Table 2. Most Frequent Adverse Events.

(number of AEs and number of participants experiencing AE denoted by [ ])

Adverse Event*	Block I (5 × 108 cfu/dose)		Block II (1 ×109 cfu/dose)		Block III (2 × 109 cfu/dose)		Total		% of affected subjects
	LACTIN-V	Placebo	LACTIN-V	Placebo	LACTIN-V	Placebo	LACTIN-V	Placebo
Vaginal Discharge	1 [1]†	-	2 [2]	-	2 [2]	-	5 [5]	-	42%
Abdominal Pain	1 [1]	-	2 [2]	-	-	1 [1]	3 [3]	1 [1]	33%
Metrorrhagia	-	1 [1]	-	-	2 [2]	1 [1]	2 [2]	2 [2]	33%
Vulvovaginitis	-	-	1 [1]	-	2 [2]	1 [1]	3 [3]	1 [1]	33%
Headache	1 [1]	-	1 [1]	1 [1]	-	-	2 [2]	1 [1]	25%
Vaginal Candidiasis	-	-	1 [1]	1 [1]	1 [1]	-	2 [2]	1 [1]	25%
Vaginal Odor	1 [1]	-	2 [2]	-	-	-	3 [3]	-	25%

^*perdefinition, AEs were new conditions occurring after enrollment. Conditions already existing at baseline were only classified as an AE if condition worsened during the study.

^†no participant experienced a similar AE twice