Phase
Condition
Crohn's Disease
Inflammatory Bowel Disease
Treatment
N/AClinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Diagnosis of ulcerative colitis (UC) established at least 3 months prior to Day 1 byclinical and endoscopic evidence
- Moderately to severely active UC as determined by an MCS of 6-12 with an endoscopicsubscore greater than or equal to (≥)2 as determined by the central reading procedure (endoscopy to be performed 4-16 days prior to Day 1), a rectal bleeding subscore ≥1,and a stool frequency subscore ≥1 during the screening period (prior to Day 1)
- Evidence of UC extending a minimum of 20 centimeters (cm) from the anal verge asdetermined by baseline endoscopy (flexible sigmoidoscopy or colonoscopy) performedduring screening, 4-16 days prior to Day 1
- Naive to treatment with any anti-TNF therapy
- Participants must have had an inadequate response, loss of response, or intolerance toprior corticosteroid and/or immunosuppressant treatment
- Background regimen for UC may include oral 5-aminosalicylate (5-ASA), oralcorticosteroids, budesonide, probiotics, azathioprine (AZA), 6-mercaptopurine (6-MP),or methotrexate (MTX) if doses have been stable during the screening period
- Use of highly effective contraception
- Must have received a colonoscopy within the past year or be willing to undergo acolonoscopy in lieu of a flexible sigmoidoscopy at screening
Exclusion
Exclusion Criteria:
- A history of or current conditions and diseases affecting the digestive tract, such asindeterminate colitis, suspicion of ischemic colitis, radiation colitis, ormicroscopic colitis, Crohn's disease, fistulas or abdominal abscesses, colonic mucosaldysplasia, intestinal obstruction, toxic megacolon, or unremoved adenomatous colonicpolyps
- Prior or planned surgery for UC
- Past or present ileostomy or colostomy
- Any prior treatment with etrolizumab or other anti-integrin agents (includingnatalizumab, vedolizumab, and efalizumab) as stated in the protocol
- Any prior treatment with anti-adhesion molecules (such as mucosal addressin celladhesion molecule [MAdCAM-1])
- Any prior treatment with rituximab
- Any treatment with tofacitinib during screening
- Cogenital or acquired immune deficiency, chronic hepatitis B or C infection, humanimmunodeficiency virus (HIV) positive, or history of tuberculosis (active or latent)
- Evidence of or treatment for Clostridium difficile within 60 days prior to Day 1 orother intestinal pathogens within 30 days prior to Day 1
- History of recurrent opportunistic infections and/or severe disseminated viralinfections
- History of organ transplant
- Any major episode of infection requiring treatment with intravenous (IV) antibioticswithin 8 weeks prior to screening or oral antibiotics within 4 weeks prior toscreening
- Received a live attenuated vaccine within 4 weeks prior to Day 1
Study Design
Connect with a study center
Hospital Universitário Professor Edgard Santos - Universidade Federal da Bahia
Salvador, BA 40110-910
BrazilSite Not Available
Hospital Universitario Walter Cantidio - UFC
Fortaleza, CE 60430-370
BrazilSite Not Available
Eurolatino Pesquisas Médicas Ltda.
