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NCT05625399Active, not recruitingPhase 3

A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma

A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination Versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants With Previously Untreated Metastatic or Unresectable Melanoma

Source: ClinicalTrials.gov · Last updated 26 Aug 2026

Brief summary (registry, in English)

The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
579 (actual)
First submitted
15 Nov 2022
Start date
6 Mar 2023
Primary completion date
4 Aug 2025
Lead sponsor
Bristol-Myers Squibb
NCT number
NCT05625399
EU CT number
2022-500967-11-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 579
  • From 6 Mar 2023 to the primary completion date, 4 Aug 2025
  • 143 sites in 19 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 must not have a condition requiring systemic treatment with either corticosteroids (\>10 milligrams \[mg\] daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \>10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.

Other illness

  • Participants must not have a history of myocarditis, regardless of etiology.

Other

  • Participants must not have ocular melanoma.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Who the study is looking for

  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1/Lansky Performance Score ≥ 80% for adolescents (≥ 12 to \< 18 years of age).
  • Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the American Joint Committee for Cancer (AJCC) staging system.
  • Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
  • Participants must be ≥ 12 years of age. Participants who are ≥ 12 years of age and \< 18 years of age (adolescents) must weigh ≥ 40 kg at the time of signing the informed consent (assent).
  • Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the AJCC staging system (8th edition).

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

Full criteria on ClinicalTrials.gov

Sites (143)

