Safety assessments
ADVERSE EVENTS
Safety assessments were performed throughout all phases of the studies and included adverse events (AE; spontaneous participant reports), vital signs (blood pressure, pulse rate, oxygen saturation, and respiratory rate), 12-lead ECGs, continuous cardiac telemetry, pulse oximetry (from ≥15 min predose to ≥4 h post dose), clinical laboratory testing, physical examinations, and the Columbia-Suicide Severity Rating Scale (C-SSRS) [