Safety analysis
ADVERSE EVENTS
Safety outcome measures were centrally assessed. The count and proportion of participants reporting adverse events (AEs) with new onset or worsening severity (relative to baseline) were compared between treatment groups and stages. AEs were coded and summarized at the participant level by Medical Dictionary for Regulatory Activities system organ class and preferred term and by seriousness, severity, and relationship to the device.The safety analysis population included all participants. Rates of AEs were compared using one-sided, two-sample Each therapy unit included an electronic data logger that tracked the intensity level of each completed TOMAC session. For each week, stimulation intensities were averaged within participants (across all sessions for that participant for that week) prior to calculating statistics across participants.