Randomization, allocation and masking
BLIND
A randomization list was generated by SAS software (version 9.4, SAS Institute Inc., USA) with a 1:1 allocation. Prior to dosing, subjects will be assigned a randomization number in accordance with the randomization code. The randomization code was maintained in a room with restricted access to pharmacy personnel only. The randomization code included 3- digit subject numbers starting with 101.Once a randomization number is allocated to one subject, it may not be assigned to another subject. If subjects withdraw prematurely from the study and are replaced, then a replacement randomization number will be assigned. A replacement randomization code will be generated such that replacement subjects are assigned to the same treatment as the discontinued subjects. The replacement randomization code will differ only in randomization numbers, which will be 4-digit numbers starting with a leading 1. In this trial, subjects and the follow-up staff were kept blind to the treatment allocation. The blind was broken after database lock.