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NCT06318169RecruitingPhase 3

A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)

A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

Source: ClinicalTrials.gov · Last updated 23 Oct 2026

Brief summary (registry, in English)

The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1350 (estimated)
First submitted
13 Mar 2024
Start date
13 Mar 2024
Primary completion date
Feb 2029
Lead sponsor
Hoffmann-La Roche
NCT number
NCT06318169
EU CT number
2023-509912-27-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 1350
  • From 13 Mar 2024 to the primary completion date, Feb 2029
  • 316 sites in 27 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.

Prior treatment

  • Participants taking vitamin E (\>400 international units \[IU\]/day) or pioglitazone must be on stable dose for at least 6 months prior to Screening
    • Other inclusion and exclusion criteria may apply.

Other illness

  • Chronic liver diseases other than MASH
  • Have type 1 diabetes or poorly controlled type 2 diabetes

Lab values

  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 units per liter (U/L)

Other

  • Evidence of cirrhosis on screening liver biopsy

Who the study is looking for

  • Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF)
  • Biopsy-confirmed MASH with fibrosis stage F2 or F3
  • Body mass index (BMI) at screening ≥25.0 kilograms (kg)/meters squared (m\^2) (≥23 kg/m\^2 for Asian participants).

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (316)

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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Capital FederalArgentinaRecruiting
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CórdobaArgentinaRecruiting
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PilarArgentinaRecruiting
Medical University of Graz
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GrazAustriaRecruiting
Medizinische Universitaet Innsbruck
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InnsbruckAustriaRecruiting
Landeskrankenanstalten-Betriebsgesellschaft Kabeg
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Klagenfurt Am WoertherseeAustriaRecruiting
Noe LGA Gesundheit Region Mitte GmbH
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St. PoeltenAustriaRecruiting
Klinikum Wels-Grieskirchen GmbH
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WelsAustriaRecruiting
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AdelaideAustraliaRecruiting
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Bedford ParkAustraliaRecruiting
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BrisbaneAustraliaRecruiting
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ClaytonAustraliaRecruiting
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FitzroyAustraliaRecruiting
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HeidelbergAustraliaRecruiting
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HerstonAustraliaRecruiting
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MurdochAustraliaRecruiting
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PerthAustraliaRecruiting
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South BrisbaneAustraliaRecruiting
Hopital Erasme
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AnderlechtBelgiumRecruiting
CHU Brugmann
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BrusselsBelgiumRecruiting
Antwerp University Hospital
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EdegemBelgiumRecruiting
Ziekenhuis Oost-Limburg
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GenkBelgiumRecruiting
Universitair Ziekenhuis Gent
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GentBelgiumRecruiting
Az Maria Middelares Gent
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GentBelgiumRecruiting
UZ Brussel
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JetteBelgiumRecruiting
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD
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Gorna OryahovitsaBulgariaRecruiting
Diagnostic Consultative Centre Ascendent EOOD
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SofiaBulgariaRecruiting
Acibadem City Clinic Tokuda University Hospital EAD
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SofiyaBulgariaRecruiting
Diagnostic-Consultative Center Alexandrovska EOOD
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SofiyaBulgariaRecruiting
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CalgaryCanadaRecruiting
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LondonCanadaRecruiting
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OttawaCanadaRecruiting
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TorontoCanadaRecruiting
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VancouverCanadaRecruiting
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VaughanCanadaRecruiting
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WinnipegCanadaRecruiting
Fakultni nemocnice Brno
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BrnoCzechiaRecruiting
Fakultni nemocnice Ostrava
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OstravaCzechiaRecruiting
Research Site s.r.o.
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Plzen 3CzechiaRecruiting
Klinikum Chemnitz gGmbH
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ChemnitzGermanyRecruiting
Goethe University Frankfurt
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Frankfurt Am MainGermanyRecruiting
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyRecruiting
Medizinische Hochschule Hannover
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HanoverGermanyRecruiting
Universitaet Des Saarlandes
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HomburgGermanyRecruiting
Universitaet Muenster
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MuensterGermanyRecruiting
Hospital Germans Trias i Pujol
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BadalonaSpainRecruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Hospital del Mar
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BarcelonaSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital General Universitario Reina Sofia
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CórdobaSpainRecruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainRecruiting
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainRecruiting
Complexo Hospitalario Universitario de Pontevedra
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PontevedraSpainRecruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainRecruiting
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainRecruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainRecruiting
Centre Hospitalier Universitaire Amiens Picardie
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Amiens Cedex 1FranceRecruiting
Centre Hospitalier Universitaire D'Angers
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AngersFranceRecruiting
Hopital Beaujon
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ClichyFranceRecruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceRecruiting
Centre Hospitalier Et Universitaire De Limoges
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Limoges Cedex 1FranceRecruiting
Hospital La Croix Rousse Hcl
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Lyon Cedex 04FranceRecruiting
Centre Hospitalier Universitaire De Montpellier
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Montpellier Cedex 5FranceRecruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceRecruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
Assistance Publique Hopitaux De Paris
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Paris Cedex 13FranceRecruiting
