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NCT05243680CompletedPhase 3

An Open-Label Extension Study of GSK3511294 (Depemokimab) in Participants Who Were Previously Enrolled in 206713 (NCT04719832) or 213744 (NCT04718103)

A Multi-centre, Single Arm, Open-label Extension Study to Evaluate the Long-term Safety of GSK3511294 (Depemokimab) in Adult and Adolescent Participants With Severe Asthma With an Eosinophilic Phenotype From Studies 206713 or 213744

Source: ClinicalTrials.gov · Last updated 15 Jan 2026

Brief summary (registry, in English)

The purpose of this open-label 12-month extension study is to continue to characterize the long-term safety, efficacy and immunogenic profile of GSK3511294 (Depemokimab) in participants with severe asthma with an eosinophilic phenotype following completion of clinical studies 206713 or 213744.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
641 (actual)
First submitted
8 Feb 2022
Start date
1 Mar 2022
Primary completion date
19 May 2025
Lead sponsor
GlaxoSmithKline
Diseases
Asthma
NCT number
NCT05243680
EU CT number
2023-505203-23-01
EudraCT number
2020-004334-38

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 641
  • From 1 Mar 2022 to the primary completion date, 19 May 2025
  • 129 sites in 14 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 with known parasitic (helminth) infections within 6 months prior to Visit 1 will be excluded from the study or required to be adequately treated for helminth infections before initiation of GSK3511294.
  • Participants with current diagnosis of vasculitis. Participants with high clinical suspicion of vasculitis at screening will be evaluated and current vasculitis must be excluded prior to enrolment.
  • Participants who for any reason permanently discontinued study treatment in the previous study 206713/213744 will be excluded from this study.
  • Other investigational product/clinical study:
    • Participants who have received treatment with an investigational agent (biologic or non-biologic) within the past 30 days or 5 drug half-lives whichever is longer, prior to the first dose, other than Study 206713/213744 study treatment. The term "investigational" applies to any drug not approved for sale for the disease/indication to treat in the country in which it is being used or investigational formulations of marketed products.
    • Participants who are currently participating in any other interventional clinical study.

Other illness

  • A current malignancy or a malignancy that developed during Study 206713 or Study 213744 (participants who had localized carcinoma of the skin that was resected for cure will not be excluded).
  • Participants who have other clinically significant medical conditions uncontrolled with Standard of Care (SoC) therapy not associated with Asthma, for example (e.g.), uncontrolled cardiovascular disease or ongoing active infectious disease which in the opinion of the investigator makes them unsuitable for the study.
  • Participants with allergy/intolerance to the excipients of GSK3511294, a monoclonal antibody, or biologic.

Lab values

  • Participants who meet the following based on results of Week 48 assessment from Study 206713 or Study 213744 or from a later result:
    • Alanine aminotransferase (ALT) greater than (\>)2 times upper limit of normal (ULN).
    • Total bilirubin \>1.5 times ULN (isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin less than \[\<\] 35 percent \[%\]).
    • Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice.
  • Electrocardiogram (ECG) assessment: QTc corrected by Fridericia's formula (QTcF) greater than or equal to (\>=)450 milliseconds (msec) or QTcF \>=480 msec for participants with Bundle Branch Block at Visit 1.

Other

  • Clinically significant change in health status during Study 206713 or Study 213744 which in the opinion of the investigator would make the participant unsuitable for participation in this study.
  • Current smokers.
  • Participants who are pregnant or breastfeeding. Participants should not be enrolled if they plan to become pregnant during the time of study participation.

Who the study is looking for

  • Participants who completed the double-blind study intervention treatment during Study 206713 or Study 213744.
  • Participants capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. In France, a participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (129)

