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NCT04036435CompletedPhase 3

Long-Term Study That Measures the Safety and Efficacy of Deucravacitinib (BMS-986165) in Participants With Psoriasis

An Open-Label, Multi-Center Extension Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis

Source: ClinicalTrials.gov · Last updated 10 Sept 2026

Brief summary (registry, in English)

The main purpose of this study is to evaluate the long-term safety and efficacy of the drug Deucravacitinib (BMS-986165) in participants who have been previously enrolled in an applicable Phase 3 psoriasis study. In addition, the study includes a vaccine cohort to evaluate whether deucravacitinib impacts the humoral immune response to 2 non-live vaccines, the Pneumovax 23 vaccine (pneumococcus), a T-cell independent vaccine, and the Boostrix vaccine (tetanus toxoid), a T-cell dependent vaccine. Additionally, this vaccine cohort assesses the safety of administering these vaccines to subjects with psoriasis receiving deucravacitinib compared to those receiving a placebo.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1466 (actual)
First submitted
25 Jul 2019
Start date
12 Aug 2019
Primary completion date
21 Jul 2026
Lead sponsor
Bristol-Myers Squibb
Diseases
Psoriasis
NCT number
NCT04036435
EU CT number
2022-502361-15-00
EudraCT number
2019-000612-29

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 1466
  • From 12 Aug 2019 to the primary completion date, 21 Jul 2026
  • 283 sites in 20 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

  • Vaccine Cohort:
    • Subject received the Pneumovax 23 vaccine ≤ 5 years before Day 1 or a pneumococcal conjugate vaccine ≤ 1 year before Day 1.
    • Subject received the Boostrix vaccine (as single or part of a combination vaccine) ≤ 5 years before Day 1.

Other illness

  • Any disease or medical condition that the investigator feels that would make the patient unsuitable for this study.
  • To be eligible for the study, a participant must not have active signs or symptoms of tuberculosis (TB) as judged by the investigator.

Other

  • Other protocol-defined inclusion/exclusion criteria apply

Who the study is looking for

  • Completion of the protocol-required treatment period in an applicable study of BMS-986165 in moderate-to-severe psoriasis.
  • Women must not be pregnant, lactating, or breastfeeding.
  • Vaccine Cohort:
    • Subject must have moderate-to-severe plaque psoriasis, be currently receiving deucravacitinib treatment in the main IM011075 LTE cohort in the United States, Canada, or Poland, and must have completed at least one year of deucravacitinib treatment.

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

Full criteria on ClinicalTrials.gov

Sites (283)

