Safety evaluations
Suicidal ideation
ADVERSE EVENTS
During the study, safety and tolerability evaluations were performed by monitoring adverse events, clinical laboratory tests (hematology, serum chemistry urinalysis and serum pregnancy test at screening and urine pregnancy tests during the treatment phase). 12-lead electrocardiograms (ECG), vital signs, and physical and neurological examination were frequently monitored and performed. Suicidal ideation and behavior was assessed using the Columbia Suicide Severity Rating Scale (C-SSRS) [