Impact of 
RECRUITMENT
Contingency measures were implemented to conduct the study during the COVID‐19 pandemic. For patients in the OLE or follow‐up period of the study, virtual, telephone, or telehealth visits were allowed as an option for sites and patients in which COVID‐19 or travel restrictions prevented an in‐person visit. In addition, collecting blood samples at the patient's home or an alternative location by home health care workers or study personnel was allowed. While the above changes to the conduct of the study were allowed to minimize disruptions, implementation varied from site to site. Study sites were instructed to consult with their IRB/IEC, ensure compliance with local laws and regulations, and assess local capabilities prior to implementation. A total of 34 remote monitoring visits were completed and, among 6 patients, a total of 17 visits were not completed across the 3 study periods. If data were missing for 2 or more patients, missing data were predicted using multiple imputation methodology for the primary endpoint at 6 weeks post‐baseline.Enrollment was closed early due to the COVID‐19 pandemic. In accordance with FDA guidelines on considerations for clinical trials during the COVID‐19 public health emergency, the sponsor decided to halt further recruitment and perform an analyses of 16 patients who had completed the double‐blind treatment period. (The target enrollment was 21 patients).