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceRecruiting
Centre Hospitalier Lyon-Sud
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Pierre-BéniteFranceRecruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg CedexFranceRecruiting
Clinique Pasteur
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Toulouse Cedex 3FranceRecruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceRecruiting
CHRU De Nancy
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Vandoeuvre Les NancyFranceRecruiting
Centre de Recherche Clinique Portes Du Sud
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VénissieuxFranceRecruiting
Assistance Publique Hopitaux De Paris
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VillejuifFranceRecruiting
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BristolUnited KingdomRecruiting
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GlasgowUnited KingdomRecruiting
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High WycombeUnited KingdomRecruiting
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HullUnited KingdomWithdrawn
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LondonUnited KingdomRecruiting
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OxfordUnited KingdomRecruiting
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PortsmouthUnited KingdomRecruiting
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PrestonUnited KingdomRecruiting
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SouthamptonUnited KingdomRecruiting
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StocktonUnited KingdomRecruiting
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SunderlandUnited KingdomRecruiting
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SwanseaUnited KingdomRecruiting
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YorkUnited KingdomRecruiting
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BatumiGeorgiaRecruiting
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TbilisiGeorgiaRecruiting
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Hong KongHong Kong SAR ChinaRecruiting
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ShatinHong Kong SAR ChinaRecruiting
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AfulaIsraelRecruiting
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BeershebaIsraelRecruiting
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HaifaIsraelRecruiting
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JerusalemIsraelRecruiting
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NahariyaIsraelRecruiting
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Petah TikvaIsraelRecruiting
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Ramat GanIsraelRecruiting
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Tel AvivIsraelRecruiting
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AllahābādIndiaRecruiting
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BhubaneswarIndiaRecruiting
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GujrātIndiaRecruiting
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GuwahatiIndiaRecruiting
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KolkataIndiaRecruiting
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NagpurIndiaRecruiting
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New DelhiIndiaRecruiting
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SūratIndiaRecruiting
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WardhaIndiaRecruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyRecruiting
Azienda Ospedaliero Universitaria Ospedali Riuniti
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FoggiaItalyRecruiting
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyRecruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyRecruiting
Azienda Ospedaliero - Universitaria di Modena
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ModenaItalyRecruiting
Azienda Ospedaliera Universitaria Federico II Di Napoli
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NaplesItalyRecruiting
Azienda Ospedaliero Universitaria Maggiore della Carità
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NovaraItalyRecruiting
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
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PalermoItalyRecruiting
Azienda Ospedaliera Policlinico Universitario Tor Vergata
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RomeItalyRecruiting
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
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RomeItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
Humanitas Mirasole S.p.A.
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RozzanoItalyRecruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyRecruiting
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EhimeJapanRecruiting
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FukuokaJapanRecruiting
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GifuJapanRecruiting
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HizumeJapanRecruiting
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KawasakiJapanRecruiting
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KumamotoJapanRecruiting
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MaebashiJapanRecruiting
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NaganoJapanRecruiting
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OkayamaJapanRecruiting
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OsakaJapanRecruiting
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SagaJapanRecruiting
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SapporoJapanRecruiting
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YokohamaJapanRecruiting
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BusanSouth KoreaRecruiting
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DaeguSouth KoreaRecruiting
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Gyeonggi-doSouth KoreaRecruiting
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IncheonSouth KoreaRecruiting
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SeoulSouth KoreaRecruiting
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Chihuahua CityMexicoRecruiting
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Cuautitlán IzcalliMexicoWithdrawn
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JaliscoMexicoRecruiting
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Mexico CityMexicoRecruiting
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MorelosMexicoRecruiting
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Nuevo LeónMexicoRecruiting
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YucatánMexicoRecruiting
Amsterdam UMC Stichting
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AmsterdamNetherlandsRecruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsRecruiting
Universitair Medisch Centrum Utrecht
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UtrechtNetherlandsRecruiting
Futuremeds Sp. z o.o.
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CracowPolandRecruiting
Futuremeds Sp. z o.o.
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LodzPolandRecruiting
Santa SP. z o.o
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LodzPolandRecruiting
ID Clinic Arkadiusz Pisula
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MyslowicePolandRecruiting
Medical Network Sp z o o
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WarsawPolandRecruiting
Futuremeds Sp. z o.o.
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WarsawPolandRecruiting
MTZ Clinical Research powered by Pratia
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WarsawPolandRecruiting
