A Study to Verify the Clinical Benefit of Aducanumab in Participants With Early Alzheimer's Disease
NCT ID: NCT05310071
Last Updated: 2025-04-23
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
1027 participants
INTERVENTIONAL
2022-06-02
2024-08-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Aducanumab
Participants will receive aducanumab, up to 10 milligrams per kilogram (mg/kg), monthly (once every four weeks), administered as intravenous (IV) infusion.
Aducanumab
Administered as specified in the treatment arm.
Placebo
Participants will receive placebo, monthly (once every four weeks), administered as IV infusion.
Placebo
Administered as specified in the treatment arm.
Interventions
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Aducanumab
Administered as specified in the treatment arm.
Placebo
Administered as specified in the treatment arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have a history of subjective memory decline with gradual onset and slow progression over the 6 months before Screening, confirmed by study partner
* The participant must have 1 informant/care partner who, in the Investigator's opinion, has frequent and sufficient contact with the participant (at least 10 hours/week in person or by phone) as to be able to provide accurate information about the participant's cognitive and functional abilities over time
* Must meet all of the following clinical criteria for MCI due to Alzheimer's disease or mild Alzheimer's disease according to National Institute on Aging and Alzheimer's Association (NIA-AA) criteria
1. Have an MMSE score between 22 and 30 inclusive
2. Have a CDR memory score \>0.5
3. Have a Clinical Dementia Rating Scale Global Score (CDR-GS) of 0.5 or 1.0
4. Have a Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score of 85 or lower indicative of objective cognitive impairment
* Apart from a clinical diagnosis of early Alzheimer's disease, the participant must be in good health as determined by the Investigator based on medical history and screening assessments
* Must consent to apolipoprotein E (ApoE) genotyping. (Note: Participants are not required to be ApoE ε4 carriers)
Exclusion Criteria
* Clinically significant and/or unstable psychiatric illness within 6 months prior to Screening
* Transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year prior to Screening
* History of severe allergic or anaphylactic reactions or of hypersensitivity to any of the inactive ingredients in the drug product
* Participation in any study with purported disease-modifying effect in Alzheimer's disease within 12 months prior to Screening unless documentation of receipt of placebo is available
* Current use or previous use of medications with a purported disease-modifying effect in Alzheimer's disease, outside of investigational studies
* Use of any medications that, in the opinion of the Investigator, may contribute to cognitive impairment, put the participant at higher risk for AEs, or impair the participant's ability to perform cognitive testing or complete study procedures
* Use of any investigational drug
* Prior exposure to aducanumab either commercially or by participation in a previous study with aducanumab. (Participants are eligible if they did not receive active aducanumab.)
* A negative PET scan result with any amyloid-targeting ligand within 12 months prior to Screening
60 Years
85 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Gilbert Neurology Partners, PLLC
Gilbert, Arizona, United States
Xenoscience Inc.
Phoenix, Arizona, United States
Banner Alzheimer's Institute
Phoenix, Arizona, United States
Barrow Neurological Institute
Phoenix, Arizona, United States
HonorHealth Neurology
Scottsdale, Arizona, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
Banner Sun Health Research Institute
Sun City, Arizona, United States
Banner Alzheimer's Institute
Tucson, Arizona, United States
Health Initiatives Research
Fayetteville, Arkansas, United States
Sun Valley Behaivoral Med Center
El Centro, California, United States
Neuropain Medical Center
Fresno, California, United States
Neurology Center of North Orange County
Fullerton, California, United States
Irvine Center for Clinical Research, Inc.
Irvine, California, United States
Mary S. Easton Center for Alzheimer's Disease Research, UCLA
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Stanford Hospital and Clinics
Palo Alto, California, United States
VA Palo Alto Health Care System
Palo Alto, California, United States
Anderson Clinical Research
Redlands, California, United States
Sutter Health-San Francisco
San Francisco, California, United States
University of California San Francisco (PARENT)
San Francisco, California, United States
The Neuron Clinic
San Marcos, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
California Neuroscience Research, LLC
Sherman Oaks, California, United States
Viking Clinical Research Center
Temecula, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Mountain Neurological Research Center
Basalt, Colorado, United States
Yale University
Fairfield, Connecticut, United States
Institute for Neurodegenerative Disorders (IND)
New Haven, Connecticut, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut, United States
Howard University Health Sciences
Washington D.C., District of Columbia, United States
Neurology of Central Florida Research Center, LLC
Altamonte Springs, Florida, United States
JEM Research Institute
Atlantis, Florida, United States
Neurology Offices of South Florida, PLLC
Boca Raton, Florida, United States
ECommunity Research, LLC
Boca Raton, Florida, United States
Nova Clinical Research, LLC
Bradenton, Florida, United States
JY Research Institute
Cutler Bay, Florida, United States
Brain Matters Research
Delray Beach, Florida, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States
Infinity Clinical Research, LLC
Hollywood, Florida, United States
Charter Research, LLC
Lady Lake, Florida, United States
ARS - Lake Oconee
Lakeland, Florida, United States
Medical Research Center
Miami, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
K2 Medical Research, LLC
Ocoee, Florida, United States
K2 Medical Research, LLC
Orlando, Florida, United States
K2 Medical Research
Orlando, Florida, United States
Headlands Research LLC
Orlando, Florida, United States
Conquest Research
Orlando, Florida, United States
Quantum Laboratories Inc.
