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NCT06268886Active, not recruitingPhase 2

Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease

A Randomized, Double-blind, Placebo-controlled, Global Proof-of-concept Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986446, an Anti-MTBR Tau Monoclonal Antibody, in Participants With Early Alzheimer's Disease (TargetTau-1)

Source: ClinicalTrials.gov · Last updated 2 Nov 2026

Brief summary (registry, in English)

The purpose of this study is to assess the effectiveness, safety, and tolerability of BMS-986446 an Anti-MTBR Tau Monoclonal Antibody in participants with Early Alzheimer's Disease.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
310 (estimated)
First submitted
13 Feb 2024
Start date
20 Mar 2024
Primary completion date
17 Dec 2026
Lead sponsor
Bristol-Myers Squibb
NCT number
NCT06268886
EU CT number
2023-504840-32-00
EudraCT number
2023-504840-32

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 310
  • From 20 Mar 2024 to the primary completion date, 17 Dec 2026
  • 176 sites in 10 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

  • Any evidence of a condition that may affect cognition other than AD.
  • Any serious medical condition that could, in the opinion of the investigator, affect the participant's safety or interfere with study assessments.

Other

  • Contraindications to PET imaging.
  • Inability to tolerate or contraindication to magnetic resonance imaging.
  • Geriatric Depression Scale (GDS) score greater than or equal to 8 at screening.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Who the study is looking for

  • Mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild AD dementia consistent with the National Institute on Aging and the Alzheimer's Association (NIA-AA) core clinical criteria.
  • Global Clinical Dementia Rating (CDR) score of 0.5 to 1.0 and a CDR-Memory Box score of 0.5 and greater at screening and Baseline.
  • Evidence of AD pathology.
  • Objective impairment in episodic memory as indicated by at least 1 standard deviation below age-adjusted mean in the Wechsler Memory Scale IV-Logical Memory Subtest II (WMS-IV LM II).
  • Mini Mental Status Examination (MMSE) score ≥ 20 to 28 (inclusive).

Age in the registry: 50 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (176)

