Results
5204, prostate or breast cancer, prostate nodule or induration
Among 32 152 screened men, 50 (0.16%) were excluded because of a history of prostate or breast cancer, 1201 (3.74%) for PSA concentrations greater than 3.0 ng/mL (or >1.5 ng/mL if receiving 5ARIs), 549 (1.71%) for IPSSs greater than 19, and 57 (0.18%) for prostate nodule or induration; these percentages should be interpreted with caution because men who failed screening at earlier screening visits did not complete subsequent screening assessments. Among 5246 identification numbers of randomized men, 42 were attributed to 20 participants with duplicate enrollment. After excluding these duplicates, the full analysis set included 5204 participants (mean [SD] age, 63.3 [7.9] years; self-reported race: 877 [16.9%] Black, 4154 [79.8%] White, and 173 [3.3%] other; self-reported Hispanic or Latinx ethnicity, 848 [16.3%]), with 2601 in the TRT group and 2603 in the placebo group. The safety set included 5198 participants (2596 in the TRT group and 2602 in the placebo group) who received at least 1 dose of study medication (