References
skeletal muscle mass
ADVERSE EVENTS, ADVERSE EVENT
Study flowchart showing subject enrollment, allocation, and analysis. ALA, 5-aminolevulinic acid; SFC, sodium ferrous citrate.Change in skeletal muscle mass index (SMI). Measurement of SMI (Backgrounds of subjects.Data are presented as mean ± standard deviation (n) or the number of subjects (%). Change in physical examination.Data are presented as mean ± standard deviation (n) for measurements and mean (standard error) for adjusted mean change from baseline. The adjusted mean change of each continuous variable was estimated using models for repeated measures (MMRM) with an unstructured covariance structure with treatment group, time, the interaction between treatment group and time, and allocation factor as fixed effects and enrolled subjects as random effects. If the results of the MMRM using the unstructured covariance structure failed to converge, Toeplits, autoregressive, or compound symmetry covariance structures were sequentially used. * Calf circumference was calculated as the mean of the left and right maximum calf circumference. ALA, 5-aminolevulinic acid; SFC, sodium ferrous citrate; BMI, body mass index.Change in physical function.Data are presented as mean ± standard deviation (n) for measurements and mean (standard error) for adjusted mean change from baseline. The adjusted mean change of each continuous variable was estimated using models for repeated measures (MMRM) with an unstructured covariance structure with treatment group, time, the interaction between treatment group and time, and allocation factor as fixed effects and enrolled subjects as random effects. If the results of the MMRM using the unstructured covariance structure failed to converge, Toeplits, autoregressive, or compound symmetry covariance structures were sequentially used. * Hand grip strength was calculated as the mean of the left and right grips. ALA, 5-aminolevulinic acid; SFC, sodium ferrous citrate; BMR, basal metabolic rate; 6 MWD, 6 min walking distance; 5STS, 5-repetition sit-to-stand test; SPPB, Short Physical Performance Battery.Change in quality of life.Data are presented as mean ± standard deviation (n) for measurements and mean ± standard deviation for change from baseline. A two-sample Adverse events.Data are presented as the number of participants (%) who experienced non-serious or serious adverse events. ALA, 5-aminolevulinic acid; SFC, sodium ferrous citrate.