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NCT04895696Active, not recruitingPhase 2

A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Afimetoran in Participants With Active Systemic Lupus Erythematosus

Source: ClinicalTrials.gov · Last updated 17 Aug 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the effectiveness, safety and tolerability of Afimetoran in participants with active Systemic Lupus Erythematosus (SLE). The extension period will provide additional long-term safety and efficacy data and enable those participants initially randomized to placebo to receive treatment with Afimetoran.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
248 (actual)
First submitted
19 May 2021
Start date
11 Oct 2021
Primary completion date
12 Jun 2026
Lead sponsor
Beeline Medicines Corporation
Diseases
Lupus (SLE)
NCT number
NCT04895696
EU CT number
2023-504320-25-00
EudraCT number
2019-004021-25

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 248
  • From 11 Oct 2021 to the primary completion date, 12 Jun 2026
  • 145 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.

Other illness

  • Diagnosis of Mixed Connective Tissue Disease for which the predominant diagnosis is not SLE
  • Antiphospholipid Syndrome
    • Other protocol-defined inclusion/exclusion criteria apply

Other

  • Active severe lupus nephritis (LN) as assessed by the investigator
  • Active or unstable neuropsychiatric lupus manifestations defined by the Hybrid SLEDAI

Who the study is looking for

  • Diagnosed ≥ 12 weeks before the screening visit and qualify as having SLE according to the SLE International Collaborating Clinics (SLICC) Classification Criteria at the screening visit
  • Test positive, as determined by the central laboratory, for at least one of the following lupus related autoantibodies at the time of screening: antinuclear antibody ≥ 1:80, anti-double-stranded deoxyribonucleic acid (dsDNA) antibody, or anti-Smith antibody.
  • Have a total Hybrid Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score ≥ 6 points and clinical Hybrid SLEDAI score ≥ 4 points with joint involvement and/or rash

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

Full criteria on ClinicalTrials.gov

Sites (145)

