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

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.

Study Overview

• Status: Recruiting
• Conditions: Menstrual Migraine
• Intervention / Treatment: Drug: Rimegepant; Drug: Rimegepant; Drug: Placebo Comparator; Drug: Standard of Care

• Study Type: Interventional
• Enrollment (Estimated): 723
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Argentina
  • Córdoba, Argentina, 5021
    • Recruiting
    • Clínica Privada Gallia
  • Buenos Aires
    • CABA, Buenos Aires, Argentina, 1428
      • Recruiting
      • Fundación para la lucha contra las enfermedades neurológicas de la infancia
    • Ciudad de Buenos Aires, Buenos Aires, Argentina, C1012AAR
      • Recruiting
      • IDIM - Instituto de Investigaciones Metabólicas
  • Buenos Aires F.D.
    • Buenos Aires, Buenos Aires F.D., Argentina, C1128AAF
      • Recruiting
      • Mautalen Salud e Investigación
  • Córdoba Province
    • Cordoba Capital, Córdoba Province, Argentina, 5004
      • Recruiting
      • Hospital Cordoba
  • Tucumán Province
    • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
      • Recruiting
      • Sanatorio del Sur
• Canada
  • Alberta
    • Red Deer, Alberta, Canada, T4P 1K4
      • Recruiting
      • CaRe Clinic
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 1Z9
      • Recruiting
      • OCT Research ULC
    • Surrey, British Columbia, Canada, V3V 0E8
      • Recruiting
      • Centre for Neurology Studies
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3S 1N2
      • Recruiting
      • Centricity Research Halifax Multispecialty
  • Ontario
    • Brampton, Ontario, Canada, L6T 0G1
      • Recruiting
      • Aggarwal and Associates Limited
    • Sarnia, Ontario, Canada, N7T 4X3
      • Recruiting
      • Bluewater Clinical Research Group Inc.
  • Quebec
    • Lévis, Quebec, Canada, G6W0M5
      • Recruiting
      • Centre de Recherche Saint-Louis inc.
• China
  • Qingdao, China, 266042
    • Recruiting
    • Qingdao Central Hospital, University of Health and Rehabilitation Sciences
  • Shanghai, China, 200123
    • Recruiting
    • Shanghai East Hospital
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100044
      • Recruiting
      • Peking University People's Hospital
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400016
      • Recruiting
      • The First Affiliated Hospital of Chongqing Medical University
  • Hebei
    • Shijiazhuang, Hebei, China, 050051
      • Recruiting
      • Hebei General Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210011
      • Recruiting
      • The Second Affiliated Hospital of Nanjing Medical University
    • Suzhou, Jiangsu, China, 215006
      • Recruiting
      • The First Affiliated Hospital of Soochow University
  • Shaanxi
    • Xi'an, Shaanxi, China, 710068
      • Recruiting
      • Shaanxi Provincial People's Hospital
    • Xianyang, Shaanxi, China, 712000
      • Recruiting
      • Xianyang Hospital of Yan'an University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200040
      • Recruiting
      • Huashan Hospital, Fudan University
• Denmark
  • Glostrup Municipality, Denmark, 2600
    • Recruiting
    • Rigshospitalet, Glostrup
  • Viborg, Denmark, 8800
    • Recruiting
    • Region Midtjylland, Regionshospitalet Viborg
• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Charité Universitaetsmedizin Berlin - Campus Mitte
  • Berlin, Germany, 10629
    • Recruiting
    • FutureMeds GmbH
  • Berlin, Germany, 12163
    • Recruiting
    • Neurologie Berlin
  • Mecklenburg-Vorpommern
    • Schwerin, Mecklenburg-Vorpommern, Germany, 19055
      • Recruiting
      • Klinische forschung Schwerin GmbH
• India
  • Andhra Pradesh
    • Guntur, Andhra Pradesh, India, 522001
      • Recruiting
      • Lalitha PVS Institute of Medical Sciences
  • Gujarat
    • Ahmedabad, Gujarat, India, 380060
      • Recruiting
      • Marengo CIMS Hospital, Ahmedabad
  • Karnataka
    • Mangaluru, Karnataka, India, 575002
      • Recruiting
      • Mallikatta Neuro Centre
  • Maharashtra
    • Mumbai, Maharashtra, India, 400008
      • Recruiting
      • Topiwala National Medical College & B. Y. L. Nair Charitable Hospital
    • Nagpur, Maharashtra, India, 440012
      • Recruiting
      • Getwell Hospital and Research Institute
    • Nashik, Maharashtra, India, 422005
      • Recruiting
      • Chopda Medicare & Research Centre Pvt. Ltd: Magnum Heart Institute
  • Rajasthan
    • Ajmer, Rajasthan, India, 305001
      • Recruiting
      • Jawahar Lal Nehru Medical College
• Italy
  • Bologna, Italy, 40139
    • Recruiting
    • Ospedale Bellaria- Azienda USL di Bologna
  • Florence, Italy, 50134
    • Recruiting
    • Azienda Ospedaliera Universitaria Careggi
  • Milan, Italy, 20132
    • Recruiting
    • Ospedale San Raffaele
  • Pavia, Italy, 27100
