For data that were identified by the Sponsor's Medical Monitor as clinical outliers, two separate analyses were conducted, one including the outlier and one from which the outlier was excluded. The impact of all possible combinations of the outliers was to be treated in the context of the parameter. For the ITT population, missing data (including missing values at intermediate visits) were imputed from scheduled visits using the last-observation-carried-forward (LOCF) method. A blind review of the data was conducted prior to statistical analysis to determine data accuracy. Safety data were compiled on all subjects without exclusion, and in the case of AEs, the relationship to study product was made. The determination that a subject was to be excluded from an analysis population was jointly made by the sponsor and the investigator in the blind review meeting.