In November 2010, Prana was still releasing statements to the market stating that they intended to have 525 participants in the Phase 2b IMAGINE trial.
In March 2011 they changed that number to just 40 participants which as I understand it is roughly the number that went through.
Two questions:
1) For those who've been around longer than I, does anyone know why the massive drop in intended participants? Did they state why? Was it just difficult to recruit for?
2) Am I right to be concerned about the difficulty of proving statistical significance with such a small number or is this concern not warranted for some reason? This is half the number of participants in the Phase 2a trial (78)!
Confused.
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