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NCT06419374RecruitingPhase 3

A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH

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

Source: ClinicalTrials.gov · Last updated 23 Oct 2026

Brief summary (registry, in English)

The study will assess the efficacy and safety of pegozafermin administered in participants with biopsy-confirmed and clinically confirmed compensated cirrhosis due to MASH .

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1800 (estimated)
First submitted
14 May 2024
Start date
24 May 2024
Primary completion date
30 Jun 2028
Lead sponsor
Hoffmann-La Roche
NCT number
NCT06419374
EU CT number
2023-510395-31-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 1800
  • From 24 May 2024 to the primary completion date, 30 Jun 2028
  • 277 sites in 25 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) must be on stable dose for at least 6 months prior to screening.
    • Other protocol-defined inclusion and exclusion criteria may apply.

Other illness

  • Liver disorder other than MASH.
  • Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.

Lab values

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

Other

  • History or evidence of hepatic decompensation.
  • History or evidence of hepatocellular carcinoma.

Who the study is looking for

  • Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF).
  • Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screening or at least 2 metabolic risk factors.
  • Evidence of both cirrhosis and MASH etiology, either through a historical biopsy or a biopsy at Screening.
  • Clinical diagnosis of cirrhosis based on the NIT algorithm.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (277)

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
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AdelaideAustraliaRecruiting
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FitzroyAustraliaRecruiting
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GreenslopesAustraliaRecruiting
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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
Antwerp University Hospital
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EdegemBelgiumRecruiting
Ziekenhuis Oost-Limburg
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GenkBelgiumRecruiting
Az Maria Middelares Gent
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GentBelgiumRecruiting
UZ Brussel
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JetteBelgiumRecruiting
Algemeen Ziekenhuis Delta
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RoeselareBelgiumRecruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumRecruiting
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
Umbal - Prof. D-R Stoyan Kirkovich AD
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Stara ZagoraBulgariaRecruiting
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BarretosBrazilRecruiting
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Belo HorizonteBrazilRecruiting
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BotucatuBrazilRecruiting
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BrasíliaBrazilRecruiting
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GoiâniaBrazilRecruiting
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Porto AlegreBrazilRecruiting
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Rio de JaneiroBrazilRecruiting
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SalvadorBrazilRecruiting
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São José do Rio PretoBrazilRecruiting
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São PauloBrazilRecruiting
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VitóriaBrazilRecruiting
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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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VaughanCanadaWithdrawn
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WinnipegCanadaRecruiting
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 Universitario Torrecárdenas
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AlmeríaSpainRecruiting
Hospital Germans Trias i Pujol
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BadalonaSpainRecruiting
Hospital del Mar
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BarcelonaSpainRecruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainRecruiting
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
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
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainRecruiting
Centre Hospitalier Universitaire Amiens Picardie
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Amiens Cedex 1FranceRecruiting
Assistance Publique Hopitaux De Paris
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ClichyFranceRecruiting
Centre Hospitalier Universitaire de Dijon
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DijonFranceRecruiting
Centre Hospitalier Et Universitaire De Limoges
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Limoges Cedex 1FranceRecruiting
Hospices Civils De Lyon
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Lyon Cedex 04FranceRecruiting
Centre Hospitalier Universitaire De Montpellier
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Montpellier Cedex 5FranceRecruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceRecruiting
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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AberdeenUnited KingdomRecruiting
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BristolUnited KingdomRecruiting
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LeedsUnited KingdomRecruiting
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LondonUnited KingdomRecruiting
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OxfordUnited KingdomRecruiting
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PlymouthUnited KingdomRecruiting
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PortsmouthUnited KingdomRecruiting
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Port TalbotUnited KingdomRecruiting
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SouthamptonUnited KingdomRecruiting
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TbilisiGeorgiaRecruiting
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Hong KongHong Kong SAR ChinaRecruiting
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ShatinHong Kong SAR ChinaRecruiting
Semmelweis University
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BudapestHungaryRecruiting
High Tech Medical Kft.
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Budapest IIHungaryRecruiting
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
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Budapest IXHungaryRecruiting
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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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Tel AvivIsraelRecruiting
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Tel HaShomerIsraelRecruiting
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GujrātIndiaRecruiting
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PrayagrajIndiaRecruiting
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Rajpur SonarpurIndiaRecruiting
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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 Maggiore della Carità
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NovaraItalyRecruiting
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
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PalermoItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
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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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Bucheon-siSouth KoreaRecruiting
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BusanSouth KoreaRecruiting
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DaeguSouth KoreaRecruiting
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IncheonSouth KoreaRecruiting
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SeoulSouth KoreaRecruiting
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Chihuahua CityMexicoRecruiting
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Cuautitlán IzcalliMexicoRecruiting
