Safety evaluation
self-injurious behaviors, suicide-related
The type, incidence, and severity of AEs were assessed for safety. AEs were classified using the Medical Dictionary for Regulatory Activities (MedDRA) Ver.25.0. All AEs included in the MedDRA SMQ Suicidal/Suicide (Narrow Range) were classified as suicide-related AEs. In addition, AEs associated with self-injurious behaviors based on C-SSRS survey items (“yes” for “self-injurious behaviors without suicidal intent”) were classified as self-injury-related AEs. Laboratory test values, vital signs, body weight, and standard 12-lead ECG were also assessed at each visit.