Treatment
EVENT, ADVERSE EVENT
Eligible study participants were randomized 1:1:1 to receive amcenestrant 400 mg (4 × 100 mg capsules), amcenestrant 200 mg (2 × 100 mg capsules), or letrozole 2.5 mg (1 × 2.5 mg tablet), beginning on Day 1 and ending on Day 14 (Additional file Randomization was achieved using a centralized, interactive telephone- and internet-based response system. Patients were issued a diary on Day 1 and asked to record the time of study drug administration each day. Compliance was assessed by reviewing participant diaries on Day 7 and by counting the number of capsules or tablets returned on Day 14.Dose modification was not mandated in participants experiencing a Grade 1 or 2 adverse event (AE), with the exception of Grade ≥ 2 elevations in alanine aminotransferase (ALT), in the event of which treatment could be stopped and restarted after recovery to Grade ≤ 1 (or baseline levels).