Last updated on September 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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Doetinchem, Netherlands
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Donald M Black, MD

Research Site
Ede, Netherlands
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Donald M Black, MD

Research Site
Goes, Netherlands
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Donald M Black, MD

Research Site
Gouda, Netherlands
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Donald M Black, MD

Research Site
Hoogeveen, Netherlands
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Donald M Black, MD

Research Site
Hoorn, Netherlands
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Donald M Black, MD

Research Site
Leeuwarden, Netherlands
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Donald M Black, MD

Research Site
Leiden, Netherlands
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Donald M Black, MD

Research Site
Rotterdam, Netherlands
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Donald M Black, MD

Research Site
Schiedam, Netherlands
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Donald M Black, MD

Research Site
Sneek, Netherlands
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Donald M Black, MD

Research Site
Tiel, Netherlands
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Donald M Black, MD

Research Site
Tilburg, Netherlands
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Donald M Black, MD

Research Site
Uden, Netherlands
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Donald M Black, MD

Research Site
Veldhoven, Netherlands
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Donald M Black, MD

Research Site
Venlo, Netherlands
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Donald M Black, MD

Research Site
Zaandam, Netherlands
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Donald M Black, MD

Research Site
Zutphen, Netherlands
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Donald M Black, MD

Research Site
Christchurch, New Zealand
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Donald M Black, MD

Research Site
Dunedin, New Zealand
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Donald M Black, MD

Research Site
Grafton, New Zealand
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Donald M Black, MD

Research Site
Lower Hutt, New Zealand
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Donald M Black, MD

Research Site
Nelson, New Zealand
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Donald M Black, MD

Research Site
New Plymouth, New Zealand
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Donald M Black, MD

Research Site
Rotorua, New Zealand
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Donald M Black, MD

Research Site
Takapuna, New Zealand
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Donald M Black, MD

Research Site
Wellington, New Zealand
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Donald M Black, MD

Research Site
Elblag, Poland
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Donald M Black, MD

Research Site
Gdynia, Poland
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Donald M Black, MD

Research Site
Kielce, Poland
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Donald M Black, MD

Research Site
Krakow, Poland
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Donald M Black, MD

Research Site
Lodz, Poland
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Donald M Black, MD

Research Site
Mragowo, Poland
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Donald M Black, MD

Research Site
Olawa, Poland
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Donald M Black, MD

Research Site
Oswiecim, Poland
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Donald M Black, MD

Research Site
Plock, Poland
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Donald M Black, MD

Research Site
Poznan, Poland
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Donald M Black, MD

Research Site
Ruda Slaska, Poland
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Donald M Black, MD

Research Site
Rzeszow, Poland
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Donald M Black, MD

Research Site
Sopot, Poland
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Donald M Black, MD

Research Site
Sroda Wielkopolska, Poland
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Donald M Black, MD

Research Site
Szczecin, Poland
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Donald M Black, MD

Research Site
Torun, Poland
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Donald M Black, MD

Research Site
Wroclaw, Poland
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Donald M Black, MD

Research Site
Zabrze, Poland
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Donald M Black, MD

Research Site
Zamosc, Poland
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Donald M Black, MD

Research Site
Almada, Portugal
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Donald M Black, MD

Research Site
Braga, Portugal
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Donald M Black, MD

Research Site
Coimbra, Portugal
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Donald M Black, MD

Research Site
Faro, Portugal
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Donald M Black, MD

Research Site
Leiria, Portugal
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Donald M Black, MD

Research Site
Lisboa, Portugal
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Donald M Black, MD

Research Site
Senhora da Hora, Portugal
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Donald M Black, MD

Research Site
Setubal, Portugal
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Donald M Black, MD

Research Site
Bayamon, Puerto Rico
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Donald M Black, MD

Research Site
Caguas, Puerto Rico
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Donald M Black, MD

Research Site
Ponce, Puerto Rico
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Donald M Black, MD

Research Site
Arad, Romania
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Donald M Black, MD

Research Site
Baia Mare, Romania
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Donald M Black, MD

Research Site
Braila, Romania
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Donald M Black, MD

Research Site
Bucharest, Romania
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Donald M Black, MD

