Analysis Data Sets Sample Clauses

Analysis Data Sets. 6.2.1 Safety Analysis Set Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis. As such, the safety analysis set will include all subjects/eyes exposed to any study lenses evaluated in this study. For treatment-emergent safety analyses, subjects/eyes will be categorized under the actual study lenses exposed.
Sample 1
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Analysis Data Sets. The all-implanted analysis set (AAS) will include all eyes with successful test or control article bilateral implantation. The best-case analysis set (BAS) will include all eyes successfully implanted with the test or control article that had at least one postoperative visit, and with no macular degeneration at any time, and no major protocol deviations. Subjects who become pregnant at any time during the study will also be excluded from the BAS. All eyes with attempted test or control article implantation (successful or aborted after contact with the eye) will be considered evaluable for the Safety Set (SS). The primary analysis set for performance analyses will be the AAS for all performance endpoints, except for binocular defocus and contrast sensitivity for which it will be considered supportive. The BAS will be the primary set for binocular defocus and contrast sensitivity. The SS will be used for analysis of safety endpoints.
Sample 1
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