TABLE 2.

Safety analysis.

Adverse events	Treatment group (n = 19)		Sham group (n = 12)
	Patients affected n (%)	Adverse events n (%)	Patients affected n (%)	Adverse events n (%)
Any adverse event	13 (68)	39 (100)	10 (83)	27 (100)
Adverse events unrelated to study device	10 (53)	23 (59)	8 (67)	18 (67)
Adverse events potentially related to study device	8 (42)	16 (41)	4 (33)	9 (33)
Mild Intensity	7 (37)	14 (36)	4 (33)	8 (30)
Anxiety	1 (5)	1 (3)	0	0
Benign positional vertigo	1 (5)	1 (3)	0	0
Confusion	0	0	1 (8)	1 (4)
Disorientation	0	0	1 (8)	1 (4)
Dizziness	1 (5)	1 (3)	1 (8)	1 (4)
Ear Irritation	1 (5)	1 (3)	0	0
Eye irritation	2 (11)	2 (5)	0	0
Fatigue	1 (5)	1 (3)	0	0
Hallucinations	0	0	1 (8)	1 (4)
Headache	5 (26)	5 (13)	2 (17)	2 (7)
Migraines	0	0	1 (8)	1 (4)
Nose irritation	1 (5)	1 (3)	0	0
Shoulder pain	1 (5)	1 (3)	0	0
Wandering	0	0	1 (8)	1 (4)
Moderate intensity	1 (5)	1 (3)	1 (8)	1 (4)
Agitation	0	0	1 (8)	1 (4)
Chest irritation	1 (5)	1 (3)	0	0
Severe intensity	1 (5)	1 (3)	0	0
Dementia exacerbation	1 (5)	1 (3)	0	0

Data are number of patients with an adverse event (percentage within study population; i.e., Treatment or Sham Group). Total number of adverse events (percentage of adverse events in the respective study population). Percentage values were rounded to the closest integer.