An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis

IDENTIFIERS
Trial Protocol: SHP647-303
Clinicaltrials.gov: NCT03290781
EudraCT: 2017-000573-37
PURPOSE

The purpose of this study is to evaluate the efficacy of ontamalimab as maintenance therapy treatment of remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).

Completed
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AU
34+
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BA
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CA
CO
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CZ
EE
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GR
HU
IE
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IT
JP
KR
LB
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NL
NZ
PL
PT
RO
RU
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GB

Trial at a glance

What medical condition is being studied?   Ulcerative Colitis
What is the trial testing?   Ontamalimab, Placebo
How many participants are being enrolled?   366
When is the trial being conducted?    - 
How long is participation in the trial?   Participation will consist of up to 17 visits to the study site. These visits will be completed over a 52-week treatment period, and a 16-week follow-up period after treatment ends.

Key requirements

Sex   
All
Age   
16 - 81 Years
Accepts Healthy Volunteers?   
No

Trial Details / Participation Requirements

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Trial Phase:   Phase 3
Trial Type:   Interventional
Trial Arms/Groups or Cohorts:   
Ontamalimab 25 mg: Participants will receive 25 milligram (mg) of ontamalimab or placebo and achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) will receive 25 mg of ontamalimab as maintenance treatment subcutaneously using a prefilled syringe once in every 4 weeks (Q4W) up to Week 52.
Ontamalimab 75 mg: Participants will receive 75 mg of ontamalimab or placebo and achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) will receive 75 mg of ontamalimab as maintenance treatment subcutaneously using a prefilled syringe Q4W up to Week 52.
Placebo: Participants will receive 25 mg or 75 mg ontamalimab or placebo matched to ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) will receive placebo matched to ontamalimab as maintenance treatment subcutaneously using a prefilled syringe Q4W up to Week 52.
Intervention:   Ontamalimab, Placebo
Primary Outcome Measure(s):
Number of Participants With Remission at Week 52 [Time Frame: Week 52]
Secondary Outcome Measure(s):   
Number of Participants With Endoscopic Remission at Week 52 [Time Frame: Week 52]
Number of Participants With Clinical Remission at Week 52 [Time Frame: Week 52]
Number of Participants With Sustained Remission at Week 52 [Time Frame: Week 52]
Number of Participants With Clinical Response Based on Composite Score at Week 52 [Time Frame: Week 52]
Number of Participants With Mucosal Healing Based on Endoscopic and Histologic Assessment at Week 52 [Time Frame: Week 52]
Number of Participants With Glucocorticoid-free Clinical Remission at Week 52 [Time Frame: Week 52]
Number of Participants With Glucocorticoid-free Remission at Week 52 [Time Frame: Week 52]
Number of Participants With Remission Based on Total Mayo Score at Week 52 [Time Frame: Week 52]
Number of Participants With Clinical Remission Over Time With Both Rectal Bleeding and Stool Frequency Subscores of 0 [Time Frame: Baseline up to Week 52]
Number of Participants With Sustained Endoscopic Remission at Week 52 [Time Frame: Baseline up to Week 52]
Number of Participants With Treatment Emergent Adverse Events (TEAEs) [Time Frame: From start of study drug administration up to Week 64]
Number of Participants With Clinically Significant Change in Clinical Laboratory Results Reported as Adverse Event [Time Frame: From start of study drug administration up to Week 64]
Number of Participants With Clinically Significant Findings in Physical Examinations Reported as Adverse Event [Time Frame: From start of study drug administration up to Week 64]
Number of Participants With Clinically Significant Change in Vital Signs Reported as Adverse Event [Time Frame: From start of study drug administration up to Week 64]
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Reported as Adverse Event [Time Frame: From start of study drug administration up to Week 52]
Number of Participants who Develop Antidrug Antibodies to Ontamalimab [Time Frame: Baseline, Week 12, 24, and 36]
Entry Criteria:
Inclusion Criteria: - Participants and/or their parent or legally authorized representative must have an understanding, ability, and willingness to fully comply with study procedures and restrictions. - Participants must be able to voluntarily provide written, signed, and dated (personally or via a legally authorized representative) informed consent and/or assent, as applicable, to participate in the study. - Participants must have completed the 12-week induction treatment period (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). - Participants must have achieved clinical response in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). Clinical response is defined as: i) A decrease from the induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) baseline in the composite score of patient reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30 percent (%), with an accompanying decrease in the sub score for rectal bleeding greater than or equal to (>=) 1 point or a sub score for rectal bleeding less than or equal to (<=) 1 OR ii) A decrease from the induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) baseline in total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding sub score of at least 1 point or an absolute rectal bleeding sub score of 0 or 1. For eligibility assessment, clinical response will be determined based on the centrally read endoscopy performed during screening and at Week 12 of induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). - Participants receiving any treatment(s) for ulcerative colitis (UC) are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time. Exclusion Criteria: - Participants who had major protocol deviation(s) (as determined by the sponsor) in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). - Participants who permanently discontinued investigational product because of an adverse event (AE), regardless of relatedness to investigational product, in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). - Participants who are likely to require surgery for UC during the study period. - Participants are females who became pregnant during induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]), females who are planning to become pregnant during the study period, or males or females of childbearing potential not agreeing to continue using appropriate contraception methods (that is [i.e,] highly effective methods for female and medically appropriate methods for male study participants) through the conclusion of study participation. - Participants who do not agree to postpone donation of any organ or tissue, including male participants who are planning to bank or donate sperm and female participants who are planning to harvest or donate eggs, for the duration of the study and through 16 weeks after last dose of investigational product. - Participants who, in the opinion of the investigator or the sponsor, will be uncooperative or unable to comply with study procedures. - Participants who have a newly diagnosed malignancy or recurrence of malignancy (other than resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix that has been treated with no evidence of recurrence). - Participants who have developed any major illness/condition or evidence of an unstable clinical condition (example [eg], renal, hepatic, hematologic, gastrointestinal (except disease under study), endocrine, cardiovascular, pulmonary, immunologic [eg, Felty's syndrome], or local active infection/infectious illness) that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study. - Participants with any other severe acute or chronic medical or psychiatric condition or laboratory or electrocardiogram (ECG) abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study. - Participants with known exposure to Mycobacterium tuberculosis (TB) since testing at screening in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) and who are without a generally accepted course of treatment. - Participants who are investigational site staff members or relatives of those site staff members or participants who are sponsor employees directly involved in the conduct of the study. - Participants who are participating in or plan to participate in other investigational studies (other than induction study SHP647- 301 [NCT03259334] and SHP647-302 [NCT03259308]) during study SHP647-303 [NCT03290781].