Research Site
Buzau, Romania
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Donald M Black, MD

Research Site
Cluj-Napoca, Romania
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Donald M Black, MD

Research Site
Craiova, Romania
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Donald M Black, MD

Research Site
Oradea, Romania
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Donald M Black, MD

Research Site
Pitesti, Romania
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Donald M Black, MD

Research Site
Timisoara, Romania
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Donald M Black, MD

Research Site
Arkhangelsk, Russian Federation
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Donald M Black, MD

Research Site
Barnaul, Russian Federation
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Donald M Black, MD

Research Site
Ekaterinburg, Russian Federation
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Donald M Black, MD

Research Site
Irkutsk, Russian Federation
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Donald M Black, MD

Research Site
Kazan, Russian Federation
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Donald M Black, MD

Research Site
Kemerovo, Russian Federation
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Donald M Black, MD

Research Site
Kirovsk, Russian Federation
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Donald M Black, MD

Research Site
Moscow, Russian Federation
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Donald M Black, MD

Research Site
Nizhny Novgorod, Russian Federation
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Donald M Black, MD

Research Site
Novosibirsk, Russian Federation
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Donald M Black, MD

Research Site
Omsk, Russian Federation
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Donald M Black, MD

Research Site
Orenburg, Russian Federation
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Donald M Black, MD

Research Site
Penza, Russian Federation
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Donald M Black, MD

Research Site
Petrozavodsk, Russian Federation
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Donald M Black, MD

Research Site
Saint-Petersburg, Russian Federation
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Donald M Black, MD

Research Site
Saratov, Russian Federation
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Donald M Black, MD

Research Site
Tomsk, Russian Federation
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Donald M Black, MD

Research Site
Tula, Russian Federation
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Donald M Black, MD

Research Site
Tyumen, Russian Federation
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Donald M Black, MD

Research Site
Yaroslavl, Russian Federation
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Donald M Black, MD

Research Site
Bardejov, Slovakia
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Donald M Black, MD

Research Site
Bratislava, Slovakia
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Donald M Black, MD

Research Site
Kosice, Slovakia
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Donald M Black, MD

Research Site
Lucenec, Slovakia
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Donald M Black, MD

Research Site
Namestovo, Slovakia
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Donald M Black, MD

Research Site
Nitra, Slovakia
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Donald M Black, MD

Research Site
Bloemfontein, South Africa
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Donald M Black, MD

Research Site
Cape Town, South Africa
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Donald M Black, MD

Research Site
Paarl, South Africa
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Donald M Black, MD

Research Site
Parow, South Africa
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Donald M Black, MD

Research Site
Somerset West, South Africa
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Donald M Black, MD

Research Site
Worcester, South Africa
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Donald M Black, MD

Research Site
A Coruna, Spain
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Donald M Black, MD

Research Site
Barcelona, Spain
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Donald M Black, MD

Research Site
Hospitalet del Llobregat, Spain
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Donald M Black, MD

Research Site
Lleida, Spain
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Donald M Black, MD

Research Site
Madrid, Spain
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Donald M Black, MD

Research Site
Malaga, Spain
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Donald M Black, MD

Research Site
Sabadell, Spain
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Donald M Black, MD

Research Site
Salamanca, Spain
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Donald M Black, MD

Research Site
Santiago de Compostela, Spain
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Donald M Black, MD

Research Site
Seville, Spain
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Donald M Black, MD

Research Site
Tarragona, Spain
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Donald M Black, MD

Research Site
Valencia, Spain
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Donald M Black, MD

Research Site
Vigo, Spain
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Donald M Black, MD

Research Site
Falun, Sweden
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Donald M Black, MD

Research Site
Karlshamn, Sweden
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Donald M Black, MD

Research Site
Koping, Sweden
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Donald M Black, MD

Research Site
Linkoping, Sweden
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Donald M Black, MD

Research Site
Malmo, Sweden
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Donald M Black, MD

Research Site
Orebro, Sweden
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Donald M Black, MD

Research Site
Umea, Sweden
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Donald M Black, MD

Research Site
Uppsala, Sweden
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Donald M Black, MD

