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Indeed, in the NAC arm in FAS population, two neonatal prematurity-related events were reported (with a diagnosis of sepsis and respiratory distress), whereas, in the placebo arm, fourteen events were diagnosed, due to seven diseases (4 cases of respiratory distress, 3 cases of BPD, 1 case of sepsis, 1 case of NEC, 2 cases of ROP, 3 cases of intraventricular hemorrhage) (Table 2A)
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