jupe, you have stated.."Therefore, I assume that a successful topline result is achieved if a statistically significant reduction in time-to-first-occurrence is achieved, regardless of the overall %RRR. " Should you have said that a successful topline is achieved if a statistically significant increase in time to the first occurrence is achieved, regardless of the overall %RRR?
In order words, this, in essence, could this simply be a horse race between the apabetalone and placebo groups as to which group ends up with least number of MACE event up to the time when 250 MACE events are reached in totality with no consideration to when they occur from the start date to the end date of the trial, the trial being event-based. So the "primary outcome measure" is calculated as a percentage on this basis. Why would it need to be more complicated than that?
ie: a) MACE with APL 75, b) MACE with placebo 175 = total 250 MACE
175 - 75 = 100/250 X 100 = 40% RRR
Or is the RRR only based on "Efficacy" to show a statistical significance in the 3 point MACE including cardiovascular death, MI (heart attack) and nonfatal stroke, compared between the 2 groups?
IMO...Koo