Herpes Virus Infections During Double-Blind Period*
Studies 1027 and 1028
Numbers of Subjects with an AE
8
3
0
0
1
2
2
Placebo
(n=209)
8
2
1
Genital herpes
21
31
20
TOTAL
0
3
0
Oral herpes
0
8
3
Labial herpes
3
8
3
Anal/rectal herpes
5
2
3
Herpes virus
5
8
10
Herpes simplex
Time-Adjusted Placebo
(Placebo x 2.6)
MVC BID
(n=426)
MVC QD
(n=414)
Adverse Event
* A subject could have more than one type of adverse event.