Candidiasis Infections During Double-Blind Period
Studies 1027 and 1028
•70 Candidiasis AEs
–MVC QD 41 AEs in 26 (6.2%) subjects
–MVC BID 18 AEs in 17 (4.0%) subjects
–Placebo 11 AEs in 11 (5.3%) subjects
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•19 Category C Candidiasis AEs
–MVC QD 14 AEs in 12 (2.9%) subjects
–MVC BID 3 AEs in 3 (0.7%) subjects
–Placebo 2 AEs in 2 (1.0%) subjects