Statistical methods and sample size
enlargement
SECONDARY, ENLARGEMENT
The primary outcome was testicular enlargement to ≥8 ml after 12 months; the new treatment would be considered clinically similar if its results (number of patients with testicular size ≥8 ml after 12 months) were 80%–125% of the number of patients with testicular size ≥8 ml after 12 months of traditional treatment.Since TE is SoC and had not been evaluated for pubertal induction, data were analyzed in agreement with the Swedish Medical Products Agency (Läkemedelsverket). The secondary outcomes were described with mean and SD and were analyzed with an independent-samples t-test.The sample size was not formally considered in terms of statistical power since TE is SoC and had not been evaluated for pubertal induction; therefore, no power analysis was conducted before this study. Our intention was to recruit 20 patients in the TU group and 20 in the TE group.