Open-label Long Term (52 Weeks) Safety and Tolerability of Agomelatine Sublingual Tablets in Major Depressive Disorder (MDD)



Status:Archived
Conditions:Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:June 2010

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Trial Summary
Trial Overview
Inclusion Criteria

A 52-week, Multi-center, Open-label Study of the Safety and Tolerability of Agomelatine Sublingual Tablets in Patients With Major Depressive Disorder (MDD)


The study will assess safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual
(under the tongue) formulation of agomelatine in patients with Major Depressive Disorder
over a 52-week open-label phase.

Cohort I is restricted to include patients who have completed a previous Novartis
agomelatine (178C) Double-blind study.

Cohort II will include de-novo patients (those who did not participate in a previous
agomelatine 178C study) and will only be open for a limited time span ranging from
approximately June to Sept 2010, at which point this cohort II will be closed to enrollment.



We found this trial at
102
sites
Advanced Research Associates
Glendale, Arizona 85308
1662
mi
from 43215
Glendale, AZ
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Emory University
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
435
mi
from 43215
Atlanta, GA
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University of Alabama at Birmingham
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
493
mi
from 43215
Birmingham, AL
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Massachusetts General Hospital
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
643
mi
from 43215
Boston, MA
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Montefiore Medical Center
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
484
mi
from 43215
Bronx, NY
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University of Cincinnati Medical Center
234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
University of Cincinnati Medical Center Opening in 1823 as the country
97
mi
from 43215
Cincinnati, OH
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Northwest Clinical Research Center
1952 - 152nd Place NE
East Seattle, Washington 98007
425-453-0404
1997
mi
from 43215
East Seattle, WA
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MD Clinical
911 E. Hallandale Beach Blvd
Hallandale Beach, Florida 33009
954-455-5757
980
mi
from 43215
Hallandale Beach, FL
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Sunstone Medical Research, LLC
1904 East Barnett Road
Medford, Oregon 97504
541-973-2080
2059
mi
from 43215
Medford, OR
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CRI Worldwide
16000 Horizon Way Mount
Mt Laurel, New Jersey 08054
856-533-5020
427
mi
from 43215
Mt Laurel, NJ
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Alliance Research Group
3212 Cutshaw Ave
Richmond, Virginia 23230
804-353-4494
341
mi
from 43215
Richmond, VA
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UCSF Helen Diller Family Comprehensive Cancer Center
1600 Divisadero Street
San Francisco, California 94115
888.689.8273
UCSF Helen Diller Family Comprehensive Cancer Center UCSF’s long tradition of excellence in cancer research...
2108
mi
from 43215
San Francisco, CA
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Miami Research Associates
6141 Sunset Dr # 301
South Miami, Florida 33143
(305) 598-3125
Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
997
mi
from 43215
South Miami, FL
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InSite Clinical Research
941 York Drive DeSoto
Southwest, Texas 75115
214-477-5162
920
mi
from 43215
Southwest, TX
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Janus Center for Psychiatric Research
5601 Corporate Way
West Palm Beach, Florida 33407
561-238-3036
927
mi
from 43215
West Palm Beach, FL
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Albuquerque Neuroscience Inc.
Albuquerque, New Mexico 87109
1327
mi
from 43215
Albuquerque, NM
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Lehigh Center for Clinical Research
Allentown, Pennsylvania 18104
397
mi
from 43215
Allentown, PA
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ICSL Clinical Studies
Altamonte Springs, Florida 32701
786
mi
from 43215
Altamonte Springs, FL
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Millwood Hospital
Arlington, Texas 76011
925
mi
from 43215
Arlington, TX
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Pharmasite Research
Baltimore, Maryland 21208
337
mi
from 43215
Baltimore, MD
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Sheppard Pratt Health System
Baltimore, Maryland 21285
343
mi
from 43215
Baltimore, MD
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Southwestern Research Institute
Beverly Hills, California 90210
1979
mi
from 43215
Beverly Hills, CA
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Boston Clinical Trials, INC.
Boston, Massachusetts 02135
643
mi
from 43215
Boston, MA
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University of Colorado, Boulder
Boulder, Colorado 80309
(303) 492-1411
University of Colorado, Boulder As the flagship university of the state of Colorado, CU-Boulder is...
1179
mi
from 43215
Boulder, CO
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Florida Clinical Research Center, LLC
8043 Cooper Creek Boulevard Suite 107
Bradenton, Florida 34201
(941) 747-7900
Florida Clinical Research Center, LLC Led by Andrew J. Cutler, M.D., Florida Clinical Research Center,...
862
mi
from 43215
Bradenton, FL
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Social Psychiatric Research Institute
Brooklyn, New York 11235
479
mi
from 43215
Brooklyn, NY
