Results
Patient disposition and baseline
characteristics
A total of 108 patients were randomized into the study.
Ninety-f ive patients (88%) completed the study, with
3.7% patients completing only Period 1. Reasons for
discontinuation included AEs (n = 9; 8.3%), protocol
deviation (n = 1; 0.9%), abnormal test results (n = 1; 0.9%),
and withdrawal of consent (n = 2; 1.9%). Mean age was
60.5 years, 58% of participants were male, and most were
Caucasian (96%). Other baseline demographic and clinical
characteristics are shown in Table 1. Mean Wmax for the
incremental work test at screening was 87.8 W (standard
deviation [SD] 28.8); submaximal workload averaged
70.2 W (SD 23.05).