Last updated on December 2018

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


Brief description of study

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 Study Description

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.

Clinical Study Identifier: NCT02525939

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Donald M Black, MD

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Alexander City, AL United States

Donald M Black, MD

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Birmingham, AL United States

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Huntsville, AL United States

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Mobile, AL United States

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Cottonwood, AZ United States

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Glendale, AZ United States

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Santa Rosa, CA United States

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Torrance, CA United States

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Denver, CO United States

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Littleton, CO United States

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Danbury, CT United States

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Hartford, CT United States

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Washington, WA United States

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Clearwater, FL United States

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Daytona Beach, FL United States

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Fort Lauderdale, FL United States

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Gainesville, FL United States

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Homestead, FL United States

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Hudson, FL United States

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Jacksonville, FL United States

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Largo, FL United States

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Miami, FL United States

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Orlando, FL United States

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Pembroke Pines, FL United States

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Safety Harbor, FL United States

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Tallahassee, FL United States

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Atlanta, GA United States

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Covington, GA United States

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Decatur, GA United States

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Macon, GA United States

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Evanston, IL United States

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Jerseyville, IL United States

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Fort Wayne, IN United States

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West Des Moines, IA United States

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Wichita, KS United States

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Owensboro, KY United States

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Alexandria, LA United States

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Bangor, ME United States

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Biddeford, ME United States

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Scarborough, ME United States

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Annapolis, MD United States

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Baltimore, MD United States

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Salisbury, MD United States

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Hyannis, MA United States

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Alpena, MI United States

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Bay City, MI United States

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Lansing, MI United States

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Midland, MI United States

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Muskegon, MI United States

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Saginaw, MI United States

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Ypsilanti, MI United States

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Coon Rapids, MN United States

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Duluth, MN United States

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Minneapolis, MN United States

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Saint Cloud, MN United States

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Saint Louis, MO United States

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Missoula, MT United States

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Omaha, NE United States

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Las Vegas, NV United States

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Bridgewater, NJ United States

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Linden, NJ United States

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Somerset, NJ United States

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Albuquerque, NM United States

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Buffalo, NY United States

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Johnson City, NY United States

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New Windsor, NY United States

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New York, NY United States

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Poughkeepsie, NY United States

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Asheville, NC United States

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Greensboro, NC United States

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Pinehurst, NC United States

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Rocky Mount, NC United States

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Wilmington, NC United States

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Winston-Salem, NC United States

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Minot, ND United States

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Canton, OH United States

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Cincinnati, OH United States

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Springfield, OH United States

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Toledo, OH United States

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Zanesville, OH United States

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Oklahoma City, OK United States

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Butler, PA United States

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Chambersburg, PA United States

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Erie, PA United States

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Hershey, PA United States

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Langhorne, PA United States

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Philadelphia, PA United States

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Wyomissing, PA United States

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York, PA United States

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Providence, RI United States

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Spartanburg, SC United States

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Rapid City, SD United States

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Greeneville, TN United States

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Jackson, TN United States

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Oak Ridge, TN United States

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Dallas, TX United States

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Houston, TX United States

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Kingwood, TX United States

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San Antonio, TX United States

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Victoria, TX United States

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Wichita Falls, TX United States

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Layton, UT United States

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Charlottesville, VA United States

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Norfolk, VA United States

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Virginia Beach, VA United States

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Winchester, VA United States

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Seattle, WA United States

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Ciudad Autonoma de Buenos Aires, Argentina

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Cordoba, Argentina

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Coronel Suarez, Argentina

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Corrientes, Argentina

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Esperanza, Argentina

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Junin, Argentina

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La Plata, Argentina

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Mar del Plata, Argentina

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Mendoza, Argentina

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Moron, Argentina

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Quilmes, Argentina

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Rosario, Argentina

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San Juan, Argentina

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San Luis, Argentina

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San Martin, Argentina

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San Miguel de Tucuman, Argentina

