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NCT05583344Active, not recruitingPhase 2

Phase 2b Study of GSK4532990 in Adults With NASH

17 β-Hydroxysteroid Dehydrogenase Type 13 Minimization for the Treatment of NASH (HORIZON): A Double-Blind, Placebo-Controlled Phase 2b Study to Evaluate the Efficacy and Safety of GSK4532990 in Adults With Nonalcoholic Steatohepatitis

Source: ClinicalTrials.gov · Last updated 18 Sept 2026

Brief summary (registry, in English)

The purpose of this study is to measure improvements in liver fibrosis and inflammation with GSK4532990 compared with placebo in participants with NASH and advanced fibrosis on biopsy (F3 or F4). The study duration will be up to 76 weeks including the screening period. The treatment duration will be up to 52 weeks.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
284 (actual)
First submitted
13 Oct 2022
Start date
2 Jan 2023
Primary completion date
31 Jan 2026
Lead sponsor
GlaxoSmithKline
NCT number
NCT05583344
EU CT number
2023-507503-62-00
EudraCT number
2022-002538-14

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 284
  • From 2 Jan 2023 to the primary completion date, 31 Jan 2026
  • 150 sites in 17 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

  • Weight reduction surgery or procedures (including gastric banding and intragastric balloon insertion) within 2 years of Screening 1 and/or planned during the study.

Other illness

  • History of cancer within previous 2 years from Screening 1, except basal or squamous cell carcinoma of the skin or in situ cervical carcinoma or any other type of cancer which has been treated medically or surgically with curative outcome.

Other

  • Current alcohol consumption ≥14 standard drinks (24 units, 196 g ethanol) per week for females or ≥21 standard drinks (37 units, 294g ethanol) per week for males.

Who the study is looking for

  • Body Mass Index (BMI) ≥25 kilogram per meter square (kg/m\^2) (all ethnic origins) except for Asian participants who qualify for the study with BMI ≥23 kg/m2 at Screening.
  • In the opinion of the investigator, there are features of metabolic syndrome and NAFLD is the most likely cause of liver disease. Metabolic syndrome may include type 2 diabetes mellitus (T2DM), obesity, dyslipidemia and hypertension.
  • A liver biopsy at baseline showing NAFLD Activity Score (NAS) \>=4 with at least 1 point each in steatosis, inflammation and ballooning and either Fibrosis 3 or Fibrosis 4 using NASH CRN Scoring System.
  • Able and willing to comply with all study assessments, including a liver biopsy at Week 52.

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

Full criteria on ClinicalTrials.gov

Sites (150)

