Adverse pregnancy outcomes and serious adverse events by study arm (safety cohort).

aMiscarriage: termination of pregnancy and expulsion of an embryo or of a foetus prior to 20 complete weeks of gestation and/or a birth weight less than 500 g.bStillbirth: foetal death that occurs after 20 complete weeks of gestation.cPrematurity: birth before the beginning of the 37th week (assessed by the Ballard score).dExcluding incomplete data on Ballard score.Adverse pregnancy outcomes and serious adverse events by study arm (safety cohort).