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San Nicolas, Argentina

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Santa Fe, Argentina

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Tucuman, Argentina

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Vicente Lopez, Argentina

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Villa Allende, Argentina

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Villa Maria, Argentina

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Bruce, Australia

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Cairns, Australia

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Milton, Australia

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Redcliffe, Australia

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Woolloongabba, Australia

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Bedford Park, Australia

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Elizabeth Vale, Australia

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Woodville South, Australia

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Hobart, Australia

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Geelong, Australia

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Murdoch, Australia

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Nedlands, Australia

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Feldkirch, Austria

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Krems, Austria

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Linz, Austria

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Vienna, Austria

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Wiener Neustadt, Austria

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Wien, Austria

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Bonheiden, Belgium

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Brussels, Belgium

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Genk, Belgium

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Liege, 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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Campinas, Brazil

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Curitiba, Brazil

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Fortaleza, Brazil

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Goiania, Brazil

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Marilia, Brazil

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Maringa, Brazil

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Porto Alegre, Brazil

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Recife, Brazil

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Salvador, Brazil

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Sao Jose do Rio Preto, 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, AB Canada

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Edmonton, AB Canada

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Vancouver, BC Canada

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Winnipeg, MB Canada

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Moncton, NB Canada

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Saint John, NB Canada

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St. John's, NL Canada

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Burlington, ON Canada

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Cambridge, ON Canada

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Hamilton, ON Canada

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London, ON Canada

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Newmarket, ON Canada

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Ottawa, ON Canada

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Sudbury, ON Canada

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Thunder Bay, ON Canada

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Toronto, ON Canada

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Chicoutimi, QC Canada

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Granby, QC Canada

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Laval, QC Canada

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Levis, QC Canada

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Longueuil, QC Canada

Colette Morin, RN

Institut de Cardiologie de Montreal
Montreal, QC Canada

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Montreal, QC Canada

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Sherbrooke, QC Canada

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St-Charles-Borromee, QC Canada

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St-Jean-sur-Richelieu, QC Canada

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St-Jerome, QC Canada

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Terrebonne, QC Canada

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Trois-Rivieres, QC Canada

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Quebec, QC Canada

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Santiago, Chile

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Vina del Mar, Chile

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Brno, Czech Republic

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Hradec Kralove, Czech Republic

