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NCT06846281RecruitingPhase 3

Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.

A Randomized, Open-label, Parallel-group, Non-inferiority Study Comparing Efficacy, Safety, and Tolerability of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis, Followed by Open-label Treatment With Remibrutinib

Source: ClinicalTrials.gov · Last updated 26 Oct 2026

Brief summary (registry, in English)

The purpose of this Phase 3b study is to assess the efficacy, safety and tolerability of remibrutinib after switching from ocrelizumab and compared to continuous ocrelizumab treatment, in patients living with relapsing multiple sclerosis (plwRMS).

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
400 (estimated)
First submitted
24 Feb 2025
Start date
23 Jun 2025
Primary completion date
25 Jul 2029
Lead sponsor
Novartis Pharmaceuticals
NCT number
NCT06846281
EU CT number
2023-509275-17-00
EudraCT number
2023-509275-17

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 400
  • From 23 Jun 2025 to the primary completion date, 25 Jul 2029
  • 132 sites in 19 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • History of clinically significant Central Nervous System disease or neurological disorders
  • History of confirmed Progressive Multifocal Leukoencephalopathy or neurological symptoms consistent
  • Active clinically significant systemic bacterial, viral, parasitic or fungal infections
  • Active, chronic disease of the immune system other than MS
  • Severe cardiac disease or significant findings on the ECG
  • History of life-threatening infusion or injection reaction related to ocrelizumab

Lab values

  • Participants not adequately controlled on ocrelizumab (CD19+ B-cell count ≥10 cells/µL at screening)
    • Other inclusion and exclusion criteria may apply

Other

  • Diagnosis of primary progressive multiple sclerosis (PPMS) according to the revised 2017 McDonald criteria
  • Participant who is unable to undergo MRI scans

Who the study is looking for

  • Male or female aged 40 to 70 years (inclusive)
  • Diagnosis of RMS according to the 2017 McDonald diagnostic criteria
  • Treated with ocrelizumab according to routine clinical practice and at standard dose
  • Neurologically stable within 30 days
  • Suitable to be switched to remibrutinib based on physician judgement or patient preference

