2.4 Randomization and masking

Suitable volunteers enrolled in the study according to the aforementioned criteria. Two volunteers received 25 mg of Sal B, which is the lowest dose in the study. Volunteers were randomized at a ratio of 1:3 in the 75, 200, and 250 mg groups and at a ratio of 1:4 in the 150 and 300 mg groups to receive either a placebo or increasing doses of Sal B in the single-ascending-dose (SAD) study. Other volunteers were randomized at a ratio of 1:3 to receive either a placebo or Sal B in the multiple-ascending-dose (MAD) study. The blind lists were kept under control and would only be uncovered in case of emergency.