Study to Assess the Safety and Effectiveness of NMRA-335140-501
NCT ID: NCT06029439
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1000 participants
INTERVENTIONAL
2023-11-10
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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NMRA-335140 80 milligrams (mg) once daily (QD)
Participants will receive a NMRA-335140 tablet at a dose of 80 mg once daily (QD) during a 52-week treatment period.
NMRA-335140
Participants will receive NMRA-335140 at a dose of 80 mg once daily (QD), orally during a 52-week treatment period.
Interventions
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NMRA-335140
Participants will receive NMRA-335140 at a dose of 80 mg once daily (QD), orally during a 52-week treatment period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signed an informed consent form (ICF) for this study.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Neumora Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Neumora Investigator site
Huntsville, Alabama, United States
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Phoenix, Arizona, United States
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Bentonville, Arkansas, United States
Neumora Investigator Site #1
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
Neumora Investigator Site #1
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 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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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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Jacksonville, Florida, United States
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Lauderhill, Florida, United States
Neumora Investigator Site #1
Maitland, 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, 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
Neumora Investigator Site #2
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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Atlanta, Georgia, United States
Neumora Investigator Site #1
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
Neumora Investigator Site #1
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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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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Fort Worth, Texas, United States
Neumora Investigator Site #1
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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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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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
Neumora Investigator Site #1
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
Neumora Investigator Site
Stockholm, Stolkholm Ian, Sweden
Countries
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Central Contacts
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Other Identifiers
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KOASTAL-LT
Identifier Type: OTHER
Identifier Source: secondary_id
NMRA-335140-501
Identifier Type: -
Identifier Source: org_study_id