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Posted On: 12/14/2017 3:00:23 PM
Post# of 72447
When the sample size is small, the placebo rate can change quickly simply by chance. As Cox pointed out, 60% was a fluke. Soligenix had 74% which was more typical.
If those five patients didn’t drop out due to severe OM, the incidence rate would be 17 of 25 patients, or 68% placebo rate. Phase 3 will contain a larger sample size so the placebo rate should be closer to the 70-75% range.
If those five patients didn’t drop out due to severe OM, the incidence rate would be 17 of 25 patients, or 68% placebo rate. Phase 3 will contain a larger sample size so the placebo rate should be closer to the 70-75% range.
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