Futuremeds Sp. z o.o.
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WroclawPolandRecruiting
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ManatiPuerto RicoRecruiting
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MayagüezPuerto RicoRecruiting
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San JuanPuerto RicoRecruiting
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SingaporeSingaporeRecruiting
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Chiayi CityTaiwanRecruiting
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Kaohsiung CityTaiwanWithdrawn
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TaipeiTaiwanRecruiting
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AkronUnited StatesRecruiting
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AlbanyUnited StatesRecruiting
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AlbuquerqueUnited StatesRecruiting
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AmarilloUnited StatesRecruiting
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AthensUnited StatesRecruiting
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AustinUnited StatesRecruiting
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BaltimoreUnited StatesRecruiting
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BellaireUnited StatesRecruiting
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BellevueUnited StatesRecruiting
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BirminghamUnited StatesRecruiting
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BrandonUnited StatesRecruiting
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BrownsvilleUnited StatesRecruiting
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BurlingtonUnited StatesRecruiting
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Canoga ParkUnited StatesRecruiting
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CarmelUnited StatesRecruiting
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ChandlerUnited StatesRecruiting
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CharlestonUnited StatesRecruiting
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CharlotteUnited StatesRecruiting
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ChattanoogaUnited StatesRecruiting
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ChesterfieldUnited StatesRecruiting
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ChicagoUnited StatesRecruiting
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ClermontUnited StatesRecruiting
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ClevelandUnited StatesWithdrawn
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Colorado SpringsUnited StatesWithdrawn
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ColumbiaUnited StatesRecruiting
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ConwayUnited StatesActive, not recruiting
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CordovaUnited StatesRecruiting
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CoronadoUnited StatesRecruiting
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Corpus ChristiUnited StatesRecruiting
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CovingtonUnited StatesRecruiting
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DaltonUnited StatesRecruiting
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DaytonUnited StatesRecruiting
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DentonUnited StatesRecruiting
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DeSotoUnited StatesRecruiting
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DurhamUnited StatesRecruiting
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East GreenwichUnited StatesRecruiting
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EdinburgUnited StatesRecruiting
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EscondidoUnited StatesRecruiting
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Farmers BranchUnited StatesRecruiting
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FayettevilleUnited StatesRecruiting
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FlagstaffUnited StatesActive, not recruiting
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Florham ParkUnited StatesWithdrawn
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FlowoodUnited StatesRecruiting
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Fort MyersUnited StatesRecruiting
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Fort Sam HoustonUnited StatesWithdrawn
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Fort WorthUnited StatesRecruiting
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Fountain ValleyUnited StatesRecruiting
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FreeholdUnited StatesRecruiting
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FresnoUnited StatesRecruiting
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GardenaUnited StatesRecruiting
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GarlandUnited StatesRecruiting
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GeorgetownUnited StatesRecruiting
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Glen BurnieUnited StatesRecruiting
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GlendaleUnited StatesRecruiting
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GreenbeltUnited StatesRecruiting
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HammondUnited StatesRecruiting
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HermitageUnited StatesRecruiting
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Hialeah GardensUnited StatesRecruiting
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HomesteadUnited StatesRecruiting
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HoumaUnited StatesRecruiting
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HoustonUnited StatesRecruiting
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Huntington ParkUnited StatesWithdrawn
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InglewoodUnited StatesWithdrawn
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Iowa CityUnited StatesRecruiting
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JacksonvilleUnited StatesRecruiting
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JupiterUnited StatesRecruiting
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KatyUnited StatesRecruiting
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Lady LakeUnited StatesRecruiting
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La JollaUnited StatesRecruiting
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Lake CharlesUnited StatesRecruiting
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Lakewood RchUnited StatesRecruiting
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LancasterUnited StatesRecruiting
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Las VegasUnited StatesRecruiting
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Lehigh AcresUnited StatesRecruiting
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LewisvilleUnited StatesRecruiting
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Liberty TownshipUnited StatesRecruiting
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LimaUnited StatesRecruiting
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Little RockUnited StatesRecruiting
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LittletonUnited StatesRecruiting
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Long BeachUnited StatesRecruiting
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Los AngelesUnited StatesWithdrawn
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LouisvilleUnited StatesRecruiting
