Table 2.

A list of all AEs encountered during the study

AE number	AE	Relationship to device	Severity	Resolution
001	FB sensation	Yes	Mild	24 hours
002	Supraorbital ache	Unlikely	Mild	1 month
003	FB sensation	Yes	Mild	24 hours
004	Herpes zoster ophthalmicus	Unlikely (contralateral)	Moderate	1 month
005	Skin electrode discomfort	Yes	Mild	Immediate
006	Skin electrode discomfort	Yes	Mild	Immediate

One participant experienced supraorbital ache, although this was with concurrent sinusitis and was not in the location of the skin electrode. One case of herpes zoster ophthalmicus was considered unrelated and affected the contralateral side.

AE, adverse effect; FB, foreign body.