Table 5.

Summary of adverse events in the safety population (N = 692)

	HA-HL (N = 347)	Placebo (N = 345)	P value
AEs
N	845	703
Treatment-related	5	13	–
Subjects	187 (53.9)	180 (52.2)	0.703
Treatment-related	5 (1.4)	9 (2.6)	0.296
SAEs
N	15	10
Subjects	9 (2.6)	9 (2.6)	1.00
Treatment-related	0 (0.0)	0 (0.0)	–
Severe AEs
N	11	2
Subjects	7 (2.0)	2 (0.6)	0.177
Treatment-related	0 (0.0)	0 (0.0)	–
AEs leading to study discontinuation
N	3	1
Subjects	1 (0.3)	1 (0.3)	1.00
AEs leading to death
N	0	0
Subjects	0 (0.0)	0 (0.0)	–

Unless otherwise stated, data are n (%)

AE adverse event, SAE serious adverse event