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New daily pill could rival infusion for slowing progressive MS

NCT ID NCT04544449

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 5 times

Summary

This phase 3 trial compares two drugs for primary progressive multiple sclerosis (PPMS), a form of MS that steadily worsens. About 985 adults with PPMS will receive either daily oral fenebrutinib or intravenous ocrelizumab (plus matching placebos) to see which better delays disability progression. The study is double-blind, meaning neither participants nor doctors know who gets which drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fenebrutinib (an oral drug) and ocrelizumab (an intravenous drug)
What this could lead to
If fenebrutinib works as well as or better than ocrelizumab, it could offer a more convenient daily pill option to slow disability progression in primary progressive MS.
What could go wrong
This is an early-stage comparison; fenebrutinib may not prove superior or even equal to ocrelizumab. Side effects and long-term risks are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

985 people

The number who actually took part.

Started

Oct 2020

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * For sites in Germany and Italy only, enrollment is restricted to participants aged 46-65 years * A diagnosis of PPMS in accordance to the revised 2017 McDonald Criteria (Thompson et al. 2018). * Disability progression in the 12 months prior to screening. * Expanded Disability Status Scale (EDSS) score from 3.0 to 6.5 inclusive at screening. * Pyramidal functional subscore \>=2 at screening. * For participants currently receiving proton pump inhibitors (PPIs), H2-receptor antagonists (H2RAs), symptomatic treatment for MS (e.g. fampridine, cannabis) and/or physiotherapy: treatment at a stable dose during the screening period prior to the initiation of study treatment and plans to remain at a stable dose for the duration of study treatment. * Neurologically stable for at least 30 days prior to randomization and baseline assessments. * Ability to complete the 9-Hole Peg Test (9-HPT) for each hand in \<240 seconds. * Ability to perform Timed 25-Foot Walk Test (T25FWT) in \<150 seconds. * For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating eggs. * For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating sperm. OLE Inclusion Criteria: * Completed the Double-Blind Treatment (DBT) phase of the study (remaining on study treatment; no other Disease-Modifying Therapy (DMT) administered) and who, in the opinion of the investigator, may benefit from treatment with fenebrutinib. * For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating eggs. * For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating sperm. Exclusion Criteria: * For participants enrolled in Germany and in Italy only: Presence of gadolinium-enhancing lesions on T1-weighted MRI (T1Gd +) lesion on the screening MRI * Any known or suspected active infection (excluding onychomycosis) at screening, including but not limited to a positive screening test for Hepatitis B and C, an active or latent or inadequately treated infection with tuberculosis (TB), a confirmed or suspected progressive multifocal leukoencephalopathy (PML). * Participants with a previous history of a serious Infusion-Related Reaction (IRR) (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade \>= 4) and/or any hypersensitivity reaction to ocrelizumab. * History of cancer including hematologic malignancy and solid tumors within 10 years of screening. Exceptions: Basal/squamous cell carcinoma of skin cured by excision. In situ carcinoma of the cervix successfully treated by curative therapy \>1 year prior to screening. * Known presence of other neurological disorders, that could interfere with the diagnosis of MS or assessments of efficacy or safety during the study, clinically significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic or gastrointestinal disease. * Presence of cirrhosis (Child-Pugh Class A, B, or C) * Chronic liver disease unless considered stable for \>6 months * Acute liver disease * Any concomitant disease that may require chronic treatment with systemic corticosteroids, immunosuppressants or specific medication that could impact the primary evaluation of the study. * History of alcohol or other drug abuse within 12 months prior to screening. * Female participants who are pregnant or breastfeeding or intending to become pregnant during the study or 6 or 12 months (as applicable from the local label for ocrelizumab) after final dose of study drug. * Male participants intending to father a child during the study or for 28 days after final dose of study drug. * Lack of peripheral venous access. * Any previous treatment with immunomodulatory or immunosuppressive medication without an appropriate washout period. * Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization. * Immunocompromised state, history of primary or secondary (non-drug related) immunodeficiency, or history of transplantation or antirejection therapy * Known bleeding diathesis, anemia, or history of hospitalization or transfusion for gastrointestinal (GI) bleed * Any previous treatment with cladribine, mitoxantrone, daclizumab, alemtuzumab, or cyclophosphamide OLE Exclusion Criteria: * Chronic liver disease unless considered stable for \> 6 months * Acute liver disease * Cirrhosis (Child-pugh Class A, B or C) * Gilbert's syndrome

