Statistical analysis
The analysis populations consisted of a full analysis set (FAS) in which the data set constituted all patients who were consented and received an implant, and a Per Protocol Set (PPS), which comprised a set of patients that completed the trial but excluded those with a serious protocol violation affecting the primary efficacy endpoint (Fig. Flow diagram showing patient enrollment and follow-up. Abbreviations: Patient demographics and baseline variables were provided for the FAS population. Descriptive statistics for continuous variables included the number of patients, mean, and standard deviation. Descriptive statistics for dichotomous/categorical variables included number and percent of patients. A two-sided alpha of 0.05 was used for statistical testing and confidence intervals unless otherwise noted.For calculating the confidence interval when both treatment and control groups were binomial extremes (0% and 100%, fractured and resolved), the Newcombe–Wilson method was applied [