Study VX16-661-114 (Study 114) is a Phase 3b, randomized, double-blind, placebo-controlled,
parallel group, multicenter study in subjects aged 12 years and older with CF who are
homozygous for the F508del mutation on the CFTR gene and who discontinued treatment with
Orkambi due to respiratory symptoms considered related to treatment. This study is designed
to evaluate the safety and efficacy of TEZ/IVA.