Statistical analysis
deaths
REGRESSION, ADVERSE EVENTS
The primary outcome was mean change from baseline to end-of-study visit for the NADSeveral bioenergetic metabolite exploratory outcomes, functional exploratory outcomes, and safety outcomes were also evaluated. Here, we report the regression of baseline values versus mean percentage change of the average brain β-ATP signal, which is regarded to reflect brain ATP levels due to the lack of overlap with overlapping phosphorous peaks [Safety was assessed via spontaneously reported adverse events, serious adverse events, discontinuations due to adverse events, deaths, and the Columbia Suicide Severity Rating Scale (C-SSRS).The sample size for this proof-of-concept study was calculated based on the observed variance in brain metabolite levels in a prior Paired t-tests were used to assess for change in NADPaired t-tests were also calculated for each individual gait or balance parameter reported by the APDM Mobility Lab Timed Up and Go (TUG), Walk, and Sway tests which were performed at baseline and on the end-of-study visit. Sidak’s correction for the APDM variables was employed to account for the large number of comparisons resulting in a significance threshold of 0.001. MDS-UPDRS parts 1, 2, and 4 were analyzed with ANOVA, while part 3 and total score was assessed using a mixed-effects model to account for the missing data caused by missed in-person visits related to the COVID-19 research suspension. Statistical analyses were performed using SAS 9.4 (SAS Institute, Inc., Cary, NC). Figures were generated in Prism 9.4.1 (Graphpad Software LLC, San Diego, CA).