2.9. Allocation (sequence generation, concealment, implementation) and blinding
Patients will be randomly allocated to either the experimental or the control group following a parallel group design and a 1:1 allocation ratio. A total of 308 opaque envelopes (154 for the experimental group and 154 for the control group) will be prepared prior to the study start. The envelopes will be stored in a secure vault and will be randomly opened by the time of the randomization.Since this is an open-label study, blinding (masking) is not applicable.