Trial Locations

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RESULTS
Advanced Research Center

1020 S Anaheim Blvd #316, Anaheim, CA 92805, USA

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Kindred Medical Institute for Clinical Trials, LLC

Corona, CA 92879, USA

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United Medical Doctors

477 N El Camino Real #C204, Encinitas, CA 92024, USA

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University of California San Diego

9500 Gilman Dr, La Jolla, CA 92093, USA

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OM Research LLC - Lancaster - ClinEdge - PPDS

44215 15th St W Suite 203, Lancaster, CA 93534, USA

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Facey Medical Foundation

11333 N Sepulveda Blvd, Mission Hills, CA 91345, USA

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United Medical Doctors

28078 Baxter Rd STE 530, Murrieta, CA 92563, USA

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Alliance Clinical Research-(Vestavia Hills)

Vestavia Hills, AL, USA

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Inland Empire Liver Foundation

2006 N Riverside Ave, Rialto, CA 92377, USA

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University of California San Francisco

1701 Divisadero St, San Francisco, CA 94115, USA

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Care Access Research, San Pablo

San Pablo, CA, USA

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Peak Gastroenterology Associates

2920 N Cascade Ave #300, Colorado Springs, CO 80907, USA

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Renaissance Research Medical Group, INC

629 SW 4th St, Cape Coral, FL 33991, USA

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Gastro Florida

508 Jeffords St STE D, Clearwater, FL 33756, USA

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Advanced Clinical Research Network

3940 W Flagler St #202, Coral Gables, FL 33134, USA

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Alliance Medical Research LLC

Pompano Beach, FL 33071, USA

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ENCORE Borland-Groover Clinical Research - ERN - PPDS

4800 Belfort Rd, Jacksonville, FL 32256, USA

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SIH Research

724 W Vine St, Kissimmee, FL 34741, USA

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Crystal Biomedical Research

Miami Lakes, FL, USA

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Hi Tech and Global Research, LLc

5524 SW 8th St, Coral Gables, FL 33134, USA

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Nuren Medical and Research Center

8260 W Flagler St # 2N, Miami, FL 33144, USA

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Sanchez Clinical Research, Inc

11468 Quail Roost Dr, Miami, FL 33157, USA

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Gastroenterology Group of Naples

1064 Goodlette-Frank Rd, Naples, FL 34102, USA

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Pharma Research International Inc

625 9th St N Suite 202, Naples, FL 34102, USA

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BRCR Medical Center, Inc

8200 W Sunrise Blvd Suite D2, Plantation, FL 33322, USA

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East Coast Institute for Research, LLC

201 Health Park Blvd Suite #105, St. Augustine, FL 32086, USA

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DBC Research

Sunrise, FL 33351, USA

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Atlanta Gastroenterology Specialists, PC

550 Peachtree St NE Suite 1600, Atlanta, GA 30308, USA

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Infinite Clinical Trials

6685 Merchants Way, Morrow, GA 30274, USA

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Atlanta Center For Gastroenterology PC

2665 N Decatur Rd STE #550, Decatur, GA 30033, USA

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Loretto Hospital

645 S Central Ave, Chicago, IL 60644, USA

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IL Gastroenterology Group

20 Tower Ct suite c, Gurnee, IL 60031, USA

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Dupage Medical Group

2 Trans Am Plaza Dr, Oakbrook Terrace, IL 60181, USA

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Medisphere Medical Research Center LLC

1401 Professional Blvd # 100, Evansville, IN 47714, USA

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Laporte County Institute For Clinical Research

Michigan City, IN, USA

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CroNOLA, LLC.

1023 Wood St, Houma, LA 70360, USA

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Louisiana Research Center LLC

1800 E 70th St, Shreveport, LA 71105, USA

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Chevy Chase Clinical Research

5550 Friendship Blvd # T90, Chevy Chase, MD 20815, USA

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Commonwealth Clinical Studies LLC

Brockton, MA 02302, USA

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UMass Memorial Medical Center

55 N Lake Ave, Worcester, MA 01655, USA

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University of Michigan

500 S State St, Ann Arbor, MI 48109, USA

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Clinical Research Institute of Michigan

30795 23 Mile Rd #206, Chesterfield, MI 48047, USA

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National Clinical, LLC

9230 Joseph Campau Ave, Hamtramck, MI 48212, USA

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Mayo Clinic Health System - PPDS

400 E 3rd St, Duluth, MN 55805, USA

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Digestive Health Center PA

3890 Bienville Blvd, Ocean Springs, MS 39564, USA

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Advanced Biomedical Research of America

Las Vegas, NV 89123, USA

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Encompass Care

6424 Losee Rd #100, North Las Vegas, NV 89086, USA

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New York Total Medical Care PC