    • Recruiting
    • Fondazione Istituto Neurologico C. Mondino
  • Roma, Italy, 00166
    • Recruiting
    • IRCCS San Raffaele Roma
  • L'aquila
    • Avezzano, L'aquila, Italy, 67051
      • Recruiting
      • Ospedale Civile SS. Nicola e Filippo Avezzano Pronto Soccorso
  • Lazio
    • Rome, Lazio, Italy, 00128
      • Recruiting
      • Fondazione Policlinico Universitario Campus Biomedico
• Japan
  • Kagoshima, Japan, 892-0844
    • Recruiting
    • Tanaka Neurosurgical Clinic
  • Kagoshima, Japan, 890-0052
    • Recruiting
    • Tanaka Neurosurgery&Headache Clinic
  • Hyōgo
    • Kobe, Hyōgo, Japan, 658-0064
      • Recruiting
      • Konan Medical Center
  • Kyoto
    • Kyoto-shi Shimogyo-ku, Kyoto, Japan, 600-8811
      • Recruiting
      • Tatsuoka Neurology Clinic
  • Miyagi
    • Sendai, Miyagi, Japan, 982-0014
      • Recruiting
      • Sendai Headache and Neurology Clinic
  • Tokyo
    • Shibuya-ku, Tokyo, Japan, 151-0051
      • Recruiting
      • Tokyo Headache Clinic
  • Yamanashi
    • Kai, Yamanashi, Japan, 400-0124
      • Recruiting
      • Nagaseki Headache Clinic
• Mexico
  • Aguascalientes, Mexico, 20230
    • Not yet recruiting
    • San Peregrino Unidad de Investigación
  • Chihuahua City, Mexico, 31203
    • Not yet recruiting
    • Operadora Unidad de Investigación en Salud de Chihuahua
  • Cuautitlán Izcalli, Mexico, 54750
    • Recruiting
    • PCR Cuautitlán Izcalli
  • Tlalnepantla, Mexico, 54055
    • Recruiting
    • Clinical Research Institute S.C.
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44130
      • Not yet recruiting
      • Centro de Investigacion Medico Biologica y Terapia Avanzada
  • Mexico City
    • Mexico City, Mexico City, Mexico, 06700
      • Not yet recruiting
      • Clinstile, S.A. de C.V.
  • Yucatán
    • Mérida, Yucatán, Mexico, 97070
      • Not yet recruiting
      • Medical Care and Research SA de CV
• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6532 SZ
      • Recruiting
      • Canisius-Wilhelmina Ziekenhuis
  • Overijssel
    • Zwolle, Overijssel, Netherlands, 8025 AB
      • Recruiting
      • Isala Klinieken Stichting
  • South Holland
    • Leiden, South Holland, Netherlands, 2333 ZA
      • Recruiting
      • Leids Universitair Medisch Centrum (LUMC)
• Poland
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-539
      • Recruiting
      • Specjalistyczne Gabinety Sp. z o. o.
    • Oświęcim, Lesser Poland Voivodeship, Poland, 32-600
      • Recruiting
      • Instytut Zdrowia Dr Boczarska Jedynak
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 52-210
      • Recruiting
      • MIGRE Polskie Centrum Leczenia Migreny
  • Lublin Voivodeship
    • Lublin, Lublin Voivodeship, Poland, 20-064
      • Recruiting
      • NZOZ Neuromed M.i M. Nastaj
    • Lublin, Lublin Voivodeship, Poland, 20-582
      • Recruiting
      • Indywidualna Praktyka Lekarska Dr Hab. Med. Anna Szczepanska-Szerej
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 00-215
      • Recruiting
      • FutureMeds Warszawa Centrum
    • Warsaw, Masovian Voivodeship, Poland, 01-018
      • Recruiting
      • Dr Sekowska Leczenie Bolu
  • Silesian Voivodeship
    • Katowice, Silesian Voivodeship, Poland, 40-282
      • Recruiting
      • Silmedic
• South Korea
  • Kyǒnggi-do
    • Hwaseong-si, Kyǒnggi-do, South Korea, 18450
      • Recruiting
      • Hallym University Dongtan Sacred Heart Hospital
  • Seoul-teukbyeolsi [seoul]
    • Gangseo-gu, Seoul-teukbyeolsi [seoul], South Korea, 07804
      • Recruiting
      • Ewha Womans University Seoul Hospital
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03722
      • Recruiting
      • Severance Hospital, Yonsei University Health System
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03181
      • Recruiting
      • Kangbuk Samsung Hospital
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 01830
      • Recruiting
      • Nowon Eulji Medical Center, Eulji University
• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitari Vall d'Hebron
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital Universitario La Paz
  • Madrid, Spain, 28006
    • Recruiting
    • Hospital La Princesa
  • Seville, Spain, 41013
    • Recruiting
    • Hospital Universitario Virgen del Rocio
  • Valladolid, Spain, 47010
    • Recruiting
    • Hospital Clinico Universitario de Valladolid
  • Zaragoza, Spain, 50009
    • Recruiting
    • Hospital Clínico Universitario Lozano Blesa
  • Barcelona [barcelona]
    • Barcelona, Barcelona [barcelona], Spain, 08036
      • Recruiting
      • Hospital Clinic de Barcelona
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Recruiting
      • Hospital Universitario Marques de Valdecilla
  • Cádiz
    • Chiclana de la Frontera, Cádiz, Spain, 11139
      • Recruiting
      • FutureMeds Spain Cádiz
