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(A) Study visits were conducted at four, eight, 13 and 17 weeks after birth. At four weeks, this visit may have been combined with the screening/baseline visit, depending on the age at inclusion. (B) Randomisation, dropouts and study completers. From the 432 randomised infants, one infant with hypothyroidism was excluded from the intention to treat population (n = 431), which constitutes the primary analysis set for GI and tolerance parameters.
