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No kidding

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)

Further details of the clinical trial protocols, study populations, statistical analysis plans, and study outcomes have been published [25, 26]

Guidance for Industry 2, Food and Drug Administration staff, and other stakeholders