Inclusion Criteria:  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:  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.