Clinical Research Directory

Inclusion Criteria Participants who meet ALL of the following criteria are eligible for this study: * Participant must have completed Study TAK-881-3001 (NCT05755035). * Participant or, in the case of minors, legally designated representative(s) is/are willing and able to comply with the requirements of the protocol. * Participant or, in the case of minors, legally designated representative(s) has/have provided informed consent/assent (if applicable), including providing consent for use of the investigational medical device (in US sites only), prior to the initiation of any study procedures. Exclusion Criteria * Participant has a serious medical condition such that the participant's safety or medical care would be impacted by participation in this long-term follow-up study. * New medical condition that developed during participation in Study TAK-881-3001 (NCT05755035), that, in the judgment of the investigator, could increase risk to the participant or interfere with the evaluation of TAK-881 and/or conduct of the study. * Participant was enrolled in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to screening (with the exception of Study TAK-881-3001 \[NCT05755035\]). * Participant is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study. * Participant is a family member or employee of the investigator or the investigator's site staff. * Participants with potential to become pregnant who meet any one of the following criteria:- 1. Participant has a positive pregnancy test. 2. Participant does not agree to employ a highly effective form of contraception for the duration of the study. * If participant is pregnant or lactating at the time of screening or intends to become pregnant or begin lactating during the study.