Participant selection criteria
Details of the inclusion and exclusion criteria for the Phase 2b and MELODY trials have been published previouslyPhase 2b enrollment began on November 3, 2016 with study completion on December 6, 2018. MELODY enrollment began July 23, 2019, and paused between March 15, 2020 and April 19, 2021; safety follow-up is ongoing. The data cut-off for MELODY post-pause cohort through 150 days post-dose was March 31, 2022.