Table 4.

Safety Profile (Safety Set)

Number (%) of Subjects Experiencing	Fasted (n=36)	Fed (n=36)
No AEs	22 (61.1)	22 (61.1)
One or more AEs	14 (38.9)	14 (38.9)
Pre-treatment AEs	0 (0.0)	0 (0.0)
One or more TEAEs	14 (38.9)	14 (38.9)
TEAE Severity
Mild	13 (36.1)	14 (38.9)
Moderate	1 (2.8)	0 (0.0)
Severe	0 (0.0)	0 (0.0)
TEAE Causality
Related	12 (33.3)	11 (30.6)
Not related	2 (5.6)	3 (8.3)
One or more TEAEs leading to drug withdrawal	0 (0.0)	0 (0.0)
One or more SAEs	0 (0.0)	0 (0.0)
SAE Causality	0 (0.0)	0 (0.0)
Related	0 (0.0)	0 (0.0)
Not related	0 (0.0)	0 (0.0)
Deaths	0 (0.0)	0 (0.0)

Note: Values are shown as n (%).

Abbreviations: AE, adverse event; SAE, serious adverse event; TEAE, treatment-emergent adverse event.