Uberlandia, MG 38411-186
BrazilSite Not Available
Centro Digestivo de Curitiba
Curitiba, PR 80430-160
BrazilSite Not Available
Hospital Universitario Gaffree e Guinle
Rio de Janeiro, RJ 20270-004
BrazilSite Not Available
Hrpc - Ulbratech
Canoas, RS 92425-900
BrazilSite Not Available
Hospital Moinhos de Vento
Porto Alegre, RS 90035-001
BrazilSite Not Available
Clinica de Neoplasias Litoral
Itajai, SC 88301-220
BrazilSite Not Available
Allergisa Pesquisa Dermato-Cosmética Ltda
Campinas, SP 13084-791
BrazilSite Not Available
CECIP - Centro de Estudos Clínicos do Interior Paulista
Jaú, SP 17210-190
BrazilSite Not Available
Hospital Estadual Mario Covas
Santo Andre, SP 09190-610
BrazilSite Not Available
Pesquisare Saúde Sociedade Simples
Santo Andre, SP 09080-000
BrazilSite Not Available
Hospital Sírio-Libanês
Sao Paulo, SP 01308-050
BrazilSite Not Available
Hospital do Servidor Público Estadual/HSPE-SP
São Paulo, SP 04039-901
BrazilSite Not Available
Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology
Edmonton, Alberta T6G 2X8
CanadaSite Not Available
Pacific Gastroenterology Associates
Vancouver, British Columbia V6Z 2K5
CanadaSite Not Available
Queen Elizabeth II Health Sciences Centre; Gastroenterology Research
Halifax, Nova Scotia B3H 1V7
CanadaSite Not Available
Toronto Digestive Disease Associates
Downsview, Ontario M3N 2V7
CanadaSite Not Available
McMaster University Health Sciences Center
Hamilton, Ontario L8N 3Z5
CanadaSite Not Available
LHSC - University Hospital; Movement Disorders Program
London, Ontario N6A 5A5
CanadaSite Not Available
London Health Sciences Centre Victoria Hospital; Research Pharmacy
London, Ontario N6A 5W9
CanadaSite Not Available
Mount Sinai Hospital
Toronto, Ontario M5G 1X5
CanadaSite Not Available
Toronto Digestive Disease Associates
Vaughan, Ontario L4L 4Y7
CanadaSite Not Available
Pharmaceutical Integrated Research Company
Waterloo, Ontario N2J 1C4
CanadaSite Not Available
CHUM Centre de Recherche - PARENT
Montreal, Quebec H2W 1T8
CanadaSite Not Available
Fakultni nemocnice Olomouc
Olomouc, 775 20
Czech RepublicSite Not Available
Thomayerova nemocnice
Praha 4 - Krc, 140 59
Czech RepublicSite Not Available
Fakultni nemocnice u sv. Anny v Brne; I.Interni kardioangiologicka klinika
Brno, 65691
CzechiaSite Not Available
Hepato-Gastroenterologie HK, s.r.o.
Hradec Kralove, 500 12
CzechiaSite Not Available
Nemocnice Na Bulovce
Prague, 180 01
CzechiaSite Not Available
Alborg Universitets Hospital
Aalborg, 9100
DenmarkSite Not Available
Rigshospitalet; Medicinsk gastroenterologisk klinik
Copenhagen, 2100
DenmarkSite Not Available
empty
Copenhagen O, 2100
DenmarkSite Not Available
Herlev og Gentofte Hospital
Herlev, 2730
DenmarkSite Not Available
Kolding Sygehus
Kolding, 6000
DenmarkSite Not Available
Rigshospitalet; Medicinsk gastroenterologisk klinik
København Ø, 2100
DenmarkSite Not Available
Regionshospitalet Silkeborg
Silkeborg, 8600
DenmarkSite Not Available
Sygehus Sønderjylland Åbenrå
Åbenrå, 6200
DenmarkSite Not Available
empty
Ålborg, 9000
DenmarkSite Not Available
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
Berlin, 10117
GermanySite Not Available
Klinikum Bielefeld gem. GmbH
Bielefeld, 33604
GermanySite Not Available
Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH
Bochum, 44789
GermanySite Not Available
Ärztezentrum Ellwangen; Gemeinschaftspraxis
Ellwangen, 73479
GermanySite Not Available
Universitaetsklinikum Erlangen
Erlangen, 91054
GermanySite Not Available
Kliniken Essen-Mitte
Essen, 45136
GermanySite Not Available
Klinik Johann Wolfgang von Goethe Uni
Frankfurt, 60590
GermanySite Not Available
Krankenhaus Martha-Maria Halle-Doelau
Halle (Saale), 06120
GermanySite Not Available
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
GermanySite Not Available
Medizinische Hochschule Hannover; Klinik für Gastroenterologie, Hepatologie und Endokrinologie
Hannover, 30625
GermanySite Not Available
Praxis fuer Gastroenterologie, Drs. Ehehalt/ Helmstaedter
Heidelberg, 69121
GermanySite Not Available
Universitaetsklinikum Jena; Apotheke des Uniersitätsklinikums Jena
Jena, 07740
GermanySite Not Available
Medizinisches Zentrum Klinikum Lueneburg
Lueneburg, 21339
GermanySite Not Available
Klinikum Mannheim GmbH Universitätsklinikum
Mannheim, 68167
GermanySite Not Available
Gastro Campus Research; Praxis am Germania Campus
Muenster, 48159
GermanySite Not Available
Klinikum rechts der Isar der Technischen Universität München
Munchen, 81675
GermanySite Not Available
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München, 81675
GermanySite Not Available
Praxis Dr. med. Volker Aldinger UG
Neustadt, 67433
GermanySite Not Available
Gastroenterologische Gemeinschaftspraxis Stade
Stade, 21682
GermanySite Not Available
Principal SMO Kft.
