2.5.4. Study Population
weight gain
The data analysis presented herein was performed using the full analysis set (FAS) and per protocol set (PPS). FAS contained all randomised infants in FF and all infants in BF, except those who turned out to be a screening failure, who did not participate in V1 or who did not receive the study product at least once (if in FF). PPS involved infants of FAS without major deviations to the protocol, which included visits outside the visit window, specified medications, or any complementary food and drinks up to V4. The results of GI tolerance are described here for PPS.The study product was intended to be the only source of nutrition, meaning no breastfeeding, no complementary food, no energy-containing liquids, no feedings of any other infant formula, and no energy-free drinks like water or unsweetened tea were to be consumed until the infant reached the age of 120 days. Infants, who received complementary liquids or foods before 120 days, were not included in the PPS analysis.The sample size calculation was based on the primary study outcome mean daily weight gain. Details are described elsewhere [BF was not randomised and therefore not included in the inferential statistical analyses. The presented results for BF and comparisons to FF are purely descriptive.Descriptive analyses were performed by group and by visit for all parameters. Data are presented as mean (SD) unless otherwise indicated.Inferential tests focused on an explorative two-sided 5% significance level. Statistical analyses were performed using the software SAS