Ann: Ethics submission to commence cardioprotection trial, page-27

all good points. There are historical randomised trials that already provide evidence that Zantrene provides reduction of cardiotoxicity.

we can’t assume that in-depth discussions with Aaron, FDA and Pharma have not already occurred. But I am sure all these points have been considered already
and factored into the trial design.

With regards to FDA one could argue placebo is not appropriate as it could create “permanent and irreversible damage”. Thus synthetic arm might be the logical choice.

the pivotal trial could be structured differently and would involve Pharma so they could design in line with their requirements and that of the FDA, if they felt a placebo effect was cause for concern.