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. The gene discussed is TARP; the disease is Abnormal cardiac septum morphology.