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

NCT ID: NCT02525939

Last Updated: 2022-10-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

6147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2021-10-31

Brief Summary

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A placebo-controlled, randomized, double-blind, parallel group, phase III 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. Subject enrollment may begin in the hospital and will continue following release from the 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 (4-12 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

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This is an event driven study to reach statistical power given all other assumptions. Subjects will visit the clinic 1 month after randomization and at regular intervals thereafter. Additionally, for any subject prematurely discontinuing study medication, assessments will be conducted every 6 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. The test is investigational and test procedures are Roche Molecular Diagnostics protocol ADCY9-COB-389.

Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dalcetrapib

Participants received dalcetrapib 600 mg (two 300 mg tablets) orally once daily.

dalcetrapib: Cholesterol Ester Transfer Protein inhibitor, 300 mg tablets

Group Type ACTIVE_COMPARATOR

dalcetrapib

Intervention Type DRUG

Cholesterol Ester Transfer Protein inhibitor

Placebo

Participants received dalcetrapib placebo tablets matching dalcetrapib orally once daily.

Placebo: dalcetrapib matching placebo tablets

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

matching placebo tablets

Interventions

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dalcetrapib

Cholesterol Ester Transfer Protein inhibitor

Intervention Type DRUG

Placebo

matching placebo tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with the appropriate genetic background and recently hospitalized for ACS (between 4 and 12 weeks following the index event), will be enrolled in this trial.
* AA genotype at variant gene as determined by Genotype Assay testing, 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, subject must have evidence of guidelines-based management of LDL-C, at a minimum to include medical and dietary treatment to a target level of LDL-C \<100 mg/dl (\<2.6 mmol/L).

Exclusion Criteria

* Females who are pregnant (negative 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 method of contraception\*
* New York Heart Association (NYHA) Class III or IV heart failure
* Last known hemoglobin \<10 g/dL
* Index ACS event presumed due to uncontrolled hypertension

(\*) Varies by region
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Montreal Health Innovations Coordinating Center (MHICC)

OTHER

Sponsor Role collaborator

Medpace, Inc.

INDUSTRY

Sponsor Role collaborator

Roche Molecular Systems, Inc

INDUSTRY

Sponsor Role collaborator

DalCor Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Donald M Black, MD

Role: STUDY_DIRECTOR

DalCor Pharmaceuticals

Locations

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Alexander City, Alabama, United States

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Huntsville, Alabama, United States

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Mobile, Alabama, United States

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Cottonwood, Arizona, United States

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Glendale, Arizona, United States

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Jonesboro, Arkansas, United States

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Huntington Beach, California, United States

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San Diego, California, United States

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Torrance, California, United States

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Denver, Colorado, United States

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Littleton, Colorado, United States

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Danbury, Connecticut, United States

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Hartford, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Clearwater, Florida, United States

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Daytona Beach, Florida, United States

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Fort Lauderdale, Florida, United States

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Gainesville, Florida, United States

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Homestead, Florida, United States

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Hudson, Florida, United States

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Jacksonville, Florida, United States

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Largo, Florida, United States

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Miami, Florida, United States

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Miramar, Florida, United States

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Orlando, Florida, United States

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Pembroke Pines, Florida, United States

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Pensacola, Florida, United States

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Port Charlotte, Florida, United States

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Safety Harbor, Florida, United States

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Tallahassee, Florida, United States

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Atlanta, Georgia, United States

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Columbus, Georgia, United States

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Covington, Georgia, United States

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Decatur, Georgia, United States

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Macon, Georgia, United States

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Evanston, Illinois, United States

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Jerseyville, Illinois, United States

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Fort Wayne, Indiana, United States

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Newburgh, Indiana, United States

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West Des Moines, Iowa, United States

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Wichita, Kansas, United States

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Owensboro, Kentucky, United States

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Alexandria, Louisiana, United States

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Covington, Louisiana, United States

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Bangor, Maine, United States

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Biddeford, Maine, United States

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Lewiston, Maine, United States

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Annapolis, Maryland, United States

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Baltimore, Maryland, United States

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Bethesda, Maryland, United States

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Columbia, Maryland, United States

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Salisbury, Maryland, United States

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Hyannis, Massachusetts, United States

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Alpena, Michigan, United States

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Bay City, Michigan, United States

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Lansing, Michigan, United States

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Midland, Michigan, United States