• United Kingdom
  • Sheffield, United Kingdom, S2 5FX
    • Recruiting
    • Panthera Biopartners - Sheffield
  • Bristol, CITY of
    • Bristol, Bristol, CITY of, United Kingdom, BS37 4AX
      • Recruiting
      • West Walk Surgery
  • Buckinghamshire
    • Milton Keynes, Buckinghamshire, United Kingdom, MK15 0DU
      • Recruiting
      • Bioluminux
  • EAST Yorkshire
    • Hull, EAST Yorkshire, United Kingdom, HU3 2JZ
      • Recruiting
      • Hull University Teaching Hospitals NHS Trust
  • England
    • London, England, United Kingdom, W1G 8TA
      • Recruiting
      • Re:Cognition Health - London
  • Liverpool
    • Fazakerley, Liverpool, United Kingdom, L9 7LJ
      • Recruiting
      • The Walton Centre NHS Foundation Trust
  • North Yorkshire
    • York, North Yorkshire, United Kingdom, YO24 4LJ
      • Recruiting
      • Panthera Clinic - York
  • Scotland
    • Glasgow, Scotland, United Kingdom, G51 4TY
      • Recruiting
      • Panthera Biopartners - Glasgow
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Recruiting
      • Mayo Clinic Hospital
    • Phoenix, Arizona, United States, 85054
      • Recruiting
      • Mayo Clinic Specialty Building
    • Scottsdale, Arizona, United States, 85259
      • Recruiting
      • Mayo Clinic Arizona
  • California
    • Canoga Park, California, United States, 91303
      • Recruiting
      • Hope Clinical Research, Inc.
    • Colton, California, United States, 92324
      • Recruiting
      • Axiom Research
    • Walnut Creek, California, United States, 94598
      • Recruiting
      • Diablo Clinical Research, Inc.
  • Florida
    • Aventura, Florida, United States, 33180
      • Recruiting
      • VIN - Aventura
    • Hallandale, Florida, United States, 33009
      • Recruiting
      • Velocity Clinical Research, Hallandale Beach
    • Jacksonville, Florida, United States, 32216
      • Recruiting
      • Jacksonville Center for Clinical Research
  • Georgia
    • Marietta, Georgia, United States, 30067
      • Recruiting
      • Urban Family Practice Associates
    • Stockbridge, Georgia, United States, 30281
      • Recruiting
      • Clinical Research Atlanta
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Recruiting
      • St Luke's Clinic - Neurology
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Recruiting
      • Alliance for Multispecialty Research - Medisphere Medical Research Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Recruiting
      • Michigan Headache & Neurological Institute
  • Missouri
    • Springfield, Missouri, United States, 65807
      • Recruiting
      • Clinvest Headlands Llc
    • Weldon Spring, Missouri, United States, 63304
      • Recruiting
      • St. Charles Clinical Research
  • Nebraska
    • Papillion, Nebraska, United States, 68046
      • Recruiting
      • McGill Family Practice
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Recruiting
      • Excel Clinical Research, LLC
  • New York
    • Rochester, New York, United States, 14609
      • Recruiting
      • Rochester Clinical Research
    • The Bronx, New York, United States, 10461
      • Recruiting
      • Montefiore Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27713
      • Recruiting
      • Carolina Women's Research and Wellness Center
  • Ohio
    • Centerville, Ohio, United States, 45459
      • Recruiting
      • Dayton Center for Neurological Disorders
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Recruiting
      • Clinical Research of Philadelphia
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University, Jefferson Headache Center
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • Recruiting
      • Velocity Clinical Research, Providence
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Recruiting
      • Alliance for Multispecialty Research, LLC
    • Knoxville, Tennessee, United States, 37909
      • Recruiting
      • Alliance for Multispecialty Research, LLC
    • Knoxville, Tennessee, United States, 37909
      • Recruiting
      • AMR Clinical
  • Texas
    • Austin, Texas, United States, 78731
      • Recruiting
      • FutureSearch Trials of Neurology
  • Utah
    • West Valley City, Utah, United States, 84119
      • Active, not recruiting
      • ChronicleBio
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Recruiting
      • Charlottesville Medical Research
    • McLean, Virginia, United States, 22101
      • Recruiting
      • MedStar Health Neurology/MedStar Georgetown Headache Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participant has regular menstrual cycles ≥24 days and ≤34 days
2. 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
3. A history of menstrual migraine attacks of at least 3 months
4. 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.
5. 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