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Neuro-Behavioral Cilnical Research Inc
Canton, Ohio 44718
103
mi
from 43215
Canton, OH
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Neurobehavioral Research, Inc.
Cedarhurst, New York 11516
491
mi
from 43215
Cedarhurst, NY
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Comprehensive NeuroScience
Cerritos, California 90703
1967
mi
from 43215
Cerritos, CA
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Medical University of South Carolina
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
524
mi
from 43215
Charleston, SC
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Metro Health Medical Center
Cleveland, Ohio 44109
123
mi
from 43215
Cleveland, OH
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North Star Medical Research
Cleveland, Ohio 44130
117
mi
from 43215
Cleveland, OH
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Ohio State University
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
2
mi
from 43215
Columbus, OH
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Arocha Research Center
Coral Gables, Florida 33134
994
mi
from 43215
Coral Gables, FL
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ATP Clinical Research, Inc.
Costa Mesa, California 92626
1964
mi
from 43215
Costa Mesa, CA
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FutureSearch Clinical Trials, LP
Dallas, Texas 75231
905
mi
from 43215
Dallas, TX
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Western Affiliated Research Institute
Denver, Colorado 80204
1163
mi
from 43215
Denver, CO
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Michigan State University
East Lansing, Michigan 48824
205
mi
from 43215
East Lansing, MI
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Alexian Brothers Neuroscience Institute
Elk Grove Village, Illinois 60007
295
mi
from 43215
Elk Grove Village, IL
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Odyssey Research Services
Fargo, North Dakota 58104
837
mi
from 43215
Fargo, ND
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SJS Clinical Research
Fort Walton Beach, Florida 32547
688
mi
from 43215
Fort Walton Beach, FL
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Psychiatric Consultants
Franklin, Tennessee 37067
346
mi
from 43215
Franklin, TN
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Collaborative Neuroscience Network
Garden Grove, California 92845
1967
mi
from 43215
Garden Grove, CA
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Pine Rest Christian Mental Health Services
Grand rapids, Michigan 49548
242
mi
from 43215
Grand rapids, MI
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Pharmquest
Greensboro, North Carolina 27408
318
mi
from 43215
Greensboro, NC
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Alexian Brothers Behavioral Health Hospital
Hoffman Estates, Illinois 60169
302
mi
from 43215
Hoffman Estates, IL
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Hawaii Clinical Research Center
Honolulu, Hawaii 96813
4501
mi
from 43215
Honolulu, HI
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Claghorn-Lesem Research Clinic
Houston, Texas 77008
991
mi
from 43215
Houston, TX
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Bayou City Research Limited
Houston, Texas 77007
992
mi
from 43215
Houston, TX
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Goldpoint Clinical Research
Indianapolis, Indiana 46260
167
mi
from 43215
Indianapolis, IN
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Clinical Neuroscience Solution, Inc.
Jacksonville, Florida 32216
673
mi
from 43215
Jacksonville, FL
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Joliet Center for Clinical Research
Joliet, Illinois 60435
288
mi
from 43215
Joliet, IL
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Dynamic Clinical Research, Inc.
Kansas City, Missouri 64114
620
mi
from 43215
Kansas City, MO
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Independent Clinical Researchers
Las Vegas, Nevada 89106
1757
mi
from 43215
Las Vegas, NV
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Capstone Clinical Research
Libertyville, Illinois 60048
302
mi
from 43215
Libertyville, IL
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Premier Psychiatry Group, LLC
Lincoln, Nebraska 68510
719
mi
from 43215
Lincoln, NE
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Clinical Study Centers, LLC
Little Rock, Arkansas 72205
624
mi
from 43215
Little Rock, AR
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Florida Clinical Research Center LLC
Maitland, Florida 32751
788
mi
from 43215
Maitland, FL
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Suburban Research Associates
Media, Pennsylvania 19063
403
mi
from 43215
Media, PA
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Research Strategies
Memphis, Tennessee 38119
503
mi
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Memphis, TN
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Clinical Trials Management
Metairie, Louisiana 70006
797
mi
from 43215
Metairie, LA
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Middlesex Hospital
Middletown, Connecticut 06457
553
mi
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Middletown, CT
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Clinical Research Associates
Nashville, Tennessee 37203
333
mi
from 43215
Nashville, TN
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UMDNJ-Robert Wood Johnson Medical Center
New Brunswick, New Jersey 08901
453
mi
from 43215
New Brunswick, NJ
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Medical & Behavioral Health Research
New York, New York 10023
478
mi
from 43215
New York, NY
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The Medical Research Network, LLC
