2.7. Statistical Methods
As this was a novel exploratory study, there was no pre-existing data to complete an a priori sample size calculation. The results presented in this paper are for the intention to treat (ITT) population if not otherwise indicated. ITT includes all randomized subjects with at least one reported consumption of any of the products. The per protocol population (PP) includes all randomized subjects with complete data for the primary outcomes, and a minimum of 80% reported compliance in terms of the amount of product consumed with no major protocol deviations. All subjects, who took at least one dose of the study product, were included in the safety population. All analyses were two-sided at a 5% significance level. However, since it is an exploratory study, some If the data were categorized, McNemar’s test was used to determine if there was a statistically significant within-group change in terms of the proportion of subjects in each category from baseline to the end of the intervention, and chi-square analysis was used to evaluate differences between the groups at each time point. All analyses were conducted using the SPSS IBM V 28.0.