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Jihlava, Czech Republic

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Kladno, Czech Republic

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Kromeriz, Czech Republic

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Liberec, Czech Republic

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Nachod, Czech Republic

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Pisek, Czech Republic

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Prague 2, Czech Republic

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Prague 5, Czech Republic

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Prague 6, Czech Republic

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Prague, Czech Republic

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Slany, Czech Republic

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Trutnov, Czech Republic

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Zlin, Czech Republic

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Aalborg, Denmark

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Glostrup, Denmark

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Hillerod, Denmark

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Kobenhavn, Denmark

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Naestved, Denmark

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Silkeborg, Denmark

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Jyvaskyla, Finland

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Oulu, Finland

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Pori, Finland

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Turku, Finland

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Besancon, France

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Bron, France

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Corbeil-Essonnes, France

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Dijon, France

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Limoges, France

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Montpellier, France

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Paris, France

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Toulouse, France

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Tourcoing, France

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Valenciennes, France

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Chemnitz, Germany

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Coburg, Germany

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Erfurt, Germany

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Heidelberg, Germany

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Leipzig, Germany

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Balatonfured, Hungary

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Budapest, Hungary

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Eger, Hungary

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Gyula, Hungary

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Hatvan, Hungary

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Kecskemet, Hungary

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Miskolc, Hungary

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Nyiregyhaza, Hungary

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Pecs, Hungary

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Szombathely, Hungary

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Zalaegerszeg, Hungary

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Afula, Israel

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Ashkelon, Israel

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Beer Sheva, Israel

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Haifa, Israel

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Holon, Israel

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Jerusalem, Israel

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Kfar Saba, Israel

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Nahariya, Israel

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Nazareth, Israel

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Petach-Tikva, Israel

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Rehovot, Israel

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Tel Aviv, Israel

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Tel Hashomer, Israel

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Ancona, Italy

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Casarano, Italy

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Firenze, Italy

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Foggia, Italy

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Napoli, Italy

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Novara, Italy

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Sanremo, Italy

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Saronno, Italy

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Scorrano, Italy

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Seriate, Italy

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Torino, Italy

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Treviglio, Italy

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Amsterdam, Netherlands

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Arnhem, Netherlands

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Den Haag, Netherlands

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Deventer, Netherlands

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Doetinchem, Netherlands

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Ede, Netherlands

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Goes, Netherlands

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Gouda, Netherlands

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Hoogeveen, Netherlands

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Hoorn, Netherlands

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Leeuwarden, Netherlands

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Leiden, Netherlands

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Rotterdam, Netherlands

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Schiedam, Netherlands

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Sneek, Netherlands

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Tiel, Netherlands

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Tilburg, Netherlands

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Uden, Netherlands

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Veldhoven, Netherlands

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Venlo, Netherlands

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Zaandam, Netherlands

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Zutphen, Netherlands

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Christchurch, New Zealand

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Dunedin, New Zealand

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Grafton, New Zealand

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Lower Hutt, New Zealand

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Nelson, New Zealand

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New Plymouth, New Zealand

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Rotorua, New Zealand

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Takapuna, New Zealand

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Wellington, New Zealand

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Elblag, Poland

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Gdynia, Poland

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Kielce, Poland

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Krakow, Poland

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Lodz, Poland

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Mragowo, Poland

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Olawa, Poland

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Oswiecim, Poland

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Plock, Poland

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Poznan, Poland

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Ruda Slaska, Poland

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Rzeszow, Poland

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Sopot, Poland

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Sroda Wielkopolska, Poland

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Szczecin, Poland

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Torun, Poland

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Wroclaw, Poland

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Zabrze, Poland

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Zamosc, Poland

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Almada, Portugal

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Braga, Portugal

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Coimbra, Portugal

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Faro, Portugal

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Leiria, Portugal

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Lisboa, Portugal

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Senhora da Hora, Portugal

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Setubal, Portugal

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Bayamon, Puerto Rico

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Caguas, 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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Braila, Romania

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Bucharest, Romania

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Buzau, Romania

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Cluj-Napoca, Romania

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Craiova, Romania

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Oradea, Romania

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Pitesti, Romania

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Timisoara, Romania

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Arkhangelsk, Russian Federation

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Barnaul, Russian Federation

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Ekaterinburg, Russian Federation

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Irkutsk, Russian Federation

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Kazan, Russian Federation

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Kemerovo, Russian Federation

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Kirovsk, Russian Federation

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Moscow, Russian Federation

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Nizhny Novgorod, Russian Federation

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Novosibirsk, Russian Federation

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Omsk, Russian Federation

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Orenburg, Russian Federation

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Penza, Russian Federation

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Petrozavodsk, Russian Federation

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Saint-Petersburg, Russian Federation

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Saratov, Russian Federation

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Tomsk, Russian Federation

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Tula, Russian Federation

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Tyumen, Russian Federation

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Yaroslavl, Russian Federation

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Bardejov, Slovakia

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Bratislava, Slovakia

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Kosice, Slovakia

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Lucenec, Slovakia

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Namestovo, 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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Paarl, South Africa

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Parow, South Africa

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Somerset West, South Africa

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Worcester, South Africa

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A Coruna, Spain

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Barcelona, Spain

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Hospitalet del Llobregat, Spain