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CuernavacaMexicoRecruiting
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JaliscoMexicoRecruiting
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MéridaMexicoRecruiting
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Mexico CityMexicoRecruiting
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MonterreyMexicoRecruiting
Stichting Amsterdam UMC
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AmsterdamNetherlandsRecruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsRecruiting
Stichting Elisabeth-TweeSteden Ziekenhuis
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TilburgNetherlandsRecruiting
Universitair Medisch Centrum Utrecht
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UtrechtNetherlandsRecruiting
Futuremeds Sp. z o.o.
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CracowPolandRecruiting
Santa SP. z o.o
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LodzPolandRecruiting
Futuremeds Sp. z o.o.
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LodzPolandRecruiting
ID Clinic Arkadiusz Pisula
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MyslowicePolandRecruiting
MTZ Clinical Research powered by Pratia
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WarsawPolandRecruiting
Medical Network Sp z o o
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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 CityTaiwanRecruiting
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TainanTaiwanRecruiting
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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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Ann ArborUnited StatesRecruiting
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AshevilleUnited StatesRecruiting
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AthensUnited StatesRecruiting
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AtlantaUnited StatesRecruiting
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AustinUnited StatesRecruiting
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BaltimoreUnited StatesRecruiting
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BellevueUnited StatesRecruiting
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BirminghamUnited StatesRecruiting
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BrownsvilleUnited StatesRecruiting
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BurlingtonUnited StatesRecruiting
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CamarilloUnited StatesRecruiting
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Canoga ParkUnited StatesRecruiting
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ChandlerUnited StatesRecruiting
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CharlestonUnited StatesRecruiting
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CharlotteUnited StatesRecruiting
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ChicagoUnited StatesRecruiting
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CincinnatiUnited StatesRecruiting
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ClermontUnited StatesRecruiting
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ClevelandUnited StatesRecruiting
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Clinton TownshipUnited StatesRecruiting
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ColumbiaUnited StatesRecruiting
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ColumbusUnited StatesRecruiting
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CordovaUnited StatesRecruiting
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CoronadoUnited StatesRecruiting
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DaytonUnited StatesRecruiting
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DeSotoUnited StatesRecruiting
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DetroitUnited StatesRecruiting
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DurhamUnited StatesRecruiting
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East GreenwichUnited StatesRecruiting
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EdinburgUnited StatesTerminated
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Farmers BranchUnited StatesRecruiting
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FayettevilleUnited StatesRecruiting
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FlagstaffUnited StatesWithdrawn
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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 WorthUnited StatesWithdrawn
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Fountain ValleyUnited StatesRecruiting
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FraminghamUnited StatesRecruiting
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FresnoUnited StatesRecruiting
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GainesvilleUnited StatesRecruiting
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GeorgetownUnited StatesRecruiting
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Glen BurnieUnited StatesRecruiting
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GlenviewUnited StatesRecruiting
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GreenbeltUnited StatesRecruiting
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GreenvilleUnited StatesWithdrawn
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HammondUnited StatesRecruiting
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HarlingenUnited StatesWithdrawn
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HermitageUnited StatesRecruiting
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Hialeah GardensUnited StatesRecruiting
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HomesteadUnited StatesRecruiting
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HomewoodUnited StatesRecruiting
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HoustonUnited StatesRecruiting
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Huntington ParkUnited StatesWithdrawn
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Iowa CityUnited StatesRecruiting
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JacksonvilleUnited StatesRecruiting
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Kansas CityUnited StatesRecruiting
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Lady LakeUnited StatesWithdrawn
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LafayetteUnited 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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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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Little RockUnited StatesRecruiting
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LittletonUnited StatesRecruiting
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Los AngelesUnited StatesRecruiting
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LouisvilleUnited StatesRecruiting
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LubbockUnited StatesWithdrawn
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MaitlandUnited StatesWithdrawn
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MansfieldUnited StatesRecruiting
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MariettaUnited StatesRecruiting
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MiamiUnited StatesRecruiting
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OcalaUnited StatesRecruiting
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OcoeeUnited StatesRecruiting
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OrlandoUnited StatesTerminated
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PasadenaUnited StatesRecruiting
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PearlandUnited StatesWithdrawn
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PeoriaUnited StatesRecruiting
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Santa AnaUnited StatesWithdrawn
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SeattleUnited StatesRecruiting
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Somers PointUnited StatesRecruiting
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TupeloUnited StatesWithdrawn
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TylerUnited StatesRecruiting
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AnkaraTurkey (Türkiye)Withdrawn
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