Study design and treatments
ICH
TANDEM (NCT03517540) was a 48-week, phase 2b randomized, multicenter, double-blind study conducted between September 2018 (first patient, first visit) and October 2020 (last patient, last visit) in 65 centers across 17 countries. The study design of TANDEM has been reported in detailThe original study treatment duration was 48 weeks. A protocol amendment allowed treatment to continue for up to ~8 additional weeks for patients who were unable to attend the study site for the scheduled week 48 end-of-treatment (EOT) assessments, including EOT liver biopsy, due to COVID-19 pandemic-related restrictions, which included temporary closures of clinics. The study protocol and all amendments were reviewed by an Independent Ethics Committee or Institutional Review Board for each center, and the study was conducted according to the ICH E6 Guidelines for Good Clinical Practice that have their origin in the Declaration of Helsinki. All patients provided written informed consent before any study-specific procedures were performed.