Baja, 6500
HungarySite Not Available
DRC Gyogyszervizsgalo Kozpont Kft
Balatonfured, 8230
HungarySite Not Available
Pannónia Klinika Magánorvosi
Budapest, 1136
HungarySite Not Available
empty
Debrecem, 4032
HungarySite Not Available
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
HungarySite Not Available
Bugat Pal Korhaz-Rendelointezet
Gyongyos, 3200
HungarySite Not Available
Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
Gyula, 5703
HungarySite Not Available
Pest Megyei Flor Ferenc Korhaz
Kistarcsa, 2143
HungarySite Not Available
Karolina Korhaz-Rendelointezet X
Mosonmagyarovar, 9200
HungarySite Not Available
Karolina Korhaz
Mosonmagyaróvár, 9200
HungarySite Not Available
Pecsi Tudomanyegyetem
Pecs, 7624
HungarySite Not Available
Csongrad Megyei Dr. Bugyi Istvan Korhaz
Szentes, 6600
HungarySite Not Available
Deccan College of Medical Sciences and Allied Hospitals
Hyderabad, Andhra Pradesh 500058
IndiaSite Not Available
Osmania General Hospital
Hyderabad, Andhra Pradesh 500012
IndiaSite Not Available
Institute of Digestive and Liver Diseases
Guwahati, Assam 781006
IndiaSite Not Available
Pushpawati Singhania Research Institute
New Delhi, Delhi 110017
IndiaSite Not Available
Kaizen Hospital
Ahmedabad, Gujarat 380020
IndiaSite Not Available
Shree Giriraj Multispeciality Hospital
Rajkot, Gujarat 360005
IndiaSite Not Available
Nirmal Hospital
Surat, Gujarat 395002
IndiaSite Not Available
K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre
Belgaum, Karnataka 590010
IndiaSite Not Available
M. S. Ramaiah Medical College and Hospital
Bengaluru, Karnataka 560054
IndiaSite Not Available
Seth Nandlal Dhoot Hospital
Aurangabad, Maharashtra 431210
IndiaSite Not Available
P. D. Hinduja National Hospital & Medical Research Centre
Mumbai, Maharashtra 400016
IndiaSite Not Available
Midas institute of Gastroenterology
Nagpur, Maharashtra 440012
IndiaSite Not Available
Sparsh Hospital
Bhubaneshwar, Odisha 751007
IndiaSite Not Available
Dayanand Medical College and Hospital
Ludhiana, Punjab 141001
IndiaSite Not Available
Govind Ballabh Pant institute of Postgraduate Medical Education & Research
Delhi, 110002
IndiaSite Not Available
S. R. Kalla Memorial General Hospital
Jaipur, 302001
IndiaSite Not Available
Kasturba Medical College & Hospital
Mangalore, 575001
IndiaSite Not Available
King Edward Memorial Hospital Research Centre
Pune, 411011
IndiaSite Not Available
Ruby Hall Clinic
Pune, 411 001
IndiaSite Not Available
Haemek Medical Center
Afula, 18101
IsraelSite Not Available
Assaf Harofeh Medical Center
Beer Yaacov, 6093000
IsraelSite Not Available
Bnei Zion Medical Center; Department of Internal Medicine B
Haifa, 31048
IsraelSite Not Available
Wolfson Medical Center
Holon, 58100
IsraelSite Not Available
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Jerusaelm, 9112001
IsraelSite Not Available
Hadassah University Hospital - Ein Kerem
Jerusalem, 9112001
IsraelSite Not Available
Shaare Zedek Medical Center
Jerusalem, 9103102
IsraelSite Not Available
Holy Family Hospital
Nazareth, 16100
IsraelSite Not Available
Ospedale Sandro Pertini
Roma, Lazio 00157
ItalySite Not Available
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Lombardia 25124
ItalySite Not Available
Ospedale di Circolo; Neuropsichiatria Infantile
Rho, Lombardia 20017
ItalySite Not Available
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Sicilia 90127
ItalySite Not Available
Gastro Medical
Mexicali, BAJA California 21100
MexicoSite Not Available
Centro Regiomontano de Estudios Clínicos Roma S.C.
