Results
We analyzed the myelin content dedicated imaging of the ReBUILD clinical trial participants (50 patients) and computed MWF (Based on the mixed effects linear modeling of the MWF values in the CC, the two groups values were comparable at baseline (group 1: mean 0.087, 95% CI [0.080, 0.095]; group 2: mean 0.088 [0.081, 0.096], Illustrative TTreatment-related MWF changes within the CC. Figure shows voxel-based monthly percentage changes “Δ” in CC: baseline to 3 mo “ΔGroup 1 and group 2 MWF values within each volume of interest and lesions are reported as mean, inferior (lcl95), and superior (ucl95) 95% CI at baseline, 3 mo, and 5 moNo statistically significant changes were observed in the OR and CST VOIs (Regarding the analysis of lesion MWF, at baseline versus 3 mo, there was no significant difference in MWF change from baseline between group 1 and group 2 (Four patients’ measurements (2 from the third month timepoint, 2 from the fifth month timepoint, all belonging to group 1) were excluded from the dataset for poor quality due to excessive patient motion during acquisition. For this reason, the analysis was based on 94 out of 100 calculated interval changes.The reliability assessment of the MWF processing based on seven healthy subjects indicated no statistical differences between the three MWF datasets, using ANOVA. The average coefficient of variation was 5.36% in the CC, 3.44% in the OR, and 8.49% in the CST.The subset analysis performed in all VOIs with a reliable HAssuming an improvement in mean MWF of the CC from baseline of 0.01 (similar to what was observed), the power analysis suggests that 58 patients per arm would need to be enrolled for a clinical trial of a similarly efficacious drug with a parallel arms study design assessing MWF in the CC (with a standard 80% power and a two-sided alpha = 0.05). In contrast, the observed difference in mean from baseline for OR and CST was lower (Furthermore, we found a negative correlation (