•Numerical increase in
mortality in MVC arms overall, however:
•
–Imbalance occurred in
only 1 of 4 trials
–Degree of imbalance
extremely small (for double-blind phase, p-value 0.60, Barnard's unconditional exact
test)
–No clustering of death
causes
–Types of deaths were
consistent with the population studied
–Sick population at
baseline (there were 11 additional deaths between screening and randomization)