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Sunday, January 30, 2022 10:16:01 AM
Maybe the study design was changed from June 2021 and new interesting elements appeared in this time frame . Maybe they want to explain why they raised enrollment from 16500 to 39600 , why they changed the protocol
June 18th presentation: – 32,000 usual care + 3200 intervention= 35,200. Which is only 4400 from the 39,600 total ‘enrollment’ now seen on updated ClinTrials site. Of those, add 4000 to ‘usual care’ group and 400 to the intervention group. And even at 60% consenting of that 400, added to the ‘almost 2000’ the presenter stated, you still are going to get less than 2200 total IPE.
They had a low incidence of moderate-severe viral infections across IPE and usual care groups (combined, blinded), as seen in presentation, and that is why they were adding more IPE's and matched controls.
They did fail to update enrollment number on September 3rd when they did ClinTrial update, but that was probably just an oversight,
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