Monterrey, Nuevo LEON 64610
MexicoSite Not Available
Centro de Investigacion; Clinica Del Pacifico
Acapulco, 39670
MexicoSite Not Available
Consultorio Particular del Dr. Miguel Cortes Hernandez
Cuernavaca, 62290
MexicoSite Not Available
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, 34000
MexicoSite Not Available
Phylasis Clinicas Research S de RL de CV
Estado de México, 54769
MexicoSite Not Available
Instituto Nacional de Ciencias; Medicas y Nutricion; Salvador Zubiran
Mexico, Distrito Federal, 14000
MexicoSite Not Available
Centro de Investigacion Torre Medica Sanatorio Toluca
Toluca de Lerdo, 50120
MexicoSite Not Available
Nasz Lekarz Osrodek Badan Klinicznych
Bydgoszcz, 85-312
PolandSite Not Available
Zespó Przychodni Specjalistycznych PRIMA
Warszawa, 02-018
PolandSite Not Available
LexMedica Osrodek Badan Klinicznych
Wroclaw, 53-114
PolandSite Not Available
IBDcentrum s.r.o.; Gastroenterologické centrum ASSIDUO a IBD centrum
Bratislava, 81108
SlovakiaSite Not Available
B+B MED, s.r.o.
Kosice, 040 22
SlovakiaSite Not Available
Fakultna nemocnica Nitra
Nitra, 950 01
SlovakiaSite Not Available
Endomed, s.r.o.
Vranov n. Toplou, 093 01
SlovakiaSite Not Available
Endomed, s.r.o.
Vranov nad Topľou, 093 01
SlovakiaSite Not Available
Dr JP Wright Practice
Cape Town, 7708
South AfricaSite Not Available
Wits Donald Gordon Clinical Trial Site
Johannesburg, 2041
South AfricaSite Not Available
Emmed Research
Pretoria, 0002
South AfricaSite Not Available
CI of Kyiv RC Kyiv Regional Clinical Hospital
Kyiv, KIEV Governorate 04107
UkraineSite Not Available
Lviv Regional Clinical Hospital
Lviv, KIEV Governorate 79010
UkraineSite Not Available
A.Novak Transcarpathian Regional Clinical Hospital
Uzhgorod, KIEV Governorate 88018
UkraineSite Not Available
CI of SRC Sumy RCH Dept of Rheumatology Sumy SU MI
Sumy, Kharkiv Governorate 40022
UkraineSite Not Available
Regional CH Dept of Proctology SHEI Ivano-Frankivsk NMU
Ivano-Frankivsk, 76018
UkraineSite Not Available
Odessa regional clinical Hospital
Odessa, 65117
UkraineSite Not Available
M.V. Sklifosovskyi Poltava RCH Dept of Gastroenterology HSEIU UMSA
Poltava, 36011
UkraineSite Not Available
SI Divisional Clinical Hospital of Uzhgorod Station of ST&BA LZ Dep of Therapy SHEI Uzhgorod NU
Uzhgorod, 88009
UkraineSite Not Available
M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
Vinnytsia, 21018
UkraineSite Not Available
Decatur Gastroenterology Associates
Decatur, Alabama 35601
United StatesSite Not Available
Digestive Health Specialists
Dothan, Alabama 36305
United StatesSite Not Available
Applied Research Center of Arkansas; Clinical Trials
Little Rock, Alaska 72212
United StatesSite Not Available
Moore Clinical Trials, LLC
Sherwood, Arkansas 72120
United StatesSite Not Available
University of California San Diego Medical Center
La Jolla, California 92093-5354
United StatesSite Not Available
Therapeutic Research Institute of Orange County
Laguna Hills, California 92653
United StatesSite Not Available
Gastrointestinal Bioscience
Los Angeles, California 90067
United StatesSite Not Available
Facey Medical Group
Mission Hills, California 91345
United StatesSite Not Available
Sutter Gould Medical Foundation
Modesto, California 95355
United StatesSite Not Available
University of California, Irvine Medical Center
Orange, California 92868
United StatesSite Not Available
Clinical Applications Laboratories, Inc.