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

SiteCityCountrySite status
The Skin Centre
Coordinator of this site? Confirm its status
BenowaAustraliaUnknown status
Local Institution - 0245
Coordinator of this site? Confirm its status
Box HillAustraliaUnknown status
Skin and Cancer Foundation
Coordinator of this site? Confirm its status
CarltonAustraliaUnknown status
Local Institution - 0246
Coordinator of this site? Confirm its status
DarlinghurstAustraliaUnknown status
Sinclair Dermatology
Coordinator of this site? Confirm its status
East MelbourneAustraliaUnknown status
North Eastern Health Specialists
Coordinator of this site? Confirm its status
HectorvilleAustraliaUnknown status
St. George Dermatology & Skin Care Centre
Coordinator of this site? Confirm its status
KogarahAustraliaUnknown status
Local Institution - 0251
Coordinator of this site? Confirm its status
ParkvilleAustraliaUnknown status
Local Institution - 0247
Coordinator of this site? Confirm its status
PerthAustraliaUnknown status
Woden Dermatology
Coordinator of this site? Confirm its status
PhillipAustraliaUnknown status
Local Institution - 0250
Coordinator of this site? Confirm its status
WestmeadAustraliaUnknown status
Local Institution - 0241
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WoolloongabbaAustraliaUnknown status
CCA Medical Research
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AjaxCanadaUnknown status
Beacon Dermatology
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CalgaryCanadaUnknown status
Stratica Medical
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EdmontonCanadaUnknown status
Mediprobe Research
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LondonCanadaUnknown status
Local Institution - 0090
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LondonCanadaUnknown status
Lynderm Research
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MarkhamCanadaUnknown status
DermEdge
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MississaugaCanadaUnknown status
Siena Medical Research
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MontrealCanadaUnknown status
Docteur David Gratton Dermatologue
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MontrealCanadaUnknown status
North Bay Dermatology Centre
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North BayCanadaUnknown status
Office of Dr. Niakosari Firouzeh
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North YorkCanadaUnknown status
Institute of Cosmetic and Laser Surgery
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OakvilleCanadaUnknown status
Local Institution - 0088
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PeterboroughCanadaUnknown status
Local Institution - 0258
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QuébecCanadaUnknown status
Local Institution - 0082
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Richmond HillCanadaUnknown status
SkinFit MD Laser and Cosmetic Clinic
Coordinator of this site? Confirm its status
SurreyCanadaUnknown status
Local Institution - 0132
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TorontoCanadaUnknown status
Toronto Dermatology Centre
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TorontoCanadaUnknown status
Local Institution - 0152
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VancouverCanadaUnknown status
Kim Papp Clinical Research
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WaterlooCanadaUnknown status
XLR8 Medical Research
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WindsorCanadaUnknown status
Wiseman Dermatology Research
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WinnipegCanadaUnknown status
Local Institution
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BeijingChinaUnknown status
Local Institution
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ChangchunChinaUnknown status
Local Institution
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ChengduChinaUnknown status
Local Institution
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ChongqingChinaUnknown status
Local Institution
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DalianChinaUnknown status
Local Institution
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HangzhouChinaUnknown status
Local Institution - 0312
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NanjingChinaUnknown status
Local Institution - 0292
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ShanghaiChinaUnknown status
Local Institution
Coordinator of this site? Confirm its status
TaiyuanChinaUnknown status
Local Institution
Coordinator of this site? Confirm its status
WuhanChinaUnknown status
Nemocnice AGEL Nový Jičín a.s.
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Nový JičínCzechiaCompleted
Fakultni nemocnice Ostrava
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OstravaCzechiaCompleted
Dermskin s.r.o.
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PovelCzechiaCompleted
Clintrial s.r.o.
Coordinator of this site? Confirm its status
Prague 10CzechiaCompleted
Sanatorium profesora Arenbergera
Coordinator of this site? Confirm its status
Praha 1CzechiaCompleted
Krajska zdravotni a.s.
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Usti Nad LabemCzechiaCompleted
Dr. Niesmann And Dr. Othlinghaus GbR
Coordinator of this site? Confirm its status
BochumGermanyCompleted
Praxis fuer Dermatologie und Venerologie
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DresdenGermanyCompleted
Synexus Clinical Research GmbH
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Frankfurt am MainGermanyCompleted
Medizinisches Versorgungszentrum DermaKiel GmbH
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KielGermanyCompleted
Praxis Dr. med. Wilfried Steinborn
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Straubing, BayernGermanyCompleted
CentroDerm GmbH
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WuppertalGermanyCompleted
Hospital Universitario Fundación Alcorcón
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AlcorcónSpainCompleted
Hospital Germans Trias i Pujol
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BadalonaSpainCompleted
Hospital Universitario de Cruces
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BarakaldoSpainCompleted
Hospital General Universitario Reina Sofia
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CórdobaSpainCompleted
El Hospital Universitario De Gran Canaria Dr. Negrin