Pompano Beach, Florida, United States
United Medical Research
Port Orange, Florida, United States
Brain Matters Research
Stuart, Florida, United States
K2 Medical Research Tampa
Tampa, Florida, United States
USF Health Byrd Institute
Tampa, Florida, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States
Great Lakes Clinical Trials, LLC Ravenswood dba Flourish Research
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Alexian Brothers Medical Center - Neuroscience Research Institute
Elk Grove Village, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
University of Kansas Medical Center Research Institute, Inc.
Fairway, Kansas, United States
Ascension Via Christi Research, a division of Ascension Via Christi Hospitals Wichita, Inc.
Wichita, Kansas, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
Ochsner Health System PARENT
New Orleans, Louisiana, United States
LSU Health Sciences Center Shreveport
Shreveport, Louisiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
McLean Hospital
Belmont, Massachusetts, United States
Brigham and Women's Hospital Department of Neurology
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
ActivMed Practices and Research
Methuen, Massachusetts, United States
Boston Center for Memory
Newton, Massachusetts, United States
Donald S. Marks, M.D., P.C.
Plymouth, Massachusetts, United States
Wayne State University - Detroit Medical Center
Detroit, Michigan, United States
Michigan Institute for Neurological Disorders
Farmington Hills, Michigan, United States
Center for Memory and Aging
Saint Paul, Minnesota, United States
Hattiesburg Clinic, PA
Hattiesburg, Mississippi, United States
Sharlin Health and Neurology
Ozark, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, United States
Las Vegas Medical Research
Las Vegas, Nevada, United States
The Cognitive Research Center of New Jersey
Springfield, New Jersey, United States
CenExel Advanced Memory Research Institute of NJ
Toms River, New Jersey, United States
Neurological Associates of Albany, PC
Albany, New York, United States
Dent Neurologic Institute
Amherst, New York, United States
Social Psychiatry Research Institute (SPRI)
Brooklyn, New York, United States
New York University Medical Center PRIME
New York, New York, United States
Mount Sinai
New York, New York, United States
South Shore Neurologic Associates, P.C.
Patchogue, New York, United States
Finger Lakes Clinical Research
Rochester, New York, United States
University of Rochester - PARENT
Rochester, New York, United States
Richmond Behavioral Associates ERG Clinical Research - New York PLLC
Staten Island, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
IMA Evaluations LLC
Tarrytown, New York, United States
Duke University
Durham, North Carolina, United States
AMC Research, LLC
Matthews, North Carolina, United States
Wake Forest Baptist Health Sciences
Winston-Salem, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Neuro-Behavioral Clinical Research, Inc.
North Canton, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Central States Research, LLC
Tulsa, Oklahoma, United States
Oregon Health & Science University (OHSU)
Portland, Oregon, United States
Abington Neurological Associates, LTD
Abington, Pennsylvania, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States
Penn Memory Center
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
East Providence, Rhode Island, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, United States
Butler Hospital
Providence, Rhode Island, United States
Coastal Neurology PA
Port Royal, South Carolina, United States
Neurology Clinic, PC
Cordova, Tennessee, United States
Genesis Neuroscience Clinic
Knoxville, Tennessee, United States
Senior Adult Specialty Research
Austin, Texas, United States
Headlands Research - Brownsville
Brownsville, Texas, United States
Kerwin Medical Center
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
University of North Texas Health Science Center
Fort Worth, Texas, United States
Baylor College Of Medicine
Houston, Texas, United States
The Methodist Hospital Research Institute
Houston, Texas, United States
Clinical Trial Network LLC
Houston, Texas, United States
Central Texas Neurology Consultants
Round Rock, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
The Memory Clinic
Bennington, Vermont, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Glennan Center for Geriatrics and Gerontology
Norfolk, Virginia, United States
National Clinical Research Inc. - Richmond
Richmond, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
Kingfisher Cooperative, LLC
Spokane, Washington, United States
University of Wisconsin-Madison
Madison, Wisconsin, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin, United States
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
KaRa Institute of Neurological Diseases
Macquarie Park, New South Wales, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Frankston Hospital
Frankston, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Australian Alzheimer's Research Foundation
Nedlands, Western Australia, Australia
UZ Leuven
Leuven, Flemish Brabant, Belgium
AZ Sint-Jan
Bruges, , Belgium
Universitair Ziekenhuis Brussel
Brussels, , Belgium
AZ Groeninge
Kortrijk, , Belgium
Trial Tech Tecnologia em Pesquisas com Medicamentos Ltda
Curitiba, Paraná, Brazil
Instituto de Neurologia de Curitiba - Hospital Ecoville
Curitiba, Paraná, Brazil
IMV Pesquisa Neurologica Sociedade Simples Ltda
Porto Alegre, Rio Grande do Sul, Brazil
Instituto do Cerebro do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
IPq-HCFMUSP - Instituto de Psiquiatria do Hospital das Clínicas da FMUSP
São Paulo, São Paulo, Brazil
University of Calgary - Heritage Medical Research Clinic
Calgary, Alberta, Canada
UBC Hospital
Vancouver, British Columbia, Canada
Centricity Research Halifax
Halifax, Nova Scotia, Canada
Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic
Ottawa, Ontario, Canada
Kawartha Centre - Redefining Healthy Aging
Peterborough, Ontario, Canada
Toronto Memory Program (Neurology Research Inc.)