San Diego, California 92103
United StatesSite Not Available
University of California at San Francisco
San Francisco, California 94115
United StatesSite Not Available
Santa Monica Research Institute
Santa Monica, California 90404
United StatesSite Not Available
Ventura Clinical Trials
Ventura, California 93003
United StatesSite Not Available
Peak Gastroenterology Associates; Gastroenterology
Colorado Springs, Colorado 80907
United StatesSite Not Available
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Englewood, Colorado 80110
United StatesSite Not Available
Clinical Research of the Rockies
Lafayette, Colorado 80026
United StatesSite Not Available
Innovative Medical Research of South Florida, Inc.
Aventura, Florida 33180
United StatesSite Not Available
West Central Gastroenterology d/b/a Gastro Florida
Clearwater, Florida 33762
United StatesSite Not Available
GastroCare
Coral Springs, Florida
United StatesSite Not Available
Homestead Medical Research
Homestead, Florida 33030
United StatesSite Not Available
Borland-Groover Clinic
Jacksonville, Florida 32256
United StatesSite Not Available
Regenerate Clinical Trials
Miami, Florida 33155
United StatesSite Not Available
IMIC, Inc
Miami Beach, Florida 33140
United StatesSite Not Available
FQL Research, LLC
Miramar, Florida 33025
United StatesSite Not Available
Med-Care Research
North Miami Beach, Florida 33162
United StatesSite Not Available
Advanced Medical Research Center
Port Orange, Florida 32127
United StatesSite Not Available
Advanced Research Institute, Inc.
Trinity, Florida 34655
United StatesSite Not Available
Shafran Gastroenterology Center
Winter Park, Florida 32789
United StatesSite Not Available
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia 30060
United StatesSite Not Available
Atlanta Gastroenterology Specialists, PC
Suwanee, Georgia 30024
United StatesSite Not Available
Northwestern University-Feinberg School of Medicine; Division of Gastroenterology and Hepatology
Chicago, Illinois 60611
United StatesSite Not Available
Southwest Gastroenterology
Oak Lawn, Illinois 60453
United StatesSite Not Available
Investigators Research Group, LLC
Brownsburg, Indiana 46112
United StatesSite Not Available
Medisphere Medical Research Center, Llc
Evansville, Indiana 47714
United StatesSite Not Available
Aquiant Research
New Albany, Indiana 47150
United StatesSite Not Available
Iowa Digestive Disease Center
Des Moines, Iowa 50312
United StatesSite Not Available
Via Christi Clinic, PA
Wichita, Kansas 67208
United StatesSite Not Available
Louisiana Research Center, LLC
Shreveport, Louisiana
United StatesSite Not Available
Chevy Chase Clinical Research
Chevy Chase, Maryland 20815
United StatesSite Not Available
Charm City Research - Prn
Towson, Maryland 21204
United StatesSite Not Available
Commonwealth Clinical Studies
Brockton, Massachusetts 02302
United StatesSite Not Available
Clin. Rsrch Inst. of Michigan
Chesterfield, Michigan 48047
United StatesSite Not Available
Henry Ford Health System
Detroit, Michigan 48202
United StatesSite Not Available
VA Medical Center
Milwaukee, Michigan 53295
United StatesSite Not Available
Consult and Research Associates
Saint Louis, Michigan 63122
United StatesSite Not Available
The iResearch Group, LLC
Southfield, Michigan 58304
United StatesSite Not Available
Consult and Research Associates
St. Louis, Michigan 63122
United StatesSite Not Available
Center for Digestive Health
Troy, Michigan 48098
United StatesSite Not Available