362 9th St, Brooklyn, NY 11215, USA

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Weill Cornell Medical College

1300 York Ave, New York, NY 10065, USA

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Southtowns Gastroenterology, PLLC

310 Sterling Dr, Orchard Park, NY 14127, USA

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East Carolina Gastroenterology

4 Office Park Dr, Jacksonville, NC 28546, USA

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Piedmont Healthcare

129 Sherlock Dr, Statesville, NC 28625, USA

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Consultants For Clinical Research Inc

2925 Vernon Pl #200, Cincinnati, OH 45219, USA

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Consultants For Clinical Research Inc

2925 Vernon Pl #200, Cincinnati, OH 45219, USA

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Consultants For Clinical Research Inc

2925 Vernon Pl #200, Cincinnati, OH 45219, USA

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Digestive Disease Associates

1011 Reed Ave Suite 300, Wyomissing, PA 19610, USA

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Gastro One

2020 Exeter Rd, Germantown, TN 38138, USA

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Vanderbilt University Medical Center

1211 Medical Center Dr, Nashville, TN 37232, USA

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Advanced Gastroenterology-Union City

1109 E Reelfoot Ave, Union City, TN 38261, USA

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Northside Gastroenterology

21212 Northwest Fwy Suite 625, Cypress, TX 77429, USA

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Digestive Health Associates of Texas, P.A.dba DHAT Research Institute

7150 N President George Bush Hwy Suite 201 & Suite 202, Garland, TX 75044, USA

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Precision Research Institute, LLC

6201 Bonhomme Rd suite 460-s, Houston, TX 77036, USA

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Biopharma Informatic Inc.

19255 Park Row Suite 205, Houston, TX 77084, USA

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Southwest Clinical Trials

5900 Chimney Rock Rd #3, Houston, TX 77081, USA

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BI Research Center

19255 Park Row Suite 205, Houston, TX 77084, USA

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Southern Star Research Institute LLC

4383 Medical Dr, San Antonio, TX 78229, USA

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HP Clinical Research

Bountiful, UT 84010, USA

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Mid Atlantic Health Specialists

103 Doctor's Pl, Galax, VA 24333, USA

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Winchester Gastroenterology Associates

190 Campus Blvd STE 300, Winchester, VA 22601, USA

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CHI Franciscan Digestive Care Associates

1112 6th Ave Suite 200, Tacoma, WA 98405, USA

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West Virginia University Hospital

1 Medical Center Dr, Morgantown, WV 26506, USA

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Fundación Favaloro

Av. Belgrano 1746, C1093 AAS, Buenos Aires, Argentina

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Hospital Privado Centro Médico de Córdoba

Av. Hugo Wast 4577, Córdoba, Argentina

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Sanatorio 9 de Julio SA

25 de Mayo 372, T4000 San Miguel de Tucumán, Tucumán, Argentina

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Concord Repatriation General Hospital

Hospital Rd, Concord NSW 2139, Australia

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Liverpool Hospital

Elizabeth &, Goulburn St, Liverpool NSW 2170, Australia

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Royal Brisbane & Women's Hospital

Butterfield St, Herston QLD 4029, Australia

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Mater Hospital Brisbane

Raymond Terrace, South Brisbane QLD 4101, Australia

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Royal Adelaide Hospital

Port Rd, Adelaide SA 5000, Australia

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The Alfred Hospital

8 Arnold St, Box Hill VIC 3128, Australia

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St Vincents Hospital Melbourne - PPDS

41 Victoria Parade, Fitzroy VIC 3065, Australia

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A.ö. Krankenhaus der Barmherzigen Brüder

Spitalgasse 26, 9300 St. Veit an der Glan, Austria

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Universitätsklinikum St. Pölten

Dunant-Platz 1, 3100 St. Pölten, Austria

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LKH-Universitätsklinikum Klinikum Graz

Auenbruggerpl. 1, 8036 Graz, Austria

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Klinikum Klagenfurt Am Woerthersee

Feschnigstraße 11, 9020 Klagenfurt am Wörthersee, Austria

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Salzburger Landeskliniken

Müllner Hauptstraße 48, 5020 Salzburg, Austria

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Klinikum Wels-Grieskirchen GmbH

Grieskirchner Str. 42, 4600 Wels, Austria

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UZ Gent

Corneel Heymanslaan 10, 9000 Gent, Belgium

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UZ Gasthuisberg

Herestraat 49, 3000 Leuven, Belgium

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AZ Groeninge

President Kennedylaan 4, 8500 Kortrijk, Belgium

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CHU Mouscron

Avenue de Fécamp 49, 7700 Mouscron, Belgium

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Clinical Center Banja Luka

Dvanaest beba, Banja Luka 78000, Bosnia and Herzegovina

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University Multiprofile Hospital for Active Treatment Sveta Anna

Iran, бул. „Цариградско шосе“, 1784 Младост 1, Babol, Bulgaria

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Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD

Boulevard "Tsarigradsko shose" 66А, 1784 7-Mi Kilometar, Sofia, Bulgaria

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University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski EAD

бул. Георги Кочев 8А, 5809 Pleven Center, Pleven, Bulgaria

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Multiprofile Hospital for Active Treatment Eurohospital

ul. "Komatevsko Shose" 79, 4004 Plovdiv, Bulgaria

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Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases Dr.D.Gramatikov- Ruse- PPDS

Ruse, Bulgaria

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Medical Center-1-Sevlievo EOOD

ul. "Stefan Peshev" 147, 5400 Tsentar, Sevlievo, Bulgaria

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Second Multiprofile Hospital for Active Treatment Sofia

