Statistical analyses
SECONDARY
Exploratory analyses of the data will provide, for quantitative variables, the mean, standard deviation, median, quartiles, and number of missing values; for qualitative variables, we will calculate the frequencies and their 95% confidence intervals. The demographic and clinical characteristics of the patients will be described. An intent-to-treat analysis will be conducted. The statistical significance level is set at 5% for each statistical analysis and confidence interval.The main objective is to compare the proportion of patients who had adherence failure 18 months after hormone therapy treatment start between the two groups. This comparison will be performed using a two-tailed Chi-squared test at the 5% level. All the measures will be used in order to reduce the number of patients lost to follow-up. For patients lost to follow-up at 18 months, with available data on adherence to hormone therapy at 6 months, data on adherence at 6 months will be retained, otherwise patients in the experimental arm will be considered as non-adherent and patients in the standard arm will be considered as adherent.For secondary objectives, secondary endpoints will be described used the methods above described. The comparison of these endpoints between both groups will be performed using the Chi-squared test (or Fisher’s exact test if necessary) for qualitative variables, and through a Student’s test (or non-parametric Wilcoxon Mann Whitney test if necessary) for quantitative variables.