University of Minnesota
Minneapolis, Minnesota 55455
United StatesSite Not Available
University of Mississippi Medical Center
Jackson, Mississippi 39216
United StatesSite Not Available
Ehrhardt Clinical Research, LLC
Belton, Missouri 64012
United StatesSite Not Available
Las Vegas Medical Research
Las Vegas, Nevada 89113
United StatesSite Not Available
Allied Gastrointestinal Associates, PA
Voorhees, New Jersey 08043
United StatesSite Not Available
Manhattan Clinical Research
New York, New York 10016
United StatesSite Not Available
Weill Cornell Medical College-New York Presbyterian Hospital
New York, New York 10021
United StatesSite Not Available
University of Rochester; Division of Pediatric Pulmonol
Rochester, New York 14642
United StatesSite Not Available
Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina 28801
United StatesSite Not Available
Clinical Trials of America Inc
Cary, North Carolina 27511
United StatesSite Not Available
UNC at Chapel Hill - Dpt of Family Medicine; Center for Functional GI and Motility Disorders
Chapel Hill, North Carolina 27599
United StatesSite Not Available
Kinston Medical Specialists
Kinston, North Carolina 28501
United StatesSite Not Available
Consultants for Clinical Research Inc.; Cornell Office
Cincinnati, Ohio 45249
United StatesSite Not Available
Toledo Clinic - Inc
Toledo, Ohio 43623
United StatesSite Not Available
Central Sooner Research
Norman, Oklahoma 73012
United StatesSite Not Available
PMA Medical Specialists
Limerick, Pennsylvania 19468
United StatesSite Not Available
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
Consultants in Gastroenterology, PA
Columbia, South Carolina 29203
United StatesSite Not Available
Gastro One
Germantown, Tennessee 38138
United StatesSite Not Available
Texas Clinical Research Institute, LLC
Arlington, Texas 76012
United StatesSite Not Available
Texas Digestive Disease Consultants - Dallas
Dallas, Texas 75231
United StatesSite Not Available
University of North Texas Health Science Center
Fort Worth, Texas 76107
United StatesSite Not Available
Baylor College of Medicine
Houston, Texas 77030
United StatesSite Not Available
Gastroenterology Research of San Antonio, LLC
San Antonio, Texas 78229
United StatesSite Not Available
Texas Digestive Disease Consultants - Southlake
Southlake, Texas 76092
United StatesSite Not Available
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Tomball, Texas 77375
United StatesSite Not Available
Digestive Health Specialists of Tyler
Tyler, Texas 75701
United StatesSite Not Available
Ericksen Research and Development
Clinton, Utah 84015
United StatesSite Not Available
University of Utah School of Medicine
Salt Lake City, Utah 84132
United StatesSite Not Available
University of Virginia Health Systems; Gastroenterology and Hepatology
Charlottesville, Virginia 22908
United StatesSite Not Available
Digestive and Liver Disease Specialists, Ltd.
Norfolk, Virginia 23502
United StatesSite Not Available
McGuire Research Institute; Gastroenterology
Richmond, Virginia 23249
United StatesSite Not Available
Northwest Gastroenterology Associates
Bellevue, Washington 98004
United StatesSite Not Available
University of Washington School of Medicine
Seattle, Washington 98104
United StatesSite Not Available
Rockwood Clinic, PS
Spokane, Washington 99204
United StatesSite Not Available
Aurora Health Care
Glendale, Wisconsin 53212
United StatesSite Not Available
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