I don't think a trial design with MORE participants leaves much room for Debate..after all, ... sheer numbers speak VOLUMES to the general population and THEY will/do decide THEIR participation... i.e. 20,000 participants VS 200....which trial APPEARS to have more credibility....really not tough to figure out..but, $$$$, TIME, and sense of urgency will ALWAYS dictate TERMS and CONDITIONS of E V E R Y T H I N G worth doing.