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Mount Clemens, Michigan, United States

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Muskegon, Michigan, United States

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Saginaw, Michigan, United States

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Saint Joseph, Michigan, United States

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Ypsilanti, Michigan, United States

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Coon Rapids, Minnesota, United States

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Duluth, Minnesota, United States

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Minneapolis, Minnesota, United States

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Saint Cloud, Minnesota, United States

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St Louis, Missouri, United States

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Washington, Missouri, United States

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Missoula, Montana, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Bridgewater, New Jersey, United States

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Linden, New Jersey, United States

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Somerset, New Jersey, United States

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Summit, New Jersey, United States

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Albuquerque, New Mexico, United States

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Buffalo, New York, United States

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Johnson City, New York, United States

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New Windsor, New York, United States

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New York, New York, United States

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Poughkeepsie, New York, United States

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Asheville, North Carolina, United States

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Greensboro, North Carolina, United States

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Pinehurst, North Carolina, United States

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Rocky Mount, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Minot, North Dakota, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Springfield, Ohio, United States

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Toledo, Ohio, United States

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Zanesville, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Butler, Pennsylvania, United States

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Chambersburg, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Hershey, Pennsylvania, United States

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Langhorne, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Wyomissing, Pennsylvania, United States

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York, Pennsylvania, United States

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Providence, Rhode Island, United States

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Spartanburg, South Carolina, United States

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Rapid City, South Dakota, United States

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Greeneville, Tennessee, United States

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Jackson, Tennessee, United States

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Oak Ridge, Tennessee, United States

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Dallas, Texas, United States

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Kingwood, Texas, United States

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Victoria, Texas, United States

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Wichita Falls, Texas, United States

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Layton, Utah, United States

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Charlottesville, Virginia, United States

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Norfolk, Virginia, United States

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Virginia Beach, Virginia, United States

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Winchester, Virginia, United States

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La Crosse, Wisconsin, United States

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Bahía Blanca, , Argentina

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Buenos Aires, , Argentina

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Coronel Suárez, , Argentina

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Corrientes, , Argentina

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Bruce, New South Wales, Australia

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Gosford, New South Wales, Australia

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Liverpool, New South Wales, Australia

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Saint Leonards, New South Wales, Australia

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Cairns, Queensland, Australia

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Chermside, Queensland, Australia

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Douglas, Queensland, Australia

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Herston, Queensland, Australia

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Milton, Queensland, Australia

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Redcliffe, Queensland, Australia

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Woolloongabba, Queensland, Australia

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Bedford Park, South Australia, Australia

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Elizabeth Vale, South Australia, Australia

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Woodville South, South Australia, Australia

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Hobart, Tasmania, Australia

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Epping, Victoria, Australia

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Geelong, Victoria, Australia

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Melbourne, Victoria, Australia

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Joondalup, Western Australia, Australia

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Murdoch, Western Australia, Australia

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Perth, Western Australia, Australia

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Braunau am Inn, , Austria

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Krems, , Austria

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Linz, , Austria

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Vienna, , Austria

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Aalst, , Belgium

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Bonheiden, , Belgium

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Brussels, , Belgium

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Genk, , Belgium

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Liège, , Belgium

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Maaseik, , Belgium

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Mechelen, , Belgium

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Ottignies, , Belgium

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Sint-Niklaas, , Belgium

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Belo Horizonte, , Brazil

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Blumenau, , Brazil

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Brasília, , Brazil

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Campinas, , Brazil

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Campo Grande, , Brazil

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Curitiba, , Brazil

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Fortaleza, , Brazil

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Goiânia, , Brazil

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Marília, , Brazil

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Natal, , Brazil

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Porto Alegre, , Brazil

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Recife, , Brazil

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Dimitrovgrad, , Bulgaria

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Haskovo, , Bulgaria

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Pazardzhik, , Bulgaria

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Pernik, , Bulgaria

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Pleven, , Bulgaria

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Plovdiv, , Bulgaria

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Sandanski, , Bulgaria

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Sofia, , Bulgaria

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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Victoria, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Moncton, New Brunswick, Canada

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Saint John, New Brunswick, Canada

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St. John's, Newfoundland and Labrador, Canada

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Bridgewater, Nova Scotia, Canada

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Burlington, Ontario, Canada

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Cambridge, Ontario, Canada

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Greater Sudbury, Ontario, Canada

