Statistics
Data were double entered and verified with the Informix database
management system. SAS (SAS, Inc)was used to perform the
statistical analysis. All tests of significance were two-sided conducted
at the 0.05 level of significance. Results are based on the “last
observation carried forward” method, with death given the worst
outcome score on all of the measures. Differences in baseline
characteristics were determined with t tests for continuous variables
and the x2 test for categories. Efficacy end points were tested by use
of a 2-sample binomial test adjusted for baseline differences if
necessary. Difference in ICH and SAEs between groups were
compared with the Fischer exact test.