Statistical analysis
URETER
Sample size was selected to provide adequate information to determine the dose of pudexacianinium for ureter visualization and was not determined based on a statistical power calculation.Efficacy analyses were performed based on the full analysis set, defined as all participants who received pudexacianinium and had at least one ureter visualization assessment during surgery. Safety was evaluated for the safety analysis set, defined as all participants who received pudexacianinium. Pharmacokinetic assessments were performed on the PK analysis set, defined as all participants who received at least one dose of pudexacianinium and had at least one plasma or urine concentration data point available at the time of dosing and sampling.All data were summarized descriptively using mean, SD, minimum, median, and maximum for continuous variables, and frequency and percentage for categorical data. No hypothesis testing or statistical comparisons were performed.