Donald M Black, MD

Research Site
Lleida, Spain

Donald M Black, MD

Research Site
Madrid, Spain

Donald M Black, MD

Research Site
Malaga, Spain

Donald M Black, MD

Research Site
Sabadell, Spain

Donald M Black, MD

Research Site
Salamanca, Spain

Donald M Black, MD

Research Site
Santiago de Compostela, Spain

Donald M Black, MD

Research Site
Seville, Spain

Donald M Black, MD

Research Site
Tarragona, Spain

Donald M Black, MD

Research Site
Valencia, Spain

Donald M Black, MD

Research Site
Vigo, Spain

Donald M Black, MD

Research Site
Falun, Sweden

Donald M Black, MD

Research Site
Karlshamn, Sweden

Donald M Black, MD

Research Site
Koping, Sweden

Donald M Black, MD

Research Site
Linkoping, Sweden

Donald M Black, MD

Research Site
Malmo, Sweden

Donald M Black, MD

Research Site
Orebro, Sweden

Donald M Black, MD

Research Site
Umea, Sweden

Donald M Black, MD

Research Site
Uppsala, Sweden

Donald M Black, MD

Research Site
Vasteras, Sweden

Donald M Black, MD

Research Site
Geneva, Switzerland

Donald M Black, MD

Research Site
Lugano, Switzerland

Donald M Black, MD

Research Site
Afyonkarahisar, Turkey

Donald M Black, MD

Research Site
Ankara, Turkey

Donald M Black, MD

Research Site
Istanbul, Turkey

Donald M Black, MD

Research Site
Izmir, Turkey

Donald M Black, MD

Research Site
Kadikoy, Turkey

Donald M Black, MD

Research Site
Kayseri, Turkey

Donald M Black, MD

Research Site
Mersin, Turkey

Donald M Black, MD

Research Site
Sivas, Turkey

Donald M Black, MD

Research Site
Ayr, United Kingdom

Donald M Black, MD

Research Site
Barnet, United Kingdom

Donald M Black, MD

Research Site
Belfast, United Kingdom

Donald M Black, MD

Research Site
Blackpool, United Kingdom

Donald M Black, MD

Research Site
Bradford, United Kingdom

Donald M Black, MD

Research Site
Bristol, United Kingdom

Donald M Black, MD

Research Site
Chertsey, United Kingdom

Donald M Black, MD

Research Site
Clydebank, United Kingdom

Donald M Black, MD

Research Site
Cornwall, United Kingdom

Donald M Black, MD

Research Site
Coventry, United Kingdom

Donald M Black, MD

Research Site
Craigavon, United Kingdom

Donald M Black, MD

Research Site
Dudley, United Kingdom

Donald M Black, MD

Research Site
Glasgow, United Kingdom

Donald M Black, MD

Research Site
High Wycombe, United Kingdom

Donald M Black, MD

Research Site
Hull, United Kingdom

Donald M Black, MD

Research Site
Inverness, United Kingdom

Donald M Black, MD

Research Site
Kirkcaldy, United Kingdom

Donald M Black, MD

Research Site
Lanark, United Kingdom

Donald M Black, MD

Research Site
Leicester, United Kingdom

Donald M Black, MD

Research Site
Lincoln, United Kingdom

Donald M Black, MD

Research Site
Liverpool, United Kingdom

Donald M Black, MD

Research Site
Londonderry, United Kingdom

Donald M Black, MD

Research Site
Luton, United Kingdom

Donald M Black, MD

Research Site
Manchester, United Kingdom

Donald M Black, MD

Research Site
Newcastle, United Kingdom

Donald M Black, MD

Research Site
Newport, United Kingdom

Donald M Black, MD

Research Site
Northampton, United Kingdom

Donald M Black, MD

Research Site
Paisley, United Kingdom

Donald M Black, MD

Research Site
Redhill, United Kingdom

Donald M Black, MD

Research Site
Romford, United Kingdom

Donald M Black, MD

Research Site
Rotherham, United Kingdom

Donald M Black, MD

Research Site
Salford, United Kingdom

Donald M Black, MD

Research Site
Stevenage, United Kingdom

Donald M Black, MD

Research Site
Stockport, United Kingdom

Donald M Black, MD

Research Site
Stockton on Tees, United Kingdom

Donald M Black, MD

Research Site
Telford, United Kingdom

Donald M Black, MD

Research Site
Westcliff on Sea, United Kingdom

Donald M Black, MD

Research Site
Wigan, United Kingdom

Donald M Black, MD

Research Site
Worthing, United Kingdom

Donald M Black, MD

Research Site
Miramar, FL United States

Donald M Black, MD