Sofia, Bulgaria

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Medical Center Excelsior OOD - PPDS

Sofia, Bulgaria

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Diagnostic and Consulting Center Aleksandrovska EOOD

ul. "Sveti Georgi Sofiyski" 1, 1431 Sofia Center, Sofia, Bulgaria

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University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD

Boulevard "Akademik Ivan Evstratiev Geshov " 15, 1431 Sofia Center, Sofia, Bulgaria

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University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD

ul. "Byalo more" 8, 1527 Sofia Center, Sofia, Bulgaria

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Medical Center Convex EOOD

ul. "Sinanishko ezero" 11А, 1680 Manastirski Livadi, Sofia, Bulgaria

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Percuro Clinical Research LTD

305-1120 Yates St, Victoria, BC V8V 3M9, Canada

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Toronto Digestive Disease Associates Inc

4600 York Regional Rd 7, Woodbridge, ON L4L 4Y7, Canada

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Hospital Pablo Tobón Uribe

Calle 78b #NO. 69 - 240, Medellín, Antioquia, Colombia

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Servimed S.A.S

Bucaramanga, Santander, Colombia

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IPS Centro Médico Julián Coronel S.A.S. - PPDS

Cra. 59 #1 E-21, Cali, Valle del Cauca, Colombia

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University Hospital Center Zagreb

Kišpatićeva ul. 12, 10000, Zagreb, Croatia

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Opca Bolnica Karlovac

Ul. Andrije Štampara 3, 47000, Karlovac, Croatia

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Opca bolnica Bjelovar

Ul. Antuna Mihanovića 8, 43000, Bjelovar, Croatia

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Clinical Hospital Centre Osijek

Ul. Josipa Huttlera 4, 31000, Osijek, Croatia

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University Hospital Centre Split

Spinčićeva ul. 1, 21000, Split, Croatia

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General Hospital Virovitica

Ul. Ljudevita Gaja 21, 33000, Virovitica, Croatia

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General County Hospital Vukovar and Croatian Veterans Hospital

Županijska ul. 35, 32000, Vukovar, Croatia

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General Hospital Zadar

Ul. Bože Peričića 5, 23000, Zadar, Croatia

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Hepato-Gastroenterologie HK, s. r. o.

tř. E. Beneše 1549/1549, Nový Hradec Králové, 500 12 Hradec Králové, Czechia

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PreventaMed s.r.o.

Domovina 2, 779 00 Olomouc, Czechia

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Institut Klinicke A Experimentalni Mediciny

9, Vídeňská 1958, 140 21 Praha 4, Czechia

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East Viru Central Hospital

Kohtla-Järve, Ida-Viru County, Estonia

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OÜ LV Venter

Rüütli 47, Pärnu, 80010 Pärnu maakond, Estonia

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West Tallinn Central Hospital

Paldiski maantee 68, 10617 Tallinn, Estonia

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Universitätsklinikum Ulm

Albert-Einstein-Allee 23, 89081 Ulm, Germany

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Universitätsklinikum der RWTH Aachen

Pauwelsstraße 30, 52074 Aachen, Germany

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Uniklinik Köln

Kerpener Str. 62, 50937 Köln, Germany

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Gastro Campus Research GbR

An der Germania Brauerei 6, 48159 Münster, Germany

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Universitatsklinikum Schleswig-Holstein

Arnold-Heller-Straße 3, 24105 Kiel, Germany

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Universitatsklinikum Jena

Am Klinikum 1, 07747 Jena, Germany

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Charité - Universitätsmedizin Berlin

Augustenburger Pl. 1, 13353 Berlin, Germany

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Sana Klinikum Biberach

Ziegelhausstraße 50, 88400 Biberach an der Riß, Germany

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Universitätsklinikum Frankfurt

Theodor-Stern-Kai, 60596 Frankfurt am Main, Germany

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Ippokrateio General Hospital of Athens

Leof. Vasilissis Sofias 114, Athina 115 27, Greece

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University General Hospital of Patras

Rio 265 04, Greece

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Theageneio Anticancer Oncology Hospital of Thessaloniki

Al. Papanastasiou 11, Thessaloniki 546 39, Greece

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Euromedica - PPDS

Marias Kallas 11, Thessaloniki 546 45, Greece

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Magyar Honvédség Egészségügyi Központ

Budapest, Róbert Károly körút 44, 1134 Hungary

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Pannónia Magánorvosi Centrum Kft

Budapest, Pannónia u. 35, 1136 Hungary

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ENDOMEDIX Kft.

Budapest, Budapest Esztergomi út 66. A. ép. fszt. 3, 1139 Hungary

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Bekes Megyei Kozponti Korhaz

Békéscsaba, Gyulai út 18, 5600 Hungary

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Debreceni Egyetem Klinikai Kozpont

Debrecen, Nagyerdei krt. 98, 4032 Hungary

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Bekes Megyei Kozponti Korhaz

Gyula, Semmelweis u. 1, 5700 Hungary

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Mohacsi Korhaz

Mohács, Szepessy tér 7, 7700 Hungary

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Tolna Megyei Balassa János Kórház

Szekszárd, Béri Balogh Ádám u., 7100 Hungary

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Csongrad Megyei Dr. Bugyi Istvan Korhaz

Szentes, Sima Ferenc u. 44, 6600 Hungary

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Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

Székesfehérvár, Seregélyesi út 3, 8000 Hungary

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Csolnoky Ferenc Korhaz

Veszprém, Kórház u. 1, 8200 Hungary

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Jávorszky Ödön Kórház

Vác, Argenti Döme tér 1-3, 2600 Hungary

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St Vincent's University Hospital

