Open Label Continuation Study in Moderate to Severe Psoriasis

Phase 3

Completed

Conditions: Moderate to Severe Plaque Psoriasis

Interventions: Drug: ABT-874

Registration Number: NCT00626002

Lead Sponsor: AbbVie (prior sponsor, Abbott)

Brief Summary: The purpose of this study is to evaluate long term safety, efficacy and tolerability of ABT-874 in adults with moderate to severe psoriasis.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2301

Inclusion Criteria

Having participated in a preceding ABT-874 clinical trial for ABT-874
Subject has a clinical diagnosis of moderate to severe plaque psoriasis

Exclusion Criteria

Subjects who prematurely discontinued in any preceding psoriasis study with ABT-874 other than protocol-required discontinuation

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	ABT-874	-

Primary Outcome Measures

Name	Time	Method
Proportion of subjects achieving a > PASI 50 clinical response that is defined as a reduction on PASI scores by at least 50% relative to Baseline, by visit.	Visit (12 weeks)
Proportion of subjects achieving PGA "clear" (0) or "minimal" (1) scores by visit.	Visit (12 weeks)
Proportion of subjects achieving a > PASI 75 clinical response that is defined as a reduction on PASI scores by at least 50% relative to Baseline, by visit.	Visit (12 weeks)
AEs, serious adverse events (SAEs), laboratory data, ADA and vital signs will be assessed throughout the study	Visit (12 weeks)