New York, New York 10128
480
mi
from 43215
New York, NY
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Eastside Comprehensive Medical Service
New York, New York 10021
480
mi
from 43215
New York, NY
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Deaconess Clinic Gateway
Newburgh, Indiana 47630
271
mi
from 43215
Newburgh, IN
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Pharmacology Research Institute
Newport Beach, California 92660
1963
mi
from 43215
Newport Beach, CA
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Cutting Edge Research
Oklahoma City, Oklahoma 73116
849
mi
from 43215
Oklahoma City, OK
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IPS Research
Oklahoma City, Oklahoma 73103
849
mi
from 43215
Oklahoma City, OK
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Red River Medical Research
Oklahoma City, Oklahoma 73112
850
mi
from 43215
Oklahoma City, OK
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SP Research, PLLC
Oklahoma City, Oklahoma 73112
850
mi
from 43215
Oklahoma City, OK
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Pacific Clinical Research Medical Group
Orange, California 92868
1959
mi
from 43215
Orange, CA
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Uc Irvine Medical Center
Orange, California 92868
1959
mi
from 43215
Orange, CA
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CNS Healthcare
Orlando, Florida 32806
796
mi
from 43215
Orlando, FL
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CRI Worldwide, LLC
Philadelphia, Pennsylvania 19139
412
mi
from 43215
Philadelphia, PA
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Southwest Health Ltd
Phoenix, Arizona 85254
1651
mi
from 43215
Phoenix, AZ
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CNS Clinical Research
Pompano Beach, Florida 33067
957
mi
from 43215
Pompano Beach, FL
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Quantum Lab. at N. Broward Memory Disorder Center
Pompano Beach, Florida 33064
960
mi
from 43215
Pompano Beach, FL
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Oregon Center for Clinical Investigations, Inc.
Portland, Oregon 97210
2028
mi
from 43215
Portland, OR
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Summit Research Network
Portland, Oregon 97210
2028
mi
from 43215
Portland, OR
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Zarzar Psychiatric Associates, PLLC
Raleigh, North Carolina 27607
371
mi
from 43215
Raleigh, NC
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VCU Medical Center
1250 E. Marshall St.
Richmond, Virginia 23298
(804) 828-9000
Virginia Commonwealth University Medical Center The Virginia Commonwealth University Health System is an urban, comprehensive...
344
mi
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Richmond, VA
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Rochester Center for Behavioral Medicine
Rochester Hills, Michigan 48307
186
mi
from 43215
Rochester Hills, MI
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Northwest Behavioral Research Center
Roswell, Georgia 30076
416
mi
from 43215
Roswell, GA
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Radiant Research
Salt Lake City, Utah 84107
1514
mi
from 43215
Salt Lake City, UT
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University Of Utah Hospital
Salt Lake City, Utah 84132
1511
mi
from 43215
Salt Lake City, UT
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California Neuropsychopharmacology Clinical Research Institute (CNRI)
San Diego, California 92102
1949
mi
from 43215
San Diego, CA
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Neuropsychiatric Research Center of Orange County
Santa Ana, California 92701
1960
mi
from 43215
Santa Ana, CA
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Rush University - Psychiatric Medicine Associates
Skokie, Illinois 60076
284
mi
from 43215
Skokie, IL
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Frontier Institute
Spokane, Washington 99204
1779
mi
from 43215
Spokane, WA
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Neurology Clinic of St. Cloud
St. Cloud, Minnesota 56303
685
mi
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St. Cloud, MN
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Comprehensive NeuroScience, Inc.
St. Petersburg, Florida 33716
835
mi
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St. Petersburg, FL
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Richmond Behavioral Associates
Staten Island, New York 10312
468
mi
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Staten Island, NY
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Viking Clinical Research
Temecula, California 92591
1926
mi
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Temecula, CA
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BioBehavioral Health
Toms River, New Jersey 08755
467
mi
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Toms River, NJ
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Collaborative Neuroscience Network, INC
Torrance, California 90502
1980
mi
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Torrance, CA
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Brighton Research Group, LLC
Virginia Beach, Virginia 23452
432
mi
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Virginia Beach, VA
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Coastal Research Associates
Weymouth, Massachusetts 02190
647
mi
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Weymouth, MA
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Grayline Clinical Drug Trials
Wichita Falls, Texas 76309
951
mi
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Wichita Falls, TX
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