Clinical Research Directory

Inclusion Criteria Cohort 1: * Active participation in SS-101-18 through Visit 9 * Provision of signed and dated informed consent form (ICF) by parent or legally authorized representative (LAR) * Stated willingness to comply with all study procedures by parent or LAR. Exclusion Criteria Cohort 1: * Did not participate in SS-101-18 * Participated in SS-101-18 that withdrew from the study for any reason prior to Visit 9 * Anything that in the opinion of the Investigator is likely to interfere with participation in the registry. Inclusion Criteria Cohort 2: * Be less than 120 days old at the time of enrollment * Provision of signed and dated informed consent form (ICF) by parent or legally authorized representative (LAR) * Stated willingness to comply with all study procedures by parent or LAR. Exclusion Criteria Cohort 2: * Participation in SS-101-18 * Anything that, in the opinion of the Investigator, is likely to interfere with participation in the registry. * In the opinion of the investigator, has a diagnosed medical condition or genetic abnormality known to impact growth or development.