Is the study drug, dronedarone, being provided to subjects randomized to the intervention arm?


  • All subjects randomized to the intervention arm will have the study drug provided to them throughout their full participation in the trial.
  • If a subject is randomized to the intervention (dronedarone) arm, they must be registered in the Almac SimplifyTM IRT System to facilitate study drug shipment and dispensation.
  • Study teams are responsible for registration of intervention arm subjects in the IRT System, completing the study drug order request process, and conducting confirmation conversations of study drug delivery and dosing initiation.