>>If you recall, the original statistical analysis plan specified that HbA1c from the aggregated insulin arms would be compared to placebo (i.e. metformin alone). Then, after the study had been in progress for a while, they added patients and changed the analysis plan to compare the individual insulin arms to placebo. <<
You sure about this? EMIS website says the expansion was to allow comparison of all arms against each other, which is rather different, no?