Statistical Analysis Plan for the manuscript reporting the primary outcome in the TESSA study
Mendham, A. E.; Goedecke, J. H.; Heckens, L.; Kengne, A. P.; Salling Quist, J.; Dave, J.; Faerch, K.; Groth Grunnet, L.; Blond, M. B.
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This paper describes the statistical analyses plan (SAP) for the following study: Exploring the effects of time-restricted eating on body weight and associated cardiometabolic outcomes in South African women living with HIV (TESSA): a protocol for a randomised controlled trial. This document is a supplement to the TESSA study protocol and contains the statistical analysis plan (SAP) for the main paper of the trial in which the primary outcome will be reported. This document complies with the guidelines for the content of statistical analysis plans in clinical trials. The SAP does not cover the statistical analysis of data for outcomes to be included in secondary manuscripts.
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