I completely agree. I think they still do not
Post# of 148161
I think they still do not control clinical trials. They should include age stratification in randomization process to make sure both groups have the same age ratio.
They should stratify in severity level to make sure both group has the same ratio of patients who has the same severity.
The premise of double blind trials is simple, make sure both group of patients are almost the same, the only difference is the drug and placebo. It is no rocket science.
Another point is maybe they should include Receptor Ocupancy test.
Surely, why 350mg? It is not the time to open the door for another dosage justification jouney. Let's keep it all the same, 700mg. That will be much simpler to justify. This is a huge trial (more than 1000 patients).
We cannot afford another failure. It is absolutely important to make sure there is no surprise, and no room for any error.