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Study to Assess the Safety and Effectiveness of NMRA-335140-501

NCT06029439 · Neumora Therapeutics, Inc.
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Official title
Long-term Study to Assess the Safety and Effectiveness of NMRA-335140 in Participants With Major Depressive Disorder
About this study
This is a 52-week open-label extension (OLE) study that will evaluate the safety, tolerability, and effectiveness of NMRA-335140 in participants with major depressive disorder (MDD). Participants who completed a parent study investigating the efficacy and safety of NMRA-335140 as a treatment for MDD (ie, NMRA-335140-301, NMRA-335140-302, or NMRA-335140-303), and complete the 6 weeks double-blind treatment, provide informed consent, and meet eligibility criteria, may enter this extension study.
Eligibility criteria
Key Inclusion Criteria: Rollover participants are eligible for the study if the following inclusion criteria are met: * Completed a previous NMRA-335140 Phase 3 MDD study (example: NMRA-335140-301, NMRA-335140-302, or NMRA-335140-303) according to the completion definition in the parent study protocol. * Signed an informed consent form (ICF) for this study. * Willing to comply with the contraception requirements described in the inclusion criteria of the parent study protocol. * Willing to comply with the concomitant medication/therapy restrictions described in the exclusion criteria of the parent study protocol. Key Exclusion Criteria: Rollover participants are excluded from the study if any of the following exclusion criteria are met: * Diagnosed with another Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) disorder that would have been exclusionary in the parent study (eg, personality disorder, bipolar 1 or 2, schizophrenia, any other psychotic disorder, or moderate or severe substance or alcohol use disorder \[excluding nicotine\]). * Considered to be at significant risk of suicide in the judgment of the Investigator. This includes participants who are actively suicidal (eg, any suicide attempts during the parent study) or are at serious suicidal risk as indicated by any current suicidal intent, including a plan, as assessed by the C-SSRS ("Since Last Visit" version, score of "YES" on suicidal ideation Item 4 or 5) and/or based on clinical evaluation by the Investigator; or are homicidal, in the opinion of the Investigator. * Non-adherent with study medication (took ≤70% of study drug over any 2-week visit interval) or procedures during the parent study. * Experienced treatment emergent adverse events (TEAEs) considered related to the study medication from the parent study and judged by the Investigator to be clinically significant to render the participant ineligible for enrollment. * Have an abnormality on ocular examination that would prohibit continued study participation as determined by the Investigator. * Use of disallowed concomitant medication or therapy that would have been exclusionary in the parent study, may compromise the safety of the participant, and/or confound the interpretation of protocol assessments. * Considered by the Investigator to be inappropriate for any other reason.
Study design
Enrollment target: 1000 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-11-10
Estimated completion: 2027-06
Last updated: 2026-04-08
Interventions
Drug: NMRA-335140
Primary outcomes
  • Safety and tolerability assessments based on Treatment Emergent Adverse Events (TEAEs) and validated clinical scales (Up to 54 Weeks)
Sponsor
Neumora Therapeutics, Inc. · industry
Contacts & investigators
ContactStudy Contact · contact · explore@koastalstudy.com
All locations (178)
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Huntsville, Alabama, United States
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Phoenix, Arizona, United States
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Bentonville, Arkansas, United States
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Little Rock, Arkansas, United States
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Little Rock, Arkansas, United States
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Rogers, Arkansas, United States
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Bellflower, California, United States
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Cerritos, California, United States
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Encino, California, United States
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Garden Grove, California, United States
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Glendale, California, United States
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Imperial, California, United States
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Irvine, California, United States
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Lafayette, California, United States
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Long Beach, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Oceanside, California, United States
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Orange, California, United States
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Orange, California, United States
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Riverside, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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San Jose, California, United States
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Santa Ana, California, United States
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Sherman Oaks, California, United States
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Temecula, California, United States
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Torrance, California, United States
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Colorado Springs, Colorado, United States
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New Haven, Connecticut, United States
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Norwalk, Connecticut, United States
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Bradenton, Florida, United States
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Brandon, Florida, United States
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Gainesville, Florida, United States
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Hallandale, Florida, United States
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Hialeah, Florida, United States
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Hialeah, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Lauderhill, Florida, United States
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Maitland, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami Beach, Florida, United States
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Miami Lakes, Florida, United States
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Miami Lakes, Florida, United States
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Miami Lakes, Florida, United States
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Miami Springs, Florida, United States
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Orlando, Florida, United States
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Orlando, Florida, United States
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Orlando, Florida, United States
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Orlando, Florida, United States
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Pembroke Pines, Florida, United States
