Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to Placebo

Last updated: April 14, 2021
Sponsor: Regeneron Pharmaceuticals
Overall Status: Completed

Phase

4

Condition

Hypercholesterolemia

Treatment

N/A

Clinical Study ID

NCT02957682
R727-CL-1532
2016-003189-16
  • Ages 40-85
  • All Genders

Study Summary

The main purpose of this study is to evaluate the effect on mental state (known as "neurocognitive function") with use of Praluent.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Men and women ≥ age 40 years and ≤ age 85 years
  • Patients with heterozygous familial hypercholesterolemia (heFH) or with non-familialhypercholesterolemia (non-FH) patients at high or very high cardiovascular risk
  • Patients with history of coronary heart disease (CHD) not having adequate control oftheir hypercholesterolemia with LDL-C ≥70 mg/dL, or all other patients with LDL-C ≥100mg/dL and be on maximally-tolerated dose of statin (unless they are statin-intolerant)
  • Patients must have successfully completed the Motor Screening Task
  • Patients must be willing and able to comply with clinic visits and study relatedprocedures
  • Patients must provide signed informed consent

Exclusion

Key Exclusion Criteria:

  • Patients with known Alzheimer's disease or other dementia, schizophrenia, bipolardisorder, severe depression, cognitive impairment, or patients with a sleep disorderrequiring daily pharmacological treatment
  • Recent (within 3 months prior to the screening visit) myocardial infarction, unstableangina leading to hospitalization, coronary artery bypass graft surgery, percutaneouscoronary intervention, uncontrolled cardiac arrhythmia, carotid surgery or stenting,stroke, transient ischemic attack, carotid revascularization, endovascular procedureor surgical intervention for peripheral vascular disease
  • Certain laboratory findings obtained during the screening visit as defined in theprotocol
  • Any condition or situation, including other significant mental or neurologicaldisorders that, in the investigator's opinion, may confound the study results, or mayinterfere significantly with the patient's participation in the study
  • Pregnant or breastfeeding women
  • A positive human immunodeficiency virus (HIV) test NOTE: Other protocol defined Inclusion/Exclusion Criteria apply

Study Design

Total Participants: 2176
Study Start date:
November 02, 2016
Estimated Completion Date:
March 05, 2020

Connect with a study center

  • Regeneron Study Site

    Pleven, 5800
    Bulgaria

    Site Not Available

  • Regeneron Study Site

    Plovdiv, 4002
    Bulgaria

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  • Regeneron Study Site

    Sofia, 1309
    Bulgaria

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  • Regeneron Study Site

    Stara Zagora, 6000
    Bulgaria

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  • Regeneron Study Site 1

    Varna, 9000
    Bulgaria

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  • Regeneron Study Site 2

    Varna, 9000
    Bulgaria

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  • Site 2

    Verna, 9000
    Bulgaria

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  • Regeneron Study Site

    Osorno, 5290000
    Chile

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  • Regeneron Study Site

    San Miguel, 8910259
    Chile

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  • Regeneron Study Site

    Santiago, 8331143
    Chile

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    Temuco, 4781156
    Chile

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    Viña del Mar, 2520997
    Chile

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  • Site 3

    Medellin, Antioquia
    Colombia

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    Manizales, Caldas
    Colombia

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    Bogota, D.c.
    Colombia

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  • Site 2

    Floridablanca, Santander
    Colombia

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    Cali, Valle del Cauca
    Colombia

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    Paide, 72713
    Estonia

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    Tallinm, 10617
    Estonia

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  • Regeneron Study Site

    Tallinn, 11911
    Estonia

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  • Regeneron Study Site 1

    Tallinn, 10617
    Estonia

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  • Regeneron Study Site 2

    Tallinn, 10617
    Estonia

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    Tartu, 51014
    Estonia

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    Nishinomiya, Hogo 663-8501
    Japan

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    Kahoku-gun, Ishikawa 920-0193
    Japan

