Statistical analysis
Fold changes were assessed by comparing baseline values (Day 0, pre-treatment) with those measured on post-infusion days. NLR was determined by dividing ANC by ALC.Descriptive statistical analyses were performed using SAS (Version 9.4) and GraphPad Prism Software (Version 6.07). Pairwise comparisons of concentrations or cell numbers between trimodulin and placebo were made using unpaired Wilcoxon–Mann–Whitney tests. If not otherwise specified, categorical variables were analyzed by two-sided Chi-square test for proportions, and continuous variables by two-sided Student’s These post hoc exploratory analyses were not adjusted for Type I error and are thus prone to an inflated error rate due to multiple comparisons. Our study aims were to identify potential predictive biomarkers and mechanistic clues as to why some patients benefited whereas others did not.