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Pompano Beach, Florida, United States
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Pompano Beach, Florida, United States
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Saint Augustine, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Decatur, Georgia, United States
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Marietta, Georgia, United States
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Savannah, Georgia, United States
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Chicago, Illinois, United States
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Warrenville, Illinois, United States
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Marrero, Louisiana, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Towson, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Methuen, Massachusetts, United States
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Springfield, Massachusetts, United States
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Watertown, Massachusetts, United States
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Bloomfield Township, Michigan, United States
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Mankato, Minnesota, United States
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Flowood, Mississippi, United States
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Saint Charles, Missouri, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Berlin, New Jersey, United States
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Princeton, New Jersey, United States
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Toms River, New Jersey, United States
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Albuquerque, New Mexico, United States
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Brooklyn, New York, United States
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Buffalo, New York, United States
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Cedarhurst, New York, United States
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Inwood, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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Staten Island, New York, United States
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Staten Island, New York, United States
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The Bronx, New York, United States
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Charlotte, North Carolina, United States
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Monroe, North Carolina, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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North Canton, Ohio, United States
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Edmond, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Allentown, Pennsylvania, United States
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Media, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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DeSoto, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Wichita Falls, Texas, United States
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Bellevue, Washington, United States
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Everett, Washington, United States
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Curitiba, Paraná, Brazil
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Botafogo - Rio de Janeiro, Rio de Janeiro, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Santa Cecília, São Paulo, Brazil
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São Bernardo do Campo, São Paulo, Brazil
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São José do Rio Preto, São Paulo, Brazil
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São Paulo, Brazil
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Cherven Bryag, Pleven, Bulgaria
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Sofia, Sofia-Grad, Bulgaria
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Sofia, Sofia-Grad, Bulgaria
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Sofia, Sofia-Grad, Bulgaria
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Varosha, Targovishte, Bulgaria
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Kardzhali, Bulgaria
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Pleven, Bulgaria
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Varna, Bulgaria
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Kelowna, British Columbia, Canada
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Hamilton, Ontario, Canada
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Markham, Ontario, Canada
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Mississauga, Ontario, Canada
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Toronto, Ontario, Canada
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Santiago, Santiago Metropolitan, Chile
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Santiago, Santiago Metropolitan, Chile
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Santiago, Santiago Metropolitan, Chile
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Santiago, Santiago Metropolitan, Chile
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Antofagasta, Chile
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Pilsen, Plzeň, Czechia
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Prague, Prague, Czechia
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Kladno, South Bohemian, Czechia
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Kladno, Czechia
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Prague, Czechia
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Helsinki, Etelä-Suomen Lääni, Finland
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Turku, Etelä-Suomen Lääni, Finland
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Oulu, Oulun Lääni, Finland
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Clermont-Ferrand, Auvergne-Rhône-Alpes, France
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Douai, Hauts-de-France, France
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Montpellier, Hérault, France
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La Roche-sur-Yon, Vendée, France
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Poitiers, Vienne, France
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Berlin, Germany
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Berlin, Germany
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Berlin, Germany
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Berlin, Germany
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Hamburg, Germany
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Suchy Las, Greater Poland Voivodeship, Poland
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Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
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Wroclaw, Lower Silesian Voivodeship, Poland
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Lublin, Lublin Voivodeship, Poland
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Lublin, Lublin Voivodeship, Poland
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Białystok, Podkarpackie Voivodeship, Poland
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Gdansk, Pomeranian Voivodeship, Poland
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Lund, Skåne County, Sweden
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Stockholm, Stolkholm Ian, Sweden
Study to Assess the Safety and Effectiveness of NMRA-335140-501 · TrialPath