Table 3:

Adverse Events and Serious Adverse Events by arm (n=540)

	Multi-dose (n=270)	2 g single-dose (n=270)	p-value
Any Adverse Event during follow-up	89 (33·0%)	90(33·5%)	0·90
Common side effects
Nausea	63 (23·3%)	61 (22·6)	0·84
Vomiting	13 (4·8%)	6 (2·2%)	0·10
Headache	23 (8·5%)	15 (5·6%)	0·18
Less common side effects
Dizziness	6 (2·2%)	2 (0·7%)	0·15
Bad/metallic taste in mouth	4 (1·5%)	3 (1·1%)	0·70
Vaginal itching	3 (1·1%)	1 (0·4%)	0·32*
Fatigue	2 (0·7%)	0 (0·0%)	0·32*
Rash	2 (0·7%)	0 (0·0%)	0·32*
Other side effects**	9 (3·3%)	9 (3·3%)	1·00
Serious Adverse Events
Spontaneous abortion***	0	2 (0.7%)	0·32*

^*Fisher’s exact

^**Other side effects assessed included, yeast infection, abdominal pain, numbness, dysuria, loss of appetite, altered mental status, myalgia, generalized itching, lightheadedness, restlessness, verbal intimidation by partner or stiff neck.

^***The two women tested negative at baseline and discovered they were pregnant during follow-up.