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

SiteCityCountrySite status
Local Institution - 0074
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Buenos AiresArgentinaUnknown status
Local Institution - 0207
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Buenos AiresArgentinaUnknown status
Local Institution - 0128
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Buenos AiresArgentinaUnknown status
Local Institution - 0040
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CABAArgentinaUnknown status
Local Institution - 0025
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CórdobaArgentinaUnknown status
Local Institution - 0130
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QuilmesArgentinaUnknown status
Local Institution - 0195
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San FernandoArgentinaUnknown status
Local Institution - 0041
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San JuanArgentinaUnknown status
Local Institution - 0027
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San Miguel de TucumánArgentinaUnknown status
Local Institution - 0063
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BotanyAustraliaUnknown status
Local Institution - 0062
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CamberwellAustraliaUnknown status
Local Institution - 0064
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IvanhoeAustraliaUnknown status
Local Institution - 0066
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MaroochydoreAustraliaUnknown status
Local Institution - 0072
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WestmeadAustraliaUnknown status
Local Institution - 0065
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WoodvilleAustraliaUnknown status
Local Institution - 0093
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CuiabáBrazilUnknown status
Local Institution - 0010
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CuritibaBrazilUnknown status
Local Institution - 0008
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Juiz de ForaBrazilUnknown status
Local Institution - 0007
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Porto AlegreBrazilUnknown status
Local Institution - 0006
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SalvadorBrazilUnknown status
Local Institution - 0031
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SalvadorBrazilUnknown status
Local Institution - 0014
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São Bernardo do CampoBrazilUnknown status
Local Institution - 0045
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São José do Rio PretoBrazilUnknown status
Local Institution - 0009
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São PauloBrazilUnknown status
Local Institution - 0127
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OsornoChileUnknown status
Local Institution - 0075
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ProvidenciaChileUnknown status
Local Institution - 0043
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SantiagoChileUnknown status
Local Institution - 0073
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SantiagoChileUnknown status
Local Institution - 0143
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ValdiviaChileUnknown status
Local Institution - 0180
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BeijingChinaUnknown status
Local Institution - 0177
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BeijingChinaUnknown status
Local Institution - 0174
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ChangchunChinaUnknown status
Local Institution - 0179
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DalianChinaUnknown status
Local Institution - 0178
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JinanChinaUnknown status
Local Institution - 0183
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JiningChinaUnknown status
Local Institution - 0188
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NanjingChinaUnknown status
Local Institution - 0176
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NanjingChinaUnknown status
Local Institution - 0184
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ShenzhenChinaUnknown status
Local Institution - 0193
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SuzhouChinaUnknown status
Local Institution - 0001
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BarranquillaColombiaUnknown status
Local Institution - 0004
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BogotáColombiaUnknown status
Local Institution - 0076
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CaliColombiaUnknown status
Local Institution - 0005
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ChíaColombiaUnknown status
Local Institution - 0190
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MedellínColombiaUnknown status
Local Institution - 0003
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ZipaquiráColombiaUnknown status
Charite Research Organisation GmbH
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BerlinGermanyActive, not recruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyActive, not recruiting
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyActive, not recruiting
Complejo Hospitalario Universitario Juan Canalejo
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A CorunaSpainActive, not recruiting
Vall D'hebron Institut De Recerca
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BarcelonaSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainActive, not recruiting
Hospital Universitario Virgen De Valme
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SevillaSpainActive, not recruiting
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceCompleted
Centre Hospitalier Regional Et Universitaire De Brest
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Brest Cedex 2FranceCompleted
Hopital Huriez
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Lille CedexFranceCompleted
Hopital Europeen Marseille
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MarseilleFranceCompleted
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceCompleted
Les Hopitaux Universitaires De Strasbourg
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Strasbourg Cedex 2FranceCompleted
Local Institution - 0110
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BradfordUnited KingdomUnknown status
Local Institution - 0111
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CambridgeUnited KingdomUnknown status
Local Institution - 0125
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ManchesterUnited KingdomUnknown status
Connolly Hospital
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Dublin 15IrelandCompleted
Merlin Park University Hospital
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GalwayIrelandCompleted
Our Ladys Hospital Manorhamilton
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SligoIrelandCompleted
Local Institution - 0226
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AhmedabadIndiaUnknown status
Local Institution - 0210
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BengaluruIndiaUnknown status
Local Institution - 0214
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GurugramIndiaUnknown status
Local Institution - 0208
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New DelhiIndiaUnknown status
Local Institution - 0209
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SecunderabadIndiaUnknown status
Local Institution - 0138
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AichiJapanUnknown status
Local Institution - 0117
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Bunkyo-kuJapanUnknown status
Local Institution - 0115
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ChibaJapanUnknown status
Local Institution - 0114
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Eiheiji-cho,Yoshida-gunJapanUnknown status
Local Institution - 0218
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FuchūJapanUnknown status
