Statistical analysis
A hierarchic closed-testing procedure was
used to control the type I error rate across
the primary and key secondary end points
at the 0.05 level (two-sided). Thus, if
noninferiority was established for the primary
end point at a one-sided 0.025
significance level, then key secondary end
point testing for superiority could proceed
in the sequence described previously. If the
first key secondary end point was signifi-
cant at a two-sided 0.05 significance level,
then the second secondary end point could
be evaluated, and so forth