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Las Palmas De Gran CanariaSpainCompleted
Hospital Universitario Virgen de la Victoria
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MálagaSpainCompleted
Hospital Universitario Quironsalud Madrid
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Pozuelo de AlarcónSpainCompleted
Suomen Terveystalo Oy
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TampereFinlandCompleted
Centre De Pharmacologie Clinique Appliquee A La Dermatologie
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NiceFranceCompleted
MAC Clinical Research - Cannock
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CannockUnited KingdomUnknown status
Synexus - Lancashire Clinical Research Centre
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ChorleyUnited KingdomUnknown status
Synexus - Merseyside Clinical Research Centre
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ChorleyUnited KingdomUnknown status
Synexus - Manchester Clinical Research Centre
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ChorleyUnited KingdomUnknown status
Mounts Bay Medical
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CornwallUnited KingdomUnknown status
The Dudley Group Nhs Foundation Trust
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DudleyUnited KingdomUnknown status
Local Institution - 0212
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DurhamUnited KingdomUnknown status
MAC Clinical Research - Blackpool
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LancashireUnited KingdomUnknown status
Burbage Surgery
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LeicestershireUnited KingdomUnknown status
Guys and Saint Thomas NHS Foundation Trust
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LondonUnited KingdomUnknown status
Salford Royal NHS Foundation Trust
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ManchesterUnited KingdomUnknown status
MAC Clinical Research - Manchester
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ManchesterUnited KingdomUnknown status
Local Institution - 0209
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PrescotUnited KingdomUnknown status
Qualiclinic Kft.
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BudapestHungaryCompleted
SYNEXUS Magyarorszag Kft.
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Budapest IIIHungaryCompleted
Semmelweis University
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Budapest VIIIHungaryCompleted
SYNEXUS Magyarorszag Kft.
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DebrecenHungaryCompleted
University of Debrecen
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DebrecenHungaryCompleted
Synexus Magyarorszag Kft
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GyulaHungaryCompleted
Pécsi Tudományegyetem Klinikai Központ
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Pecs BARANYAHungaryCompleted
Allergo-Derm Bakos Kft
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SzolnokHungaryCompleted
Synexus Magyarorszag Kft
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ZalaegerszegHungaryCompleted
Local Institution - 0237
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HaifaIsraelUnknown status
Local Institution
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Petah TikvaIsraelUnknown status
Local Institution
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Ramat GanIsraelUnknown status
Local Institution - 0069
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FukuokaJapanUnknown status
Hamamatsu University Hospital
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HamamatsuJapanUnknown status
Tokai University Hospital
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IseharaJapanUnknown status
Kobe University Hospital
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KobeJapanUnknown status
Local Institution - 0096
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KumamotoJapanUnknown status
Kurashiki Central Hospital
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KurashikiJapanUnknown status
Local Institution - 0066
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KyotoJapanUnknown status
Local Institution - 0093
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KyotoJapanUnknown status
Local Institution - 0072
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MatsumotoJapanUnknown status
The Jikei University Hospital
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Minato-kuJapanUnknown status
Local Institution - 0065
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NagoyaJapanUnknown status
Local Institution - 0076
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NankokuJapanUnknown status
Local Institution - 0067
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OsakaJapanUnknown status
Local Institution - 0073
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OsakaJapanUnknown status
Sapporo Skin Clinic
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SapporoJapanUnknown status
Jichi Medical University Hospital
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ShimotsukeJapanUnknown status
Local Institution - 0062
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ShinagawaJapanUnknown status
Japan Community Health Care Organization Tokyo Yamate Medical Center
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Shinjuku-kuJapanUnknown status
Tokyo Medical University Hospital
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Shinjuku-kuJapanUnknown status
Local Institution - 0061
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tabashi CityJapanUnknown status
Nihon University Itabashi Hospital
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tabashi CityJapanUnknown status
Mie University Hospital
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TsuJapanUnknown status
Yokohama City University Hospital
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YokohamaJapanUnknown status
Local Institution - 0075
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YokohamaJapanUnknown status
Local Institution
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Bucheon-siSouth KoreaUnknown status
Local Institution - 0054
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BusanSouth KoreaUnknown status
Local Institution
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Goyang-siSouth KoreaUnknown status
Local Institution - 0310
