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That would require dose-escalation studies in animal models followed by human pharmacokinetic trials

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We will analyse the effect of vitamin B 12 separately in the following subgroups: Vitamin B 12 status: based on cobalamin (cut-off: 150 pmol/L) based on low total homocysteine (cut-off: 10 mol/L) based on low methylmalonic acid (cut-off: 0.26 mol/L) Maternal body mass index (cut-off: 18.5) Vegetarian (yes/no) Birth weight (cut-off: 2500 g) In these subgroup analyses, the differences in the effect between the levels of the subgroups will be measured by including two-way interaction terms in multiple regression models