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NCT05925803Active, not recruitingPhase 3

Determine effectiveness of Anifrolumab In Systemic sclerosis

A Multicenter, Randomized, Parallel-group, Double-blind, Two-arm, Phase III Study to Evaluate the Safety and Efficacy of Anifrolumab Compared with Placebo in Male and Female Participants 18 to 70 Years of Age Inclusive with Systemic Sclerosis

Source: EU CTIS (euclinicaltrials.eu) · Last updated 1 Sept 2026

Brief summary (registry, in English)

To demonstrate the superiority of anifrolumab to placebo with or without standard therapy on measures of signs, symptoms, and impacts associated with SSc.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
112 (estimated)
First submitted
1 Jun 2023
Start date
24 Nov 2023
Lead sponsor
Astrazeneca AB
NCT number
NCT05925803
EU CT number
2023-505976-31-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 112
  • 54 sites in 10 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Evidence of moderately severe concurrent nervous system, renal, endocrine, hepatic (eg, underlying chronic liver disease \[Child Pugh A, B, C hepatic impairment\]), or gastrointestinal disease (eg, clinical signs of malabsorption or needing parenteral nutrition) not related to SSc, as determined by the investigator
  • Hematopoietic stem cell transplantation or solid organ/limb transplantation
  • Major surgery within 8 weeks prior to and/or during study enrollment

Other illness

  • Severe cardiopulmonary disease as defined by the protocol
  • Overlap syndromes, systemic lupus erythematosus with anti-double-stranded deoxyribonucleic acid antibody seropositivity or anti-citrullinated protein antibodies-positive rheumatoid arthritis, or SSc mimics (eg, scleromyxedema, eosinophilic fasciitis)
  • History of, or current, any other inflammatory diseases, eg, inflammatory bowel disease, skin disease, that, in the opinion of the investigator, could interfere with efficacy and safety assessments or require immunomodulatory therapy
  • Any severe case of Herpes Zoster infection as defined by the protocol
  • Known malignancy or a history of malignancy within 5 years, with exception of excised/cured local basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix
  • Known active current or history of recurrent infections
  • Any condition that, in the opinion of the investigator or AstraZeneca, would interfere with the efficacy or safety evaluation of the study intervention or put participant at safety risk

Lab values

  • Anticentromere antibody seropositivity on central laboratory
  • History of systemic sclerosis renal crisis within past 12 months (estimated glomerular filtration rate(eGFR) \< 45 mL/min/1.73m2)

Who the study is looking for

  • Adult patients from 18 to 70 years of age inclusive
  • Systemic sclerosis according to 2013 ACR/EULAR classification criteria
  • Limited or diffuse cutaneous subsets
  • Systemic sclerosis disease duration within 6 years from first non-Raynaud's phenomenon manifestation at the time of signing the ICF
  • Either HAQ-DI score ≥ 0.25 points or PtGA score ≥ 3 points
  • mRSS \> 10 with early disease or rapid progression as defined by the protocol
  • mRSS ≥ 15 with disease duration ≥ 18 months and active disease as defined by the protocol
  • Stable background therapies can be used including hydroxychloroquine, methotrexate, azathioprine, mycophenolate mofetil, mycophenolate sodium, mycophenolic acid, oral glucocorticoids or tacrolimus
  • Women of childbearing potential with a negative urine pregnancy test
  • Uninvolved skin at injection sites

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (143)

