Participant flow diagram.
ADVERSE EVENT
Populations used to evaluate the findings of this study are presented in bold text. AE, adverse event; FAS, Full Analysis Set; PPS, Per-Protocol Set.The mean age of participants was 41.2 years (range 18–79 years), with 300 (60.5%) participants aged 18–44 years, 161 (32.5%) aged 45–59 years, and 35 (7.1%) aged 60 years or older (