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jq1234

04/15/11 5:28 PM

#118295 RE: dav1234 #118293

The 53,000-patient number is total from 5 different trials, where 4 of them with 11,700-patient each. This isn't that large for phase 4. FDA had asked for one with more than 20,000-patient safety trial BEFORE approval in the past. I'll leave it as a quiz.