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    Kawasaki, Kanagawa 216-8511
    Japan

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    Yokohama, Kanagawa 236-0004
    Japan

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    Uji-shi, Kyoto 611-0002
    Japan

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    Nakagami-gun, Okinawa 901-2393
    Japan

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  • Regeneron Study Site

    Iruma-gun, Saitama 350-0495
    Japan

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    Bunkyō-Ku, Tokyo 112-0033
    Japan

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    Chuo Ku, Tokyo 103-0027
    Japan

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    Hachiōji, Tokyo 192-0918
    Japan

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    Itabashi-ku, Tokyo 173-8610
    Japan

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    Shinagawa-Ku, Tokyo 141-0001
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    Aguascalientes, 20230
    Mexico

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  • Site 4

    Ciudad de mexico,
    Mexico

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    Cuernavaca, 62250
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    Culiacán, 80230
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    Distrito Federal, 03100
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    Durango, 34000
    Mexico

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    Guadalajara, 44130
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    Merida, 97070
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    Mexico City, 07760
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    Monterrey, 64710
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    Monterrey, 64460
    Mexico

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    Monterrey, 64460
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    Pachuca, 42090
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    Querétaro, 76000
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    San Juan Del Río, 76800
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    Torreon, 27000
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    Ivanovo, 153012
    Russian Federation

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    Kemerovo,
    Russian Federation

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    Kirov, 610014
    Russian Federation

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    Moscow, 121359
    Russian Federation

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    Novosibirsk, 630008
    Russian Federation

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    Rostov-on-Don, 344068
    Russian Federation

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    Saint Petersburg, 192288
    Russian Federation

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    Saratov, 410028
    Russian Federation

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    Tyumen', 625000
    Russian Federation

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    Yaroslavl, 150003
    Russian Federation

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  • Regeneron Study Site 1

    Yaroslavl, 150030
    Russian Federation

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  • Regeneron Study Site 2

    Yaroslavl, 150030
    Russian Federation

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    Kuils River, Cape Town 7580
    South Africa

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    Port Elizabeth, Eastern Cape 6001
    South Africa

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    Halfway House, Gauteng 1685
    South Africa

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    Pretoria, Gauteng 0002
    South Africa

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    Pretoria West, Gauteng 183
    South Africa

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    Kempton Park, Johannesburg 1619
    South Africa

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    Soweto, Johannesburg 2013
    South Africa

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    Middelburg, Mpumalanga 1050
    South Africa

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    Cape Town, Western Cape 7530
    South Africa

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    Paarl, Western Cape 7500
    South Africa

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    Somerset West, Western Cape 7130
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    Worcester, Western Cape 6850
    South Africa

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    Bloemfontein, 9301
    South Africa

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    Bloemfontein, 9301
    South Africa

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    Claremont, 7708
    South Africa

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    Durban,
    South Africa

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    Mamelodi East,
    South Africa

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    Observatory,
    South Africa

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    Úzhgorod, Transcarpathian Region 88000
    Ukraine

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    Kharkiv, 61039
    Ukraine

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    Kharkov, 61039
    Ukraine

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    Kiev, 02091
    Ukraine

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    Kiev, 02091
    Ukraine

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    Kyiv, 01601
    Ukraine

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    Kyiv, 03049
    Ukraine

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    Kyiv, 02002
    Ukraine

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    L'viv, 79015
    Ukraine

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  • Regeneron Study Site

    Vinnitsa, 21029
    Ukraine

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  • Regeneron Study Site 1

    Vinnitsa, 21018
    Ukraine

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  • Regeneron Study Site 2

    Vinnitsa, 21018
    Ukraine

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    Alexander City, Alabama
    United States

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  • Regeneron Study Site

    Auburn, Alabama 36830
    United States

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    Birmingham, Alabama 35209
    United States

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  • Regeneron Study Site

    Mobile, Alabama 36608
    United States

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  • Regeneron Study Site

    Beverly Hills, California 90210
    United States

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    Los Gatos, California 95032
    United States

