Quantification and statistical analysis
PD
EVENTS
All statistical tabulations and analyses were done using SAS Grid/SAS Linux: SAS 9.4. Formal statistical tests were conducted at a 2-sided 5% significance level.Disposition, demographics, baseline characteristics and all safety parameters were summarized by cohort and treatment. Placebo was pooled across cohorts for summary and analysis. The PK full set includes all subjects who received at least 1 dose of study treatment and have at least 1 plasma concentration data point. The PD set will include those subjects in the safety analysis set who have pre-dose and at least 1 of the post-dose PD parameter concentrations and have no events or deviations that would affect PD variables.All descriptions of Materials and Methods should be included in the main paper. The Materials and Methods should be broken up into sections, each with a short subheading. Please include a study design paragraph at the start of the Materials and Methods and a statistical paragraph at the end of the Materials and Methods in the main text. If the Materials and Methods make the paper exceed the length limitations, less important sections of the Materials and Methods can be moved to the Supplementary Materials.