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considered: the endpoints, the treatment periods, and the methods. You have already

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heard a lot of information about these issues. I am going to mention a few statistical

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aspects. You have heard from several speakers detailing about the two endpoints defined

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by FDA. Because these endpoints were not adjudicated, and were defined post talk, there

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was an effort to capture any cardiovascular signal by including a broad endpoint. With

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the SMQ endpoint, we are aiming to show consistency of a fact with the custom

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endpoint. Adjusting from multiple endpoints though is not an issue because it is the

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“Custom MACE” endpoint, which is of primary concern.

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you some of the issues we considered when planning the MACE analyses, including

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the choice of statistical methods. Then I will present the results starting with an overview

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followed by some specifics about the SMQ in “Custom MACE” results. At the end of

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my talk I will show some sub group results.

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impact of the use of open label rescue medication. About one-third of the patients in

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these trials entered the long-term period on rescue medication and rescue was generally

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higher in the placebo groups. So, we wondered about the influence of rescue on

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followup. The addition of low dose rescue medication in the long-term period may or

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may not bias towards the alternative hypothesis that of showing non inferiority when

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looking at these cardiovascular endpoints. So, we decided we should look at both the

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short-term period where no events on rescue medication are captured and also look at the

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short-term plus long-term period.

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When planning the MACE analyses, there were three issues we

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With regard to the time period to use in our analyses, we considered the

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About 85% of the patients continue to be followed on double-blind

treatment into the long-term period and so the randomized groups were largely preserved.

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