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This document outlines a randomized controlled trial comparing early arthroscopic meniscal surgery to supervised exercise therapy in young adults. It details study design, objectives, and statistical methodologies.
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A statistical analysis plan (SAP) is a document that outlines the statistical techniques and methodologies that will be used to analyze data collected from a study or clinical trial.
Researchers and organizations conducting clinical trials or studies, particularly those seeking regulatory approval for their findings, are typically required to file a statistical analysis plan.
To fill out a statistical analysis plan, researchers should include sections such as study objectives, statistical methods, data management procedures, sample size calculations, and plans for addressing potential biases.
The purpose of a statistical analysis plan is to ensure clarity, reproducibility, and transparency in data analysis, helping to prevent data dredging and ensuring adherence to pre-specified methodologies.
The SAP must report information such as the study design, statistical endpoints, analysis methods, handling of missing data, and any planned interim analyses.
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