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ratio for primary MACE. The second analysis is an analysis based upon including a

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time-dependent co-variate for rescue and a second co-variate for the baseline A1C. The

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final analysis includes only rescue as time-dependant co-variate, and our view of these

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data is that including a co-variate for rescue did not seem to impact the effect. Now,

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obviously there are limitations to these analyses, but based on these analyses we were not

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able to detect an impact of rescue. Thank you.

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occurred before and after rescue. We were prompted by the FDAs posing this particular

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discussion issue. If you could show slide 3-148 please. This slide describes the total

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number of events for primary MACE that occurred prior to rescue and number of events

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that occurred after rescue. As you can see on the slide, 10 of the 41 primary MACE

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events occurred after rescue. So most of them actually occurred prior to rescue. We have

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also done some sensitivity analyses where we have looked at the potential impact of

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rescue on these events. We used a Cox proportional hazards model where we included a

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time-dependant co-variate for rescue to try to tease out whether there was any impact of

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rescue. Please display slide 3-138.

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here is whether the trial design, which was originally short-term period and then placebo-

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controlled in general or comparative control and then were administered open label

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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

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we break at 2:30 p.m. for 15 minutes and come back and discuss Question 4 and then go

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DR. WOLF: We specifically examined the issue of how many events

149

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(No response.)

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Okay. Then what I would like to do is summarize Question 3. The issue

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on to the voting questions?

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