Statistical Analyses
hemoglobinopathies, anemia
CVD, EVENTS, HEMOGLOBINOPATHIES, ANEMIA
The prespecified statistical analysis plan is provided in Prespecified subgroup analyses were performed in subgroups categorized by preexisting CVD, baseline testosterone (below 250 ng/dL, 250 ng/dL and above), age (younger than 65 years, 65 years or older) and race (Black or African American, White, and other [including American Indian and Alaskan Native, Asian, Native Hawaiian or other Pacific Islander, and multiple reported races]). Race was identified by self-report, with groups with insufficient numbers for meaningful analysis grouped as other. Prespecified subgroup analyses by race were performed because racial differences in hemoglobin levels, prevalence of hemoglobinopathies, and in pharmacokinetics could contribute to differences in response to study intervention. Specifically, because of the greater prevalence of hemoglobinopathies in Black or African American populations, the rationale for subgroup analysis by race was stronger than for other racial groups.For all subgroup analyses, models with a 3-way interaction between treatment-visit-subgroup were fit, assuming a compound symmetric covariance matrix and type 1 error was not adjusted for multiplicity; therefore, these Changes in hemoglobin, hematocrit, red cell counts and indices, and sex hormones were analyzed using linear mixed effects models with fixed effects for treatment, visit, treatment-visit interaction, baseline value, and prior CVD status, and allowing for intraparticipant correlation using an unstructured covariance matrix, unless otherwise noted. An omnibus The TRAVERSE parent study planned to enroll 6000 participants based on the projection that this sample size would accrue 256 primary composite MACE events to rule out a hazard ratio of 1.5 at the 95% (2-sided) upper confidence limit with 90% power. The sample size for the anemia study was not prespecified but defined by the number of men in the TRAVERSE Trial who had anemia at baseline.