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Re: Black-Ops post# 167428

Monday, 05/24/2021 12:30:22 PM

Monday, May 24, 2021 12:30:22 PM

Post# of 233646

When way, way to much progress was made the FDA changed the time to 28 days.

Then 42 days.


What are you talking about progress? The trial started with a primary endpoint at 28 days. The trial ended with a primary endpoint at 28 days. During the interim analyis, the DSMC recommended an endpoint at 42 days. I don't think the 42 day endpoint was ever adopted. The DSMC probably recommended the 42 day endpoint because they saw that there was no benefit at 28 days.
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