Statistical analysis
This is a pilot, exploratory dose-adoptive study and power calculations were based on significant dose response under varying assumed true dose response when using matched controls. Baseline data are presented as means (standard deviation) or medians (interquartile range) depending on the Normality of distribution. Categorical and binary variables are summarised as frequency and percentage of total. Baseline characteristics were compared between groups using independent samples t-tests for means, Mann–Whitney-U test for medians, and Fisher’s exact test for categorical data. Significance was defined at 