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Conditions

The condition(s) this trial relates to.

chronic progressive multiple sclerosis primary progressive multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple sclerosis, primary progressive

Contacts and locations

Locations

  • "Neurofocus" LLC

    Lviv, 79029, Ukraine

  • 401 Military Hospital of Athens

    Athens, 11525, Greece

  • A.O.U. di Parma

    Parma, Emilia-Romagna, 43126, Italy

  • A.R.N.A.S. Civico Di Cristina Benfratelli

    Palermo, Sicily, 90127, Italy

  • AHEPA Univ. General Hospital of Thessaloniki

    Thessaloniki, 54636, Greece

  • AOU Seconda Università degli Studi

    Naples, Campania, 80138, Italy

  • Aarhus Universitetshospital

    Aarhus N, 8200, Denmark

  • Alabama Neurology Associates

    Homewood, Alabama, 35209, United States

  • Ams of Ukraine

    Kharkiv, Kharkiv Governorate, 61068, Ukraine

  • Atrium Health Neurosciences Institute ? Charlotte

    Charlotte, North Carolina, 28204, United States

  • Austin Hospital

    Heidelberg, Victoria, 3084, Australia

  • Barnabas Health Ambulatory Care Center

    Livingston, New Jersey, 07039, United States

  • Baskent Universitesi Ankara Hastanesi

    Çankaya, 06490, Turkey (Türkiye)

  • Box Hill Hospital

    Box Hill, Victoria, 3128, Australia

  • Brain and Mind Research Institute

    Camperdown, New South Wales, 2050, Australia

  • Budapesti Jahn Ferenc Dél-pesti Kórház és Rendel?intézet

    Budapest, 1204, Hungary

  • CHRU de Montpellier, Hopital Gui de Chauliac

    Montpellier, 34295, France

  • CNPE City Clinical Hospital #3 of Chernivtsi City Council

    Chernivtsi, Chernihiv Governorate, 58022, Ukraine

  • Care Clinic

    Katowice, 40-568, Poland

  • CeCim Biocinetic

    Santiago, 8331143, Chile

  • Center of Cardiology and Neurology

    Kirov, 610007, Russia

  • Centro de Especialidades Neurológicas y Rehabilitación - CENyR

    Buenos Aires, C1424, Argentina

  • Centro de Investigaciones Médicas Tucuman

    San Miguel, T4000AXL, Argentina

  • Centro de Pesquisas Clinicas

    São Paulo, São Paulo, 01228-200, Brazil

  • Centrum Medyczne "MEDYK"

    Rzeszów, 35-055, Poland

  • Centrum Medyczne NeuroProtect

    Warsaw, 01-684, Poland

  • Centrum Neurologii Krzysztof Selmaj

    Lodz, 90-324, Poland

  • Charing Cross Hospital

    London, W6 8RF, United Kingdom

  • Charite - Universitatsmedizin Berlin

    Berlin, 10117, Germany

  • City Clinical Hospital #24

    Moskva, Moscow Oblast, 127015, Russia

  • City Hospital #40 of Resort Administrative District

    Saint Petersburg, Sankt-Peterburg, 197706, Russia

  • Cleveland Clinic Lou Ruvo

    Las Vegas, Nevada, 89106, United States

  • Clinexpert Kft.

    Budapest, 1033, Hungary

  • Clinica Alemana

    Vitacura, 0, Chile

  • Clinica Internacional

    Lima, 15001, Peru

  • Clinica Neurologica

    Joinville, Santa Catarina, 89202-190, Brazil

  • Clinical Research Institute

    Tialnepantla, Mexico, 54055, Mexico

  • Clinique NeuroOutaouais

    Gatineau, Quebec, J8Y 1W2, Canada

  • Clinstile S.A de C.V.

