Statistical analysis
SE, DSPN, neuropathy
NEUROPATHY
Analyses were performed in the modified intention-to-treat subpopulation as a complete case analysis, with available neuropathy assessment data at baseline and after 6 months. To check if the randomization was still valid in the subpopulation, a Mann-Whitney test was applied for comparison of baseline values. Descriptive data are shown as mean ± SD for normally distributed variables, median (interquartile range) for log-normally distributed variables, and frequencies for categorical variables. Distribution was evaluated by the Kolmogorov-Smirnov test. The Chi-square test was used to compare categorical variables. For within-group comparison a Wilcoxon matched-pair signed rank test was used. For comparison of between-groups differences Mann-Whitney test was applied and data are presented as mean ± SE of mean, unless otherwise stated. The mean value of the second SD was taken as the lower cut-off for non-measurable nerve conduction velocity when DSPN was clinically present. Because of the exploratory nature of the analyses, p-value < 0.05 was considered statistically significant and was not adjusted for multiplicity. Statistical data analysis was performed using GraphPad Prism 9 (