Table 3.

Safety outcome measures.

1. Assess incidence of AEs during Dosing Sessions that may be indicative of a medical complication of the Investigational Product (IP), such as clinical signs and symptoms of chest pain, shortness of breath, or neurological symptoms or any other signs or symptoms that prompt additional vital sign measurements

2. Assess incidence of AEs by severity

3. Assess incidence of Treatment Emergent AEs (TEAEs) by severity

4. Assess incidence of TEAEs by severity taken during a Dosing Session and 2 days after IP administration

5. Assess incidence of AESIs, defined as AEs specified in the protocol related to cardiac function, suicide risk, and abuse liability

6. Assess incidence of AEs by severity categorized as leading to discontinuation of IP, resulting in death or hospitalization, and continuing at Study Termination

7. Assess incidence of SAEs

8. Assess incidence of psychiatric concomitant medications taken during a Dosing Session and 2 days after IP administration

9. Assess incidence of any psychiatric concomitant medications taken during the Treatment Period

10. Assess incidence of serious suicidal ideation and positive suicidal behavior assessed with the Columbia Suicide Severity Rating Scale (C-SSRS)

11. Assess mean changes in blood pressure, heart rate, and body temperature from pre-IP administration to the end of each Dosing Session