2.2. Preparation of Medical Intervention
ADVERSE REACTIONS
Unicenta was used as the investigational drug, while Melsmon was used as the comparator in the clinical trial. The assigned study number was sequentially given to participants, and the assigned number of investigational drugs matching the study number was delivered to the administering nurse by the pharmacist. The nurse administered one ampoule (2 mL) per session, three times a week for a total of six doses, with subcutaneous injections performed in subcutaneous tissues, such as the abdomen, upper arm, or thigh. The investigational drug was packaged in six ampoules per package, and the allocation number and visit number were written on each ampoule to minimize errors in administration and delivery.To prevent biases that could occur when assigning registered participants to either the study group or the control group and to enhance comparability between the two groups, randomization was planned. Stratified block randomization was employed to ensure a balanced distribution between the groups by stratifying participating trial institutions and randomly assigning participants to one of the study groups using blocks.The participants who were taking medications before 4 weeks prior to their participation in this clinical trial and those medications that were deemed not to have an impact on the interpretation of the trial results, as well as other medications used for the treatment of concurrent conditions or adverse reactions, were administered as concomitant medications after the participant’s judgment and consultation with the sponsor. After the concomitant medication or therapy, the administered medications were reviewed for the medication’s name (product name), daily dosage, reason for administration, duration of administration, and route of administration.