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

SiteCityCountrySite status
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Carlton NorthAustraliaUnknown status
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East GosfordAustraliaUnknown status
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Griffith UniversityAustraliaUnknown status
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IvanhoeAustraliaUnknown status
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Macquarie ParkAustraliaUnknown status
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MalvernAustraliaUnknown status
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MelbourneAustraliaUnknown status
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NedlandsAustraliaUnknown status
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ParkvilleAustraliaUnknown status
Hopital Erasme
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AnderlechtBelgiumActive, not recruiting
Antwerp University Hospital
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EdegemBelgiumActive, not recruiting
Algemeen Ziekenhuis Groeninge
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KortrijkBelgiumActive, not recruiting
UZ Leuven
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LeuvenBelgiumActive, not recruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumActive, not recruiting
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Greenfield ParkCanadaUnknown status
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MontrealCanadaUnknown status
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OttawaCanadaUnknown status
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QuébecCanadaUnknown status
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TorontoCanadaUnknown status
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TorontoCanadaUnknown status
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TorontoCanadaUnknown status
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainActive, not recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Hospital del Mar
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BarcelonaSpainActive, not recruiting
Hospital Universitari de Santa Maria
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LleidaSpainActive, not recruiting
Hospital Universitari General de Catalunya
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Sant Cugat del VallèsSpainActive, not recruiting
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BathUnited KingdomUnknown status
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ChertseyUnited KingdomUnknown status
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EnfieldUnited KingdomUnknown status
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LondonUnited KingdomUnknown status
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Bunkyo-KuJapanUnknown status
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ChūōkuJapanUnknown status
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Hachioji-ShiJapanUnknown status
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Himeji-shiJapanUnknown status
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Hirakata-ShiJapanUnknown status
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Kasukabe-ShiJapanUnknown status
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Kodaira-ShiJapanUnknown status
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Kurashiki-ShiJapanUnknown status
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Musashimurayama-ShiJapanUnknown status
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Musashino-shiJapanUnknown status
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NagoyaJapanUnknown status
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NagoyaJapanUnknown status
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ŌbuJapanUnknown status
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OsakaJapanUnknown status
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OsakaJapanUnknown status
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Setagaya-KuJapanUnknown status
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Tachikawa-ShiJapanUnknown status
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Takatsuki-ShiJapanUnknown status
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Toride-ShiJapanUnknown status
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Toyonaka-ShiJapanUnknown status
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GwangjinguSouth KoreaUnknown status
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IncheonSouth KoreaUnknown status
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JungguSouth KoreaUnknown status
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Songpa-guSouth KoreaUnknown status
Region Skane Skanes Universitetssjukhus
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MalmoSwedenActive, not recruiting
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SingaporeSingaporeUnknown status
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AlbanyUnited StatesUnknown status
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Altamonte SpringsUnited StatesUnknown status
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AmherstUnited StatesUnknown status
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AtlantisUnited StatesUnknown status
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AustinUnited StatesUnknown status
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BeaumontUnited StatesUnknown status
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Boca RatonUnited StatesUnknown status
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Boca RatonUnited StatesUnknown status
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BostonUnited StatesUnknown status
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BostonUnited StatesUnknown status
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BradentonUnited StatesUnknown status
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BraintreeUnited StatesUnknown status
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ChandlerUnited StatesUnknown status
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ChicagoUnited StatesUnknown status
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ChicagoUnited StatesUnknown status
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ClermontUnited StatesUnknown status
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ColumbusUnited StatesUnknown status
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CordovaUnited StatesUnknown status
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DallasUnited StatesUnknown status
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DanburyUnited StatesUnknown status
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DaytonUnited StatesUnknown status
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Daytona BeachUnited StatesUnknown status
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East ProvidenceUnited StatesUnknown status
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Elk Grove VillageUnited StatesUnknown status
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EncinoUnited StatesUnknown status
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FairfaxUnited StatesUnknown status
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Fort MyersUnited StatesUnknown status
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FoxboroughUnited StatesUnknown status
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FranklinUnited StatesUnknown status
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FullertonUnited StatesUnknown status
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GilbertUnited StatesUnknown status
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Greenacres CityUnited StatesUnknown status
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GurneeUnited StatesUnknown status
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HialeahUnited StatesUnknown status
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HialeahUnited StatesUnknown status
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HialeahUnited StatesUnknown status
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HoustonUnited StatesUnknown status
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IndependenceUnited StatesUnknown status
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IrvineUnited StatesUnknown status
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Lady LakeUnited StatesUnknown status
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LakelandUnited StatesUnknown status
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Long BeachUnited StatesUnknown status
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Los AlamitosUnited StatesUnknown status
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MaitlandUnited StatesUnknown status
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MaitlandUnited StatesUnknown status
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ManhassetUnited StatesUnknown status
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MatthewsUnited StatesUnknown status
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Merritt IslandUnited StatesUnknown status
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MethuenUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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Miami SpringsUnited StatesUnknown status
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NapaUnited StatesUnknown status
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NaplesUnited StatesUnknown status
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NashvilleUnited StatesUnknown status
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New HavenUnited StatesUnknown status
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New HavenUnited StatesUnknown status
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New Port RicheyUnited StatesUnknown status
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NewtonUnited StatesUnknown status
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New YorkUnited StatesUnknown status
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New YorkUnited StatesUnknown status
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New YorkUnited StatesUnknown status
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New YorkUnited StatesUnknown status
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OcalaUnited StatesUnknown status
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OrlandoUnited StatesUnknown status
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OrlandoUnited StatesUnknown status
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OrlandoUnited StatesUnknown status
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OrlandoUnited StatesUnknown status
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Park RidgeUnited StatesUnknown status
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PhoenixUnited StatesUnknown status
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PlymouthUnited StatesUnknown status
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Plymouth MeetingUnited StatesUnknown status
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Port OrangeUnited StatesUnknown status
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PortsmouthUnited StatesUnknown status
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PrincetonUnited StatesUnknown status
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ProvidenceUnited StatesUnknown status
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RichmondUnited StatesUnknown status
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SacramentoUnited StatesUnknown status
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San FranciscoUnited StatesUnknown status
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Santa AnaUnited StatesUnknown status
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SarasotaUnited StatesUnknown status
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ScottsdaleUnited StatesUnknown status
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ScottsdaleUnited StatesUnknown status
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Sherman OaksUnited StatesUnknown status
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SpringfieldUnited StatesUnknown status
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StamfordUnited StatesUnknown status
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StuartUnited StatesUnknown status
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StuartUnited StatesUnknown status
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TampaUnited StatesUnknown status
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TampaUnited StatesUnknown status
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TampaUnited StatesUnknown status
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TampaUnited StatesUnknown status
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Toms RiverUnited StatesUnknown status
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TucsonUnited StatesUnknown status
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TucsonUnited StatesUnknown status
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VieraUnited StatesUnknown status
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WatertownUnited StatesUnknown status
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WellingtonUnited StatesUnknown status
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West Palm BeachUnited StatesUnknown status
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West Palm BeachUnited StatesUnknown status
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WindermereUnited StatesUnknown status
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Winter ParkUnited StatesUnknown status
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Winter ParkUnited StatesUnknown status

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