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

SiteCityCountrySite status
Noe LGA Gesundheit Region Mitte GmbH
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St. PoeltenAustriaRecruiting
Medical University of Vienna
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ViennaAustriaRecruiting
-
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BendigoAustraliaUnknown status
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BirtinyaAustraliaUnknown status
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Box HillAustraliaUnknown status
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Coffs HarbourAustraliaUnknown status
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HeidelbergAustraliaUnknown status
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MelbourneAustraliaUnknown status
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NedlandsAustraliaUnknown status
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NedlandsAustraliaUnknown status
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OrangeAustraliaUnknown status
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Port MacquarieAustraliaUnknown status
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TraralgonAustraliaUnknown status
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Wagga WaggaAustraliaUnknown status
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WaratahAustraliaUnknown status
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WestmeadAustraliaUnknown status
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WollstonecraftAustraliaUnknown status
Grand Hopital de Charleroi
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CharleroiBelgiumRecruiting
CHU de Liège
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LiègeBelgiumRecruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumRecruiting
-
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BarretosBrazilUnknown status
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Belo HorizonteBrazilUnknown status
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BlumenauBrazilUnknown status
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FortalezaBrazilUnknown status
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IjuíBrazilUnknown status
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Porto AlegreBrazilUnknown status
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Porto AlegreBrazilUnknown status
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Porto AlegrelegreBrazilUnknown status
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Rio de JaneiroBrazilUnknown status
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São José do Rio PretoBrazilUnknown status
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São PauloBrazilUnknown status
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VitóriaBrazilUnknown status
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CalgaryCanadaUnknown status
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HamiltonCanadaUnknown status
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OttawaCanadaUnknown status
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QuébecCanadaUnknown status
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TorontoCanadaUnknown status
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BernSwitzerlandUnknown status
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ChurSwitzerlandUnknown status
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LausanneSwitzerlandUnknown status
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Port MonttChileUnknown status
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RecoletaChileUnknown status
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SantiagoChileUnknown status
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SantiagoChileUnknown status
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SantiagoChileUnknown status
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SantiagoChileUnknown status
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SantiagoChileUnknown status
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TemucoChileUnknown status
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Viña del MarChileUnknown status
Fakultni Nemocnice Hradec Kralove
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Novy Hradec KraloveCzechiaRecruiting
University Hospital Olomouc
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OlomoucCzechiaRecruiting
University Hospital Ostrava
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Ostrava-PorubaCzechiaRecruiting
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaRecruiting
University Hospital Kralovske Vinohrady
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Prague 10CzechiaRecruiting
Charite Universitatsmedizin Berlin KöR
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BerlinGermanyRecruiting
Elbe Kliniken Stade-Buxtehude Elbe Klinikum Buxtehude gGmbH
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BuxtehudeGermanyRecruiting
Klinikum Dortmund gGmbH
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DortmundGermanyRecruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyRecruiting
Goethe University Frankfurt
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Frankfurt Am MainGermanyRecruiting
Justus Liebig University Giessen
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GiessenGermanyRecruiting
University Medical Center Hamburg-Eppendorf
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HamburgGermanyRecruiting
Heidelberg University Hospital AöR
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HeidelbergGermanyRecruiting
University Medical Centre Schleswig-Holstein
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LübeckGermanyRecruiting
Philipps University Marburg
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MarburgGermanyRecruiting
Muhlenkreiskliniken AöR
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MindenGermanyRecruiting
Klinikum Nuernberg
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NurembergGermanyRecruiting
Universitaetsklinikum Regensburg
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RegensburgGermanyRecruiting
Rostock University Medical Center
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RostockGermanyRecruiting
Universitaetsklinikum Tuebingen
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TuebingenGermanyRecruiting
Universitaetsklinikum Ulm AoR
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UlmGermanyRecruiting
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainRecruiting
Institut Catala d'Oncologia
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BadalonaSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Fundacion Onkologikoa Fundazioa
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DonostiaSpainRecruiting
Hospital Universitario de Jaén
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JaénSpainRecruiting
Complejo Hospitalario Universitario Insular Materno Infantil
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Las Palmas de Gran CanariaSpainRecruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hospital Universitario HM Sanchinarro
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MadridSpainRecruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainRecruiting
Fundación Instituto Valenciano de Oncología
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ValenciaSpainRecruiting
Hospital General Universitario de Valencia
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ValenciaSpainRecruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainRecruiting
HUS Helsinki University Hospital
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HelsinkiFinlandRecruiting
Tampere University Hospital
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TampereFinlandRecruiting
Turku University Hospital
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TurkuFinlandRecruiting
Centre Hospitalier Universitaire Amiens - Picardie
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AmiensFranceRecruiting
Centre Hospitalier de la Cote Basque
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BayonneFranceRecruiting
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceRecruiting
Centre Hospitalier Regional Universitaire De Tours
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Chambray Les ToursFranceRecruiting
University Hospital Of Clermont-Ferrand
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Clermont Ferrand Cedex 1FranceRecruiting
Centre Hospitalier Universitaire de Dijon
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DijonFranceRecruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceRecruiting
Assistance Publique Hôpitaux de Marseille
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MarseilleFranceRecruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
Hospices Civils de Lyon
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Pierre-BéniteFranceRecruiting
Centre De Lutte Contre Le Cancer Eugene Marquis
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Rennes CedexFranceRecruiting
CHU De Rouen
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Rouen CedexFranceRecruiting
Institut Claudius Regaud
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ToulouseFranceRecruiting
Institut Gustave Roussy
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VillejuifFranceRecruiting
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Headington, OxfordUnited KingdomUnknown status
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LondonUnited KingdomUnknown status
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Newcastle upon TyneUnited KingdomUnknown status
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AfulaIsraelUnknown status
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JerusalemIsraelUnknown status
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Petah-TikvahIsraelUnknown status
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Tel AvivIsraelUnknown status
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Tel HaShomerIsraelUnknown status
Istituto Tumori Bari Giovanni Paolo II
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BariItalyRecruiting
IRCCS Ospedale Policlinico San Martino
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GenoaItalyRecruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyRecruiting
IRCCS Istituto Nazionale Tumori Fondazione Pascale
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NaplesItalyRecruiting
Hospital Santa Maria Della Misericordia
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PerugiaItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
Azienda Ospedaliera Universitaria Senese
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SienaItalyRecruiting
Nordlandssykehuset HF
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BodoNorwayRecruiting
Ostfold Hospital Trust
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FredrikstadNorwayRecruiting
Akershus University Hospital
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LoerenskogNorwayRecruiting
Oslo University Hospital HF
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OsloNorwayRecruiting
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
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BydgoszczPolandRecruiting
Pratia MCM Krakow
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CracowPolandRecruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Opolskie Centrum Onkologii Im Prof Tadeusza Koszarowskiego W Opolu
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OpolePolandRecruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
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PoznanPolandRecruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandRecruiting
Region Skane Skanes Universitetssjukhus
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LundSwedenRecruiting
Karolinska University Hospital
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SolnaSwedenRecruiting
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BaltimoreUnited StatesUnknown status
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ClevelandUnited StatesUnknown status
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EastonUnited StatesUnknown status
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EnglewoodUnited StatesUnknown status
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FairfaxUnited StatesUnknown status
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JacksonvilleUnited StatesUnknown status
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Los AngelesUnited StatesUnknown status
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MurrayUnited StatesUnknown status
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OmahaUnited StatesUnknown status
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OrangeUnited StatesUnknown status
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PhiladelphiaUnited StatesUnknown status
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PhoenixUnited StatesUnknown status
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RochesterUnited StatesUnknown status
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SpringdaleUnited StatesUnknown status
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StanfordUnited StatesUnknown status

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