New depression drug tested for long-term safety in 1,000 patients
NCT ID NCT06029439
First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 2 times
Summary
This study looks at the long-term safety and effectiveness of an experimental drug called NMRA-335140 for people with major depressive disorder. About 1,000 adults who completed earlier studies of this drug will take it for 52 weeks. Researchers will track side effects and changes in depression symptoms to see if the drug remains safe and helpful over time.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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904 people
The number who actually took part.
- Started
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Nov 2023
- Finished
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Aug 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Major depressive disorder are added.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Neumora Investigator Site
Phoenix, Arizona, 85012, United States
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Bentonville, Arkansas, 72712, United States
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Rogers, Arkansas, 72758, United States
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Cerritos, California, 90703, United States
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Encino, California, 91316, United States
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Garden Grove, California, 92845, United States
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Glendale, California, 91206, United States
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Imperial, California, 92251, United States
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Irvine, California, 92614, United States
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Lafayette, California, 94549, United States
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Los Angeles, California, 90015, United States
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Newport Beach, California, 92660, United States
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Oceanside, California, 92056, United States
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Orange, California, 92868, United States
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Riverside, California, 92506, United States
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San Diego, California, 92103, United States
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San Francisco, California, 94107, United States
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San Jose, California, 95124, United States
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Santa Ana, California, 92704, United States
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Sherman Oaks, California, 91403, United States
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Temecula, California, 92591, United States
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Torrance, California, 90504, United States
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Colorado Springs, Colorado, 80910, United States
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New Haven, Connecticut, 06520, United States
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Norwalk, Connecticut, 06851, United States
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Bradenton, Florida, 34205, United States
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Brandon, Florida, 33511, United States
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Gainesville, Florida, 32607, United States
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Hallandale, Florida, 33009, United States
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Hialeah, Florida, 33012, United States
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Hialeah, Florida, 33016, United States
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Hollywood, Florida, 33024, United States
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Jacksonville, Florida, 32256, United States
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Lauderhill, Florida, 33319, United States
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Maitland, Florida, 32751, United States
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Miami, Florida, 33122, United States
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Miami, Florida, 33126, United States
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Miami, Florida, 33133, United States
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Neumora Investigator Site
Miami, Florida, 33137, United States
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Miami, Florida, 33143, United States
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Miami, Florida, 33165, United States
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Miami, Florida, 33174, United States
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Miami Beach, Florida, 33140, United States
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Miami Springs, Florida, 33166, United States
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Orlando, Florida, 32803, United States
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Orlando, Florida, 32807, United States
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Pembroke Pines, Florida, 33024, United States
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Pompano Beach, Florida, 33060, United States
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Saint Augustine, Florida, 32086, United States
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Tampa, Florida, 33607, United States
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Tampa, Florida, 33613, United States
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Atlanta, Georgia, 30318, United States
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Atlanta, Georgia, 30328, United States
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Atlanta, Georgia, 30338, United States
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Decatur, Georgia, 30030, United States
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Marietta, Georgia, 30060, United States
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Savannah, Georgia, 31405, United States
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Chicago, Illinois, 60634, United States
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Warrenville, Illinois, 60555, United States
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Marrero, Louisiana, 70072, United States
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New Orleans, Louisiana, 70115, United States
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Baltimore, Maryland, 21208, United States
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Boston, Massachusetts, 02116, United States
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Boston, Massachusetts, 02131, United States
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Watertown, Massachusetts, 02472, United States
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Mankato, Minnesota, 56001, United States
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Flowood, Mississippi, 39232, United States
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Saint Charles, Missouri, 63304, United States
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St Louis, Missouri, 63141, United States
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Las Vegas, Nevada, 89102, United States
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Berlin, New Jersey, 08009, United States
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Toms River, New Jersey, 08755, United States
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Albuquerque, New Mexico, 87109, United States
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Brooklyn, New York, 11224, United States
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Buffalo, New York, 14215, United States
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Cedarhurst, New York, 11516, United States
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Inwood, New York, 11096, United States
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New York, New York, 10017, United States
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New York, New York, 10029, United States
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New York, New York, 10036, United States
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Staten Island, New York, 10310, United States
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Staten Island, New York, 10314, United States
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The Bronx, New York, 10461, United States
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Charlotte, North Carolina, 28211, United States
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Monroe, North Carolina, 28112, United States
