Schematic diagram of the design of the BTOUGH study

Participants were randomized to receive TK-98 or placebo. The primary endpoint was evaluated with data from week 12. Patients with an average MMT score <9.5 at week 12 were enrolled in an open label extension study and all received TK-98. BTOUGH: the ‘BCAA for Treatment of Underpowered muscles during Glucocorticoid Healing of PM and DM’ study.