Bioequivalence and non-inferiority interpretation
The Swedish Medical Products Agency (Läkemedelsverket) requested that a bioequivalence and non-inferiority interpretation of the primary outcome be made after the study; the new treatment would be considered not clinically relevant if the results of TU treatment were outside 80%–125% of the TE results. The statistical analysis of the number of boys was conducted using Fisher’s exact chi-square test.Statistical analyses were conducted using IBM SPSS version 28 statistical software.