Study Schema and CONSORT Diagram
RECRUITMENT
IE indicates inclusion/exclusion; PP, per-protocol; PSM, poststudy monitoring.Participants were randomized to treatment group 1 (received active treatment first then control treatment) or group 2 (received control treatment first then active treatment) in a 1:1 allocation for a balanced study design. In periods 1 and 2, each group received 6 weeks of active and control treatments (phases 1 and 3) followed by 6 weeks of washout phases (phases 2 and 4) in which no treatment was given but weekly primary end point measurements were taken. Period 3 encompassed extended follow-up of TFI score at weeks 28, 32, and 36 (phase 5) (Data collection began in March 2019, with follow-up finishing in July 2022. Recruitment ended after 100 participants were enrolled (1 participant withdrew after enrolling but before receiving treatment). Due to the COVID-19 pandemic, study enrollment and in-clinic evaluations were paused from March through August 2020, resulting in incomplete data during this time. However, all enrolled participants were able to complete survey-based end points online.