Sample size and statistical analyses
ADVERSE EVENTS, SECONDARY
We estimated that 8 patients were needed in each group to detect a 15% difference in the change rate of CD8Efficacy analyses were performed on the mITT population, where patients without receiving the study treatment at any time, without any observations on efficacy/safety, or with eligibility violations were excluded from all randomized patients.The primary outcome, a difference in the change rate of CD8Regarding secondary outcomes, differences in the change in or change rate of T cells (CD8The safety assessment was based on adverse events reported during this trial. We calculated the number and percentage of all adverse events, which were coded according to Medical Dictionary for Regulatory Activities (MedDRA) terms.All analyses were conducted with SAS Version 9.4 software (SAS Institute, Inc., Cary, NC).