Table 3.

Sub-distribution hazard ratios of mastitis or breast inflammation while breastfeeding, by treatment group and nutritional supplement group¹

		Early Mastitis (weeks 0 – 4)	Late Mastitis (weeks 5-28)
		Hazard Ratios (95% CI)	Hazard Ratios (95% CI)
Primary Analysis: Mastitis or breast inflammation2
Treatment Group	Maternal ART	0.9 (0.4, 1.8)	6.7 (2.0, 22.6)
	Infant NVP	1.0 (0.5, 1.9)	5.1 (1.5, 17. 5)
	Standard of Care	1.0 (Reference)	1.0 (Reference)
Nutritional Supplement	Yes	1.0 (0.6, 1.8)	1.5 (0.8, 2.8)
	No	1.0 (Reference)	1.0 (Reference)
Sensitivity Analyses: Severe Mastitis3
Treatment Group	Maternal ART	0.8 (0.3, 1.8)	8.0 (1.8, 35.0)
	Infant NVP	0.9 (0.4, 2.0)	7.7 (1.8, 33.3)
	Standard of Care	1.0 (Reference)	1.0 (Reference)
Nutritional Supplement	Yes	1.1 (0.6, 2.3)	1.5 (0.7, 2.9)
	No	1.0 (Reference)	1.0 (Reference)

¹This cohort consisted of 1317 women enrolled in the BAN study between April 2004-July 7, 2007. To estimate the effect of treatment assignment on mastitis, sub-distribution hazard ratios were estimated and an interaction term between treatment group and time (0-4 weeks vs 5-28 weeks) was included.

²Mastitis or breast inflammation while breastfeeding includes women who had severe mastitis or breast infection or had any of the following breast problems: discolored or shiny, hard, lumpy, hot, painful, tight breasts, tender axilla nodes, cracks, blood, rash, exudate, open or oozing sores on breast or areola.

³Severe mastitis is defined as breasts that, upon exam, had tender axilla nodes or were discolored or shiny, hard, lumpy, hot or painful during exam.