Table 4. Side Effects^*

Side Effects, n (%)	Randomized Placebo	Randomized Azithromycin	Open-Label Azithromycin	P^{^†}
Nausea				.016/.008/.458
None	31 (91)	25 (71)	12 (60)
Mild to moderate	1 (3)	9 (26)	6 (30)
Severe	2 (6)	1 (3)	2 (10)
Vomiting				1.000/.128/.456
None	32 (94)	33 (94)	18 (90)
Mild to moderate	0 (0)	1 (3)	2 (10)
Severe	2 (6)	1 (3)	0 (0)
Stomach pain				.076/.001/.196
None	30 (88)	24 (69)	9 (45)
Mild to moderate	3 (9)	10 (29)	10 (50)
Severe	1 (3)	1 (3)	1 (5)
Diarrhea				.106/.002/.196
None	29 (85)	23 (66)	9 (45)
Mild to moderate	3 (9)	10 (29)	10 (50)
Severe	2 (6)	2 (6)	1 (5)
Rash				.743/.046/.420
None	33 (97)	33 (94)	16 (80)
Mild to moderate	0 (0)	2 (6)	3 (15)
Severe	1 (3)	1 (3)	1 (5)
Swelling				.239/.716/.128
None	32 (94)	35 (100)	18 (90)
Mild to moderate	1 (3)	0 (0)	2 (10)
Severe	1 (3)	0 (0)	0 (0)
Hearing loss				.743/1.000/.999
None	32 (94)	34 (97)	19 (95)
Mild to moderate	1 (3)	1 (3)	1 (5)
Severe	1 (3)	0 (0)	0 (0)
Vaginal candidiasis				.670/1.000/.999
None	20 (91)	21 (84)	7 (88)
Mild to moderate	3 (9)	4 (16)	1 (13)
Severe	0 (0)	0 (0)	0 (0)

↵* Worst reported severity during the 12-week treatment period.
↵† Fisher exact tests: randomized placebo versus randomized azithromycin/randomized placebo versus open-label azithromycin/randomized azithromycin versus open-label azithromycin.