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    North Hollywood, California 91606
    United States

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    Port Hueneme, California 93041
    United States

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    Westminster, California 92683
    United States

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  • Regeneron Study Site 1

    Aurora, Colorado 80012
    United States

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  • Regeneron Study Site 2

    Aurora, Colorado 80012
    United States

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    Colorado Springs, Colorado 80906
    United States

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    Denver, Colorado
    United States

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    Atlantis, Florida
    United States

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  • Regeneron Study Site

    Lake Worth, Florida 33462
    United States

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    Miami Springs, Florida 33166
    United States

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    Covington, Georgia 30014
    United States

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    Champaign, Illinois 61822
    United States

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    Chicago, Illinois 60640
    United States

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    Rock Island, Illinois 61201
    United States

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    Evansville, Indiana 47714
    United States

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    Indianapolis, Indiana 46237
    United States

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    Ames, Iowa 50010-3014
    United States

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    Iowa City, Iowa 52242
    United States

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    Waterloo, Iowa 50702
    United States

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    Hutchinson, Kansas 67502
    United States

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    Newton, Kansas 67114
    United States

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    Overland Park, Kansas 66209
    United States

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    Louisville, Kentucky 40213
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    Bangor, Maine 04401
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    Baltimore, Maryland 21229
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    Oxon Hill, Maryland 20745
    United States

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    Minneapolis, Minnesota 55407
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    Olive Branch, Mississippi 38654
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    Washington, Missouri 63090
    United States

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    Buffalo, New York 14215
    United States

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    New Hyde Park, New York 11042
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    Cary, North Carolina 27518
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    Charlotte, North Carolina 28277
    United States

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    Greensboro, North Carolina 27401
    United States

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    Hickory, North Carolina 28601
    United States

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    High Point, North Carolina 27262
    United States

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    Raleigh, North Carolina 27609
    United States

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    Rocky Mount, North Carolina 27804
    United States

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    Salisbury, North Carolina 28144
    United States

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    Statesville, North Carolina 28625
    United States

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  • Regeneron Study Site

    Wilmington, North Carolina 28401
    United States

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    Winston Salem, North Carolina
    United States

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  • Regeneron Study Site

    Winston-Salem, North Carolina 27103
    United States

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    Cincinnati, Ohio 45219
    United States

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    Cleveland, Ohio 44122
    United States

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    Dayton, Ohio 45414
    United States

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  • Regeneron Study Site

    Duncansville, Pennsylvania 16635
    United States

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    Charleston, South Carolina 29407
    United States

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  • Regeneron Study Site

    Greenville, South Carolina 29485
    United States

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  • Regeneron Study Site

    Summerville, South Carolina 29615
    United States

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    Rapid City, South Dakota 57701
    United States

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  • Regeneron Study Site

    Bristol, Tennessee 37620
    United States

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    Jefferson City, Tennessee
    United States

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  • Regeneron Study Site

    Knoxville, Tennessee 37912
    United States

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  • Regeneron Study Site

    Powell, Tennessee 37849
    United States

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    Dallas, Texas 75231
    United States

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  • Regeneron Study Site

    Houston, Texas 77027
    United States

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    Schertz, Texas 78154
    United States

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  • Regeneron Study Site

    Shavano Park, Texas 78231
    United States

    Site Not Available

  • Regeneron Study Site

    Falls Church, Virginia 22601
    United States

    Site Not Available

  • Regeneron Study Site

    Winchester, Virginia 22042
    United States

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    Burien, Washington 98166
    United States

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  • Regeneron Study Site

    Everett, Washington 98405
    United States

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    Puyallup, Washington
    United States

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    Tacoma, Washington 98405
    United States

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    Walla Walla, Washington 99362
    United States

    Site Not Available

  • Regeneron Study Site

    Manitowoc, Wisconsin 54220
    United States

    Site Not Available

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