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NCT06641466RecruitingPhase 3

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, PARALLEL GROUP STUDY TO INVESTIGATE INTERMITTENT PREVENTION OF MENSTRUAL MIGRAINE WITH RIMEGEPANT COMPARED WITH PLACEBO IN WOMEN PARTICIPANTS 18 TO 45 YEARS OF AGE

Source: ClinicalTrials.gov · Last updated 9 Jul 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the efficacy and safety of rimegepant when administered during the peri-menstrual period (PMP) for intermittent prevention of migraine in women who experience menstrual migraine attacks.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
723 (estimated)
First submitted
11 Oct 2024
Start date
Mar 2025
Primary completion date
Nov 2026
Lead sponsor
Pfizer
Diseases
Migraine
NCT number
NCT06641466
EU CT number
2024-517121-10-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 723
  • From Mar 2025 to the primary completion date, Nov 2026
  • 122 sites in 15 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

  • Greater than 6 migraine days per month that are outside of the perimenstrual period in the 3 months prior to Screening
  • A diagnosis of chronic migraine or a history of more than 14 headache days per month on average, in the 3 months prior to Screening

Other illness

  • History of retinal migraine, basilar migraine or hemiplegic migraine
  • Current diagnosis of schizophrenia, bipolar, or borderline personality disorder
  • Other pain syndromes (eg, fibromyalgia, complex regional pain syndrome), or significant neurological disorders (other than migraine), or other medical conditions (including endocrine and gynecological eg, severe dysmenorrhea

Who the study is looking for

  • Participant has regular menstrual cycles ≥24 days and ≤34 days
  • A minimum 1-year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition
  • A history of menstrual migraine attacks of at least 3 months
  • Participant reported history of experiencing at least 1 migraine attack during the perimenstrual period in at least 2 out of 3 menstrual cycles immediately prior to screening.
  • If the participant is receiving a permitted background continuous prophylactic migraine medication, the medication dose must be stable for at least 3 months prior to the Screening visit and, the dose is not expected to change during the course of the study

Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (122)

