Blinding
Patients, clinicians, and independent outcome raters were masked to treatment allocation, and tablets in each group were identical in package and appearance. The database was locked when the final visit of the last randomized patient was completed, data entry for all patients was completed, and the database for all patients was deemed clean without any outstanding queries. After all of the above work was completed, an independent statistician operated the unblinding method, and a two-level unblinding method was used in the study.