2.2.2. Study Design and Intervention
This study was conducted as a randomized, double-blind, placebo-controlled parallel-group study approved by the Institutional Review Board of Chiyoda Paramedical Care Clinic (Tokyo, Japan). The study protocol was registered in the UMIN Clinical Trials Registry (UMIN000045564). One hundred participants were randomly assigned to the placebo or BB536 group based on the pDC and mDC FACS results, sex, BMI, and blood and urine parameters before administration. Randomized participants received lyophilized powder containing 