Table 2.

Treatment‐Related Adverse Events.

		HFS (N = 50), N (%)	LFS (N = 49), N (%)	Whole group (N = 99), N (%)
SAEs total	Subjects	0	1 (2)	1 (1)
AEs total	Subjects	6 (12)	19 (39)	25 (25)
Type of AE	Migration	3 (6)	7 (14)	10 (10)
	Unintended stimulation	0	5 (10)	5 (5)
	Incisional pain	0	3 (6)	3 (3)
	Loss of stimulation	0	2 (4)	2 (2)
	Infection SAE	0	1 (2)	1 (1)
	Other	3 (6)	2 (4)	5 (10)

SAE = serious adverse event; AE = adverse event; HFS = high frequency stimulation; LFS = lower frequency stimulation; N = number.