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age was low to mid 50s, subjects had diabetes for a mean of two to three years and in

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study 11, 2.5% of subjects had prior diabetes treatment while 5% of subjects in study 38

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had prior treatment. The history of coronary artery disease reported was approximately

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5% in study 11 and was higher at 13% in study 38. This is the demographic data for

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subjects in the initial combination with Metformin study with data fairly consistent with

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those seen in the monotherapy studies. Again, the mean age was 52 years, subjects had

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duration of diabetes of 1.7 years, 8% of subjects had a history of coronary artery disease

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and 2% reported previous diabetes treatment.

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important when interpreting the Forest plots that will be shown in the statistical

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presentation. Because these are the major contributor to the Forest plots, I will be

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presenting the study separately as un-pool data. Within each study however, the

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treatment groups are pooled since they were well balanced.

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I will next present disposition data emphasizing the short-term period here

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since the MACE analysis will rely heavily on the short-term periods as well as the short-

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Here is the demographic data for the two monotherapy studies. The mean

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The main differences from previous slides are the duration of diabetes and previous

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diabetes treatment. The duration of diabetes-ranged from five to 6.9 years which we

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would expect as these subjects entered the study already on medical therapy. Therefore

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100% of these subjects had previous diabetes treatment.

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term plus long-term periods. It is important to remember that the short-term safety data

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includes subjects who have not been rescued. Across all the core phase 2I studies, 74%

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of subjects completed the short-term period. The majority of dropouts were due to

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rescue. I would reiterate that these were not typical dropouts since they continued on

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Finally, the demographic data for the three add-on combination studies.

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