ratio for primary MACE. The second analysis is an analysis based upon including a
time-dependent co-variate for rescue and a second co-variate for the baseline A1C. The
final analysis includes only rescue as time-dependant co-variate, and our view of these
data is that including a co-variate for rescue did not seem to impact the effect. Now,
obviously there are limitations to these analyses, but based on these analyses we were not
able to detect an impact of rescue. Thank you.
occurred before and after rescue. We were prompted by the FDAs posing this particular
discussion issue. If you could show slide 3-148 please. This slide describes the total
number of events for primary MACE that occurred prior to rescue and number of events
that occurred after rescue. As you can see on the slide, 10 of the 41 primary MACE
events occurred after rescue. So most of them actually occurred prior to rescue. We have
also done some sensitivity analyses where we have looked at the potential impact of
rescue on these events. We used a Cox proportional hazards model where we included a
time-dependant co-variate for rescue to try to tease out whether there was any impact of
rescue. Please display slide 3-138.
here is whether the trial design, which was originally short-term period and then placebo-
controlled in general or comparative control and then were administered open label
At the top of the slide we display the un-adjusted Cox proportional hazard
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DR. BURMAN: Thank you. Any other comments on Question 3 before
we break at 2:30 p.m. for 15 minutes and come back and discuss Question 4 and then go
DR. WOLF: We specifically examined the issue of how many events
Okay. Then what I would like to do is summarize Question 3. The issue
on to the voting questions?