2.4. Statistical Analysis
non-compliance
SENSITIVITY
The number of infants needed for detecting a statistical difference was calculated based on differences in the BEBQ Enjoyment of Food subscale reported by Llewellyn et al. [Summary statistics described the demographic and clinical characteristics of participants. Categorical data were described using frequencies and percentages. Quantitative data were described by the mean and standard deviation (SD).The ITT population was included in the primary outcome analysis. Participants from parents who refused to participate just after randomization and refused the milk delivery were excluded from the study. Changes in BEBQ and modified QUALIN scores for the two groups were compared using Student’s Sensitivity analyses were performed for the PP population, composed of all participants who underwent randomization but for whom no severe non-compliance to the intervention was observed. Analysis of outcomes for the PP population applied the same methods as for the ITT population.All statistical tests were two-sided. The threshold for statistical significance was set to 