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GwangjuSouth KoreaUnknown status
Local Institution
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Hwaseong-siSouth KoreaUnknown status
Local Institution
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IncheonSouth KoreaUnknown status
Local Institution - 0051
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Seongnam-siSouth KoreaUnknown status
Local Institution - 0306
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Seongnam-siSouth KoreaUnknown status
Local Institution
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SeoulSouth KoreaUnknown status
Local Institution - 0305
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SeoulSouth KoreaUnknown status
Local Institution - 0055
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SeoulSouth KoreaUnknown status
Local Institution - 0053
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SeoulSouth KoreaUnknown status
Local Institution
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SuwonSouth KoreaUnknown status
Local Institution
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Mount CookNew ZealandUnknown status
Local Institution
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TaurangaNew ZealandUnknown status
Osteo Medic s.c. Artur Racewicz Jerzy Supronik
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BialystokPolandCompleted
Clinicmed Daniluk Nowak Sp. k.
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BialystokPolandCompleted
INTER CLINIC Piotr Adrian Klimiuk
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BialystokPolandCompleted
Pratia S.A.
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CracowPolandCompleted
Krakowskie Centrum Medyczne Sp. z o.o.
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CracowPolandCompleted
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
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ElblagPolandCompleted
Synexus Polska Sp z o.o.
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GdanskPolandCompleted
Synexus Polska Sp. z o.o.
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GdyniaPolandCompleted
Zespol Naukowo-Leczniczy Iwolang Dermatologiczne Centrum Uzdrowiskowe Sp. z o.o.
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Iwonicz-ZdrojPolandCompleted
Synexus Polska Sp. z o.o.
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KatowicePolandCompleted
DERMED Centrum Medyczne Sp. z o.o.
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LodzPolandCompleted
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
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LodzPolandCompleted
Centrum Medyczne All-Med
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ŁódźPolandCompleted
Dermoklinika-Medyczne Centrum s.c. M.Kierstan J.Narbutt A.Lesiak
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ŁódźPolandCompleted
Niepubliczny Zakład Opieki Zdrowotnej MED-LASER
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LublinPolandCompleted
Miejski Szpital Zespolony w Olsztynie
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OlsztynPolandCompleted
Dermodent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski S C
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OsielskoPolandCompleted
Solumed Sp. z o.o. sp.k.
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PoznanPolandCompleted
Reumedika Sp. z o.o.
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PoznanPolandCompleted
Lukmed 2 Sp. z o.o.
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SiedlcePolandCompleted
Velocity Skierniewice Sp. z o.o.
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SkierniewicePolandCompleted
Medicover Integrated Clinical Services Sp. z o.o.
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TorunPolandCompleted
Etg Warszawa Sp. z o.o.
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WarsawPolandCompleted
Mcm Polimedica 2 Sp. z o.o.
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WarsawPolandCompleted
Klinika Ambroziak Sp. z o.o.
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WarsawPolandCompleted
Clinical Research Group Sp. z o.o.
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WarsawPolandCompleted
ROYALDERM AGNIESZKA NAWROCKA
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WarszawaPolandCompleted
Dorota Bystrzanowska High­ Med Przychodnia Specjalistyczna
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WarszawaPolandCompleted
dermMedica Sp. z o.o
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WroclawPolandCompleted
WroMedica I Bielicka A Strzalkowska s c
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WroclawPolandCompleted
Centrum Medyczne Oporow
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WroclawPolandCompleted
Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p
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WroclawPolandCompleted
Local Institution - 0289
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San JuanPuerto RicoUnknown status
Local Institution - 0172
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Kazan'RussiaUnknown status
Local Institution - 0187
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KrasnodarRussiaUnknown status
Local Institution - 0175
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MoscowRussiaUnknown status
Local Institution - 0169
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MoscowRussiaUnknown status
Local Institution - 0171
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MoscowRussiaUnknown status
Local Institution - 0190
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RyazanRussiaUnknown status
Local Institution - 0179
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Saint PetersburgRussiaUnknown status
Local Institution - 0182
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Saint PetersburgRussiaUnknown status
Local Institution - 0201
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Saint PetersburgRussiaUnknown status
Local Institution - 0202
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SaratovRussiaUnknown status
Local Institution - 0184
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SmolenskRussiaUnknown status
Local Institution - 0222
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YaroslavlRussiaUnknown status
Local Institution - 0178
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YekaterinburgRussiaUnknown status
Ladulaas AB
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BorasSwedenCompleted