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Hamilton, Ontario, Canada

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London, Ontario, Canada

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Newmarket, Ontario, Canada

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Ottawa, Ontario, Canada

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Peterborough, Ontario, Canada

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Scarborough Village, Ontario, Canada

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Thunder Bay, Ontario, Canada

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Toronto, Ontario, Canada

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Chicoutimi, Quebec, Canada

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Granby, Quebec, Canada

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Laval, Quebec, Canada

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Lévis, Quebec, Canada

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Longueuil, Quebec, Canada

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Institut de Cardiologie de Montreal

Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Saint George, Quebec, Canada

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Saint-Charles-Borromée, Quebec, Canada

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Saint-Jean-sur-Richelieu, Quebec, Canada

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Saint-Jérôme, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Terrebonne, Quebec, Canada

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Thetford-Mines, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Québec, , Canada

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Santiago, , Chile

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Temuco, , Chile

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Viña del Mar, , Chile

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Bílina, , Czechia

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Brno, , Czechia

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Hradec Králové, , Czechia

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Jihlava, , Czechia

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Kladno, , Czechia

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Kroměříž, , Czechia

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Liberec, , Czechia

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Náchod, , Czechia

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Pilsen, , Czechia

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Písek, , Czechia

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Prague, , Czechia

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Slaný, , Czechia

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Trutnov, , Czechia

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Zlín, , Czechia

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Aalborg, , Denmark

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Copenhagen, , Denmark

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Frederiksberg, , Denmark

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Glostrup Municipality, , Denmark

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Hellerup, , Denmark

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Herning, , Denmark

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Hillerød, , Denmark

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Næstved, , Denmark

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Silkeborg, , Denmark

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Jyväskylä, , Finland

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Oulu, , Finland

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Pori, , Finland

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Turku, , Finland

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Besançon, , France

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Bron, , France

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Dijon, , France

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Poitiers, , France

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Chemnitz, , Germany

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Fürth, , Germany

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Mainz, , Germany

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Rehovot, , Israel

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Ẕerifin, , Israel

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Foggia, , Italy

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Seriate, , Italy

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Torino, , Italy

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Deventer, , Netherlands

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Ede, , Netherlands

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Goes, , Netherlands

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Oświęcim, , Poland

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Oława, , Poland

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Poznan, , Poland

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Płock, , Poland

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Ruda Śląska, , Poland

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Torun, , Poland

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Zabrze, , Poland

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Zamość, , Poland

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Almada, , Portugal

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Faro, , Portugal

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Leiria, , Portugal

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Lisbon, , Portugal

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Senhora da Hora, , Portugal

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Setúbal, , Portugal

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Bayamón, , Puerto Rico

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Ponce, , Puerto Rico

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Arad, , Romania

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Baia Mare, , Romania

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Brăila, , Romania

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Bucharest, , Romania

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Cluj-Napoca, , Romania

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Craiova, , Romania

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Oradea, , Romania

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Piteşti, , Romania

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Timișoara, , Romania

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Arkhangelsk, , Russia

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Barnaul, , Russia

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Irkutsk, , Russia

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Kazan', , Russia

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Kemerovo, , Russia

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Kirovsk, , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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Novosibirsk, , Russia

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Omsk, , Russia

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Orenburg, , Russia

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Penza, , Russia

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Petrozavodsk, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Tomsk, , Russia

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Tula, , Russia

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Tyumen, , Russia

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Yaroslavl, , Russia

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Yekaterinburg, , Russia

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Bardejov, , Slovakia

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Bratislava, , Slovakia

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Košice, , Slovakia

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Lučenec, , Slovakia

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Námestovo, , Slovakia

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Nitra, , Slovakia

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Bloemfontein, , South Africa

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Cape Town, , South Africa

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Gatong, , South Africa

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Johannesburg, , South Africa

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Kuils River, , South Africa

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Paarl, , South Africa

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Parow, , South Africa

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Somerset West, , South Africa

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A Coruña, , Spain

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Barcelona, , Spain

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Hospitalet Del Llobregat, , Spain

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Lleida, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Sabadell, , Spain

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Salamanca, , Spain

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Santiago de Compostela, , Spain

