Statistical analysis
REGRESSION, SECONDARY
Descriptive statistics (n, mean, standard deviation, 95-CI, median, minimum and maximum) will be calculated for each quantitative variable; frequency counts by category will be made for each qualitative variable. Two sets of study data will be evaluated: the primary endpoint will be evaluated in the Full Analysis Set. The Full Analysis Set is defined as the set of data generated from the included patients who received at least the treatment dose. The secondary endpoints will be evaluated in both Full Analysis Set and Per Protocol Set. The Per Protocol Set is defined as the set of data generated from the included patients who complied with the protocol. A linear mixed effects regression model will be used to evaluate the relationship between absorbed dose- and studied effect. An analysis of variance method with a Chi-square test will be used to compare nested models and generate p-values for the fixed effects. The explained variance by the model, with and without random intercept, will be assessed with R