DR. SIMMONS-O'BRIEN: Dr. Kaufman, I have two questions: did the patients fill out at baseline a sexual function questionnaire?

DR. KAUFMAN: Yes, they did.

DR. SIMMONS-O'BRIEN: And every time the patients were checked and monitored, did they have to go through a whole point checklist in terms of sexual function at that particular visit?

DR. KAUFMAN: They would fill out the sexual function questionnaire at every visit.

DR. SIMMONS-O'BRIEN: At every visit?

DR. KAUFMAN: Yes.

DR. SIMMONS-O'BRIEN: In any of the groups, was there a noticeable increase or decrease in their sexual activity over the period that they were on the medication? And did you advise--was there any advice on the men to use condoms?

DR. KAUFMAN: The sexual function questionnaire in the slide that I showed previously did show small but statistically significant changes between the two treatment groups but no effect on the patients' overall satisfaction with their sex life, and the changes that were seen were very small compared to patients who clinically had an adverse event related to sexual function.

I think it's fair to say that there are sporadic reports of patients who actually report increased libido as well as decreased libido on finasteride, and the last part of your question was whether we recommended that patients use condoms. In the Phase III trials, patients were just discontinued if they fathered a child, pending additional animal safety data which confirmed that exposure of women to finasteride through semen was not a risk to the human fetus.