Research Site
Vasteras, Sweden
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Donald M Black, MD

Research Site
Geneva, Switzerland
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Donald M Black, MD

Research Site
Lugano, Switzerland
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Donald M Black, MD

Research Site
Afyonkarahisar, Turkey
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Donald M Black, MD

Research Site
Ankara, Turkey
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Donald M Black, MD

Research Site
Istanbul, Turkey
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Donald M Black, MD

Research Site
Izmir, Turkey
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Donald M Black, MD

Research Site
Kadikoy, Turkey
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Donald M Black, MD

Research Site
Kayseri, Turkey
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Donald M Black, MD

Research Site
Mersin, Turkey
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Donald M Black, MD

Research Site
Sivas, Turkey
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Donald M Black, MD

Research Site
Ayr, United Kingdom
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Donald M Black, MD

Research Site
Barnet, United Kingdom
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Donald M Black, MD

Research Site
Belfast, United Kingdom
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Donald M Black, MD

Research Site
Blackpool, United Kingdom
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Donald M Black, MD

Research Site
Bradford, United Kingdom
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Donald M Black, MD

Research Site
Bristol, United Kingdom
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Donald M Black, MD

Research Site
Chertsey, United Kingdom
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Donald M Black, MD

Research Site
Clydebank, United Kingdom
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Donald M Black, MD

Research Site
Cornwall, United Kingdom
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Donald M Black, MD

Research Site
Coventry, United Kingdom
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Donald M Black, MD

Research Site
Craigavon, United Kingdom
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Donald M Black, MD

Research Site
Dudley, United Kingdom
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Donald M Black, MD

Research Site
Glasgow, United Kingdom
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Donald M Black, MD

Research Site
High Wycombe, United Kingdom
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Donald M Black, MD

Research Site
Hull, United Kingdom
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Donald M Black, MD

Research Site
Inverness, United Kingdom
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Donald M Black, MD

Research Site
Kirkcaldy, United Kingdom
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Donald M Black, MD

Research Site
Lanark, United Kingdom
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Donald M Black, MD

Research Site
Leicester, United Kingdom
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Donald M Black, MD

Research Site
Lincoln, United Kingdom
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Donald M Black, MD

Research Site
Liverpool, United Kingdom
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Donald M Black, MD

Research Site
Londonderry, United Kingdom
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Donald M Black, MD

Research Site
Luton, United Kingdom
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Donald M Black, MD

Research Site
Manchester, United Kingdom
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Donald M Black, MD

Research Site
Newcastle, United Kingdom
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Donald M Black, MD

Research Site
Newport, United Kingdom
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Donald M Black, MD

Research Site
Northampton, United Kingdom
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Donald M Black, MD

Research Site
Paisley, United Kingdom
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Donald M Black, MD

Research Site
Redhill, United Kingdom
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Donald M Black, MD

Research Site
Romford, United Kingdom
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Donald M Black, MD

Research Site
Rotherham, United Kingdom
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Donald M Black, MD

Research Site
Salford, United Kingdom
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Donald M Black, MD

Research Site
Stevenage, United Kingdom
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Donald M Black, MD

Research Site
Stockport, United Kingdom
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Donald M Black, MD

Research Site
Stockton on Tees, United Kingdom
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Donald M Black, MD

Research Site
Telford, United Kingdom
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Donald M Black, MD

Research Site
Westcliff on Sea, United Kingdom
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Donald M Black, MD

Research Site
Wigan, United Kingdom
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Donald M Black, MD

Research Site
Worthing, United Kingdom
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Donald M Black, MD

Research Site
Miramar, FL United States
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Donald M Black, MD

Research Site
Bethesda, MD United States
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Donald M Black, MD

Research Site
Columbia, MD United States
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Donald M Black, MD

Research Site
Mount Clemens, MI United States
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Donald M Black, MD

Research Site
Saint Joseph, MI United States
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Donald M Black, MD

Research Site
Summit, NJ United States
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Donald M Black, MD

Research Site
La Crosse, WI United States
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Donald M Black, MD

Research Site
Venado Tuerto, Argentina
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Donald M Black, MD

Research Site
Gosford, Australia
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Donald M Black, MD

