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suggesting some treatment effect differences between males and females, and younger

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and older. Actually the estimate for males and females was about 0.11 and 0.17 for this

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comparison. I want to point out that none of these estimates provide evidence of

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significant increased risk. I also would like to add at the end here that the analyses by

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FDA pharmacologists’ suggested higher exposure based on AUC for elderly patients than

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younger patients. Thank you for your attention and now Dr. Lowy will return to

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summarize.

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risk would also be seen in a higher risk subgroup. I am showing here the results by

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type of study, here at the top by gender and by age. As Dr. Lowy showed earlier, the

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add-on studies were comprised of patients who had a longer history of diabetes than the

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patients in the monotherapy trials and all had been previously treated with anti diabetic

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drugs. So the control event rate of one is much higher for those studies in monotherapy.

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The control event rate is 1.8% for the add-on trials compared to six times - which is about

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six times the rate seen for the monotherapy trials, but what we see is that the odds ratios

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are essentially the same.

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mentioned. I summarize with this slide to place the FDA requested analyses in the

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context of the Sponsors analysis, particularly when comparing the point estimate of 0.5,

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an upper limit of 1.2 in the Sponsors analysis, to the custom MACE numbers already

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presented. A consistency of results is seen. Therefore, in summary, we have shown you

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that patient populations were comparable across the studies used in the MACE analysis.

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With this, low event rates were seen in all studies. Consistent results for Custom MACE

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and SMQ broad MACE were seen particularly when excluding the preferred term of

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For gender and age test for inner actions yielded P values under 0.2

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DR. LOWY: The Sponsors own initial MACE analysis has already been

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