196 Merrion Road, Elm Park, Dublin, D04 T6F4, Ireland

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Shaare Zedek Medical Center

Shmu'el Bait St 12, Jerusalem, 9103102, Israel

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Hadassah Medical Center - PPDS

Jerusalem, Israel

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Galilee Medical Center

89 Nahariya-Cabri, Nahariya, Israel

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Baruch Padeh Poriya Medical Center

Dov Hoz St 0, Tiberias, Israel

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Azienda Ospedaliera Mater Domini Di Catanzaro

Viale Tommaso Campanella, 115, 88100 Catanzaro CZ, Italy

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Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

Via Giuseppe Massarenti, 13, 40138 Bologna BO, Italy

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Azienda Ospedaliero Universitaria Di Modena Policlinico

Largo del Pozzo, 71, 41125 Modena MO, Italy

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Azienda Ospedaliera San Camillo Forlanini

Circonvallazione Gianicolense, 87, 00152 Roma RM, Italy

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Azienda Ospedaliera Universitaria Careggi

Largo Piero Palagi, 1, 50139 Firenze FI, Italy

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A.O.U. Maggiore della Carità

Corso Giuseppe Mazzini, 18, 28100 Novara NO, Italy

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Fondazione IRCCS Policlinico San Matteo di Pavia

Viale Camillo Golgi, 19, 27100 Pavia PV, Italy

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La Sapienza-Università di Roma-Policlinico Umberto I

Viale del Policlinico, 155, 00161 Roma RM, Italy

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Fondazione Policlinico Universitario A Gemelli

Via Giuseppe Moscati, 31, 00168 Roma RM, Italy

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Istituto Clinico Humanitas

Via Alessandro Manzoni, 56, 20089 Rozzano MI, Italy

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Azienda Ospedaliera Città della Salute e della Scienza di Torino

Corso Bramante, 88, 10126 Torino TO, Italy

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Azienda Ospedaliera Ordine Mauriziano di Torino

Corso Re Umberto, 109, 10128 Torino TO, Italy

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Sapporo Medical University Hospital

16 Chome-291 Minami 1 Jonishi, Chūō-ku, Sapporo, Hokkaido 060-8543, Japan

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Medical Corporation Aoyama Clinic

神戸楠公前ビル 5f, 3-chōme-3-9 Tamondōri, Chūō-ku, Kobe, Hyogo 650-0015, Japan

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Hyogo College of Medicine

1-1 Mukogawachō, Nishinomiya, Hyogo 663-8501, Japan

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Sagamihara Kyodo Hospital

2-chōme-8-18 Hashimoto, Midori-ku, Sagamihara, Kanagawa 252-5188, Japan

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Dokkyo Medical University Saitama Medical Center

2-chōme-1-50 Minamikoshigaya, Koshigaya, Saitama 343-8555, Japan

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Jikei University Hospital

3-chōme-19-18 Nishishinbashi, Minato City, Tōkyō-to 105-0003, Japan

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Kitasato University Kitasato Institute Hospital

5-chōme-9-1 Shirokane, Minato City, Tōkyō-to 108-8642, Japan

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Ome Municipal General Hospital

4-chōme-16-5 Higashioume, Ome, Tōkyō-to 198-0042, Japan

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Tokatsu Tsujinaka Hospital

946-1 Nedo, Abiko, Chiba 270-1168, Japan

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Kunimoto Hospital

070-0061, Japan

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Fukuoka University Chikushi Hospital

1-chōme-1-1 Zokumyōin, Chikushino, Fukuoka 818-0067, Japan

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38-3 Goryōkakuchō, Hakodate, Hokkaido 040-0001, Japan

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Kawabe Clinic

2-chōme-17-14 Honchō, Koganei, Tōkyō-to 184-0004, Japan

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Yuai Memorial Hospital

Japan, 〒306-0232 茨城県古河市東牛谷707

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Hidaka Coloproctology Clinic

839-0809, Japan

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Aizawa Hospital

2-chōme-5-1 Honjō, Matsumoto, Nagano 390-0814, Japan

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Aichi Medical University Hospital

Japan, 〒480-1195 Aichi, Nagakute, Yazako, Karimata−1−1

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8-24 Hayashidachō, Nishinomiya, Hyogo 663-8014, Japan

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Ishida Clinic of IBD and Gastroenterology

870-0823, Japan

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Onomichi General Hospital

1-chōme-10-23 Hirahara, Onomichi, Hiroshima 722-8508, Japan

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Kinshukai Infusion Clinic

Japan, 〒530-0011 Osaka, Kita-ku, Ōfukachō, 3, 北区大深町3−1

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Chiinkai Dojima General & Gastroenterology Clinic

Dojima, Kita Ward, Osaka, 530-0003, Japan

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Shiga University of Medical Science Hospital

7 Chome-6 Setatsukinowacho, 大津市 Shiga 520-2192, Japan

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Bellland General Hospital

500-3 Higashiyama, Naka-ku, Sakai, Osaka 599-8247, Japan

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5-chōme-21-16 Ōmorinishi, Ota City, Tōkyō-to 143-8540, Japan

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Sapporo Tokushukai Hospital

14-chōme-3-1 Kita 33 Jōhigashi, Higashi-ku, Sapporo, Hokkaido 065-0033, Japan

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4-chōme-3-21 Dainohara, Aoba-ku, Sendai, Miyagi 981-8563, Japan

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Dokkyo Medical University Hospital

880 Kitakobayashi, Mibu, Shimotsuga-gun, Tochigi 321-0207, Japan

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Medical Corporation Shoyu-kai Fujita Gastroenterology Hospital

569-0086, Japan

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Japan, 〒150-0013 Tōkyō-to, Shibuya City, Ebisu, 4-chōme−1−18 恵比寿ネオナート2F

