3.1. Analysis Population
Eighty-eight (88) healthy, full-term infants between 7 days and 2 months (60 ± 7 days) of age were enrolled. They were randomized in a 1:1:1 ratio to receive Moreover, the mITT completers and PP completers were subjects in the mITT or PP population with weight measurements at month 4, respectively. As shown in Of the 88 infants, 11 (12.5%) withdrew consent, and one (1.1%) was lost to follow-up before completing the treatment. The total number of infants that completed the 4-month treatment was 76 (86.4%), 29 in the AP-32 group, 28 in the CP-9 group, and 31 in the placebo group. The dropout rate in the CP-9 group (21.4%) was slightly higher than in the placebo group (12.9%). A flowchart of participants is shown in There were no significant differences observed among the groups in terms of age, sex, birth weight, and anthropometric data.