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of events in the broad SMQ analysis, I am now showing the preferred terms under the

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SOC of investigations. It is the term blood CPK increased that clearly drives the number

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of events seen on the broad SMQ analysis with the rates ranging from 1.5% in the

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comparator group to 2.2% in the 5-milligram group. Just as a reminder, increased CPK

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was not included in the “Custom MACE” endpoint. The FDA statistician, Ms. Mele, will

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now present the statistical analyses of these MACE events.

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MACE” endpoint. I will now present the incidents of “MACE” events using the broad

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SMQ endpoint. Again, overall event rates were relatively low. In the short-term period,

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1.4 to 1.9% in the Saxagliptin groups versus 2% in the comparator. In the short-term plus

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long-term period, rates were similar across all groups, all around 3%. Again the same

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data with the Saxagliptin groups pooled showing you an incidence rate of 1.7% versus

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2% in the short-term period and similar rates of 3 and 3.2% in the combined short-term

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plus long-term periods. When these events are then broken down by SOC for the short-

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term period; it is clear that one SOC investigations which I have highlighted, contains

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most of the events with incidence rates of 1.1 to 1.6%.

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Thank you. Thank you, Dr. Lowy. Now you have seen the MACE results

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from the company and our results do not differ from those results in any notable way. So

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To illustrate the point that the SOC investigations, comprises the majority

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was observed only once in the 2.5 milligram, 5 milligram and comparator groups,

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while hemorrhagic stroke was seen once in the 10-milligram group.

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FDA PRESENTATIONS

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JOY MELE, M.S.

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in addition to showing you these results again with some other details, I will describe to

Scribes, LLC Toll Free 1-800-675-8846 www.scribesllc.com

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So far, I have discussed the incidences of events under the “Custom

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