Toronto, Ontario, Canada
Centricity Research Toronto LMC
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Baycrest Centre for Geriatric Care
Toronto, Ontario, Canada
Clinique de la Memoire de l'Outaouais
Gatineau, Quebec, Canada
MoCA Research and Innovation Inc
Greenfield Park, Quebec, Canada
Montreal Neurological Institute Clinical Research Unit
Montreal, Quebec, Canada
CHU de Quebec- Hopital de l Enfant Jesus
Québec, , Canada
Terveystalo Ruoholahti
Helsinki, , Finland
CRST, Clinical Research Services Turku
Turku, , Finland
CHU Strasbourg - Hôpital Hautepierre
Strasbourg, Bas Rhin, France
Hôpital de la Timone
Marseille, Bouches-du-Rhône, France
Groupe Hospitalier Pellegrin - Hôpital Pellegrin
Bordeaux, Gironde, France
Hôpital La Grave
Toulouse, Haute Garonne, France
Hopital Gui de Chauliac
Montpellier, Herault, France
CHU Rennes - Pontchaillou
Rennes, Ille Et Vilaine, France
CHU Nantes - Hopital Nord Laënnec
Saint-Herblain, Loire Atlantique, France
Hopital Roger Salengro - CHU Lille
Lille, Nord, France
Hôpital Lariboisière
Paris, Paris, France
Hôpital des Chapennes
Villeurbanne, Rhone, France
Groupe Hospitalier Pitie-Salpetriere
Paris, , France
Hôpital Broca
Paris, , France
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
ISPG - Institut fuer Studien zur Psychischen Gesundheit
Mannheim, Baden-Wurttemberg, Germany
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg, Germany
Klinikum Bayreuth GmbH- Hohe Warte
Bayreuth, Bavaria, Germany
Institut fuer Schlaganfall- und Demenzforschung (ISD)
Munich, Bavaria, Germany
Klinikum rechts der Isar der TU Muenchen
Munich, Bavaria, Germany
Zentrum für klinische Forschung Dr.med. Irma Schöll
Bad Homburg, Hesse, Germany
Universitaetsklinikum Frankfurt Goethe-Universitaet
Frankfurt am Main, Hesse, Germany
Universitaetsmedizin Goettingen
Göttingen, Lower Saxony, Germany
Universitaetsmedizin Greifswald
Greifswald, Mecklenburg-Vorpommern, Germany
Katholisches Klinikum Bochum gGmbH
Bochum, North Rhine-Westphalia, Germany
Deutsches Zentrum fuer Neurodegenerative Erkrankungen (DZNE)
Bonn, North Rhine-Westphalia, Germany
Universitaetsklinikum Koeln
Cologne, North Rhine-Westphalia, Germany
Universitaetsklinikum Duesseldorf AoeR
Düsseldorf, North Rhine-Westphalia, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, Saxony, Germany
Universitaetsklinikum Magdeburg
Magdeburg, Saxony-Anhalt, Germany
NEUROZENTRUM tempelhof.berlin
Berlin, , Germany
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Azienda Ospedaliera Card. G. Panico
Tricase, Lecce, Italy
ASST di Monza
Monza, Milano, Italy
Fondazione Istituto G.Giglio di Cefalù
Cefalù, Palermo, Italy
Ospedale di Arzignano
Arzignano VI, Vicenza, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia, , Italy
IRCCS Ospedale Policlinico San Martino
Genova, , Italy
Ospedale San Raffaele
Milan, , Italy
Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"
Napoli, , Italy
Azienda Ospedaliera e Universitaria di Perugia
Perugia, , Italy
Fondazione Santa Lucia IRCCS
Roma, , Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
Roma, , Italy
Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona
Salerno, , Italy
National Center For Geriatrics And Gerontology
Obu-shi, Aichi-ken, Japan
Hakuyokai Kashiwado Hospital
Chiba, Chiba, Japan
Inage Neurology and Memory Clinic
Chiba, Chiba, Japan
Southern Tohoku Medical Clinic
Koriyama-shi, Fukushima, Japan
NHO Hiroshima-Nishi Medical Center
Otake-shi, Hiroshima, Japan
Himeji Central Hospital Clinic
