Statistical analysis
REGRESSION
The categorical data were presented as a frequency (percentage) and compared between the study groups using Fisher’s exact test. For parametric data, the continuous data were reported as a mean with standard deviation (SD), and for non-parametric data, as a median with interquartile range (IQR). The multiple comparisons between the intervention groups and the placebo were performed using one-way ANOVA test for parametric data or Kruskal–Wallis test for non-parametric data. If there is a significant difference from the aforementioned tests, a post-hoc pairwise comparison using Bonferroni correction was performed to identify a significantly different pair. The analysis of the primary outcome was performed in accordance with a modified intention-to-treat principle, which included all patients who had undergone randomization and had available primary outcome data. The repeated measurement outcomes of hsTnI, NT-proBNP, LVEF, and GLS were analyzed using a multilevel mixed-effects linear regression with time interaction to determine the effect of treatments or chemotherapy on clinical outcomes over time. Based on the anticipated change in hsTnI and NT-proBNP levels following chemotherapy treatment, a quadratic time interaction term was included in the models. The changes in mitochondrial function in each group and the comparison between the study groups in each period were analyzed by Kruskal–Wallis test with post-hoc pairwise comparisons using Bonferroni correction. Two-tailed p-values of 0.05 were considered statistically significant. All statistical analysis was performed by the statistical software STATA16 (Stata Corp. 2019, Stata Statistical Software: Release 16, Stata Corp. LLC, College Station, TX, USA).