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begin by describing the CV risk profile in the phase 2b/phase 3 pool population. The

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presence of type 2 diabetes in and of itself is a significant risk factor for future CV events

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as noted in various epidemiologic studies. 80% of the patients in our pool phase 2b/phase

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3 population had at least one of the four additional risk factors for cardiovascular events

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that are listed on this slide.

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MACE and primary MACE, is shown at the bottom of the slide. There were 40 patients

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with custom MACE and 41 patients with primary MACE. There were 40 patients in the

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overlap. In other words, custom MACE and primary MACE identified nearly identical

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sets of patients differing by a single individual. This is important because the results for

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primary MACE will be nearly identical to the results for custom MACE.

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factors including male gender and duration of type 2 diabetes. Our statistical analysis

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plan specified primary MACE as the primary endpoint for assessment of the

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cardiovascular safety profile for Saxagliptin. Accordingly, the next few slides will focus

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Next I will summarize the results of our analysis of CV events. I will

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SMQ MACE and acute CV events. However, there were clear differences in these two

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populations as shown. Among the patients with SMQ MACE but not acute CV events, a

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majority were accounted for by the single preferred term, a blood creatine phosphokinase

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increase, which was in the FDAs definition of SMQ MACE.

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cardiovascular disease upon entry to the phase 2b/phase 3 studies defined as a prior

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history of myocardial infarction, heart failure, angina pectoris, coronary, carotid or

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peripheral vascular disease or prior revascularization procedures.

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The relationship of the two most narrowly defined endpoints, custom

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There are 569 patients in our experience who had clinically evident

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Dr. Chen previously described the prevalence of some other potential risk

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