All P values are two-sided, with a level of 0.05
considered to indicate statistical significance. P val-
ues other than that for the primary hypothesis
have not been adjusted for multiplicity and have
been calculated to test for null hypotheses of no
difference. All results were analyzed on an inten-
tion-to-treat basis that included the full analysis
set (i.e., all patients who underwent randomiza-
tion according to the planned treatment), with
the exception of adverse events leading to prema-
ture discontinuation, which were included in the
as-treated safety analysis.
Results