Unless specified otherwise, all summaries will be comprised of standard descriptive statistics. Standard descriptive statistics include:  For continuous parameters: number of observations (or subjects), mean, sta ndard deviation, median, minimum and maximum  For categorical p arameters: frequency and percent of observations in each category The following rules will be used for the days to months/years conversion:  1 month = 30.4375 days  1 year = 365.25 days As appropriate, all data collected on the electronic case report form (eCRF) will be presented in data listings. All statistical analyses will be performed using SAS® version 9.4 or above.