Randomization, allocation, and blinding
Participants were randomized using a sequence generated by the Excel program with a blocking scheme in a 1:1 ratio, and treatment was available as per the randomization list. A biostatistician-validated randomization list of masked treatments was provided, and the allocation of the research participants was carried out sequentially in the order of inclusion in the study until the final number of evaluable participants was reached. To ensure blinding, the sponsor was responsible for randomization and distribution, and the medication was dispensed to the participant by a professional chosen by the principal investigator. Additionally, participants were instructed not to report to the investigators changes in urinary color or any product characteristic.