I agree, Brazil, seems to be doing it right. The only thing I didn't find in the link is any upper limit on age, which could still be pointed to as a factor working for or against us. If it's later discovered, for instance, that an inordinate number of people over the age of 65 was in either arm of the study then each side of the equation could be determined as being an issue.
If in the placebo arm of the trial it's determined that a disproportionate number of people over the age of 65 were present and the death rate was unusually high then the argument could be made that there's no proof that LL was better than placebo or that placebo wasn't worse than LL because of the deck being stacked.
If in the LL arm of the trial the number over 65 was disproportionately high then the same argument as previously experienced could also be made that the lack of efficacy was skewed.
It would be helpful, if age is indeed a factor, and it appears to be just that, that >= 65 should be an exclusion factor. Having said that, it would be most unfortunate for those who are >=65 to not have the chance to be treated and potentially live in spite of their age.
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