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (152): Site Reference ID/Investigator# 7899
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Columbus, Ohio, United States
Site Reference ID/Investigator# 7239
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Los Angeles, California, United States
Site Reference ID/Investigator# 7498
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Dallas, Texas, United States
Site Reference ID/Investigator# 6947
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Dallas, Texas, United States
Site Reference ID/Investigator# 7930
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Philadelphia, Pennsylvania, United States
Site Reference ID/Investigator# 8149
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Boston, Massachusetts, United States
Site Reference ID/Investigator# 7044
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Cleveland, Ohio, United States
Site Reference ID/Investigator# 7234
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Bakersfield, California, United States
Site Reference ID/Investigator# 17193
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Henderson, Kentucky, United States
Site Reference ID/Investigator# 6930
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St. Louis, Missouri, United States
Site Reference ID/Investigator# 8392
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New York, New York, United States
Site Reference ID/Investigator# 7434
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Hickory, North Carolina, United States
Site Reference ID/Investigator# 10201
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New York, New York, United States
Site Reference ID/Investigator# 7333
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Stoney Brook, New York, United States
Site Reference ID/Investigator# 7497
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Goodlettsville, Tennessee, United States
Site Reference ID/Investigator# 16845
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Graz, Austria
Site Reference ID/Investigator# 6997
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Vancouver, Canada
Site Reference ID/Investigator# 17781
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Aarhus, Denmark
Site Reference ID/Investigator# 16161
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Muenster, Germany
Site Reference ID/Investigator# 16381
🇩🇪
Kiel, Germany
Site Reference ID/Investigator# 16143
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Munich, Germany
Site Reference ID/Investigator# 15921
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Athens, Greece
Site Reference ID/Investigator# 15922
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Thessaloniki, Greece
Site Reference ID/Investigator# 15401
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Modena, Italy
Site Reference ID/Investigator# 15341
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Madrid, Spain
Site Reference ID/Investigator# 15422
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Manchester, United Kingdom
Site Reference ID/Investigator# 7933
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Little Rock, Arkansas, United States
Site Reference ID/Investigator# 7785
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Greer, South Carolina, United States
Site Reference ID/Investigator# 7882
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New Brunswick, New Jersey, United States
Site Reference ID/Investigator# 18661
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Helsinki, Finland
Site Reference ID/Investigator# 6944
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Houston, Texas, United States
Site Reference ID/Investigator# 6932
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Seattle, Washington, United States
Site Reference ID/Investigator# 7503
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San Diego, California, United States
Site Reference ID/Investigator# 7520
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San Diego, California, United States
Site Reference ID/Investigator# 7010
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San Diego, California, United States
Site Reference ID/Investigator# 7716
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Miami, Florida, United States
Site Reference ID/Investigator# 7657
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Miami, Florida, United States
Site Reference ID/Investigator# 6933
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Indianapolis, Indiana, United States
Site Reference ID/Investigator# 10422
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Indianapolis, Indiana, United States
Site Reference ID/Investigator# 6945
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Cincinnati, Ohio, United States
Site Reference ID/Investigator# 23345
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Cincinnati, Ohio, United States
Site Reference ID/Investigator# 10962
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San Francisco, California, United States
Site Reference ID/Investigator# 7758
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San Antonio, Texas, United States
Site Reference ID/Investigator# 6931
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Nashville, Tennessee, United States
Site Reference ID/Investigator# 8108
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San Antonio, Texas, United States
Site Reference ID/Investigator# 10207
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Salt Lake City, Utah, United States
Site Reference ID/Investigator# 7992
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Overland Park, Kansas, United States
Site Reference ID/Investigator# 7496
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Birmingham, Alabama, United States
Site Reference ID/Investigator# 8438
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Birmingham, Alabama, United States
Site Reference ID/Investigator# 7929
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Denver, Colorado, United States
Site Reference ID/Investigator# 9823
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Detroit, Michigan, United States
Site Reference ID/Investigator# 7703
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Portland, Oregon, United States
Site Reference ID/Investigator# 11424
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Portland, Oregon, United States
Site Reference ID/Investigator# 6948
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Portland, Oregon, United States
Site Reference ID/Investigator# 7005
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Windsor, Canada
Site Reference ID/Investigator# 7240
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Omaha, Nebraska, United States
Site Reference ID/Investigator# 9567
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Omaha, Nebraska, United States
Site Reference ID/Investigator# 9681
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Winston-Salem, North Carolina, United States
Site Reference ID/Investigator# 7884
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Milwaukee, Wisconsin, United States
Site Reference ID/Investigator# 7522
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Huntsville, Alabama, United States
Site Reference ID/Investigator# 7774
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Scottsdale, Arizona, United States
Site Reference ID/Investigator# 7435
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Tucson, Arizona, United States
Site Reference ID/Investigator# 8249
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Fresno, California, United States
Site Reference ID/Investigator# 8390
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Oceanside, California, United States
Site Reference ID/Investigator# 7793
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Vallejo, California, United States
Site Reference ID/Investigator# 7334
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Santa Monica, California, United States
Site Reference ID/Investigator# 7653
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Doral, Florida, United States
Site Reference ID/Investigator# 8341
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Jacksonville, Florida, United States
Site Reference ID/Investigator# 7331
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Alpharetta, Georgia, United States
Site Reference ID/Investigator# 7893
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West Palm Beach, Florida, United States