Research Site
Bethesda, MD United States

Donald M Black, MD

Research Site
Columbia, MD United States

Donald M Black, MD

Research Site
Mount Clemens, MI United States

Donald M Black, MD

Research Site
Saint Joseph, MI United States

Donald M Black, MD

Research Site
Summit, NJ United States

Donald M Black, MD

Research Site
La Crosse, WI United States

Donald M Black, MD

Research Site
Venado Tuerto, Argentina

Donald M Black, MD

Research Site
Gosford, Australia

Donald M Black, MD

Research Site
Saint Leonards, Australia

Donald M Black, MD

Research Site
Chermside, Australia

Donald M Black, MD

Research Site
Douglas, Australia

Donald M Black, MD

Research Site
Herston, Australia

Donald M Black, MD

Research Site
Epping, Australia

Donald M Black, MD

Research Site
Melbourne, Australia

Donald M Black, MD

Research Site
Joondalup, Australia

Donald M Black, MD

Research Site
Perth, Australia

Donald M Black, MD

Research Site
Braunau Am Inn, Austria

Donald M Black, MD

Research Site
Aalst, Belgium

Donald M Black, MD

Research Site
Brasilia, Brazil

Donald M Black, MD

Research Site
Campina Grande do Sul, Brazil

Donald M Black, MD

Research Site
Campo Grande, Brazil

Donald M Black, MD

Research Site
Natal, Brazil

Donald M Black, MD

Research Site
Ribeirao Preto, Brazil

Donald M Black, MD

Research Site
Sao Paulo, Brazil

Donald M Black, MD

Research Site
Uberlandia, Brazil

Donald M Black, MD

Research Site
Vitoria, Brazil

Donald M Black, MD

Research Site
Blagoevgrad, Bulgaria

Donald M Black, MD

Research Site
Peterborough, ON Canada

Donald M Black, MD

Research Site
Bilina, Czechia

Donald M Black, MD

Research Site
Plzen, Czechia

Donald M Black, MD

Research Site
Monchengladbach, Germany

Donald M Black, MD

Research Site
Poriyya 'Illit, Israel

Donald M Black, MD

Research Site
Ascoli Piceno, Italy

Donald M Black, MD

Research Site
Cagliari, Italy

Donald M Black, MD

Research Site
Empoli, Italy

Donald M Black, MD

Research Site
Giugliano in Campania, Italy

Donald M Black, MD

Research Site
Gubbio, Italy

Donald M Black, MD

Research Site
Milano, Italy

Donald M Black, MD

Research Site
Roma, Italy

Donald M Black, MD

Research Site
Rozzano, Italy

Donald M Black, MD

Research Site
Hastings, New Zealand

Donald M Black, MD

Research Site
Gatong, South Africa

Donald M Black, MD

Research Site
Johannesburg, South Africa

Donald M Black, MD

Research Site
Samsun, Turkey

Donald M Black, MD

Research Site
Dubai, United Arab Emirates

Donald M Black, MD

Research Site
Sharjah, United Arab Emirates

Donald M Black, MD

Research Site
West Midlands, United Kingdom

Donald M Black, MD

Research Site
Huntington Beach, CA United States

Donald M Black, MD

Research Site
Lewiston, ME United States

Donald M Black, MD

Research Site
Bydgoszcz, Poland

Donald M Black, MD

Research Site
Bahía Blanca, Argentina

Donald M Black, MD

Research Site
Santo André, Brazil

Donald M Black, MD

Research Site
Québec, Canada

Donald M Black, MD

Research Site
Bnei Brak, Israel

Donald M Black, MD

Research Site
Cortona, Italy

Donald M Black, MD

Research Site
Capelle Aan Den IJssel, Netherlands

Donald M Black, MD

Research Site
Kuils River, South Africa

Donald M Black, MD

Research Site
Sant Joan, Spain

Donald M Black, MD

Research Site
Basildon, United Kingdom

Donald M Black, MD

Research Site
Burton Upon Trent, United Kingdom

Donald M Black, MD

Research Site
Chelmsford, United Kingdom

Donald M Black, MD

Research Site
Dartford, United Kingdom

Donald M Black, MD

Research Site
Harrow, United Kingdom

Donald M Black, MD

Research Site
Nuneaton, United Kingdom

Donald M Black, MD

Research Site
Sheffield, United Kingdom

Donald M Black, MD

Research Site
Swindon, United Kingdom

Donald M Black, MD

Research Site
Taunton, United Kingdom

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


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