MNBio - It has to do with the scientific issue called "generalizability." Basically, you cannot apply results from a study sample (e.g. showing V-related MACE reductions) to a population that is different in key characteristics from that study sample. No one in R-It was statin-free, so you cannot generalize R-It results to people not on statins. Not saying V alone would fail, but the FDA would have no proof of this yet to justify a statin-free label.