 - Participant has homicidal ideationintent, per the Investigators clinical judgment, or has suicidal ideation with some intent to act within 6 months prior to the start of the Screeningprospective observational Phase, per the Investigators clinical judgment or based on the Columbia Suicide Severity Rating Scale C-SSRS and also includes history of suicidal behavior within the past year prior to start of the screeningprospective observational phase 