2.5. Sample Size Calculation and Statistical Analysis
sarcopenia
SECONDARY, TYPE 2 DIABETES MELLITUS, SARCOPENIA, SENSITIVITY
The target sample size in this study was determined based on a previous cross-sectional study investigating the prevalence of sarcopenia in an elderly Japanese population aged 65 years or older with type 2 diabetes mellitus [Analyses of the primary and secondary endpoints were performed with data from the full analysis set population, including all subjects enrolled in this study who were subsequently randomized to one of the study groups but excluding those with a significant study protocol violation (e.g., registration without consent or registration out of the enrollment period). Sensitivity analysis of the primary endpoint was performed with the per-protocol set by excluding subjects with a protocol violation, such as violation of eligibility criteria, use of prohibited drugs, or poor medication adherence to the study or control agents (<70% or >120%). The safety analysis included all subjects registered in this study who adhered to the study’s food intake. All tests were two-sided, and statistical significance was set at 