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Shinbeppu Hospital

3898番地 Tsurumi, Beppu, Oita 874-8538, Japan

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1-chōme-7-50 Kunijima, Higashiyodogawa-ku, Osaka, 533-0024, Japan

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130 Dongdeok-ro, Samdeokdong 2(i)-ga, Jung-gu, Daegu, South Korea

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1 Yeonsedae-gil, Heungeop-myeon, Weonju, Gangwon-do, South Korea

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CHA Bundang Medical Center, CHA University

59 Yatap-ro, Yatap-dong, Bundang-gu, Seongnam-si, Gyeonggi-do, South Korea

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93 Jungbu-daero, Ji-dong, Paldal-gu, Suwon, Gyeonggi-do, South Korea

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875 Haeun-daero, Jwa-dong, Haeundae, Busan, South Korea

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179 Gudeok-ro, Amidong 1(il)-ga, Seo-gu, Busan, South Korea

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South Korea, Daegu, Daemyeong 5(o)-dong, 영대병원역

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Chilgok Kyungpook National Univ. Medical Center, Dongho-dong, Daegu, South Korea

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21 Namdong-daero 774beon-gil, Guwol-dong, Namdong-gu, Incheon, South Korea

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23 Kyungheedae-ro, Hoegi-dong, Dongdaemun-gu, Seoul, South Korea

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South Korea, Seoul, Jongno-gu, Ihwa-dong, 대학로 101

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29 Saemunan-ro, Pyeong-dong, Jongno-gu, Seoul, South Korea

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50-1, Yonsei-Ro, Seodaemun-Gu

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Asan Medical Center - PPDS

88 Olympic-ro 43-gil, Pungnap 2(i)-dong, Songpa-gu, Seoul, South Korea

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81 Irwon-ro, Irwonbon-dong, Gangnam-gu, Seoul, South Korea

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9 Mareunnae-ro, Euljiro-dong, Jung-gu, Seoul, South Korea

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Jnah, Lebanon

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Dr. Ghassan Hammoud Street، Saida, Lebanon

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Eivenių g. 2, Kaunas 50161, Lithuania

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08406, Santariškių g. 2, Vilnius 08410, Lithuania

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Antakalnio g. 57, Vilnius 10207, Lithuania

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Clinica de Higado y Gastroenterologia Integral, S.C.

Av. Lázaro Cárdenas 120-A, Jiquilpan, 62170 Cuernavaca, Mor., Mexico

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JM Research S.C

Av Teopanzolco 217, Vista Hermosa, 62290 Cuernavaca, Mor., Mexico

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Unidad de Atencion Medica e Investigacion en Salud

Av. Colon 505, García Ginerés, 97070 Mérida, Yuc., Mexico

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Av Independencia 2130, Trojes de Alonso, 20116 Aguascalientes, Ags., Mexico

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Phylasis Clinicas Research S. de R.L. de C.V.

Hacienda del Parque, 54769 Cuautitlán Izcalli, Méx., Mexico

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Interior 1, Montiel 87, Tepeyac Insurgentes, Gustavo A. Madero, 07029 Ciudad de México, CDMX, Mexico

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Pasteur 205, Zona Centro, 34000 Durango, Dgo., Mexico

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Accelerium, S. de R.L. de C.V.

Centro, 64000 Monterrey, N.L., Mexico

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Clinical Research Institute

Boulevard Manuel Avila Camacho 1994-1103 San lucas tepetlacalco Tlalnepantla, San Lucas Tepetlacalco, 54055 Ciudad de México, Méx., Mexico

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Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.

Av. Sebastian Bach 5257, La Estancia, 45030 Zapopan, Jal., Mexico

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ETZ-Elisabeth

Hilvarenbeekse Weg 60, 5022 GC Tilburg, Netherlands

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NWZ, location Alkmaar

Wilhelminalaan 12, 1815 JD Alkmaar, Netherlands

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Leids Universitair Medisch Centrum

Albinusdreef 2, 2333 ZA Leiden, Netherlands

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De Boelelaan 1117, 1118, 1081 HV Amsterdam, Netherlands

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Academisch Medisch Centrum Amsterdam

Meibergdreef 9, 1105 AZ Amsterdam, Netherlands

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2 Park Road, Grafton, Auckland 1023, New Zealand

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201 Great King Street, Dunedin Central, Dunedin 9016, New Zealand

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49 Riddiford Street, Newtown, Wellington 6021, New Zealand

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Pembroke Street, 183 Pembroke Street, Hamilton 3204, New Zealand

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Generała Romualda Traugutta 1/7, 50-123 Wrocław, Poland

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Lexmedica

Weigla 12, 53-114 Wrocław, Poland

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Vitamed Galaj i Cichomski sp.j.

Tadeusza Kościuszki, 85-079 Bydgoszcz, Poland

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Grudziądzka 11/13-14, 87-100 Toruń, Poland

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Stanisława Wigury 19, 90-057 Łódź, Poland

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Stefana Żeromskiego 113, 90-549 Łódź, Poland

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Rzgowska 281/289, 93-338 Łódź, Poland

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Mikołaja Kopernika 32, 31-501 Kraków, Poland

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Zamiejska 17, 03-580 Warszawa, Poland

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Bursztynowa 2, 04-749 Warszawa, Poland

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Marii Skłodowskiej-Curie 24A, 15-276 Białystok, Poland

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Endoskopia Sp. z o.o.