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

SiteCityCountrySite status
IDIM - Instituto de Investigaciones Metabólicas
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Buenos AiresArgentinaRecruiting
Mautalen Salud e Investigación
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Buenos AiresArgentinaRecruiting
Fundación para la lucha contra las enfermedades neurológicas de la infancia
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CABAArgentinaRecruiting
Clínica Privada Gallia
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CórdobaArgentinaRecruiting
Hospital Cordoba
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Cordoba CapitalArgentinaRecruiting
Sanatorio del Sur
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San Miguel de TucumánArgentinaRecruiting
Aggarwal and Associates Limited
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BramptonCanadaRecruiting
Centricity Research Halifax Multispecialty
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HalifaxCanadaRecruiting
OCT Research ULC
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KelownaCanadaRecruiting
Centre de Recherche Saint-Louis inc.
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LévisCanadaRecruiting
CaRe Clinic
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Red DeerCanadaRecruiting
Bluewater Clinical Research Group Inc.
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SarniaCanadaRecruiting
Centre for Neurology Studies
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SurreyCanadaRecruiting
Peking University People's Hospital
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BeijingChinaRecruiting
The First Affiliated Hospital of Chongqing Medical University
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ChongqingChinaRecruiting
The Second Affiliated Hospital of Nanjing Medical University
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NanjingChinaRecruiting
Qingdao Central Hospital, University of Health and Rehabilitation Sciences
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QingdaoChinaRecruiting
Shanghai East Hospital
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ShanghaiChinaRecruiting
Huashan Hospital, Fudan University
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ShanghaiChinaRecruiting
Hebei General Hospital
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ShijiazhuangChinaRecruiting
The First Affiliated Hospital of Soochow University
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SuzhouChinaRecruiting
Shaanxi provincial people's hospital
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Xi'anChinaRecruiting
Xianyang Hospital of Yan'an University
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XianyangChinaRecruiting
FutureMeds GmbH
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BerlinGermanyActive, not recruiting
Neurologie Berlin
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BerlinGermanyActive, not recruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyActive, not recruiting
Klinische Forschung Schwerin GmbH
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SchwerinGermanyActive, not recruiting
Rigshospitalet
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GlostrupDenmarkActive, not recruiting
Region Midtjylland
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ViborgDenmarkActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Futuremeds Spain S.L.
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Chiclana De La FronteraSpainActive, not recruiting
Hospital Universitario de la Princesa
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MadridSpainActive, not recruiting
Hospital Universitario La Paz
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MadridSpainActive, not recruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainActive, not recruiting
Hospital Clínico Universitario de Valladolid
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ValladolidSpainActive, not recruiting
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainActive, not recruiting
West Walk Surgery
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BristolUnited KingdomRecruiting
The Walton Centre NHS Foundation Trust
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FazakerleyUnited KingdomRecruiting
Panthera Biopartners - Glasgow
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GlasgowUnited KingdomRecruiting
Hull University Teaching Hospitals NHS Trust
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HullUnited KingdomRecruiting
Re:Cognition Health - London
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LondonUnited KingdomRecruiting
Bioluminux
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Milton KeynesUnited KingdomRecruiting
Panthera Biopartners - Sheffield
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SheffieldUnited KingdomRecruiting
Panthera Clinic - York
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YorkUnited KingdomRecruiting
Marengo CIMS Hospital, Ahmedabad
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AhmedabadIndiaRecruiting
Jawahar Lal Nehru Medical College
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AjmerIndiaRecruiting
Lalitha PVS Institute of Medical Sciences
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GunturIndiaRecruiting
Sanjay Gandhi Post Graduate Institute of Medical Sciences
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LucknowIndiaRecruiting
Mallikatta Neuro Centre
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MangaluruIndiaRecruiting
Topiwala National Medical College & B. Y. L. Nair Charitable Hospital
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MumbaiIndiaRecruiting
Getwell Hospital and Research Institute
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NagpurIndiaRecruiting
Chopda Medicare & Research Centre Pvt. Ltd - Magnum Heart Institute
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NashikIndiaRecruiting
Azienda Unita Sanitaria Locale Di Bologna
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BolognaItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Careggi
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FlorenceItalyActive, not recruiting
Azienda Sanitaria Locale Avezzano Sulmona L'Aquila
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L'aquilaItalyActive, not recruiting
Ospedale San Raffaele S.r.l.
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MilanItalyActive, not recruiting
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
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PaviaItalyActive, not recruiting
Irccs San Raffaele Roma S.r.l.
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RomeItalyActive, not recruiting
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
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RomeItalyActive, not recruiting
Tanaka Neurosurgical Clinic
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KagoshimaJapanRecruiting
Tanaka Neurosurgery & Headache Clinic
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KagoshimaJapanRecruiting
