Table 3. Overall summary of TEAEs by severity: safety set population.

All TEAEs	Placebo (n=31)		GV1001 1.12 mg (n=32)		Overall (n=63)		p-value*	p-value†
	No. (%)*	Events†	No. (%)*	Events†	No. (%)	Events
Mild	12 (38.7)	32	10 (31.3)	34	22 (34.9)	66	0.122	0.179
Moderate	2 (6.5)	4	5 (15.6)	10	7 (11.1)	14
Severe	2 (6.5)	2	0 (0.0)	0	2 (3.2)	2

The differences between the treatment group and placebo group were assessed using the χ² test.

TEAE: treatment-emergent adverse event.

^*p-value for the differences in the number of patients between the GV1001 and placebo groups.

^†p-value for the differences in the number of events between the GV1001 and placebo groups.