Safety and demographi c data will be summarized using standard tabulations and listings. Continuous variables will be summarized using descriptive statistics such as mean, standard deviation, median, minimum value, and maximum value. Continuous variables may be summarized by a clinically relevant discretization, as appropriate. Categorical variables will be summarized using frequency counts and percentages. Time-to-event data will be summarized using the Kaplan -Meier method. Where appropriate, 95% confidence intervals around poi nt estimates will be presented, and estimates of the median and other quantiles, as well as individual time points (e.g., 3-month, 6-month, and 12-month rates), will be produced. Data will be provided in data listings. Details of the statistical analyses, methods, and data conventions are described in the SAP.