Research Site
Saint Leonards, Australia
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Donald M Black, MD

Research Site
Chermside, Australia
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Donald M Black, MD

Research Site
Douglas, Australia
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Donald M Black, MD

Research Site
Herston, Australia
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Donald M Black, MD

Research Site
Epping, Australia
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Donald M Black, MD

Research Site
Melbourne, Australia
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Donald M Black, MD

Research Site
Joondalup, Australia
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Donald M Black, MD

Research Site
Perth, Australia
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Donald M Black, MD

Research Site
Braunau Am Inn, Austria
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Donald M Black, MD

Research Site
Aalst, Belgium
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Donald M Black, MD

Research Site
Brasilia, Brazil
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Donald M Black, MD

Research Site
Campina Grande do Sul, Brazil
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Donald M Black, MD

Research Site
Campo Grande, Brazil
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Donald M Black, MD

Research Site
Natal, Brazil
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Donald M Black, MD

Research Site
Ribeirao Preto, Brazil
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Donald M Black, MD

Research Site
Sao Paulo, Brazil
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Donald M Black, MD

Research Site
Uberlandia, Brazil
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Donald M Black, MD

Research Site
Vitoria, Brazil
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Donald M Black, MD

Research Site
Blagoevgrad, Bulgaria
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Donald M Black, MD

Research Site
Peterborough, ON Canada
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Donald M Black, MD

Research Site
Bilina, Czechia
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Donald M Black, MD

Research Site
Plzen, Czechia
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Donald M Black, MD

Research Site
Monchengladbach, Germany
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Donald M Black, MD

Research Site
Poriyya 'Illit, Israel
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Donald M Black, MD

Research Site
Ascoli Piceno, Italy
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Donald M Black, MD

Research Site
Cagliari, Italy
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Donald M Black, MD

Research Site
Empoli, Italy
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Donald M Black, MD

Research Site
Giugliano in Campania, Italy
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Donald M Black, MD

Research Site
Gubbio, Italy
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Donald M Black, MD

Research Site
Milano, Italy
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Donald M Black, MD

Research Site
Roma, Italy
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Donald M Black, MD

Research Site
Rozzano, Italy
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Donald M Black, MD

Research Site
Hastings, New Zealand
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Donald M Black, MD

Research Site
Gatong, South Africa
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Donald M Black, MD

Research Site
Johannesburg, South Africa
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Donald M Black, MD

Research Site
Samsun, Turkey
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Donald M Black, MD

Research Site
Dubai, United Arab Emirates
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Donald M Black, MD

Research Site
Sharjah, United Arab Emirates
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Donald M Black, MD

Research Site
West Midlands, United Kingdom
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Donald M Black, MD

Research Site
Huntington Beach, CA United States
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Donald M Black, MD

Research Site
Lewiston, ME United States
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Donald M Black, MD

Research Site
Bydgoszcz, Poland
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Donald M Black, MD

Research Site
Bahía Blanca, Argentina
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Donald M Black, MD

Research Site
Santo André, Brazil
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Donald M Black, MD

Research Site
Québec, Canada
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Donald M Black, MD

Research Site
Bnei Brak, Israel
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Donald M Black, MD

Research Site
Cortona, Italy
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Donald M Black, MD

Research Site
Capelle Aan Den IJssel, Netherlands
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Donald M Black, MD

Research Site
Kuils River, South Africa
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Donald M Black, MD

Research Site
Sant Joan, Spain
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Donald M Black, MD

Research Site
Basildon, United Kingdom
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Donald M Black, MD

Research Site
Burton Upon Trent, United Kingdom
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Donald M Black, MD

Research Site
Chelmsford, United Kingdom
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Donald M Black, MD

Research Site
Dartford, United Kingdom
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Donald M Black, MD

Research Site
Harrow, United Kingdom
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Donald M Black, MD

Research Site
Nuneaton, United Kingdom
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Donald M Black, MD

Research Site
Sheffield, United Kingdom
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Donald M Black, MD

Research Site
Swindon, United Kingdom
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Donald M Black, MD

Research Site
Taunton, United Kingdom
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Recruitment Status: Open


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