Study design.
The study was a two-sequence, two-way crossover design in which patients were randomized to either 8 days of treatment with luvadaxistat 50 or 500 mg followed by 8 days of placebo, or 8 days of placebo followed by luvadaxistat 50 or 500 mg. Each treatment period was separated by a 2- to 3-week washout period. Assessments on day 7 or day 8 were flexible, with one day earlier or later allowed.