ProbarE i Lund AB
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LundSwedenCompleted
Karolinska University Hospital
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SolnaSwedenCompleted
Local Institution - 0297
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Kaohsiung CityTaiwanUnknown status
Local Institution - 0079
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Kaohsiung CityTaiwanUnknown status
Local Institution
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TaipeiTaiwanUnknown status
Local Institution - 0153
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TaipeiTaiwanUnknown status
Radiant Research - Anderson
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AndersonUnited StatesUnknown status
David Fivenson MD, Dermatology
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Ann ArborUnited StatesUnknown status
Local Institution - 0006
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ArlingtonUnited StatesUnknown status
Bellaire Dermatology
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BellaireUnited StatesUnknown status
Hassman Research Institute
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BerlinUnited StatesUnknown status
Total Skin and Beauty Dermatology Center
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BirminghamUnited StatesUnknown status
Local Institution - 0278
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BirminghamUnited StatesUnknown status
Local Institution - 0170
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Boca RatonUnited StatesUnknown status
Tufts Medical Center
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BostonUnited StatesUnknown status
Local Institution - 0291
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BostonUnited StatesUnknown status
New England Research Associates
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BridgeportUnited StatesUnknown status
PMG Research of Cary
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CaryUnited StatesUnknown status
Clinical Research Center of the Carolinas
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CharlestonUnited StatesUnknown status
Ora
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Chestnut HillUnited StatesUnknown status
Radiant Research - Columbus
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ColumbusUnited StatesUnknown status
ClinOhio Research Services
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ColumbusUnited StatesUnknown status
Local Institution - 0195
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DallasUnited StatesUnknown status
Local Institution - 0015
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DallasUnited StatesUnknown status
Menter Dermatology Research Institute
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DallasUnited StatesUnknown status
Local Institution - 0030
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DallasUnited StatesUnknown status
ERN - Accel Research Sites
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DeLandUnited StatesUnknown status
Local Institution - 0016
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East WindsorUnited StatesUnknown status
Deaconess Clinic Downtown
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EvansvilleUnited StatesUnknown status
Clinical Research Advantage - Evansville - South Kenmore Drive
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EvansvilleUnited StatesUnknown status
Local Institution - 0045
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ExtonUnited StatesUnknown status
Local Institution - 0176
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FairbornUnited StatesUnknown status
Hamzavi Dermatology
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Fort GratiotUnited StatesUnknown status
Johnson Dermatology
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Fort SmithUnited StatesUnknown status
Local Institution - 0046
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Fountain ValleyUnited StatesUnknown status
Local Institution - 0206
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FresnoUnited StatesUnknown status
Rivergate Dermatology - Main Office
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GoodlettsvilleUnited StatesUnknown status
Local Institution - 0037
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GreerUnited StatesUnknown status
Indago Research and Health Center
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HialeahUnited StatesUnknown status
Burke Pharmaceutical Research
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Hot SpringsUnited StatesUnknown status
Center for Clinical Studies Texas Medical Center
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HoustonUnited StatesUnknown status
Dawes Fretzin Dermatology Group
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IndianapolisUnited StatesUnknown status
Local Institution - 0017
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IrvineUnited StatesUnknown status
Clinical Research Solutions - Jackson
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JacksonUnited StatesUnknown status
Forest Hills Dermatology Group
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Kew GardensUnited StatesUnknown status
The Skin Wellness Center
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KnoxvilleUnited StatesUnknown status
Dermatology Associates of Knoxville
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KnoxvilleUnited StatesUnknown status
Shondra L. Smith, M.D.
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Lake CharlesUnited StatesUnknown status
Clinical Research Consortium - Las Vegas
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Las VegasUnited StatesUnknown status
Interspond - Long Beach Clinical Trials
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Long BeachUnited StatesUnknown status
Local Institution - 0236
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Los AngelesUnited StatesUnknown status
Dermatology Research Associates - Los Angeles
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Los AngelesUnited StatesUnknown status
Local Institution - 0040
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LouisvilleUnited StatesUnknown status
Local Institution - 0013
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MariettaUnited StatesUnknown status
Treasure Valley Dermatology & Skin Cancer Center
