Analysis Sets. Five analysis sets will be defined:
Analysis Sets. 2.1 Definition of analysis sets The main analysis sets are defined below for this study:
Analysis Sets. Analysis datasets used for safety and effectiveness analyses of this study are defined as follows. Safety Analysis Set The treatment-emergent safety analysis set will include all eyes with attempted implantation with the test article (successful or aborted after contact with the eye). All-Implanted Analysis Set (AAS) All-Implanted Analysis Set (AAS) will include all eyes with successful test article implantation. Best-Case Analysis Set (BAS) Best-Case Analysis Set (BAS) will include all eyes with successful test article implantation that had ・ at least 1 postoperative visit; ・ no macular degeneration at any time; and ・ no major protocol violation
Analysis Sets. The set of randomized patients will include all patients randomly assigned to a treatment at enrollment, regardless of whether or not a patient took any study drug. The safety analysis set will include all patients who took at least 1 dose of study drug. The full analysis set will include all patients in the safety analysis set.
Analysis Sets. There will be one analysis population, the Safety set, which includes all patients who are enrolled in the study and receive at least 1 dose of eteplirsen.
Analysis Sets. All analysis sets will be defined prior to final database closure. In addition to the analysis sets listed below, further exploratory analyses may be performed using other subgroups of patients.
Analysis Sets