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

SiteCityCountrySite status
Medical University of Graz
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GrazAustriaActive, not recruiting
Medizinische Universitaet Innsbruck
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InnsbruckAustriaActive, not recruiting
Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken
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ViennaAustriaActive, not recruiting
Hopital Erasme
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AnderlechtBelgiumActive, not recruiting
Universitair Ziekenhuis Gent
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GentBelgiumActive, not recruiting
UZ Leuven
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LeuvenBelgiumActive, not recruiting
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CalgaryCanadaUnknown status
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MontrealCanadaUnknown status
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QuébecCanadaUnknown status
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TorontoCanadaUnknown status
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BeijingChinaUnknown status
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GuangzhouChinaUnknown status
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HangzhouChinaUnknown status
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LanzhouChinaUnknown status
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ShanghaiChinaUnknown status
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TianjinChinaUnknown status
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyActive, not recruiting
Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz
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MainzGermanyActive, not recruiting
Johannes Wesling Klinikum Minden
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MindenGermanyActive, not recruiting
Universitaetsklinikum Muenster AöR
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MuensterGermanyActive, not recruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyActive, not recruiting
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainActive, not recruiting
Hospital del Mar
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BarcelonaSpainActive, not recruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Hospital Universitario Regional de Málaga
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MálagaSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
Hospital Universitario Dr. Peset Aleixandre
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ValenciaSpainActive, not recruiting
Complexo Hospitalario Universitario De Vigo
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VigoSpainActive, not recruiting
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceActive, not recruiting
Centre Hospitalier Regional Et Universitaire De Brest
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Brest Cedex 2FranceActive, not recruiting
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceActive, not recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceActive, not recruiting
Assistance Publique Hopitaux De Paris
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Paris Cedex 13FranceActive, not recruiting
Centre Hospitalier Universitaire Reims
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Reims CedexFranceActive, not recruiting
Centre Hospitalier Universitaire de Rennes
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RennesFranceActive, not recruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg Cedex 2FranceActive, not recruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceActive, not recruiting
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CannockUnited KingdomUnknown status
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LeedsUnited KingdomUnknown status
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LondonUnited KingdomUnknown status
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SheffieldUnited KingdomUnknown status
Semmelweis University
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BudapestHungaryActive, not recruiting
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz
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Budapest IIHungaryActive, not recruiting
Budai Egeszsegkoezpont Zrt.
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Budapest XIIIHungaryActive, not recruiting
University of Debrecen
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DebrecenHungaryActive, not recruiting
University of Pecs
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PécsHungaryActive, not recruiting
University of Szeged
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SzegedHungaryActive, not recruiting
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AfulaIsraelUnknown status
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HaifaIsraelUnknown status
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JerusalemIsraelUnknown status
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Kfar SabaIsraelUnknown status
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Ramat GanIsraelUnknown status
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AhmedabadIndiaUnknown status
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DelhiIndiaUnknown status
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GurugramIndiaUnknown status
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HyderabadIndiaUnknown status
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KolkataIndiaUnknown status
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MumbaiIndiaUnknown status
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MysuruIndiaUnknown status
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New DelhiIndiaUnknown status
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PuneIndiaUnknown status
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SecunderabadIndiaUnknown status
Azienda Ospedaliero-Universitaria delle Marche
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AnconaItalyActive, not recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyActive, not recruiting
University Hospital Of Ferrara
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FerraraItalyActive, not recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyActive, not recruiting
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto
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MilanItalyActive, not recruiting
Azienda Ospedale Universita Padova
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PadovaItalyActive, not recruiting
Fondazione Policlinico Universitario Campus Bio-Medico
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RomeItalyActive, not recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyActive, not recruiting
Azienda Ospealiero Universitaria Policlinico Umberto I
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RomeItalyActive, not recruiting
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Bunkyō CityJapanUnknown status
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FukuokaJapanUnknown status
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Iruma-GunJapanUnknown status
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KanazawaJapanUnknown status
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MaebashiJapanUnknown status
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NagasakiJapanUnknown status
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NagoyaJapanUnknown status
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SapporoJapanUnknown status
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SendaiJapanUnknown status
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Shinjuku-kuJapanUnknown status
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Suita-shiJapanUnknown status
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Takatsuki-shiJapanUnknown status
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Toyoake-shiJapanUnknown status
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YokohamaJapanUnknown status
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BusanSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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Chihuahua CityMexicoUnknown status
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GuadalajaraMexicoUnknown status
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Mexico CityMexicoUnknown status
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San Luis Potosí CityMexicoUnknown status
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Kuala LumpurMalaysiaUnknown status
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KuchingMalaysiaUnknown status
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SerembanMalaysiaUnknown status
Amsterdam UMC
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AmsterdamNetherlandsActive, not recruiting
University Medical Center Groningen
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GroningenNetherlandsActive, not recruiting
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
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BydgoszczPolandActive, not recruiting
Malopolskie Badania Kliniczne Sp. z o.o.
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CracowPolandActive, not recruiting
Linden Sp. z o.o. sp.k.
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CracowPolandActive, not recruiting
Wojewódzki Szpital Specjalistyczny nr 5 im. św. Barbary w Sosnowcu
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SosnowiecPolandActive, not recruiting
Medicover Integrated Clinical Services Sp. z o.o.
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WarsawPolandActive, not recruiting
Saint Maria Hospital
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BucharestRomaniaActive, not recruiting
Spitalul Clinic Dr. I. Cantacuzino
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BucharestRomaniaActive, not recruiting
Spitalul Clinic Judetean De Urgenta Cluj
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Cluj-NapocaRomaniaActive, not recruiting
Spitalul Clinic de Recuperare Iasi
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IasiRomaniaActive, not recruiting
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AllenUnited StatesUnknown status
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Ann ArborUnited StatesUnknown status
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AuroraUnited StatesUnknown status
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BabylonUnited StatesUnknown status
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BaltimoreUnited StatesUnknown status
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Boca RatonUnited StatesUnknown status
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ChicagoUnited StatesUnknown status
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Chula VistaUnited StatesUnknown status
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CincinnatiUnited StatesUnknown status
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Fort LauderdaleUnited StatesUnknown status
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GainesvilleUnited StatesUnknown status
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HoustonUnited StatesUnknown status
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JacksonvilleUnited StatesUnknown status
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Kansas CityUnited StatesUnknown status
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Los AngelesUnited StatesUnknown status
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MargateUnited StatesUnknown status
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New HavenUnited StatesUnknown status
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New OrleansUnited StatesUnknown status
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New YorkUnited StatesUnknown status
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OrangeUnited StatesUnknown status
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PittsburghUnited StatesUnknown status
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RochesterUnited StatesUnknown status
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ScottsdaleUnited StatesUnknown status
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South MiamiUnited StatesUnknown status
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TamaracUnited StatesUnknown status
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Washington D.C.United StatesUnknown status
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HanoiVietnamUnknown status
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Hà NộiVietnamUnknown status
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HochiminhVietnamUnknown status
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Ho Chi Minh CityVietnamUnknown status
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ParktownSouth AfricaUnknown status
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PretoriaSouth AfricaUnknown status
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AnkaraTurkey (Türkiye)Unknown status
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AntalyaTurkey (Türkiye)Unknown status
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CenterTurkey (Türkiye)Unknown status
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KazımkarabekirTurkey (Türkiye)Unknown status
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KocaeliTurkey (Türkiye)Unknown status

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