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Rdunn88

05/18/21 1:32 PM

#359671 RE: Jhawker #359666

There's a post observation period of 29 days, since there's few subjects they'll wait until the last observation is completed. Early August will be the data lock... Shame, interim for 60 would be finishing up soon...

Time to sustained recovery through Day 29 [ Time Frame: Day 1 through Day 29 ]

Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale with response sustained through Day 29:

Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than for per protocol dosing or assessments, as appropriate);
Not hospitalized, limitation on activities and/or requiring home oxygen;
Not hospitalized, no limitations on activities.