Statistical analysis
SD
SECONDARY
For the primary endpoint and efficacy assessment, the primary efficacy analysis set was the modified intention-to-treat population. The modified intention-to-treat population included all enrolled patients who received at least one dose of the study drug and had measurements of serum phosphorus levels from the study initiation. Safety was analyzed for all patients who received the study drug.Categorical data were summarized as frequencies and percentages, and continuous data were summarized using mean ± SD, median, and range (minimum and maximum). The mean and 95% CI (t distribution) for the change in serum phosphorus levels from baseline to week 8 and week 16 were calculated for the primary and secondary endpoints.The proportion of patients meeting the target serum phosphorus level at each assessment point and the respective 95% CIs were calculated using the Clopper–Pearson method. In the case of missing data, data for the changes in serum phosphorus levels from baseline at week 8, and change in the serum phosphorus levels collected at the last measurement time point until week 8 were carried forward for missing values using the last observation carried forward (LOCF) method. For the changes in serum phosphorus levels from baseline at week 16, change in the serum phosphorus levels collected at the last measurement time point was carried forward for missing values using the LOCF method. Statistical hypothesis testing was not conducted for the primary endpoint. The statistical software used for analysis was SAS version 9.4 (SAS Institute Inc, Cary, NC).