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Thanks for staying after this.

If we bend over backwards to be generous: “We are doing three days of dosing” could mean “We have already decided to do three days of dosing.” However, “Thats what is being administered” is a little harder to interpret this way. And, if this is the case, it would be easy for them to say so. Plus, as you’ve indicated, there are some independent reasons to suspect that this dosing did begin early.

A plausible story is that things got a little sloppy and someone started dotting their T’s before crossing their eyes. Then, realizing that those dosed prior to approval could not “ethically” be included, they were (silently) dropped.

It’s not good, but it might not have serious implications for the validity of the (wrongly interpreted) results. Still, it should be addressed along with the other issues. We deserve to know exactly what happened here.

And, for all we know now, what happened to those who were dropped (if you are right) just might turn out to be revealing.

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