Adverse events (AEs) will be coded using medical dictionary for regulatory activities (MedDRA). An AE is any untoward medical occurrence in a participant administered a study drug and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical product whether or not considered related to the medical product. An AE is considered "serious" if, in the view of either the investigator or sponsor, the event: results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, requires hospitalization or prolongation to hospitalization, or other medically important event.

Number of participants with potentially clinically significant laboratory values (hematology/chemistry/urinalysis)

Number of participants with potentially clinically significant vital sign values

Number of participants with potentially clinically significant temperature values

Number of participants with potentially clinically significant ECG values.

Number of participants with potentially clinically significant changes in physical examination.

Number of participants with potentially clinically significant changes in neurological examination.

Number of participants with potentially clinically significant changes in Profile of Mood States (Brief) values.

Number of participants with potentially clinically significant changes in Bond-Lader VAS values.