The applicant has presented a number of publications from the literature in order to discuss the rational for deviation from the ICH Guideline on Clinical Investigation of Medicinal Products in the Paediatric Population (CPMP/ ICH/ 2711/ 99) and the basis of differentiation of 0-14 and 15-28 days instead of the more general definition of neonates as ‘ up to 28 days after birth’, as well as the different dosing regimens used.