Statistical Analysis Plan
Description
We provide full transparency of the pre-defined predictors we aim to test in this available statistical analysis plan before database lock and before the described analysis is to be carried out. We plan to report all findings in the main tables/supplemental tables of a finalized manuscript, reporting each result and interpretation. Results will be reported upon publication of the manuscript with final analysis and interpretations.
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IRB Approval: This study was approved by the Mass General Brigham institutional review board under Protocol #: 2019P002459 and was conducted in accordance with Good Clinical Practice Guidelines and the Declaration of Helskinki. Study Type: Retrospective Study: the collection, storage, and retrieval of data were performed in compliance with the hospital’s institutional review board and the Health Insurance Privacy and Portability Act. We provide full transparency of the pre-defined predictors we aim to test in this available statistical analysis plan before database lock and before the described analysis is to be carried out. We plan to report all findings in the main tables/supplemental tables of a finalized manuscript, reporting each result and interpretation. Results will be reported upon publication of the manuscript with final analysis and interpretations.