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MeridianUnited StatesUnknown status
Local Institution - 0234
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MethuenUnited StatesUnknown status
Well Pharma Medical Research
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MiamiUnited StatesUnknown status
LCC Medical Research
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MiamiUnited StatesUnknown status
International Dermatology Research
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MiamiUnited StatesUnknown status
Local Institution - 0216
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MiamiUnited StatesUnknown status
Local Institution - 0007
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Miami LakesUnited StatesUnknown status
Interspond - Savin Medical Group
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Miami LakesUnited StatesUnknown status
Clinical Trials of America - Monroe
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MonroeUnited StatesUnknown status
Associated Skin Care Specialists Minnesota Clinical Study Center
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New BrightonUnited StatesUnknown status
Local Institution - 0058
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New YorkUnited StatesUnknown status
Central Sooner Research
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NormanUnited StatesUnknown status
Coastal Carolina Research Center - Mount Pleasant
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North CharlestonUnited StatesUnknown status
Unity Clinical Research
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Oklahoma CityUnited StatesUnknown status
Austin Institute for Clinical Research - Pflugerville
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PflugervilleUnited StatesUnknown status
Alliance Dermatology and Mohs Center - Phoenix
Coordinator of this site? Confirm its status
PhoenixUnited StatesUnknown status
Arizona Research Center
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PhoenixUnited StatesUnknown status
Local Institution - 0282
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PittsburghUnited StatesUnknown status
Local Institution - 0020
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PlainfieldUnited StatesUnknown status
Local Institution - 0167
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PortlandUnited StatesUnknown status
Local Institution - 0009
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PortlandUnited StatesUnknown status
Local Institution - 0198
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Port OrangeUnited StatesUnknown status
DermCare Experts
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QuincyUnited StatesUnknown status
Local Institution - 0004
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Rapid CityUnited StatesUnknown status
Northwest Arkansas Clinical Trials Center, PLLC
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RogersUnited StatesUnknown status
Dermatology Clinical Research Center of San Antonio
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San AntonioUnited StatesUnknown status
University of Texas Health Science Center at San Antonio
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San AntonioUnited StatesUnknown status
Therapeutics Clinical Research
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San DiegoUnited StatesUnknown status
University Dermatology Group
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San DiegoUnited StatesUnknown status
University of California San Diego Health Systems
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San DiegoUnited StatesUnknown status
Local Institution - 0235
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Sandy SpringsUnited StatesUnknown status
Local Institution - 0094
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San Luis ObispoUnited StatesUnknown status
Clinical Science Institute
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Santa MonicaUnited StatesUnknown status
Synexus - Santa Rosa
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Santa RosaUnited StatesUnknown status
NorthBay Clinical Research
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Santa RosaUnited StatesUnknown status
Local Institution - 0265
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SeattleUnited StatesUnknown status
Local Institution - 0042
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Sherman OaksUnited StatesUnknown status
The South Bend Clinic
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South BendUnited StatesUnknown status
Springfield Clinic
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SpringfieldUnited StatesUnknown status
Stamford Therapeutics Consortium
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StamfordUnited StatesUnknown status
Washington University School of Medicine - West County Dermatology
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St LouisUnited StatesUnknown status
Local Institution - 0218
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Stony BrookUnited StatesUnknown status
Interspond - Acclaim Dermatology
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Sugar LandUnited StatesUnknown status
Interspond - Houston Center for Clinical Research
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Sugar LandUnited StatesUnknown status
Local Institution - 0008
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TampaUnited StatesUnknown status
Local Institution - 0233
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TampaUnited StatesUnknown status
Montefiore Medical Center - Bronx
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The BronxUnited StatesUnknown status
Local Institution - 0025
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TroyUnited StatesUnknown status
Synexus - Orange Grove Family Practice
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TucsonUnited StatesUnknown status
Care Access Research - Walnut Creek
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Walnut CreekUnited StatesUnknown status
Center for Clinical Studies - Webster
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WebsterUnited StatesUnknown status
Dundee Dermatology
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West DundeeUnited StatesUnknown status
Wilmington Dermatology Center
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WilmingtonUnited StatesUnknown status

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