Figure 1.
CONSORT diagram for the four randomized groups by delivery mode and formula type.
Notes: Visits were numerated as follows: V0, enrollment date: 0–3 days of life; V1, 10 ± 2 days; V2, 4 weeks ± 3 days; V3, 6 weeks ± 3 days; V4, 3 months ± 3 days; V5, 4 months ± 3 days; V6, 6 months ± 3 days; V7, 9 months ± 14 days; and V8, 12 months ± 14 days.
Abbreviations: FAS, full analysis data set (FASE for Efficacy, FASS for Safety); PP, per protocol data set (PPE for efficacy, and PPS for safety).