Age in the registry: 40 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (132)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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Buenos AiresArgentinaRecruiting
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CABAArgentinaRecruiting
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RosarioArgentinaRecruiting
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LiverpoolAustraliaWithdrawn
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MelbourneAustraliaRecruiting
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ParkvilleAustraliaRecruiting
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St LeonardsAustraliaRecruiting
Az St-Jan Brugge-Oostende A.V.
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BruggeBelgiumRecruiting
Noorderhart
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PeltBelgiumRecruiting
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FortalezaBrazilRecruiting
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JoinvilleBrazilRecruiting
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Porto AlegreBrazilRecruiting
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São PauloBrazilRecruiting
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EdmontonCanadaRecruiting
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LévisCanadaRecruiting
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MontrealCanadaRecruiting
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VancouverCanadaRecruiting
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BernSwitzerlandRecruiting
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LausanneSwitzerlandRecruiting
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ZurichSwitzerlandRecruiting
Fakultni nemocnice Brno
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BrnoCzechiaRecruiting
Fakultni Nemocnice U Sv Anny V Brne
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Brno-StredCzechiaRecruiting
Fakultni nemocnice Hradec Kralove
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Hradec KrálovéCzechiaRecruiting
Nemocnice Jihlava prispevkova organizace
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Jihlava 1CzechiaRecruiting
Nemocnice Pardubickeho kraje a.s.
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PardubiceCzechiaRecruiting
Fakultni Nemocnice Motol a Homolka
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PragueCzechiaRecruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
Katholisches Klinikum Bochum gGmbH
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BochumGermanyRecruiting
Neuro Centrum Science GmbH
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ErbachGermanyRecruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyRecruiting
Universitaetsmedizin Greifswald KöR
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GreifswaldGermanyRecruiting
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyRecruiting
Philipps-Universitaet Marburg
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MarburgGermanyRecruiting
Universitaet Muenster
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MuensterGermanyRecruiting
Universitaetsklinikum Regensburg AöR
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RegensburgGermanyRecruiting
Universitaetsklinikum Ulm AoR
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UlmGermanyRecruiting
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege GmbH
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UlmGermanyRecruiting
Region Midtjylland
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Aarhus NDenmarkRecruiting
Rigshospitalet
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GlostrupDenmarkRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital Universitario Reina Sofia
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CórdobaSpainRecruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainRecruiting
Hospital Clínico San Carlos
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MadridSpainRecruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainRecruiting
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainRecruiting
Hospital Universitario Regional de Málaga
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MálagaSpainRecruiting
University Clinical Hospital Virgen De La Arrixaca
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MurciaSpainRecruiting
Hospital Santa Caterina Ias
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SaltSpainRecruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainRecruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainRecruiting
Hospital Universitario Dr. Peset Aleixandre
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ValenciaSpainRecruiting
CHU Besançon
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BesançonFranceRecruiting
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceRecruiting
Chu Gabriel Montpied
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Clermont-FerrandFranceRecruiting
Groupement Des Hopitaux De L'Institut Catholique De Lille
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Lille CedexFranceRecruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceRecruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceRecruiting
Centre Hospitalier Universitaire de Nîmes
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NîmesFranceRecruiting
Fondation A. de Rothschild
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ParisFranceRecruiting
Centre Hospitalier Intercommunal De Poissy Saint Germain
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PoissyFranceRecruiting
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceRecruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg Cedex 2FranceRecruiting
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceRecruiting
Centre Hospitalier Régional Universitaire de Tours
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ToursFranceRecruiting
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LeedsUnited KingdomRecruiting
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LondonUnited KingdomRecruiting
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SheffieldUnited KingdomRecruiting
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SwanseaUnited KingdomRecruiting
University General Hospital Attikon
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AthensGreeceRecruiting
General University Hospital of Larissa
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LarissaGreeceRecruiting
St. Luke's Hospital S.A.
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ThessalonikiGreeceRecruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyRecruiting
Azienda Ospedaliero Universitaria Ospedali Riuniti
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FoggiaItalyRecruiting
IRCCS Ospedale Policlinico San Martino
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GenoaItalyRecruiting
Ospedale San Raffaele S.r.l.
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MilanItalyRecruiting
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
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PaviaItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
Azienda Ospedaliera Policlinico Universitario Tor Vergata
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RomeItalyRecruiting
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Mexico CityMexicoRecruiting
CCAB Centro Clinico Academico Braga Associacao
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BragaPortugalRecruiting
Unidade Local de Saúde de Coimbra, E.P.E.
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CoimbraPortugalRecruiting
Unidade Local De Saude De Sao Jose E.P.E.
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LisbonPortugalRecruiting
University Hospital Bratislava
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BratislavaSlovakiaRecruiting
Fakultna nemocnica Trnava
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TrnavaSlovakiaRecruiting
University of New Mexico
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AlbuquerqueUnited StatesRecruiting
Neurology of Central FL Res Ctr
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Altamonte SpringsUnited StatesRecruiting
Austin Regional Clinic
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AustinUnited StatesRecruiting
Tufts Medical Center
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BostonUnited StatesWithdrawn
SUNY Buffalo The Jacobs Neuro Inst
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BuffaloUnited StatesRecruiting
Lahey Hospital and Medical Center
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BurlingtonUnited StatesRecruiting
Premier Health
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CentervilleUnited StatesRecruiting
University of North Carolina
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Chapel HillUnited StatesRecruiting
University of Chicago
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ChicagoUnited StatesRecruiting
Rush University Medical Center
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ChicagoUnited StatesRecruiting
Univ of Cincinnati Medical Center
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CincinnatiUnited StatesRecruiting
Cleveland Clinic Foundation
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ClevelandUnited StatesRecruiting
Ohio Health Research Institute
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ColumbusUnited StatesRecruiting
Univ of Texas Southwest Med Center
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DallasUnited StatesRecruiting
Sanford Health
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FargoUnited StatesRecruiting
Michigan Institute of Neurological
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Farmington HillsUnited StatesRecruiting
John Peter Smith Hospital
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Fort WorthUnited StatesRecruiting
Neurology Center of New England, PC
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FoxboroughUnited StatesRecruiting
University of Florida
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GainesvilleUnited StatesRecruiting
Center for Neurological Disorders G
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GreenfieldUnited StatesRecruiting
Premier Neurology
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GreenvilleUnited StatesRecruiting
Memorial Healthcare System
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HollywoodUnited StatesRecruiting
University of California, Irvine
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IrvineUnited StatesRecruiting
University of Kansas Hospital
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Kansas CityUnited StatesRecruiting
Sibyl Wray MD Neurology PC
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KnoxvilleUnited StatesRecruiting
Cleveland Clinic Foundation
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Las VegasUnited StatesRecruiting
Neurology Associates PA
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MaitlandUnited StatesRecruiting
Elite Clinical Research
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MiamiUnited StatesRecruiting
Medical College of Wisconsin
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MilwaukeeUnited StatesRecruiting
Aqualane Clinical Research
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NaplesUnited StatesRecruiting
Medstar Montgomery Medical Center
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OlneyUnited StatesRecruiting
Orlando Health Clinical Trials
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OrlandoUnited StatesRecruiting
Advent Health Orlando
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OrlandoUnited StatesRecruiting
Memorial HC Ins for Neuroscience
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OwossoUnited StatesRecruiting
Saturn Research Solutions LLC
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PlanoUnited StatesRecruiting
Providence Neurological Services West
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PortlandUnited StatesRecruiting
Velocity Clinical Research
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RaleighUnited StatesRecruiting
Virginia Commonwealth University
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RichmondUnited StatesRecruiting
Perseverance Research Center
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ScottsdaleUnited StatesRecruiting
WA Uni School Of Med
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St LouisUnited StatesRecruiting
Tallahassee Neurological Clinic
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TallahasseeUnited StatesRecruiting
University of South Florida
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TampaUnited StatesRecruiting
Holy Name Medical Center
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TeaneckUnited StatesRecruiting
Vero Beach Neurology
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Vero BeachUnited StatesRecruiting
MedStar Washington Hospital Center
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Washington D.C.United StatesRecruiting
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Cape TownSouth AfricaRecruiting
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PretoriaSouth AfricaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.