Trial schema. Dose escalation of FF-10101 was carried out in cohorts 3 participants from 10 mg QD up to 225 mg QD. If any participant experienced a grade ≥3 AE that was possibly, probably, or definitely attributed to FF-10101, 3 additional participants were added to the cohort. After 100 mg QD was deemed safe and tolerable, cohorts receiving BID dosing were opened in parallel.