Site Reference ID/Investigator# 9743
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Atlanta, Georgia, United States
Site Reference ID/Investigator# 10841
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South Miami, Florida, United States
Site Reference ID/Investigator# 8379
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Arlington Heights, Illinois, United States
Site Reference ID/Investigator# 7891
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Newnan, Georgia, United States
Site Reference ID/Investigator# 7932
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Snellville, Georgia, United States
Site Reference ID/Investigator# 10703
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Schaumburg, Illinois, United States
Site Reference ID/Investigator# 7892
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West Dundee, Illinois, United States
Site Reference ID/Investigator# 6950
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Skokie, Illinois, United States
Site Reference ID/Investigator# 8529
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Andover, Massachusetts, United States
Site Reference ID/Investigator# 9962
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Owensboro, Kentucky, United States
Site Reference ID/Investigator# 16581
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Plainfield, Indiana, United States
Site Reference ID/Investigator# 7883
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Fort Gratiot, Michigan, United States
Site Reference ID/Investigator# 7238
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Grand Blanc, Michigan, United States
Site Reference ID/Investigator# 7656
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Fridley, Minnesota, United States
Site Reference ID/Investigator# 6949
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St. Louis, Missouri, United States
Site Reference ID/Investigator# 7330
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East Windsor, New Jersey, United States
Site Reference ID/Investigator# 7757
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Berlin, New Jersey, United States
Site Reference ID/Investigator# 7455
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Albuquerque, New Mexico, United States
Site Reference ID/Investigator# 8078
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Buffalo, New York, United States
Site Reference ID/Investigator# 8006
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New York, New York, United States
Site Reference ID/Investigator# 7230
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New York, New York, United States
Site Reference ID/Investigator# 8117
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Wilmington, North Carolina, United States
Site Reference ID/Investigator# 8037
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Rochester, New York, United States
Site Reference ID/Investigator# 8389
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Dayton, Ohio, United States
Site Reference ID/Investigator# 11181
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Oklahoma City, Oklahoma, United States
Site Reference ID/Investigator# 6936
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Lake Oswego, Oregon, United States
Site Reference ID/Investigator# 6934
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Johnston, Rhode Island, United States
Site Reference ID/Investigator# 6935
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Providence, Rhode Island, United States
Site Reference ID/Investigator# 8494
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Hershey, Pennsylvania, United States
Site Reference ID/Investigator# 7684
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Arlington, Texas, United States
Site Reference ID/Investigator# 7388
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Knoxville, Tennessee, United States
Site Reference ID/Investigator# 6937
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Tyler, Texas, United States
Site Reference ID/Investigator# 7655
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Webster, Texas, United States
Site Reference ID/Investigator# 10306
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Spokane, Washington, United States
Site Reference ID/Investigator# 6946
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Norfolk, Virginia, United States
Site Reference ID/Investigator# 18183
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Vienna, Austria
Site Reference ID/Investigator# 15761
🇧🇪
Brussels, Belgium
Site Reference ID/Investigator# 7991
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Barrie, Canada
Site Reference ID/Investigator# 6996
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Halifax, Canada
Site Reference ID/Investigator# 7236
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Hamilton, Canada
Site Reference ID/Investigator# 7996
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Edmonton, Canada
Site Reference ID/Investigator# 8047
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Calgary, Canada
Site Reference ID/Investigator# 6995
🇨🇦
Laval, Canada
Site Reference ID/Investigator# 6998
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London, Canada
Site Reference ID/Investigator# 7043
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London, Canada
Site Reference ID/Investigator# 6999
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Montreal, Canada
Site Reference ID/Investigator# 7329
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Markham, Canada
Site Reference ID/Investigator# 7652
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Montreal, Canada
Site Reference ID/Investigator# 7006
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North Bay, Canada
Site Reference ID/Investigator# 8102
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Ottawa, Canada
Site Reference ID/Investigator# 6993
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Quebec City, Canada
Site Reference ID/Investigator# 8112
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St. John's, Canada
Site Reference ID/Investigator# 8118
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Vancouver, Canada
Site Reference ID/Investigator# 7931
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Surrey, Canada
Site Reference ID/Investigator# 8348
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Winnipeg, Canada
Site Reference ID/Investigator# 6994
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Waterloo, Canada
Site Reference ID/Investigator# 8111
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Westmount, Canada
Site Reference ID/Investigator# 18041
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Copenhagen NV, Denmark
Site Reference ID/Investigator# 7979
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Windsor, Canada
Site Reference ID/Investigator# 19241
🇫🇮
Turku, Finland
Site Reference ID/Investigator# 18701
🇫🇮
Kuopio, Finland
Site Reference ID/Investigator# 14962
🇫🇮
Lahti, Finland
Site Reference ID/Investigator# 16781
🇫🇷
Paris Cedex 10, France
Site Reference ID/Investigator# 18502
🇫🇷
Nice, France
Site Reference ID/Investigator# 18506
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Toulouse, Cedex 9, France
Site Reference ID/Investigator# 15664
🇩🇪
Frankfurt am Main, Germany
Site Reference ID/Investigator# 16281
🇩🇪
Berlin, Germany
Site Reference ID/Investigator# 15663
🇩🇪
Hamburg, Germany
Site Reference ID/Investigator# 16282
🇬🇷
Athens, Greece
Site Reference ID/Investigator# 17676
🇩🇪
Tuebingen, Germany
Site Reference ID/Investigator# 14881
🇮🇹
Rome, Italy
Site Reference ID/Investigator# 16142
🇸🇪
Stockholm, Sweden
Site Reference ID/Investigator# 19322
🇪🇸
Barcelona, Spain
Site Reference ID/Investigator# 17721
🇨🇭
Geneva 14, Switzerland
Site Reference ID/Investigator# 16749
🇨🇭
Zurich, Switzerland
Site Reference ID/Investigator# 19045
🇬🇧
Aberdeen, United Kingdom
Site Reference ID/Investigator# 7332
🇺🇸
Irvine, California, United States
Site Reference ID/Investigator# 8798
🇺🇸
Maywood, Illinois, United States
Site Reference ID/Investigator# 7436
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Longmont, Colorado, United States
Site Reference ID/Investigator# 7521
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New Haven, Connecticut, United States
Site Reference ID/Investigator# 8528
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Louisville, Kentucky, United States
Site Reference ID/Investigator# 10842
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Austin, Texas, United States