For those worried that the limited 008 trial of n=60 is too...

For those worried that the limited 008 trial of n=60 is too small to definitively prove DMOAD, it occurred to me that one possible reason for the small patient size is perhaps the results will be measured objectively. This is not your usual double-blinded placebo trial where the true effect of the active drug is eroded in the results by the placebo effect, which makes a big difference. As far as the primary endpoints of 008 are concerned, placebo will not have any placebo effect whatsoever (which is one of the main clinical trial design risks). A massive sample size may therefore not be required to demonstrate statistical significance (compared to a subjective measurement like pain). IF the science behind iPPS is indeed true like we suspect, then a clear trend is almost 100% guaranteed to show up in the results. Even if the confidence intervals are quite wide due to the small sample size, the result bands should be further apart from each other thus making it much easier to demonstrate statistical significance than otherwise would be. One thing I've learnt about PR is that there is a rationale behind every decision and he is always willing to listen to the right people, no corners are ever cut. I doubt the number n=60 was just plucked out of thin air. There would've been input from the whole team including the chief statistician in selecting the patient population during the design of this trial.