The IDE approval was granted on the basis of the FDA's determination that this is a non-significant risk study.
Accordingly, Brainsway plans to act quickly in order to initiate the study. About 10 medical centers in the United States, Europe and Israel are expected to participate in the study, which will involve about 220 patients. The trial subjects will be divided into two groups: a sham treatment group and a real stimulation treatment group.
The primary outcome measure for therapeutic efficacy will be the change in patients' cigarette consumption levels, as measured both by self-report and by urinary cotinine levels at the end of the treatment period, and again six months after the end of treatment using only self-report.