Statistical analyses
hepatic impairment
REGRESSION, HEPATIC IMPAIRMENT
The planned sample size for this trial was not based on a power calculation. This study planned to include 64 participants: 16 HVs and 48 patients (8 patients per patient group [CP-A/-B] and dose group: 6 on active treatment, 2 on placebo; this is common in multiple rising dose studies of this type and is considered sufficient to detect major differences between dose groups and placebo in terms of the primary end point). A sample size of 6 per group (patients with hepatic impairment and HVs) is considered sufficient for hepatic impairment trials.Safety, tolerability, PK, and exploratory end points were assessed using descriptive statistics. The effect of hepatic impairment on the PK of BI 685509 was assessed using an ANOVA model, and differences between BI 685509 treatment and placebo for systolic BP, diastolic BP, and MAP were assessed at day 28 using a linear regression model. PK parameters were calculated by noncompartmental analysis using Phoenix WinNonlin software (version 8.1; Pharsight Corporation, Mountain View, CA, USA).