Trial Design and Oversight
RECURRENCE
This randomized clinical trial was an academic, open-label, 1:1 controlled phase II/III trial with parallel group design. Adult patients with first recurrence of GB were eligible for inclusion. The open-label study design was chosen as a pragmatic solution, as complete temperance was deemed too intrusive for the control group. Patients were recruited at 7 study sites in Sweden (Göteborg, Lund, Örebro, Linköping, Stockholm, Jönköping, and Uppsala) and 2 sites in Norway (Trondheim and Oslo), from January 16, 2017, until November 15, 2020.The trial (