2.4.3. Randomization and blinding.
blindness
BLIND, BLINDNESS
Both the placebo and ARE capsules were identical in appearance to maintain the blindness of the study treatment. Subjects were randomized, using a predetermined randomization schedule generated using a computer-based randomization software (SAS 9.3), prepared by a statistician, independent of the sponsoring organization, and not involved in the conduct or reporting of the study. Block randomization was followed to generate an alphabetic code for the 2 groups to conceal allocations and to reduce any allocation bias. Both the investigational products were coded centrally with randomization codes. The participants were recruited by the principal investigator, who assigned them to the 2 groups as per the randomization sequence. The investigators, study staff, subjects, and statistician were blinded to the study. Sealed envelopes containing the randomization numbers were provided to the investigators, to be kept in a safe and access-controlled place to deal with any unforeseen emergency that warrants the breaking of blind codes. The codes were revealed to the statistician after data base lock.