2.7.3. Registration and random allocation (Date -5~-2).
The principal investigator or sub-investigator confirms whether the subjects meet all the inclusion criteria and none of the exclusion criteria and performs the registration and random allocation of eligible subjects using the Electronic Data Capture (EDC) system (V1). The EDC system immediately checks patient and case registration information, issues a subject identification number, and assigns either a low- or a high-dose group if eligibility is met. The results of the assignment are automatically sent via e-mail to the principal investigator, sub-investigator, and the data center for registration confirmation notification. The principal investigator or sub-investigator will review the allocation results and perform the assigned study intervention.