Clinical Research Directory

Inclusion Criteria: Participants are eligible to be included in this study only if all the following criteria apply: * Investigator confirmation of the participant's continued clinical benefit from the parent study intervention and the participant's completion of the protocol-defined treatment period in the parent study. The Investigator should ensure that the participant is still eligible for the parent study (i.e., have not met parent study discontinuation/ withdrawal criteria). * Participants or legally authorized representative (LAR) who are willing and able to comply with all scheduled visits, treatment plan, and other study procedures as outlined in the applicable appendix and determined by the Investigator. * Participant or LAR is able and willing to provide signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and this protocol. Where applicable, participants must provide written assent. Exclusion Criteria: Participants are excluded from participating in this study if the following criterion applies: • Any reason that, in the opinion of the Investigator or Sponsor, precludes the participant's inclusion in the study.