Statistical analysis
Data listings were provided for PK and safety data. Summaries were presented overall and by cohort. Summary statistics for continuous data contained number of subjects, mean, median, standard deviation, and range (minimum, maximum); summary statistics for categorical data contained number and percentage. The Safety Population includes all subjects who received all or part of the study drug who have at least one post-dose safety assessment. The pharmacokinetic population (PP) includes all subjects who received all or part of the study drug and have at least one valid PK parameter.