Table 3.

AEs. The number of AEs is shown in each severity and relatedness category. The number of AEs in each cell is further divided into the number of AEs that occurred in the real and sham months (in parenthesis). In addition, the number of participants out of a total of 25 who experienced AEs is shown in each severity and relatedness category. The number of participants is further divided into the number of participants that experienced AEs in the real month only, sham month only, and both (in parenthesis).

	#=Number of AEs (in real month/sham month) n=Number of participants with AE (in real month only/sham month only/both)
Relatedness╲Severity	Mild	Moderate	Severe
Not Related	#=12 (8/4) n=8 (6/1/1)	0	#=1 (1*/0) n=1 (1/0/0)
Unlikely	#=32 (18/14) n=14 (4/3/7)	0	#=2 (0/2†) n=2 (0/2/0)
Reasonable possibility	#=29 (9/20) n=6 (2/3/1)	0	0
Definitely	0	0	0
Total	#=73 (35/38) n=18 (6/3/9)	0	#=3 (1/2) n=3 (1/2/0)

The AE severity and relatedness categorization was reviewed and approved by the DSMB in blinding.

^*Facial skin surgery which has been routine for this participant for past 30 years.

^†Transient ischemic attack-like symptoms were experienced. Both participants were medically examined and no diagnosis was given.