Exclusion Criteria:

1. Greater than 6 migraine days per month that are outside of the perimenstrual period in the 3 months prior to Screening
2. 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
3. History of retinal migraine, basilar migraine or hemiplegic migraine
4. Current diagnosis of schizophrenia, bipolar, or borderline personality disorder
5. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo Comparator; Matching placebo oral disintegrating tablets for 7 days
Active Comparator: Standard of Care	Drug: Standard of Care; Standard of care for acute treatment as needed
Experimental: Rimegepant 75 mg Orally Disintegrating Tablet (ODT) 7-Day Dosing	Drug: Rimegepant; Rimegepant 75 mg ODT for 7 days; Drug: Rimegepant; Rimegepant 75 mg ODT for acute treatment as needed
Experimental: Rimegepant 75 mg Orally Disintegrating Tablet (ODT) Acute Treatment Dosing	Drug: Rimegepant; Rimegepant 75 mg ODT for 7 days; Drug: Rimegepant; Rimegepant 75 mg ODT for acute treatment as needed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from the Observation Period in number of migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase	Change from Observation Period in the number of migraine days per the 5-day perimenstrual period	5 months (5 menstrual cycles)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from the Observation Period in number of headache days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase	Change from the Observation Period in number of headache days per 5-day perimenstrual period	5 months (5 menstrual cycles)
Percentage of participants with ≥50% reduction from the Observation Period in number of migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase (50% responder)	Patients with ≥50% reduction from the Observation Period in number of migraine days per 5-day perimenstrual period	5 months (5 menstrual cycles)
Mean change from the Observation Period in number of acute migraine medication days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase	Change from the Observation Period in number of acute migraine medication days per 5-day perimenstrual period	5 months (5 menstrual cycles)
Mean change from the Observation Period in number of acute migraine-specific medication days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase	Change from the Observation Period in number of acute migraine specific medication days per 5-day perimenstrual period	5 months (5 menstrual cycles)
Mean change from the Observation Period in number of migraine days with moderate-severe functional disability per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase	Change from the Observation Period in number of migraine days with moderate-severe functional disability per 5-day perimenstrual period	5 months (5 menstrual cycles)
Mean change from the Observation Period in number of moderate-severe headache days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase	Change from the Observation Period in number of moderate-severe headache days per 5-day perimenstrual period	5 months (5 menstrual cycles)
Mean change from the Observation Period in number of moderate-severe migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase	Change from the Observation Phase in number of moderate-severe migraine days per 5-day perimenstrual period	5 months (5 menstrual cycles)
Mean change from baseline in the MiCOAS Cognition score at postdosing (ie, 1 day after the 7-day dosing period) across each cycle of the Double-Blind Treatment Phase	Change from baseline in the MiCOAS Cognition score at post-dosing across each cycle	5 months (5 menstrual cycles)
Mean change from the Observation Period in monthly migraine days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase	Change from the Observation Phase in monthly migraine days	5 months (5 menstrual cycles)
Mean change from the Observation Period in monthly headache days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase	Change from the Observation Phase in monthly headache days	5 months (5 menstrual cycles)
Mean change from the Observation Phase in monthly acute migraine-specific medication days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase	Change from the Observation Phase in monthly acute migraine-specific medication days	5 months (5 menstrual cycles)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2025
• Primary Completion (Estimated): November 29, 2026
• Study Completion (Estimated): March 30, 2027

Study Registration Dates

• First Submitted: October 11, 2024
• First Submitted That Met QC Criteria: October 11, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Headache Disorders, Primary; Headache Disorders; Menstruation Disturbances; Migraine Disorders; Premenstrual Syndrome; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care; rimegepant sulfate
• Other Study ID Numbers: C4951063; NCT06641466 (Registry Identifier: ClinicalTrials.gov)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No