3.1. Subjects’ Eligibility, Registration, and Flowchart
A total of 258 participants who provided consent were screened of whom 120 individuals who met the selection criteria and did not violate the exclusion criteria were enrolled as subjects. Out of the enrolled subjects, 119 completed the trial; 1 individual was excluded who discontinued participation after the start of the study. A total of 112 subjects, excluding those who did not meet the defined criteria in the statistical analysis plan, were analyzed as per protocol set (PPS) (