EF-recovery (IIEF-EF ≥ 22) and EF category improvement during DBT. CI confidence interval, DBT double-blind treatment, EF erectile function, IIEF-EF International Index of Erectile Function-Erectile Function domain, LSmean least square mean, MCID minimal clinically important difference, MMRM mixed model for repeated measures, n number of events, N number of patients, n.e. not estimable, n.s. not significant, OaD once a day, PLC placebo, PRN “pro-re-nata”/on demand, TAD tadalafil, yrs years. a Event (EF-recovery) was defined as change in IIEF-EF from <22 at screening to ≥22. P values are obtained from Cox proportional hazard model including terms for treatment, country, and age. b
p value obtained from an MMRM model, assuming an unstructured covariance structure, including terms for visit, treatment, treatment-by-visit interaction, country, age group, and baseline IIEF-EF score as fixed effects, and patient and error as random effects. Previously published in: Montorsi et al. 2014 [15]