Himeji-shi, Hyōgo, Japan
Kagawa University Hospital
Kita-gun, Kagawa-ken, Japan
Tokushukai Shonan Atsugi Hospital
Atsugi-shi, Kanagawa, Japan
Tokushukai Shonan Kamakura General Hospital
Kamakura-shi, Kanagawa, Japan
Teikyo University Hospital, Mizonokuchi
Kawasaki-shi, Kanagawa, Japan
Rakuwakai Otowa Rehabilitation Hospital
Kyoto, Kyoto, Japan
NHO Utano National Hospital
Kyoto, Kyoto, Japan
Katayama Medical Clinic
Kurashiki-shi, Okayama-ken, Japan
Tokushukai Kishiwada Tokushukai Hospital
Kishiwada-shi, Osaka, Japan
Osaka University Hospital
Suita-shi, Osaka, Japan
Midorikai Takesato Hospital
Kasukabe-shi, Saitama, Japan
Memory Clinic Ochanomizu
Bunkyō City, Tokyo-To, Japan
National Center of Neurology and Psychiatry
Kodaira-shi, Tokyo-To, Japan
Tokushukai Yamagata Tokushukai Hospital
Yamagata, Yamagata, Japan
Hospital Mexico Americano SC
Guadalara, Jalisco, Mexico
Health Pharma Professional Research S.A. de C.V.
Mexico City, Mexico City, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León, Mexico
Centro de Estudios Clinicos y Especialidades Medicas, S.C.
Monterrey, Nuevo León, Mexico
AVIX Investigación Clínica S.C
Monterrey, Nuevo León, Mexico
PROMENTE Sp. z o.o.
Bydgoszcz, Kujawsko-Pomorskie Województwo, Poland
Centrum Medyczne NeuroProtect
Warsaw, Mazowieckie Województwo, Poland
Podlaskie Centrum Psychogeriatrii
Bialystok, Podkarpackie Wojewódctwo, Poland
Centrum Medyczne Senior
Sopot, Pomorskie Województwo, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Kliniczny Oddział Neurologii Oddział Udarowy
Lublin, , Poland
NZOZ Wroclawskie Centrum Alzheimerowskie
Wroclaw, , Poland
Nzoz Novo-Med
Katowice, Śląskie Województwo, Poland
Neuro-Care Gabriela Klodowska
Siemianowice Śląskie, Śląskie Województwo, Poland
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Konkuk University Medical Center
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Hospital Universitario Reina Sofia
Córdoba, Córdoba, Spain
Policlinica Gipuzkoa
Donostia / San Sebastian, Guipuzcoa, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Fundacio ACE
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitari de Santa Maria
Lleida, , Spain
Clinica Universidad de Navarra (MAD)
Madrid, , Spain
Hospital Victoria Eugenia
Seville, , Spain
Hospital Universitario Dr. Peset
Valencia, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Skane University Hospital
Malmo, Skåne County, Sweden
Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus
Mölndal, Västra Götaland County, Sweden
Karolinska Universitetssjukhuset
Stockholm, , Sweden
The University of Edinburgh
Edinburgh, East Lothian, United Kingdom
Institute of Psychiatry, Psychology and Neuroscience
London, Greater London, United Kingdom
Re:Cognition Health Ltd (London)
London, Greater London, United Kingdom
Charing Cross Hospital
London, Greater London, United Kingdom
Park House
Manchester, Greater Manchester, United Kingdom
Southampton General Hospital
Southampton, Hampshire, United Kingdom
Moorgreen Hospital
Southampton, Hampshire, United Kingdom
Brain Health Scotland Life Sciences
Edinburgh, Lothian Region, United Kingdom
The RICE Centre
Bath, Somerset, United Kingdom
Glasgow Memory Clinic Ltd
Motherwell, Strathclyde, United Kingdom
Re Cognition Health Bristol
Bristol, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2022-001671-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
221AD305
Identifier Type: -
Identifier Source: org_study_id
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