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

SiteCityCountrySite status
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Buenos AiresArgentinaUnknown status
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Capital FederalArgentinaUnknown status
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Ciudad Autonoma de BuenoArgentinaUnknown status
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Ciudad Autonoma de Buenos AireArgentinaUnknown status
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Derqui PilarArgentinaUnknown status
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RosarioArgentinaUnknown status
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San Miguel de TucumánArgentinaUnknown status
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NedlandsAustraliaUnknown status
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PerthAustraliaUnknown status
Hopital Erasme
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AnderlechtBelgiumCompleted
Antwerp University Hospital
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EdegemBelgiumCompleted
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumCompleted
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CalgaryCanadaUnknown status
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TorontoCanadaUnknown status
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Hospital Universitario Ramón y Cajal
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MadridSpainCompleted
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainCompleted
Hospital Universitario Virgen de la Victoria
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MálagaSpainCompleted
Complexo Hospitalario Universitario de Pontevedra
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PontevedraSpainCompleted
Parc Tauli Hospital Universitari
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SabadellSpainCompleted
Hospital Universitario Marqués de Valdecilla
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SantanderSpainCompleted
University Hospital Virgen Del Rocio S.L.
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SevillaSpainCompleted
Centre Hospitalier Universitaire D'Angers
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AngersFranceCompleted
Centre Hospitalier Et Universitaire De Limoges
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Limoges Cedex 1FranceCompleted
Assistance Publique Hopitaux De Paris
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Paris Cedex 13FranceCompleted
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceCompleted
Centre Hospitalier Lyon-Sud
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Pierre-BéniteFranceCompleted
Les Hopitaux Universitaires De Strasbourg
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Strasbourg CedexFranceCompleted
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CannockUnited KingdomUnknown status
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LondonUnited KingdomUnknown status
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ManchesterUnited KingdomUnknown status
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Newcastle upon TyneUnited KingdomUnknown status
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NottinghamUnited KingdomUnknown status
Ippokratio General Hospital of Thessaloniki
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ThessalonikiGreeceCompleted
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BhubaneswarIndiaUnknown status
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ChandigarhIndiaUnknown status
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CoimbatoreIndiaUnknown status
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GuhawatiIndiaUnknown status
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MumbaiIndiaUnknown status
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NagpurIndiaUnknown status
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New DelhiIndiaUnknown status
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SecunderabadIndiaUnknown status
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SuratIndiaUnknown status
Careggi University Hospital
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FlorenceItalyCompleted
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyCompleted
Azienda Ospedaliero - Universitaria di Modena
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ModenaItalyCompleted
Azienda Ospedale Universita Padova
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PadovaItalyCompleted
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
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PalermoItalyCompleted
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyCompleted
Humanitas Research Hospital
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RozzanoItalyCompleted
Casa Sollievo della Sofferenza
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San Giovanni RotondoItalyCompleted
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FukuiJapanUnknown status
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FukuokaJapanUnknown status
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GifuJapanUnknown status
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HiroshimaJapanUnknown status
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KagawaJapanUnknown status
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KagoshimaJapanUnknown status
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KanagawaJapanUnknown status
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NaganoJapanUnknown status
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NagasakiJapanUnknown status
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NaraJapanUnknown status
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NumakunaiJapanUnknown status
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OkayamaJapanUnknown status
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OsakaJapanUnknown status
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SagaJapanUnknown status
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ShimaneJapanUnknown status
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YamanashiJapanUnknown status
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IncheonSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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Yongsan-Ku SeoulSouth KoreaUnknown status
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Cuernavaca MorelosMexicoUnknown status
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GuadalajaraMexicoUnknown status
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MéridaMexicoUnknown status
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Panama CityPanamaUnknown status
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San JuanPuerto RicoUnknown status
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AkronUnited StatesUnknown status
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Ann ArborUnited StatesUnknown status
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AthensUnited StatesUnknown status
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AtlantaUnited StatesUnknown status
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AustinUnited StatesUnknown status
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BastropUnited StatesUnknown status
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BradentonUnited StatesUnknown status
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BrownsvilleUnited StatesUnknown status
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ChandlerUnited StatesUnknown status
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Chapel HillUnited StatesUnknown status
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ChattanoogaUnited StatesUnknown status
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ChesterfieldUnited StatesUnknown status
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ClarksvilleUnited StatesUnknown status
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Colorado SpringsUnited StatesUnknown status
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ColumbiaUnited StatesUnknown status
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Coral GablesUnited StatesUnknown status
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DallasUnited StatesUnknown status
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DurhamUnited StatesUnknown status
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EdinburgUnited StatesUnknown status
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Fort MyersUnited StatesUnknown status
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GeorgetownUnited StatesUnknown status
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GreenbeltUnited StatesUnknown status
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HallandaleUnited StatesUnknown status
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HialeahUnited StatesUnknown status
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HomesteadUnited StatesUnknown status
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HomewoodUnited StatesUnknown status
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HoustonUnited StatesUnknown status
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Huntington ParkUnited StatesUnknown status
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IndianapolisUnited StatesUnknown status
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Iowa CityUnited StatesUnknown status
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JonesboroUnited StatesUnknown status
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JupiterUnited StatesUnknown status
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La JollaUnited StatesUnknown status
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Lakewood RchUnited StatesUnknown status
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LancasterUnited StatesUnknown status
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Las VegasUnited StatesUnknown status
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MariettaUnited StatesUnknown status
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MarreroUnited StatesUnknown status
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MesaUnited StatesUnknown status
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MetairieUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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Miami LakesUnited StatesUnknown status
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MonroeUnited StatesUnknown status
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Morehead CityUnited StatesUnknown status
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New YorkUnited StatesUnknown status
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North Little RockUnited StatesUnknown status
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OrangeUnited StatesUnknown status
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PittsburghUnited StatesUnknown status
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PowayUnited StatesUnknown status
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PrincetonUnited StatesUnknown status
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RialtoUnited StatesUnknown status
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RichmondUnited StatesUnknown status
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SacramentoUnited StatesUnknown status
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San AntonioUnited StatesUnknown status
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San FranciscoUnited StatesUnknown status
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Santa AnaUnited StatesUnknown status
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SeattleUnited StatesUnknown status
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ShreveportUnited StatesUnknown status
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SnellvilleUnited StatesUnknown status
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South BendUnited StatesUnknown status
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SouthfieldUnited StatesUnknown status
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SpartaUnited StatesUnknown status
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SpringboroUnited StatesUnknown status
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TopekaUnited StatesUnknown status
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Van NuysUnited StatesUnknown status
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WacoUnited StatesUnknown status
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West JordanUnited StatesUnknown status
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WestlakeUnited StatesUnknown status
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West Palm BeachUnited StatesUnknown status
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WyomissingUnited StatesUnknown status
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YpsilantiUnited StatesUnknown status
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AnkaraTurkey (Türkiye)Unknown status
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KocaeliTurkey (Türkiye)Unknown status
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RizeTurkey (Türkiye)Unknown status

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