    Mexico City, Mexico CITY (federal District), 06700, Mexico

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Complejo Hospitalario Universitario A Coruña (CHUAC)

    A Coruña, LA Coruna, 15006, Spain

  • Dent Neurological Institute

    Amherst, New York, 14226, United States

  • Deutsche Klinik für Diagnostik

    Wiesbaden, 65191, Germany

  • Dragonfly Research, LLC

    Wellesley, Massachusetts, 02481, United States

  • Evergreen MS Center

    Kirkland, Washington, 98034, United States

  • FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency

    Krasnoyarsk, Krasnoyarsk Krai, 660037, Russia

  • Federal center of brain research and neurotechnologies

    Moskva, Moscow Oblast, 117997, Russia

  • Focus CECIC

    Buenos Aires, Argentina

  • Fraser Health Authority - Fraser Health Multiple Sclerosis

    Burnaby, British Columbia, V5G 2X6, Canada

  • Freire Pesquisa Clinica

    Belo Horizonte, Minas Gerais, 30150-320, Brazil

  • Fullerton Neurology and Headache Center

    Fullerton, California, 92835, United States

  • Fundacion Clinica Valle del Lili

    Cali, Colombia

  • Fundacion Rosarina de Neurorehabilitacion

    Rosario, 2000, Argentina

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007, United States

  • Groupe Hospitalier Pellegrin

    Bordeaux, 33076, France

  • Grupo Médico Camino S.C.

    México, Mexico CITY (federal District), 03600, Mexico

  • Hacettepe University Medical Faculty

    Ankara, 06100, Turkey (Türkiye)

  • Hackensack U Med Ctr

    Hackensack, New Jersey, 07601, United States

  • Holy Name Hospital

    Teaneck, New Jersey, 07666, United States

  • Hope Neurology

    Knoxville, Tennessee, 37922, United States

  • Hopital Guillaume Et Rene Laennec

    Nantes, 44805, France

  • Hopital Pierre Wertheimer

    Bron, 69677, France

  • Hopitaux Universitaires de Strasbourg

    Strasbourg, 67091, France

  • Hospital Alvaro Cunqueiro

    Vigo, Pontevedra, 36213, Spain

  • Hospital Eginition

    Athens, 115 28, Greece

  • Hospital Geral de Santo Antonio

    Porto, 4099-001, Portugal

  • Hospital IV Alberto Sabogal Sologuren

    Bellavista, Callao 2, Peru

  • Hospital Juarez de Mexico

    Mexico City, Mexico CITY (federal District), 07760, Mexico

  • Hospital Puerta del Mar

    Cadiz, 11009, Spain

  • Hospital Quiron de Madrid

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Regional Universitario de Malaga ? Hospital General

    Málaga, 29010, Spain

  • Hospital Santo Antonio dos Capuchos

    Lisbon, 1169-050, Portugal

  • Hospital Universitari Arnau de Vilanova de Lleida

    Lleida, Lerida, 25198, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Gaffree e Guinle

    Rio de Janeiro, 20270-004, Brazil

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital de Santa Maria

    Lisbon, 1649-035, Portugal

  • Hospital de Sao Joao

    Porto, 4200-319, Portugal

  • Hôpital Pasteur

    Nice, 06002, France

  • IMV Pesquisa Neurológica

    Porto Alegre, Rio Grande do Sul, 90620-130, Brazil

  • IRCCS Istituto Neurologico Neuromed

    Pozzilli, Molise, 86077, Italy

  • IRCCS Ospedale San Raffaele

    Milan, Lombardy, 20132, Italy

  • Inselspital Bern Medizin Neurologie

    Bern, 3010, Switzerland

  • Instituto De Neurología Cognitiva - INECO

    Capital Federal, 000C1021, Argentina

  • Instituto Nacional de Ciencias Neurológicas - Hospital Mogrovejo

    Lima, Lima 01, Peru

  • Instituto Neurologico de Colombia INDEC

    Medellín, Colombia

  • Instituto Reumatológico Strusberg

    Córdoba, X5000EDC, Argentina

  • Instituto de Neurologia de Curitiba

    Curitiba, Paraná, 81210-310, Brazil

  • Irccs A.O.U.San Martino Ist

    Genoa, Liguria, 16132, Italy

  • Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi

    Istanbul, 34098, Turkey (Türkiye)

