Table 2.

Summary of Mild Adverse Events. No Serious Adverse Experiences were reported, and all Adverse Events were Mild.

Mild Adverse Events				Relationship to the study device
	N° pat. (%)	N° AE	Duration (days)*	Definitely	Probably	Possibly	Unrelated
Total (n=34)	5 (14.7%)	9	10.3 (20.4)	5	2	1	1
Skin and subcutaneous tissue disorders	3 (8.8%)	4	21.7 (33.2)	3	1
Erythema	1 (2.9%)	1	4.0 ( .)		1
Paraesthesia	1 (2.9%)	2	1.0 ( .)	2
Skin burning sensation	1 (2.9%)	1	60.0 ( .)	1
Nervous system disorders	2 (5.9%)	2	1.5 ( 0.7)		1	1
Headache	2 (5.9%)	2	1.5 ( 0.7)		1	1
Infections and infestations	1 (2.9%)	1	11.0 ( .)				1
Sinusitis	1 (2.9%)	1	11.0 ( .)				1
Musculoskeletal and connective tissue disorders	1 (2.9%)	2	1.5 ( 0.7)	2
Myalgia	1 (2.9%)	2	1.5 ( 0.7)	2