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Stool consistency became softer over Day 1-3 (Control 2.5 ± 0.1, PHF 2.6 ± 0.1) and remained similar from Day 4 to 6 through study end ( analysis). For PHF vs Control, endpoint stool consistency was significantly softer (3.4 ± 0.1 vs 3.0 ± 0.1; = 0.019) and frequency significantly higher (1.5 ± 0.1 vs 1.0 ± 0.1; = 0.002). Crying, fussing, and appearance of pain during stooling decreased from baseline to study end in both groups. Formula intake, infant fussiness and incidence of adverse events were similar between groups. An infant formu