  • Jersey Shore University Medical Centre

    Neptune City, New Jersey, 07753, United States

  • John Hunter Hospital

    New Lambton, New South Wales, 2305, Australia

  • Johns Hopkins University School Of Medicine

    Baltimore, Maryland, 21287, United States

  • Josephson Wallack Munshower Neurology PC

    Indianapolis, Indiana, 46256, United States

  • Karadeniz Tecnical Uni. Med. Fac.

    Trabzon, 61080, Turkey (Türkiye)

  • Kepler Universitätsklinikum GmbH - Neuromed Campus

    Linz, 4020, Austria

  • Klinikum rechts der Isar der TU Muenchen

    München, 81675, Germany

  • Kocaeli University Hospital

    Kocaeli, 41380, Turkey (Türkiye)

  • Krasnoyarsk State Medical Academy

    Krasnoyarsk, Krasnoyarsk Krai, 660022, Russia

  • Liverpool Hospital

    Liverpool, New South Wales, 2170, Australia

  • London Health Sciences Centre Uni Campus

    London, Ontario, N6A 5A5, Canada

  • Lviv Regional Clinical Hospital

    Lviv, KIEV Governorate, 79010, Ukraine

  • MEDBUD

    Kyiv, KIEV Governorate, 03037, Ukraine

  • Markhot Ferenc Oktatokorhaz és Rendelointezet

    Eger, 3300, Hungary

  • Med Polonia

    Późna, 60-693, Poland

  • Medical Centre of PE First Private Clinic

    Zhytomyr, Crimean Regional Governmenta, 10008, Ukraine

  • Medical Clinical Research Center of Medical Center LLC Health Clinic

    Vinnytsia, 21009, Ukraine

  • Medical College of Wisconsin, Inc.

    Milwaukee, Wisconsin, 53226-3596, United States

  • Medizinische Universität Wien

    Vienna, 1090, Austria

  • Mersin University Medical Faculty

    Mersin, 33079, Turkey (Türkiye)

  • Mexico Centre for Clinical Research

    Mexico City, Mexico CITY (federal District), 03100, Mexico

  • Miami Valley Hospital South

    Centerville, Ohio, 45459, United States

  • Minneapolis Clinic of Neurology

    Golden Valley, Minnesota, 55422, United States

  • Montreal Neurological Institute and Hospital

    Montreal, Quebec, H3A 2B4, Canada

  • Morriston Hospital

    Swansea, SA6 6NL, United Kingdom

  • Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD

    Sofia, 1113, Bulgaria

  • Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council

    Zaporizhzhya, Kharkiv Governorate, 69600, Ukraine

  • NEURO-CARE Sp. z o.o. Sp. Komandytowa

    Katowice, 40-749, Poland

  • National Center of Social Significant Disease

    Saint Petersburg, Sankt-Peterburg, 197110, Russia

  • Neurocentrum Bydgoszcz sp. z o.o

    Bydgoszcz, 85-796, Poland

  • Neurological Services of Orlando

    Orlando, Florida, 32806, United States

  • Neurology Associates PA

    Maitland, Florida, 32751, United States

  • Neurology Clinic PC

    Cordova, Tennessee, 38018, United States

  • Nmedis sp. z o.o.

    Rzeszów, 35-323, Poland

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG7 2UH, United Kingdom

  • Núcleo de Pesquisa do Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul, 90430-001, Brazil

  • Odesa Regional Clinical Hospital

    Odesa, 65117, Ukraine

  • OhioHealth Riverside Methodist Hospital

    Columbus, Ohio, 43214, United States

  • Ondokuz Mayis Univ. Med. Fac.

