DR.
SIMMONS-O'BRIEN: Okay; and I just have one more question. In
the breast-related experiences in the Phase III controlled trial,
you have increased gynecomastia.
DR. KAUFMAN: Yes.
DR. SIMMONS-O'BRIEN: What was your percentage of gynecomastia
in the Phase II?
DR. KAUFMAN: Yes; could I have the slide which shows the gynecomastia
in Phase II and Phase III? This shows all of the reports of
breast-related clinical adverse experiences by dose in both
Phase III and Phase II, so, the combined experience. As you
recall, for the placebo group in the Phase III experience, there
were four cases. So, those were shown here. Four of the finasteride
1 milligram cases are shown here from the Phase III experience,
and the remainder of these are from the Phase II experience
at a variety of doses.
|