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LubbockUnited StatesRecruiting
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MaitlandUnited StatesRecruiting
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MaplewoodUnited StatesRecruiting
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MariettaUnited StatesRecruiting
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MarreroUnited StatesRecruiting
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MiamiUnited StatesRecruiting
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MontclairUnited StatesRecruiting
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Morehead CityUnited StatesWithdrawn
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NashvilleUnited StatesRecruiting
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New AlbanyUnited StatesRecruiting
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New OrleansUnited StatesWithdrawn
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New Port RicheyUnited StatesRecruiting
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New YorkUnited StatesRecruiting
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North Little RockUnited StatesRecruiting
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OcalaUnited StatesRecruiting
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OcoeeUnited StatesRecruiting
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OgdenUnited StatesRecruiting
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OrangeUnited StatesRecruiting
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Panorama CityUnited StatesWithdrawn
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PasadenaUnited StatesRecruiting
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PowayUnited StatesRecruiting
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Coordinator of this site? Confirm its status
RaleighUnited StatesRecruiting
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Coordinator of this site? Confirm its status
RialtoUnited StatesRecruiting
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Coordinator of this site? Confirm its status
RichmondUnited StatesRecruiting
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Coordinator of this site? Confirm its status
RoanokeUnited StatesRecruiting
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Coordinator of this site? Confirm its status
RochesterUnited StatesRecruiting
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Coordinator of this site? Confirm its status
San AntonioUnited StatesRecruiting
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Coordinator of this site? Confirm its status
Santa AnaUnited StatesWithdrawn
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Coordinator of this site? Confirm its status
SarasotaUnited StatesRecruiting
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Coordinator of this site? Confirm its status
SeattleUnited StatesRecruiting
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Coordinator of this site? Confirm its status
South BendUnited StatesRecruiting
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Coordinator of this site? Confirm its status
SouthlakeUnited StatesRecruiting
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Coordinator of this site? Confirm its status
SpringboroUnited StatesRecruiting
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Coordinator of this site? Confirm its status
StaffordUnited StatesRecruiting
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Coordinator of this site? Confirm its status
StanfordUnited StatesRecruiting
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Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting
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Coordinator of this site? Confirm its status
Sugar LandUnited StatesRecruiting
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Coordinator of this site? Confirm its status
Sun CityUnited StatesRecruiting
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Coordinator of this site? Confirm its status
TacomaUnited StatesRecruiting
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Coordinator of this site? Confirm its status
TomballUnited StatesRecruiting
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Coordinator of this site? Confirm its status
TopekaUnited StatesRecruiting
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Coordinator of this site? Confirm its status
TucsonUnited StatesRecruiting
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Coordinator of this site? Confirm its status
TylerUnited StatesRecruiting
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Coordinator of this site? Confirm its status
VictorvilleUnited StatesRecruiting
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Coordinator of this site? Confirm its status
WacoUnited StatesRecruiting
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Coordinator of this site? Confirm its status
Warren TownshipUnited StatesRecruiting
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Coordinator of this site? Confirm its status
WestlakeUnited StatesRecruiting
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Coordinator of this site? Confirm its status
West MonroeUnited StatesRecruiting
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Coordinator of this site? Confirm its status
WilmingtonUnited StatesRecruiting
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Coordinator of this site? Confirm its status
Winston-SalemUnited StatesRecruiting
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Coordinator of this site? Confirm its status
Winter ParkUnited StatesRecruiting
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Coordinator of this site? Confirm its status
WyomingUnited StatesRecruiting
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Coordinator of this site? Confirm its status
YpsilantiUnited StatesRecruiting
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Coordinator of this site? Confirm its status
Cape TownSouth AfricaRecruiting
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Coordinator of this site? Confirm its status
JohannesburgSouth AfricaRecruiting
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Coordinator of this site? Confirm its status
WorcesterSouth AfricaRecruiting
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Coordinator of this site? Confirm its status
AdanaTurkey (Türkiye)Recruiting
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Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Recruiting
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Coordinator of this site? Confirm its status
BursaTurkey (Türkiye)Recruiting
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Coordinator of this site? Confirm its status
CenterTurkey (Türkiye)Recruiting
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Coordinator of this site? Confirm its status
FatihTurkey (Türkiye)Recruiting
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Coordinator of this site? Confirm its status
GaziantepTurkey (Türkiye)Recruiting
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Coordinator of this site? Confirm its status
IstanbulTurkey (Türkiye)Withdrawn
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Coordinator of this site? Confirm its status
IzmirTurkey (Türkiye)Recruiting
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Coordinator of this site? Confirm its status
SarıçamTurkey (Türkiye)Recruiting
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Coordinator of this site? Confirm its status
ÜmraniyeTurkey (Türkiye)Withdrawn

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