There is so little data required for the endpoints

There is so little data required for the endpoints: 5 integers and 14 real numbers.

There is a 7-point ordinal scale - an integer between one and seven, with death being a one. It is collected four or five times - the last for 42 day data if we use it. There is the SOFA score, calculated from seven real numbers. It is collected twice. That's all there is for primary and secondary endpoints.

Yeah, there is data on who-got-what-when. And I think the biggest issue: determining cause for all adverse events - that could require discussion.

But to verify data to calculate significance, I see appx 400 x 19 = 7600 data points. Not a time driver.