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Columbus, Ohio, 43210, United States
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Dayton, Ohio, 45417, United States
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North Canton, Ohio, 44720, United States
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Edmond, Oklahoma, 73013, United States
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Oklahoma City, Oklahoma, 73118, United States
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Allentown, Pennsylvania, 18104, United States
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Media, Pennsylvania, 19063, United States
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Philadelphia, Pennsylvania, 19104, United States
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Memphis, Tennessee, 38119, United States
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Austin, Texas, 78737, United States
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Dallas, Texas, 75243, United States
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DeSoto, Texas, 75115, United States
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Fort Worth, Texas, 76104, United States
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Houston, Texas, 77030, United States
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Houston, Texas, 77090, United States
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Wichita Falls, Texas, 76309, United States
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Bellevue, Washington, 98007, United States
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Curitiba, Paraná, 80240280, Brazil
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Botafogo - Rio de Janeiro, Rio de Janeiro, 22270-060, Brazil
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Porto Alegre, Rio Grande do Sul, 90610-001, Brazil
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Santa Cecília, São Paulo, 01228-000, Brazil
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São Bernardo do Campo, São Paulo, 09726150, Brazil
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São José do Rio Preto, São Paulo, 15090-000, Brazil
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São Paulo, 01236030, Brazil
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Cherven Bryag, Pleven, 5980, Bulgaria
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Sofia, Sofia-Grad, 1408, Bulgaria
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Sofia, Sofia-Grad, 1463, Bulgaria
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Sofia, Sofia-Grad, 1680, Bulgaria
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Varosha, Targovishte, 7700, Bulgaria
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Kardzhali, 6600, Bulgaria
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Pleven, 5800, Bulgaria
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Varna, 9020, Bulgaria
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Kelowna, British Columbia, V1Y 1Z9, Canada
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Hamilton, Ontario, L8S 1B7, Canada
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Markham, Ontario, L3R 1A3, Canada
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Mississauga, Ontario, L5L 1W8, Canada
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Toronto, Ontario, M5S 1M2, Canada
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Santiago, Santiago Metropolitan, 7500710, Chile
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Santiago, Santiago Metropolitan, 7560356, Chile
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Santiago, Santiago Metropolitan, 7561282, Chile
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Santiago, Santiago Metropolitan, 8330034, Chile
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Antofagasta, 1270244, Chile
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Pilsen, Plzeň, 301 00, Czechia
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Prague, Prague, 186 00, Czechia
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Kladno, South Bohemian, 272 01, Czechia
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Kladno, 272 01, Czechia
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Prague, 109 00, Czechia
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Helsinki, Etelä-Suomen Lääni, 00100, Finland
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Turku, Etelä-Suomen Lääni, 20520, Finland
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Oulu, Oulun Lääni, 90100, Finland
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Clermont-Ferrand, Auvergne-Rhône-Alpes, 63000, France
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Douai, Hauts-de-France, 59500, France
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Montpellier, Hérault, 34295, France
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La Roche-sur-Yon, Vendée, 85000, France
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Poitiers, Vienne, 86000, France
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Berlin, 10117, Germany
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Berlin, 10629, Germany
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Berlin, 13187, Germany
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Hamburg, 20253, Germany
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Suchy Las, Greater Poland Voivodeship, 62-002, Poland
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Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-133, Poland
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Wroclaw, Lower Silesian Voivodeship, 50-414, Poland
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Lublin, Lublin Voivodeship, 20-109, Poland
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Lublin, Lublin Voivodeship, 20-582, Poland
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Białystok, Podkarpackie Voivodeship, 15-879, Poland
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Gdansk, Pomeranian Voivodeship, 80-438, Poland
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Lund, Skåne County, 222 22, Sweden
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Stockholm, Stolkholm Ian, 113 29, Sweden
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Neumora Investigator Site #1
Little Rock, Arkansas, 72211, United States
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Neumora Investigator Site #1
Long Beach, California, 90807, United States
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Neumora Investigator Site #1
Orange, California, 92868, United States
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Neumora Investigator Site #1
Miami Lakes, Florida, 33016, United States
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Neumora Investigator Site #1
Orlando, Florida, 32801, United States
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Neumora Investigator Site #1
Pompano Beach, Florida, 33060, United States
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Neumora Investigator Site #1
Tampa, Florida, 33613, United States
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Neumora Investigator Site #1
Atlanta, Georgia, 30328, United States
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Neumora Investigator Site #1
Houston, Texas, 77030, United States
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Neumora Investigator Site #1
Everett, Washington, 98201, United States
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Neumora Investigator Site #1
Berlin, 10117, Germany
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Neumora Investigator Site #2
Miami Lakes, Florida, 33016, United States
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Neumora Investigator site
Huntsville, Alabama, 35801, United States
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Neumora Investigator site
Little Rock, Arkansas, 72211, United States
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Neumora Investigator site
Bellflower, California, 90706, United States
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Long Beach, California, 90807, United States
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Miami, Florida, 33183, United States
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Miami Lakes, Florida, 33014, United States
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Orlando, Florida, 32801, United States
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Towson, Maryland, 21204, United States
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Methuen, Massachusetts, 01844, United States
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Springfield, Massachusetts, 01103, United States
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Bloomfield Township, Michigan, 48302, United States
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Princeton, New Jersey, 08540, United States
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Neumora Investigator site
Austin, Texas, 78759, United States
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