Primary Endpoint
tremor, Tremor
The study’s pre-specified primary endpoint was the difference in median tremor power for patients in the TX versus SOC arm in the mITT, with statistical significance evaluated using a Wilcoxon rank-sum test. Tremor power for each patient in the TX arm was the median tremor power measured during postural holds performed after each self-administered TAPS session over the month of home use. Tremor power for each patient in the SOC arm was the median tremor power measured during postural holds performed daily over the month of home use. Tremor power for both arms was summarized as a geometric mean and geometric standard error, equivalent in range to the mean and standard error of log-transformed data, because tremor power is logarithmically distributed.