Ethics approval and consent to participate
The ROLO and ROLO Kids studies were carried out in accordance with the Helsinki Declaration of 1975 as revised in 1983. Institutional ethical approval was obtained from the National Maternity Hospital in November 2006 for the original ROLO study. The ROLO Kids 5-year follow-up was approved by the Ethics (Medical Research) Committee in Our Lady’s Children’s Hospital, Dublin in October 2012, REC reference: GEN/279/12. Informed written maternal consent was obtained during pregnancy and at each subsequent follow-up from all subjects.