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NCT05918861PHASE3Recruiting

Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS

DalCor Pharmaceuticals

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

Inclusion Criteria: * Subjects with the appropriate genetic background and recently hospitalized for ACS (up to 3 months following the index event), will be enrolled in this trial. * Both male and female subjects age 45 years and over at screening visit (V1) * AA genotype at variant gene as determined by Genotype Assay Test, conducted at a designated investigational testing site (ITS) * Clinically stable, ie, free of ischemic symptoms at rest or with minimal exertion for at least 1 week prior to randomization * Prior to randomization, subjects must have evidence of guidelines-based management of LDL-C, at a minimum to include medical and dietary treatment. * Randomization within 3 months of the index ACS event Exclusion Criteria: * Females who are pregnant (negative urine pregnancy test required for all women of child-bearing potential at Visit 2, Day 0) or breast-feeding * Women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for \>12 months) who are not using at least one highly effective method of contraception. * New York Heart Association (NYHA) Class III or IV heart failure * Index ACS event presumed due to uncontrolled hypertension * Systolic blood pressure (BP) \>180 mmHg and/or diastolic blood pressure \>110 mmHg at the time of randomization despite anti-hypertensive therapy * Subjects with clinically apparent liver disease, eg, jaundice, cholestasis, hepatic synthetic impairment, active hepatitis or last known ALT or AST level \>3 x ULN within 6 months prior to randomization (excluding index event) * History of persistent and unexplained creatine phosphokinase (CPK) levels \> 5 times the ULN as assessed within 6 months prior to randomization (excluding index event) * Last known eGFR \< 30 mL/min/1.73m2 as assessed within 6 months prior to randomization * History of malignancy or any other significant comorbidity, the prognosis or management of which is likely to interfere with study conduct or subjects with a life expectancy of less than 3 years. * Presence of any last known laboratory value as evaluated prior to randomization that is considered by the investigator to potentially limit the patient's successful participation in the study * Subjects who have received any investigational drug within 1 month of randomization, or who expect to participate in any other investigational drug or device study during the conduct of this trial * Subjects who have undergone coronary artery bypass graft (CABG) surgery between the index event and randomization

Interventions

DRUG

Dalcetrapib

DRUG

Placebo

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Conditions

Acute Coronary Syndrome

Locations

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Alexander City, Alabama 35010

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Birmingham, Alabama 35211

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Fairhope, Alabama 36532

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Huntsville, Alabama 35801

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Mobile, Alabama 36608

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Scottsdale, Arizona 85258

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Tucson, Arizona 85724

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Jonesboro, Arkansas 72405

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North Little Rock, Arkansas 72117

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Garden Grove, California 92844

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Huntington Beach, California 92648

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La Jolla, California 92037

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Long Beach, California 90813

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Los Angeles, California 90025

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Newport Beach, California 92648

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Newport Beach, California 92658

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San Francisco, California 94143

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Santa Barbara, California 93105

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Stanford, California 94305

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Torrance, California 90502

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West Hills, California 91307

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Aurora, Colorado 80011

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Golden, Colorado 80401

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Hartford, Connecticut 06102

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New Haven, Connecticut 06519

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Newark, Delaware 19718

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Washington D.C., District of Columbia 20010

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Boca Raton, Florida 33434

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Boca Raton, Florida 33486

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Clearwater, Florida 33756

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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

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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

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Acworth, Georgia 30101

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Atlanta, Georgia 30310

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Atlanta, Georgia 30322

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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

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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

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Hackensack, New Jersey 07601

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Pomona, New Jersey 08240

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Albuquerque, New Mexico 87102

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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

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Calgary, Alberta T1Y0B4

Canada

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Edmonton, Alberta T6G2B7

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Abbotsford British Columbia, British Columbia V2S 0C2

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Burnaby, British Columbia V5G 2X6

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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

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Moncton, New Brunswick E1C 2Z3

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Moncton, New Brunswick E1G 1A7

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

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Halifax, Nova Scotia B3H3A7

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Brampton, Ontario L6R3J7

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Cambridge, Ontario N1R 6V6

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Kingston, Ontario K7L2V7

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London, Ontario N6A 5A5

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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

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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

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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

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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

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Sherbrooke, Quebec City J1H5N4

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Saskatoon, Saskatchewan S7N 0W8

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Caguas, Puerto Rico 00726

Puerto Rico

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Carolina, 00984

Puerto Rico