Randomization and blinding
SECONDARY, RECRUITMENT
Each eligible patient was randomly assigned into either the Cerebrolysin or control group by simple randomization procedure. One randomization list for all centers was issued by generating Bernoulli variates with the probability parameter of 0.333. The Mersenne twister was used as an active generator and the starting point was set at random.Allocation instructions were sealed in opaque envelopes, mixed and distributed between the centers by an independent statistician. Each envelop was randomly picked by the investigators and was opened after the subject’s recruitment.Investigators enrolled participants, assigned them to the intervention, and assessed clinically the primary and secondary endpoints. Imaging data were evaluated locally by radiologists who were blinded to the intervention. However, investigators and participants were not blinded to the treatment assignment because Cerebrolysin had its particular yellowish color and we were not able to conceal it properly.