    Samsun, 55139, Turkey (Türkiye)

  • Organizacion Sanitas Internacional

    Bogotá, Colombia

  • Ospedale Civile di Montichiari

    Montichiari, Lombardy, 25018, Italy

  • Palo Alto Medical Foundation Research Center

    Sunnyvale, California, 94086, United States

  • Pest Megyei Flor Ferenc Korhaz

    Kistarcsa, 2143, Hungary

  • Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla

    Rome, Lazio, 00133, Italy

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • Providence Brain and Spine Institute

    Portland, Oregon, 97225, United States

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF, United Kingdom

  • Raleigh Neurology Associates

    Raleigh, North Carolina, 27607-6520, United States

  • Rambam Medical Center

    Haifa, 3109601, Israel

  • Recherche Sepmus Inc.

    Greenfield Park, Quebec, J4V 2J2, Canada

  • Regional Clinical Hospital

    Ivano-Frankivsk, 76008, Ukraine

  • Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik

    Tyumen, Tyumen Oblast, 625048, Russia

  • Rigshospitalet

    Glostrup Municipality, 2600, Denmark

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050, Australia

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07103, United States

  • S-Medicon Egeszsegugyi Szolgaltato Kft.

    Budapest, 1044, Hungary

  • SPSK nr 1

    Zabrze, 41-800, Poland

  • SUNY Upstate Medical University

    Syracuse, New York, 13210, United States

  • Salutem Medical Center

    Vinnytsia, KIEV Governorate, 21009, Ukraine

  • San Juan MS Center

    Guaynabo, 968, Puerto Rico

  • Sancaktepe Training and Research Hospital

    Istanbul, 34785, Turkey (Türkiye)

  • Selcuk University Medical Faculty

    Istanbul, 42131, Turkey (Türkiye)

  • Separated structural unit ?University hospital? of Dnipro State Medical University

    Dnipro, Tavria Okruha, Ukraine

  • St. Michael's Hospital

    Toronto, Ontario, M5B-1W8, Canada

  • State Novosibirsk Regional Clinical Hospital

    Novosibirsk, 630087, Russia

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794, United States

  • Studienzentrum Dr. Bischof GmbH

    Böblingen, 71034, Germany

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5, Canada

  • Sutter East Bay Medical Foundation

    Berkeley, California, 94705, United States

  • Sverdlovsk Regional Clinical Hospital 1

    Yekaterinburg, Sverdlovsk Oblast, 620102, Russia

  • Swedish Medical Center

    Seattle, Washington, 98122, United States

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906, Israel

  • Texas Institute for Neurological Disorders

    Sherman, Texas, 75092, United States

  • The Chaim Sheba Medical Center

    Ramat Gan, 5262100, Israel

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H 8L6, Canada

  • UC Health, LLC.

    Cincinnati, Ohio, 45267, United States

  • UMHAT Dr. Georgi Stranski

    Pleven, 5800, Bulgaria

  • Uni of Texas Health Science Center At Houston

    Houston, Texas, 77030, United States

  • Unidade Local de Saúde de Braga

    Braga, 4710-243, Portugal

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076, Germany

  • University Clinic of Neurology

    Skopje, 1000, North Macedonia

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 1Z1, Canada

  • University of British Columbia

    Vancouver, British Columbia, V6T 1Z3, Canada

  • University of Colorado Denver

    Aurora, Colorado, 80045, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • University of South Florida

    Tampa, Florida, 33612, United States

  • Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften

    Dresden, 01307, Germany

  • Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie

    Freiburg im Breisgau, 79106, Germany

  • Universitätsspital Basel

    Basel, 4031, Switzerland

  • Van Yuzuncu Yil University Hospital

    Van, 65080, Turkey (Türkiye)

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Vertebronevrologiya LLC

    Kazan', Tatarstan Republic, 420047, Russia

  • Volyn Regional Clinical Hospital

    Lutsk, 43024, Ukraine

  • Washington University

    St Louis, Missouri, 63128, United States

  • Wayne State University

    Detroit, Michigan, 48201, United States

  • West Virginia University

    Morgantown, West Virginia, 26506, United States

  • Wro Medica

    Wroc?aw, 51-685, Poland

  • Yale University School Of Medicine

    Fairfield, Connecticut, 06824, United States

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