Changes in conduct of study
RECRUITMENT
The study enrolled the first patient on 20 Nov 2018 but was prematurely discontinued on 21 Jul 2020 due to protracted recruitment, exacerbated by the COVID-19 pandemic; all randomized patients had to stop their study participation in 12 weeks and have a follow-up visit at 6 weeks following treatment cessation (and no later than 24 Nov 2020). As the majority of enrolled patients had the opportunity to reach the week 24 visit, and it was considered a clinically meaningful timepoint to evaluate response, the following additional endpoints were added at week 24: the proportion of patients achieving SR; components of SR composite measure; and GTI (CWS and AIS).