Two infants in the EFV-ART arm had congenital malformations, one with syndactyly considered unlikely to be related to maternal study drug and one with multiple skeletal, limb and cardiac malformations (possibly TARP [Talipes equinovarus, Atrial septal defect, Robin sequence, and Persistent left superior vena cava] syndrome) considered not related to the mother’s study drug. Here, TARP is linked to atrial septal defect.