2.3. Outcome Measures
ADVERSE EVENTS
The primary outcome measure was the change in food enjoyment, assessed as the difference in BEBQ Enjoyment of Food subscale scores between the inclusion visit (baseline) and final visit (day 28 ± 3). Secondary outcome measures were the other BEBQ subscale scores; Montreal Children’s Hospital Feeding Scale (MCH-FS) scores; quality of life, as reflected by modified QUALIN scores; GI symptoms; and anthropometric variables.The BEBQ, developed in 2011 by Llewelyn et al. [Designed by pediatricians and healthcare professionals, the MCH-FS is a 14-item parent reporting instrument for identifying feeding difficulties in children [At baseline and the final visit, health-related quality of life was assessed using a modified version of the 34-item QUALIN questionnaire (French version), intended for children 3 months to 3 years old and completed by parents or caregivers [Data on adverse events during the study period were recorded during each participant visit. Safety was evaluated in all participants who underwent randomization and received ≥1 serving of formula.