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On the clinical trial of Prasugrel, what is the reason for the increase to 13,600 patients from the 13,000 that was originally planned as the registered patient count?

April 26, 2017clinical trial increase originally Patients planned prasugrel registered

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On the clinical trial of Prasugrel, what is the reason for the increase to 13,600 patients from the 13,000 that was originally planned as the registered patient count?

1 Answer

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10 Posted

A10. The reason for the increase in patient count from 13,000 to 13,600 is based on number of events. In November, we assessed how many events there would be and prepared a projection, and upon a review of the necessary patient count, we increased this number.