RANDOMIZATION AND MASKING
blindness
BLINDNESS
Patients were randomly assigned in a 1:1 ratio to either melatonin + valproic acid or placebo + valproic acid groups. A computer‐generated randomization system was used to create the balanced blocks of patient numbers for each of the two therapy groups. Every patient received a specific six‐digit code, which was the same as a bottle of the drug. Only a nurse was informed of the contents of the bottles and the related code, and she was not involved in any of the study's processes until the data were collected. To ensure blindness, both active medicines were over tables equally, and matched placebo pills were administered in the double‐blind study, resulting in the same quantity of oral tablets being eaten. Patients, investigators, clinical researchers, and sponsor employees who supplied drugs, assessed outcomes, and processed data were unaware of the allocation until all of the data needed for the trial were collected.