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Seville, , Spain

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Tarragona, , Spain

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Valencia, , Spain

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Vigo, , Spain

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Falun, , Sweden

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Karlshamn, , Sweden

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Köping, , Sweden

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Linköping, , Sweden

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Malmo, , Sweden

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Umeå, , Sweden

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Uppsala, , Sweden

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Västerås, , Sweden

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Geneva, , Switzerland

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Afyonkarahisar, , Turkey (Türkiye)

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Mersin, , Turkey (Türkiye)

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Samsun, , Turkey (Türkiye)

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Sivas, , Turkey (Türkiye)

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Dubai, , United Arab Emirates

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Sharjah city, , United Arab Emirates

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Ayr, , United Kingdom

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Barnet, , United Kingdom

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Basildon, , United Kingdom

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Belfast, , United Kingdom

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Birmingham, , United Kingdom

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Blackpool, , United Kingdom

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Bradford, , United Kingdom

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Burton-on-Trent, , United Kingdom

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Chelmsford, , United Kingdom

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Chertsey, , United Kingdom

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Clydebank, , United Kingdom

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Coventry, , United Kingdom

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Craigavon, , United Kingdom

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Dartford, , United Kingdom

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Dudley, , United Kingdom

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Glasgow, , United Kingdom

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Harrow, , United Kingdom

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High Wycombe, , United Kingdom

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Hull, , United Kingdom

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Inverness, , United Kingdom

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Kirkcaldy, , United Kingdom

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Lanark, , United Kingdom

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Leicester, , United Kingdom

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Lincoln, , United Kingdom

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London, , United Kingdom

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Londonderry, , United Kingdom

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Luton, , United Kingdom

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Manchester, , United Kingdom

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Newcastle, , United Kingdom

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Newport, , United Kingdom

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Nuneaton, , United Kingdom

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Paisley, , United Kingdom

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Redhill, , United Kingdom

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Romford, , United Kingdom

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Rotherham, , United Kingdom

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Salford, , United Kingdom

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Sheffield, , United Kingdom

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Stevenage, , United Kingdom

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Stockport, , United Kingdom

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Stockton-on-Tees, , United Kingdom

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Swindon, , United Kingdom

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Taunton, , United Kingdom

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Telford, , United Kingdom

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Truro, , United Kingdom

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West Bromwich, , United Kingdom

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Westcliff-on-Sea, , United Kingdom

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Wigan, , United Kingdom

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Worcester, , United Kingdom

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Worthing, , United Kingdom

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United States Argentina Australia Austria Belgium Brazil Bulgaria Canada Chile Czechia Denmark Finland France Germany Hungary Israel Italy Netherlands New Zealand Poland Portugal Puerto Rico Romania Russia Slovakia South Africa Spain Sweden Switzerland Turkey (Türkiye) United Arab Emirates United Kingdom

References

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Tardif JC, Pfeffer MA, Kouz S, Koenig W, Maggioni AP, McMurray JJV, Mooser V, Waters DD, Gregoire JC, L'Allier PL, Wouter Jukema J, White HD, Heinonen T, Black DM, Laghrissi-Thode F, Levesque S, Guertin MC, Dube MP; dal-GenE Investigators. Pharmacogenetics-guided dalcetrapib therapy after an acute coronary syndrome: the dal-GenE trial. Eur Heart J. 2022 Oct 14;43(39):3947-3956. doi: 10.1093/eurheartj/ehac374.

Reference Type DERIVED
PMID: 35856777 (View on PubMed)

Black DM, Miller M, Heinonen TM, Zhang G. Advancing Beyond Failed High-density Lipoprotein Clinical Trials to Pharmacogenetic Studies of ADCY9 and Cholesterol Ester Transfer Protein Inhibition. J Cardiovasc Pharmacol. 2021 Oct 1;78(4):496-500. doi: 10.1097/FJC.0000000000001093.

Reference Type DERIVED
PMID: 34173811 (View on PubMed)

Tardif JC, Dube MP, Pfeffer MA, Waters DD, Koenig W, Maggioni AP, McMurray JJV, Mooser V, White HD, Heinonen T, Black DM, Guertin MC; dal-GenE Investigators. Study design of Dal-GenE, a pharmacogenetic trial targeting reduction of cardiovascular events with dalcetrapib. Am Heart J. 2020 Apr;222:157-165. doi: 10.1016/j.ahj.2020.01.007. Epub 2020 Jan 17.

Reference Type DERIVED
PMID: 32087417 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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DAL-301

Identifier Type: -

Identifier Source: org_study_id

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