Local Institution - 0162
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FukushimaJapanUnknown status
Local Institution - 0104
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KanazawaJapanUnknown status
Local Institution - 0095
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KitakyushuJapanUnknown status
Local Institution - 0150
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Meguro-kuJapanUnknown status
Local Institution - 0096
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SapporoJapanUnknown status
Local Institution - 0099
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SendaiJapanUnknown status
Local Institution - 0098
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Shinjuku-kuJapanUnknown status
Local Institution - 0105
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Shinjuku-kuJapanUnknown status
Local Institution - 0113
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tabashi CityJapanUnknown status
Local Institution - 0116
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TokyoJapanUnknown status
Local Institution - 0097
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TokyoJapanUnknown status
Local Institution - 0021
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Chihuahua CityMexicoUnknown status
Local Institution - 0017
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GuadalajaraMexicoUnknown status
Local Institution - 0020
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LeónMexicoUnknown status
Local Institution - 0061
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MéridaMexicoUnknown status
Local Institution - 0018
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Mexico CityMexicoUnknown status
Local Institution - 0060
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Mexico CityMexicoUnknown status
Local Institution - 0158
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Mexico CityMexicoUnknown status
Local Institution - 0071
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MonterreyMexicoUnknown status
Local Institution - 0022
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ZapopanMexicoUnknown status
Medyczne Centrum Hetmańska
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PoznanPolandCompleted
Centrum Medyczne Reuma Park
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WarszawaPolandCompleted
MICS Centrum Medyczne Warszawa
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WarszawaPolandCompleted
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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WroclawPolandCompleted
Local Institution - 0037
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San JuanPuerto RicoUnknown status
Hightech Medical Services S.R.L.
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BucharestRomaniaActive, not recruiting
Saint Maria Hospital
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BucharestRomaniaActive, not recruiting
SC MedAudio-Optica SRL
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Râmnicu VâlceaRomaniaActive, not recruiting
Centrul de Kinetoterapie si Masaj Banat SRL
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TimisoaraRomaniaActive, not recruiting
Local Institution - 0080
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Kaohsiung Niao Sung DistTaiwanUnknown status
Local Institution - 0081
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TaichungTaiwanUnknown status
Local Institution - 0078
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TaichungTaiwanUnknown status
Local Institution - 0079
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TaipeiTaiwanUnknown status
Local Institution - 0077
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TaipeiTaiwanUnknown status
Local Institution - 0152
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AllenUnited StatesUnknown status
Local Institution - 0197
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AllenUnited StatesUnknown status
Local Institution - 0136
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AmarilloUnited StatesUnknown status
Local Institution - 0160
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AtlantaUnited StatesUnknown status
Local Institution - 0171
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Baton RougeUnited StatesUnknown status
Local Institution - 0223
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BellevueUnited StatesUnknown status
Local Institution - 0100
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BirminghamUnited StatesUnknown status
Local Institution - 0203
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CharlotteUnited StatesUnknown status
Local Institution - 0103
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CharlotteUnited StatesUnknown status
Local Institution - 0121
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ClearwaterUnited StatesUnknown status
Local Institution - 0151
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ColumbusUnited StatesUnknown status
Local Institution - 0070
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EaganUnited StatesUnknown status
Local Institution - 0187
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HopkinsvilleUnited StatesUnknown status
Local Institution - 0123
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Huntington BeachUnited StatesUnknown status
Local Institution - 0167
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KissimmeeUnited StatesUnknown status
Local Institution - 0170
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La JollaUnited StatesUnknown status
Local Institution - 0159
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La PalmaUnited StatesUnknown status
Local Institution - 0091
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Las VegasUnited StatesUnknown status
Local Institution - 0140
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ManhassetUnited StatesUnknown status
Local Institution - 0029
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MesquiteUnited StatesUnknown status
Local Institution - 0042
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Middleburg HeightsUnited StatesUnknown status
Local Institution - 0122
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OrlandoUnited StatesUnknown status
Local Institution - 0146
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Orland ParkUnited StatesUnknown status
Local Institution - 0173
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Ormond BeachUnited StatesUnknown status
Local Institution - 0154
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PlantationUnited StatesUnknown status
Local Institution - 0163
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San AntonioUnited StatesUnknown status
Local Institution - 0172
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San DiegoUnited StatesUnknown status
Local Institution - 0137
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South MiamiUnited StatesUnknown status
Local Institution - 0124
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St LouisUnited StatesUnknown status
Local Institution - 0165
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St LouisUnited StatesUnknown status
Local Institution - 0205
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SuwaneeUnited StatesUnknown status
Local Institution - 0155
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TamaracUnited StatesUnknown status
Local Institution - 0132
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The BronxUnited StatesUnknown status
Local Institution - 0219
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West Long BranchUnited StatesUnknown status
Local Institution - 0134
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WheatonUnited StatesUnknown status
Local Institution - 0164
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Woodland HillsUnited StatesUnknown status

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