I estimate that the day 0 score for all of the 85

I estimate that the day 0 score for all of the 85 m2m trial patients (0 to 12 possible score) is likely to be a 7. At end of trial, it's likely that the Placebo group's score will deteriorate to possibly 8 or 9 (i.e., some will get better but more will get worse). The Leron group's score will likely improve to likely a 5 (i.e., most will get better and minority no change/worse). So, we're looking at a difference of 3 or 4 which will blow away the statistical significance level of p<.05.