Table 3.

Overview of adverse events (safety population)^a

Event	Before rehabilitation	Rehabilitation alone	ARCEX Therapy	Any time
Any adverse event	3 (4.7)	44 (68.8)	34 (53.1)	50 (78.1)
Any serious adverse event	1 (1.6)	1 (1.6)	1 (1.6)	3 (4.7)
Adverse event related to device	–	–	17 (26.6)	17 (26.6)
Serious adverse event related to device	–	–	0 (0.0)	0 (0.0)
Adverse event related to study procedures	0 (0.0)	8 (12.5)	13 (20.3)	18 (28.1)
Adverse event leading to discontinuation	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Total number of adverse events	5	105	128	238

^a Data shown are the number of participants (percent). The safety population included participants (n = 64) exposed to any study procedure.