Dataset from Follow-Up Study to Assess Long-Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies

The primary objective of this study is to assess the safety and outcomes of infants and
children who were exposed to retosiban or comparator in utero in the Phase III spontaneous
preterm labor (SPTL) treatment studies, to provide assurance that treatment is not associated
with significant adverse outcomes in early childhood. The enrolled infants and children will
be followed at pre-specified intervals until they reach 24 months chronological age. This
study does not require medical interventions or study visits to an investigational site,
instead, parents or legal guardians will be prompted at certain time points to complete
developmental questionnaires and other data on their children's health status via an
electronic device. Data collected during the infant and child follow up study will be managed
by a centralized research coordinating center (RCC). Regionally based pediatricians will
serve as study principal investigators (referred to as RCC-PIs) for this study. All
communications the RCC-PI has with the parent/legal guardian or the child's health care
provider (HCP) will occur remotely; there will be no clinic visits.