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Overview

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Pre-analysis plan checklist

• Brief background on the study (a condensed version of the introduction section of the paper)
• Hypotheses / objectives
• Study design
• Description of data
• Definition of outcomes
• Definition of interventions / exposures
• Definition of covariates
• Statistical power calculation
• Statistical model description
• Covariate selection / screening
• Standard error estimation method
• Missing data analysis
• Assessment of effect modification / subgroup analyses
• Sensitivity analyses