Jmp version 5.0.1a

The sample size was not calculated because this study was exploratory. Data were expressed as the mean ± standard deviation or median (interquartile range; IQR).
We conducted a statistical analysis using Pearson's correlation coefficient and multiple regression analysis to investigate the relationships between clinical outcome and patients' baseline characteristics, including tolvaptan concentration, as well as the relationships among PK parameters. Specifically, we utilized Pearson's correlation coefficient to assess the linear relationship between two continuous variables and to evaluate the strength and direction of the association between our variables of interest. Given that our variables were measured on a continuous scale, this test was selected for our analysis. Multiple regression analysis was performed to determine which covariates significantly influenced the clinical outcome. The method used to select the variables in the model was a stepwise selection. The significance level of the score of entering an effect into the model was .20. Independent predictive variables with p values of less than .05 were considered statistically significant. Overall, the selection of these statistical tests was based on the nature of our research questions and the types of variables we were examining. Data were analyzed using JMP version 5.0.1a (SAS).

Statistical analyses were carried out with GraphPad Prism 5.02 software (GraphPad Software Inc., San Diego, CA, USA) and JMP version 5.0.1a (SAS Institute, Cary, NC, USA). Data are presented as the mean ± standard deviation, unless otherwise indicated. The Wilcoxon signed‐rank test was used to evaluate differences in ordinal data between two groups. P < 0.05 was considered to show statistical significance.