport, Iowa 52801
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Iowa City, Iowa 52242
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West Des Moines, Iowa 50266
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Kansas City, Kansas 66160
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Edgewood, Kentucky 41017
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Lexington, Kentucky 40536
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Louisville, Kentucky 40202
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Hammond, Louisiana 70403
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Lafayette, Louisiana 70503
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Mandeville, Louisiana 70448
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New Orleans, Louisiana 70121
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Bangor, Maine 04401
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Baltimore, Maryland 21215
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Bethesda, Maryland 20814
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Bowie, Maryland 20715
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Columbia, Maryland 21044
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Lutherville, Maryland 21093
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Bay City, Michigan 48708
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Dearborn, Michigan 48126
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Detroit, Michigan 48202
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Kalamazoo, Michigan 49048
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Lansing, Michigan 48912
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Midland, Michigan 48670
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Mount Clemens, Michigan 48043
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Petoskey, Michigan 49770
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Traverse City, Michigan 49684
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Ypsilanti, Michigan 48197
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Coon Rapids, Minnesota 55433
United States
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Duluth, Minnesota 55805
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Minneapolis, Minnesota 55407
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Minneapolis, Minnesota 55417
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Saint Cloud, Minnesota 56303
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Tupelo, Mississippi 38801
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Springfield, Missouri 65804
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St Louis, Missouri 63110
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St Louis, Missouri 63136
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Lincoln, Nebraska 68506
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Omaha, Nebraska 68124
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Las Vegas, Nevada 89102
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Bridgewater, New Jersey 08807
United States
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Hackensack, New Jersey 07601
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Pomona, New Jersey 08240
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Albuquerque, New Mexico 87102
United States
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Albany, New York 12211
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Buffalo, New York 14203
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Johnson City, New York 13790
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New York, New York 10028
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Poughkeepsie, New York 12601
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Staten Island, New York 10310
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Stony Brook, New York 11794
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The Bronx, New York 10467
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Pinehurst, North Carolina 28374
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Rocky Mount, North Carolina 27804
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Sanford, North Carolina 27330
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Winston-Salem, North Carolina 27103
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Winston-Salem, North Carolina 27157
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Canton, Ohio 44710
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Cincinnati, Ohio 45219
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Cincinnati, Ohio 45267
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Cleveland, Ohio 44106
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Springfield, Ohio 45504
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Toledo, Ohio 43608
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Bartlesville, Oklahoma 74006
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Oklahoma City, Oklahoma 73112
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Tulsa, Oklahoma 74104
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Allentown, Pennsylvania 18013
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Allentown, Pennsylvania 18103
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Chambersburg, Pennsylvania 17201
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Hershey, Pennsylvania 17033
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Langhorne, Pennsylvania 19047
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Philadelphia, Pennsylvania 19104
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Philadelphia, Pennsylvania 19107
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Philadelphia, Pennsylvania 19152
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West Reading, Pennsylvania 19611
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Wyomissing, Pennsylvania 19610
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Providence, Rhode Island 02906
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Rock Hill, South Carolina 29732
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Spartanburg, South Carolina 29303
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Rapid City, South Dakota 57701
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Chattanooga, Tennessee 37403
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Greeneville, Tennessee 37745
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Jefferson City, Tennessee 37760
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Memphis, Tennessee 38120
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Oak Ridge, Tennessee 37830
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Powell, Tennessee 37849
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Amarillo, Texas 79106
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Beaumont, Texas 77702
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Corpus Christi, Texas 78404
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Cypress, Texas 77429
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Dallas, Texas 75216
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Dallas, Texas 75235
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Houston, Texas 77070
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Houston, Texas 77089
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Houston, Texas 77090
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Kingwood, Texas 77339
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McKinney, Texas 75071
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Mesquite, Texas 75149
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Port Arthur, Texas 77642
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San Antonio, Texas 78207
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Victoria, Texas 77901
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Waco, Texas 76712
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Fredericksburg, Virginia 22401
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Newport News, Virginia 23606
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Norfolk, Virginia 23504
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Richmond, Virginia 23219
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Winchester, Virginia 22601
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Seattle, Washington 98122
United States
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Calgary, Alberta T1Y0B4
Canada
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Edmonton, Alberta T6G2B7
Canada
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Abbotsford British Columbia, British Columbia V2S 0C2
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Burnaby, British Columbia V5G 2X6
Canada
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Kamloops, British Columbia V2C2T1
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North Vancouver, British Columbia V7M 2H4
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Vancouver, British Columbia V5Z 1M9
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Victoria, British Columbia V8R 1B2
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Winnipeg, Manitoba R2H 2A6
Canada
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Moncton, New Brunswick E1C 2Z3
Canada
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Moncton, New Brunswick E1G 1A7
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St. John's, Newfoundland and Labrador A1B 3V6
Canada
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Halifax, Nova Scotia B3H3A7
Canada
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Brampton, Ontario L6R3J7
Canada
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Cambridge, Ontario N1R 6V6
Canada
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Kingston, Ontario K7L2V7
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London, Ontario N6A 5A5
Canada
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Newmarket, Ontario L3Y 2R2
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Ottawa, Ontario K1Y4W7
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Scarborough Village, Ontario M1B 4Z8
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Scarborough Village, Ontario M1B 5N1
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Toronto, Ontario M4N 3M5
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Toronto, Ontario M5B 1W8
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Toronto, Ontario M5G 2C4
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Chicoutimi, Quebec G7H 7K9
Canada
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Granby, Quebec J2G 1T7
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Greenfield Park, Quebec J4V 2H1
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Laval, Quebec H7M 3L9
Canada
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Lévis, Quebec G6V 9H4
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Montreal, Quebec H1T1C8
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Montreal, Quebec H2X 0C1
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Montreal, Quebec H3G1A4
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Montreal, Quebec H4J 1C5
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Québec, Quebec G1R 2J6
Canada
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Québec, Quebec G1V 4G5
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Rimouski, Quebec G5L5T1
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Saint-Charles-Borromée, Quebec J6E 6J2
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Saint-Hubert, Quebec J3Z 0C8
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Saint-Jérôme, Quebec J7Z 2V4
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Terrebonne, Quebec J6V 2H2
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Trois-Rivières, Quebec G8Z 3R9
Canada
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Sherbrooke, Quebec City J1H5N4
Canada
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Saskatoon, Saskatchewan S7N 0W8
Canada
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Caguas, Puerto Rico 00726
Puerto Rico
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Carolina, 00984
Puerto Rico