Outcomes

Non-inferiority is established if the upper 95% confidence limit of the AUC difference is 1.3 or lower. Harmful outcomes do not necessarily prove harmful intent. Falls are defined as unintended events where a participant comes to rest on the ground, floor, or lower level due to loss of balance, excluding near misses. The primary efficacy outcome is seizure cessation confirmed clinically or by EEG. Selected outcomes, including unscheduled hospitalisations for heart failure, are blindly adjudicated by an independent adjudication committee. Most secondary analyses are exploratory or hypothesis-generating and will emphasize effect sizes and 95% confidence intervals. If outcome definitions differ too much for valid pooling, the data will be analysed separately, narratively, or in sensitivity analyses where feasible. Body weight is a co-primary outcome assessed at two years. The co-primary outcomes assessed at two years are MetS Z-score and body weight. The primary effectiveness outcome is the rate of falls per 1000 patient bed days. Secondary outcomes include quality of life, physical function, and the proportion achieving at least 20% weight loss. Pain may be measured using visual ana…