Nagaseki Headache Clinic
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KaiJapanRecruiting
Konan Medical Center
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KobeJapanRecruiting
Tatsuoka Neurology Clinic
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Kyoto-shi Shimogyo-kuJapanRecruiting
Sendai Headache and Neurology Clinic
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SendaiJapanRecruiting
Tokyo Headache Clinic
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Shibuya-kuJapanRecruiting
Ewha Womans University Seoul Hospital
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Gangseo-guSouth KoreaRecruiting
Hallym University Dongtan Sacred Heart Hospital
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Hwaseong-siSouth KoreaRecruiting
Nowon Eulji Medical Center, Eulji University
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SeoulSouth KoreaRecruiting
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaRecruiting
Kangbuk Samsung Hospital
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SeoulSouth KoreaRecruiting
San Peregrino Unidad de Investigacion
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AguascalientesMexicoRecruiting
Operadora Unidad de Investigación en Salud de Chihuahua
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Chihuahua CityMexicoRecruiting
PCR Cuautitlán Izcalli
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Cuautitlán IzcalliMexicoRecruiting
Centro de Investigación Médico Biológica y Terapia Avanzada
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GuadalajaraMexicoRecruiting
Medical Care and Research Sa de Cv
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MéridaMexicoRecruiting
Clinstile, S.A. de C.V.
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Mexico CityMexicoRecruiting
Clinical Research Institute S.C.
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TlalnepantlaMexicoRecruiting
Leids Universitair Medisch Centrum (LUMC)
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LeidenNetherlandsActive, not recruiting
Canisius Wilhelmina Ziekenhuis
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NijmegenNetherlandsActive, not recruiting
Isala Klinieken Stichting
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ZwolleNetherlandsActive, not recruiting
Specjalistyczne Gabinety Sp. z o.o.
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CracowPolandActive, not recruiting
Silmedic Sp. z o.o.
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KatowicePolandActive, not recruiting
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.
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LublinPolandActive, not recruiting
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej
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LublinPolandActive, not recruiting
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
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OswiecimPolandActive, not recruiting
Futuremeds Sp. z o.o.
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WarsawPolandActive, not recruiting
Dr Sękowska Leczenie Bólu
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WarsawPolandActive, not recruiting
MIGRE Polskie Centrum Leczenia Migreny
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WroclawPolandActive, not recruiting
Michigan Headache & Neurological Institute
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Ann ArborUnited StatesRecruiting
FutureSearch Trials of Neurology
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AustinUnited StatesRecruiting
VIN - Aventura
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AventuraUnited StatesRecruiting
Hope Clinical Research, Inc.
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Canoga ParkUnited StatesRecruiting
Dayton Center for Neurological Disorders
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CentervilleUnited StatesRecruiting
Charlottesville Medical Research
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CharlottesvilleUnited StatesRecruiting
Axiom Research
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ColtonUnited StatesRecruiting
FutureSearch Trials of Dallas
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DallasUnited StatesRecruiting
Carolina Women's Research and Wellness Center
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DurhamUnited StatesRecruiting
Velocity Clinical Research, Providence
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East GreenwichUnited StatesRecruiting
Alliance for Multispecialty Research - Medisphere Medical Research Center
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EvansvilleUnited StatesRecruiting
Velocity Clinical Research, Hallandale Beach
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HallandaleUnited StatesRecruiting
Jacksonville Center for Clinical Research
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JacksonvilleUnited StatesRecruiting
Alliance for Multispecialty Research, LLC
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KnoxvilleUnited StatesRecruiting
AMR Clinical
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KnoxvilleUnited StatesRecruiting
Excel Clinical Research, LLC
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Las VegasUnited StatesRecruiting
Urban Family Practice Associates
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MariettaUnited StatesRecruiting
MedStar Health Neurology/MedStar Georgetown Headache Center
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McLeanUnited StatesRecruiting
St Luke's Clinic - Neurology
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MeridianUnited StatesRecruiting
McGill Family Practice
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PapillionUnited StatesRecruiting
Clinical Research of Philadelphia
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PhiladelphiaUnited StatesRecruiting
Thomas Jefferson University, Jefferson Headache Center
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PhiladelphiaUnited StatesRecruiting
Mayo Clinic Specialty Building
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PhoenixUnited StatesRecruiting
Mayo Clinic Hospital
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PhoenixUnited StatesRecruiting
Rochester Clinical Research
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RochesterUnited StatesRecruiting
Mayo Clinic - Arizona
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ScottsdaleUnited StatesRecruiting
Clinvest Headlands LLC
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SpringfieldUnited StatesRecruiting
Clinical Research Atlanta
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StockbridgeUnited StatesRecruiting
Montefiore Medical Center
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The BronxUnited StatesRecruiting
Diablo Clinical Research, Inc.
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Walnut CreekUnited StatesRecruiting
St. Charles Clinical Research
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Weldon SpringUnited StatesRecruiting

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