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broad SMQ MACE endpoint is a composite endpoint that included all cardiovascular

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deaths and all preferred terms in the SMQ for myocardial infarction and central nervous

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system hemorrhages and cerebrovascular accidents. On the other hand, the so-called

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custom MACE is essentially a subset of the broad SMQ MACE. It was developed by

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collaboration and consensus of three FDA reviewers.

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populations and the intent of choosing these endpoints was twofold. First, to broadly

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capture all possible strokes and myocardial infarctions and secondly to more specifically

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include terms which when chosen by the investigator were likely to represent true

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myocardial infarction or stroke. It is with this intent that the agency termed these

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endpoints, broad SMQ MACE and custom. These endpoints separately with the addition

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of cardiovascular deaths were thus chosen as the MACE endpoints of interest.

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to represent events that would truly be an MI or stroke and that represented events, which

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were acute and atherosclerotic in mechanism. The complete list of all terms used on both

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endpoints is included in your briefing document. Here, I provide examples of which

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terms were chosen for these two endpoints. Under myocardial infarction terms, acute MI

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was chosen for both the broad and custom endpoints while blood CPK increased was

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listed only under broad. Under stroke terms, CVA was listed under both endpoints, while

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paralysis was chosen for broad only.

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I will now more specifically define each of these endpoints. The so called

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In defining these endpoints, we selected terms, which seemed highly likely

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the incidence of custom MACE data for all treatment groups, for both the short-term and

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short-term plus long-term periods. These numbers represent the first event for a subject.

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FDA requested two separate endpoints be analyzed for these

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I will now start presenting results of the analyses. In this slide, I present

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