Fig. 2

Patient disposition. The per protocol set (PPS) comprised 30 patients, after exclusion of 22 patients from the full analysis set (FAS) for violations of protocol (study drug not administered in compliance with the Japanese package insert of mirogabalin, such as not at twice-daily dosage and not at an effective dosage, n = 20; other violations of eligibility criteria or protocol, n = 2). A total of 40 patients in the FAS and 24 patients in the PPS completed the study; most withdrawals were at the patients’ request