Randomization and blinding
BLIND
After eligibility is confirmed at V1b, patients are randomized (1:1) to receive ESL or placebo. The randomization list is produced using validated Statistical Analysis System (SAS) software (SAS Institute Inc.). ESL and placebo tablets are identical in size, color, taste, and appearance. The packaging and labeling do not allow for any distinction between test drug and placebo. No person involved in conducting the study may have access to the randomization code before the blind is officially broken. Unblinding will not occur unless an actual emergency occurs, and knowledge of the patient's randomization code affects his/her medical treatment. A record, signed by the investigator, will be made of the date, time, and reason for breaking the blind.