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

SiteCityCountrySite status
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Coffs HarbourAustraliaUnknown status
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South BrisbaneAustraliaUnknown status
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AjaxCanadaUnknown status
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KamloopsCanadaUnknown status
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OttawaCanadaUnknown status
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Sherwood ParkCanadaUnknown status
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ChangchunChinaUnknown status
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ChangshaChinaUnknown status
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ChengduChinaUnknown status
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GuangzhouChinaUnknown status
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HaikouChinaUnknown status
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HangzhouChinaUnknown status
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HefeiChinaUnknown status
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HohhotChinaUnknown status
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JinanChinaUnknown status
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ShanghaiChinaUnknown status
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ShenyangChinaUnknown status
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ÜrümqiChinaUnknown status
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WenzhouChinaUnknown status
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WuhanChinaUnknown status
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XuzhouChinaUnknown status
Fakultni nemocnice Brno
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BrnoCzechiaCompleted
MEDITRIAL s.r.o.
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Jindrichuv Hradec IIICzechiaCompleted
Fakultni Nemocnice Hradec Kralove
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Novy Hradec KraloveCzechiaCompleted
University Hospital Olomouc
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OlomoucCzechiaCompleted
MUDr. Jaroslav Mareš
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StrakoniceCzechiaCompleted
KASMED s.r.o.
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TáborCzechiaCompleted
Plicni Stredisko Teplice S.R.O
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TepliceCzechiaCompleted
KPPK GmbH
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BendorfGermanyCompleted
Studienzentrum Dr. med. Claus Keller
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Frankfurt am MainGermanyCompleted
ME Clinical Respiratory Research Hamburg GmbH
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HamburgGermanyCompleted
Berufsausuebungsgemeinschaft Bag Prof. Dr. Med Gerhard Hoheisel Dr. Med Andreas Bonitz GbR
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LeipzigGermanyCompleted
POIS Sachsen GmbH
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LeipzigGermanyCompleted
SMO.MD GmbH
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MagdeburgGermanyCompleted
IKF Pneumologie GmbH & Co. KG
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MainzGermanyCompleted
Ballenberger, Freytag, Wenisch
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Neu-IsenburgGermanyCompleted
UOMI Cancer Center-Clinica Tres Torres
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BarcelonaSpainCompleted
Giromed Institute S.L.P.
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BarcelonaSpainCompleted
Hospital Vithas Xanit Internacional
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BenalmádenaSpainCompleted
Hospital Universitario Basurto
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BilbaoSpainCompleted
Giromed Institute S.L.P.
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GironaSpainCompleted
Hospital Universitario Virgen de las Nieves
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GranadaSpainCompleted
Hospital Universitario Infanta Leonor
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MadridSpainCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Hospital Universitario Virgen de la Victoria
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MálagaSpainCompleted
University Hospital Son Espases
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PalmaSpainCompleted
Hospital Universitario Quironsalud Madrid
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Pozuelo de AlarcónSpainCompleted
Hospital Universitario Marqués de Valdecilla
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SantanderSpainCompleted
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainCompleted
Hospital Arnau de Vilanova de Valencia
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ValenciaSpainCompleted
Hospital Clinico Universitario de Valencia
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ValenciaSpainCompleted
Hospital Unviersitario Miguel Servet
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ZaragozaSpainCompleted
Centre Hospitalier Universitaire De Caen Normandie
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Caen Cedex 9FranceCompleted
Centre Hospitalier De Cannes Simone Veil
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Cannes CedexFranceCompleted
Centre Hospitalier de Cholet
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CholetFranceCompleted
Assistance Publique Hôpitaux de Marseille
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MarseilleFranceCompleted
Centre Hospitalier Annecy Genevois
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Pringy CedexFranceCompleted
Les Hopitaux Universitaires De Strasbourg
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Strasbourg CedexFranceCompleted
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BradfordUnited KingdomUnknown status
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ChertseyUnited KingdomUnknown status
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LondonUnited KingdomUnknown status
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ManchesterUnited KingdomUnknown status
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NottinghamUnited KingdomUnknown status
Erzsebet Gondozohaz Kft.
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GödöllőHungaryCompleted
Omnimodus Elixír Kft.
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MosonmagyaróvárHungaryCompleted
Spiroped Szigetvar Kft.
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SzigetvarHungaryCompleted
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyCompleted
Azienda Ospedaliero Universitaria Ospedali Riuniti
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FoggiaItalyCompleted
Università degli Studi di Messina
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MessinaItalyCompleted
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyCompleted
Azienda Ospedaliera Universitaria Di Cagliari
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MonserratoItalyCompleted
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
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PalermoItalyCompleted
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyCompleted
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyCompleted
Humanitas Research Hospital
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RozzanoItalyCompleted
Azienda Ospedaliera Universitaria Senese
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SienaItalyCompleted
Istituti Clinici Scientifici Maugeri In Forma Abbreviata Istituti Clinici Scientifici Maugeri O Anche Ics Maugeri O Maugeri S.p.A. Sb
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TradateItalyCompleted
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AichiJapanUnknown status
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ChibaJapanUnknown status
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FukuokaJapanUnknown status
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FukushimaJapanUnknown status
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HiroshimaJapanUnknown status
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HokkaidoJapanUnknown status
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KagawaJapanUnknown status
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KagoshimaJapanUnknown status
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KanagawaJapanUnknown status
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NiigataJapanUnknown status
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OkayamaJapanUnknown status
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SagaJapanUnknown status
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TokyoJapanUnknown status
Malopolskie Centrum Alergologii Sp. z o.o.
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CracowPolandCompleted
Centrum Medyczne All-Med Badania Kliniczne
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CracowPolandCompleted
Uniwersyteckie Centrum Kliniczne
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GdanskPolandCompleted
Polimedica Centrum Badan Profilaktyki I Leczenia Sp. z o.o. S.K.
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KielcePolandCompleted
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
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LodzPolandCompleted
Centrum Alergologii Sp. z o.o.
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LublinPolandCompleted
Ostrowieckie Centrum Medyczne Anna Olech Cudzik Krzysztof Cudzik s.c.
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Ostrowiec ŚwiętokrzyskiPolandCompleted
Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz
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RzeszówPolandCompleted
Lekarze Specjalisci - J. Malolepszy I Partnerzy
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WroclawPolandCompleted
ALL-MED - Specjalistyczna Opieka Medyczna - Medyczny Instytut Badawczy
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WrocławPolandCompleted
Centrum Medyczne Lucyna Andrzej Dymek s.c.
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ZawadzkiePolandCompleted
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Kaohsiung CityTaiwanUnknown status
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TaichungTaiwanUnknown status
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AllenUnited StatesUnknown status
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BellinghamUnited StatesUnknown status
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BoerneUnited StatesUnknown status
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Colorado SpringsUnited StatesUnknown status
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Coral GablesUnited StatesUnknown status
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DallasUnited StatesUnknown status
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DuBoisUnited StatesUnknown status
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GastoniaUnited StatesUnknown status
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HialeahUnited StatesUnknown status
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HuntersvilleUnited StatesUnknown status
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KerrvilleUnited StatesUnknown status
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LafayetteUnited StatesUnknown status
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LancasterUnited StatesUnknown status
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LexingtonUnited StatesUnknown status
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Loxahatchee GrovesUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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MobileUnited StatesUnknown status
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NormalUnited StatesUnknown status
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NorthfieldUnited StatesUnknown status
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OrlandoUnited StatesUnknown status
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San AntonioUnited StatesUnknown status
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SavannahUnited StatesUnknown status
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The BronxUnited StatesUnknown status
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Toms RiverUnited StatesUnknown status
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Winston-SalemUnited StatesUnknown status
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YpsilantiUnited StatesUnknown status

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