Bolesława Chrobrego 6/8, 81-756 Sopot, Poland

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Markiefki 87, 40-211 Katowice, Poland

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Gimnazjalna 41B, 26-200 Końskie, Poland

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Juliusza Słowackiego 19, 71-434 Szczecin, Poland

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Kornela Ujejskiego 75, 85-168 Bydgoszcz, Poland

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Wojciecha Łochowskiego 7a, 85-796 Bydgoszcz, Poland

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42-200 Częstochowa, Poland

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Bernarda Chrzanowskiego 3/5, 81-338 Gdynia, Poland

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NZOZ All Medicus

Harcerzy Września 1939r. 5, 40-659 Katowice, Poland

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Orkana 3, 95-054 Ksawerów, Poland

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Głowackiego 8e/14, 67-100 Nowa Sól, Poland

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lok. 49, Ludwika Czajewicza 5/7, 05-500 Piaseczno, Poland

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Poznańska 3, 60-848 Poznań, Poland

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Króla Stanisława Augusta 44B, 35-001 Rzeszów, Poland

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Bandurskiego 98/U12

Sonomed, księdza Biskupa Władysława Bandurskiego 98, 71-685 Szczecin, Poland

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Sonomed Sp. z o.o.

księdza Biskupa Władysława Bandurskiego 98, 71-685 Szczecin, Poland

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Aleja Bielska 105, 43-100 Tychy, Poland

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Polna 30b, 00-635 Warszawa, Poland

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Marymoncka 14/1, 01-868 Warszawa, Poland

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Centralny Szpital Kliniczny MSW

Wołoska 137, 02-507 Warszawa, Poland

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aleje Jana Pawła II 10, 22-400 Zamość, Poland

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R. das Comunidades Lusíadas 133, 4710 Braga, Portugal

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Estr. do Poço Seco, 8500-338 Portimão, Portugal

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R. Camilo Castelo Branco 175, 2910-549 Setúbal, Portugal

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Strada Clinicilor 3-5, Cluj-Napoca 400000, Romania

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Bucharest, Romania

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Bucharest, Romania

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Șoseaua Ștefan cel Mare 19-21, București, Romania

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Strada Dr. Calistrat Grozovici 1, București 021105, Romania

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Fundeni Clinical Institute

Calea București 258, București, Romania

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Strada Pictor Ion Negulici nr. 27, București 014192, Romania

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Affidea Romania SRL

Bulevardul Tomis 141A, Constanța 900591, Romania

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et. 1, Strada Garabet Ibrăileanu nr. 4B, Iași, Romania

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Strada Gheorghe Doja 24, Oradea 410163, Romania

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Timișoara, Romania

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Ulitsa Butlerova, 49, Kazan, Respublika Tatarstan, Russia, 420012

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Moscow, Russia, 129110

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Ulitsa Rodionova, 190, Nizhnij Novgorod, Nizhegorodskaya oblast', Russia, 603126

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Research Institute of Physiology and Basic Medicine

Novosibirsk, Novosibirsk Oblast, Russia, 630117

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Ulitsa Suvorova, 119, Rostov, Rostovskaya oblast', Russia, 344022

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Rostov State Medical University

Ulitsa Suvorova, 119, Rostov, Rostovskaya oblast', Russia, 344022

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Russian Medical Military Academy n.a. S.M. Kirov

улица Академика Лебедева лит. Ж, Sankt-Peterburg, Russia, 194044

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Ulitsa Chapayevskaya, 227, Samara, Samarskaya oblast', Russia, 443001

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Private Healthcare Institution Clinical Hospital RZD-Medicina of Samara city

Samara, Samara Oblast, Russia, 443029

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Medical Company Hepatolog, LLC

Samara, Samara Oblast, Russia, 443063

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Saratov, Saratov Oblast, Russia, 410012

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St Petersburg, Russia, 195257

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Ulitsa L'va Tolstogo, 6-8, Sankt-Peterburg, Russia, 197022

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Stavropol State Medical University

Ulitsa Mira, 310, Stavropol, Stavropolskiy kray, Russia, 355017

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Tyumen, Tyumen Oblast, Russia, 625026

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8 Trg Svetog Teodora Vršačkog, 26300, Vršac, Južno-banatski okrug, Vršac, Serbia

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Ružinovská 4810/6, 821 01 Bratislava-Ružinov, Slovakia

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KM Management, spol. s r.o.

13, Špitálska 563, 949 01 Nitra, Slovakia

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Jurkovičova 18, 080 01 Prešov-Sekčov, Slovakia

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20 Pine Ave, Kempton Park Cbd, Kempton Park, 1619, South Africa

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Pretoria, 0002, South Africa

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Av. Menendez Pidal, s/n, 14004 Córdoba, Spain

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Camino del Molino, 2, 28942 Fuenlabrada, Madrid, Spain

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Calle de Diego de León, 62, 28006 Madrid, Spain

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Av. de los Reyes Católicos, 2, 28040 Madrid, Spain

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Paseo de la Castellana, 261, 28046 Madrid, Spain

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Av. Manuel Siurot, S/n, 41013 Sevilla, Spain

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Avinguda de Fernando Abril Martorell, 106, 46026 València, Valencia, Spain

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Rämistrasse 71, 8006 Zürich, Switzerland

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Cerrahpaşa, Cerrahpaşa Tıp Fakültesi No:1, 34098 Fatih/İstanbul, Turkey

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Mesudiye, MEÜ ÇİFTLİKKÖY KAMPUSU, 33110 Camili Köyü/Yenişehir/Mersin, Turkey

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Konstytutsii Square, 7, Kharkiv, Kharkivs'ka oblast, Ukraine, 61003

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Bahhovutivska St, 1, Kyiv, Ukraine, 02000

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Pyrohova St, 46, Vinnytsia, Vinnyts'ka oblast, Ukraine, 21000

