Fig. 1.

Patient disposition. ^#Patients were not treated for the following reasons: violations of the inclusion criteria (N = 4), patient’s request (N = 4), incorrect randomization (N = 2), advanced operation (1), stroke before the operation (N = 2). ^§Patients in each group were withdrawn from the study due to both major and minor protocol deviations and in one case also due to one SAE. AE adverse event, SAE serious adverse event