Participants
The trial included a screening period from the day of diagnosis until baseline (up to 3 weeks), a 26-week treatment period and a 26-week off-therapy follow-up period, and an ongoing extended follow-up of 2 additional years (to be reported). Out of 96 randomized participants, 47 (19 females and 28 males) were randomized to pleconaril and ribavirin and 49 (21 females and 28 males) to placebo. Participants were recruited between 20 August 2018 and 20 October 20. Details of the screening, randomization and follow-up of participants are provided in the CONSORT diagram (Fig. 