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Zaporizhzhia, Zaporizhia Oblast, Ukraine, 69061

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Soborna Square, 14, Dnipropetrovs'k, Dnipropetrovs'ka oblast, Ukraine, 49000

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Kharkiv, Kharkiv Oblast, Ukraine

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Kryvyi Rih, Dnipropetrovsk Oblast, Ukraine, 50000

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Lviv, Lviv Oblast, Ukraine, 79000

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Akademika Zabolotnoho St, 26/32, Odesa, Odes'ka oblast, Ukraine, 65000

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Zaporizhzhia, Zaporizhia Oblast, Ukraine, 69061

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Whipps Cross Rd, Leytonstone, London E11 1NR, UK

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Rake Ln, Tyne and Wear, North Shields NE29 8NH, UK

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Crewe Rd S, Edinburgh EH4 2XU, UK

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Cardiff Rd, Newport NP20 2UB, UK

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200 Medical Center Dr #2B, Hazard, KY 41701, USA

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2C, Jankovcova 1569, Holešovice, 170 00 Praha-Praha 7, Czechia

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10012 Kennerly Rd # 101, St. Louis, MO 63128, USA

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333 Conover Dr # D, Franklin, OH 45005, USA

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4520 E Indian School Rd, Phoenix, AZ 85018, USA

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11321 I-30 #308, Little Rock, AR 72209, USA

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5901 E 7th St, Long Beach, CA 90822, USA

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2709 N Tejon St, Colorado Springs, CO 80907, USA

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816 Mercy Dr, Orlando, FL 32808, USA

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Pinellas Park, FL 33781, USA

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7918 W Hillsborough Ave, Tampa, FL 33615, USA

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600 Bayou Pines E, Lake Charles, LA 70601, USA

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660 S Euclid Ave, St. Louis, MO 63110, USA

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NYU Langone Long Island Clinical Research Associates

1999 Marcus Ave Suite 202, Lake Success, NY 11042, USA

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Veteran's Research and Education Foundation - NAVREF - PPDS

Oklahoma City, OK 73104, USA

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Veterans Research Foundation of Pittsburgh - NAVREF - PPDS

1010 Delafield Rd, Pittsburgh, PA 15215, USA

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Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - PPDS

10021 S Main St, Houston, TX 77025, USA

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DM Clinical Research - ERN - PPDS

13406 Medical Complex Dr Suite 53, Tomball, TX 77375, USA

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Exemplar Research, Inc. - Elkins

1175 Beverly Pike, Elkins, WV 26241, USA

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Medizinische Universitat Wien (Medical University of Vienna)

Spitalgasse 23, 1090 Wien, Austria

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Diagnostic Consultative Centre Mladost - M OOD

9020 Varna, Bulgaria

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Klinikum rechts der Isa der Technischen Universitaet Muenchen

Ismaninger Str. 22, 81675 München, Germany

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Ospedale Casa Sollievo Della Sofferenza IRCCS

Viale Padre Pio, 7d, 71013 San Giovanni Rotondo FG, Italy

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IRCCS Ospedale Sacro Cuore Don Calabria

Via Don A. Sempreboni, 5, 37024 Negrar di Valpolicella VR, Italy

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Azienda Ospedale Università Padova - Dipartimento Salute della Donna e del Bambino

Via Nicolò Giustiniani, 2, 35128 Padova PD, Italy

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Nihonbashi Egawa Clinic

Japan, 〒103-0028 Tokyo, Chuo City, Yaesu, 1-chōme−1−3 寿ビル 2F

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Sapporo Higashi Tokushukai Hospital

14-chōme-3-1 Kita 33 Jōhigashi, Higashi-ku, Sapporo, Hokkaido 065-0033, Japan

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BioVirtus Centrum Medyczne

aleja Nadwiślańska 37, 05-410 Józefów, Poland

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Hospital da Luz

Av. Lusíada 100, 1500-650 Lisboa, Portugal

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Hospital Senhora da Oliveira - Guimaraes, E.P.E

R. dos Cutileiros 114, 4805 Creixomil, Portugal

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Clinical Hospital Center Bezanijska Kosa

Zemun, Belgrade, Serbia

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University Clinical Center Nis

Bulevar Dr Zorana Đinđića 48, Niš 18000, Serbia

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University Clinical Center Kragujevac

Zmaj Jovina 30, Kragujevac, Serbia

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CHUVI - H.U. Alvaro Cunqueiro

Estrada de Clara Campoamor, 341, 36213 Vigo, Pontevedra, Spain

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Centro Medico Teknon - Grupo Quironsalud

Carrer de Vilana, 12, 08022 Barcelona, Spain

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Hospital Universitario Juan Ramon Jimenez

Ronda Norte, s/n, 21005 Huelva, Spain

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Regional Municipal Non-profit Enterprise "Chernivtsi Regional Clinical Hospital"

Holovna St, 137, Chernivtsi, Chernivets'ka oblast, Ukraine, 58000

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State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"

Dnipro, Dnipropetrovsk Oblast, Ukraine, 49000

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Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital

Kharkiv, Kharkiv Oblast, Ukraine

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MNPE of Kharkiv Regional Council Regional Clinical Specialized Dispensary of Radiation Protection

Kharkiv, Kharkiv Oblast, Ukraine

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Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh

Kherson, Kherson Oblast, Ukraine, 73000

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Treatment and Diagnostic Center "Healthy and Happy" of LLC "Healthy and Happy"

Kyiv, Ukraine, 02000

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Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1

Khmel'nyts'ke Hwy, 96, Vinnytsia, Vinnyts'ka oblast, Ukraine, 21000

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View all (401)
Trial Protocol ID: SHP647-303
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