Study design (if review, criteria of inclusion for studies)
Controlled: No.1 Randomised: No.2 Open: Yes.3 Single blind: No.4 Double blind: No.5 Parallel group: No.6 Cross over: No
Participants
Principal inclusion criteria: 1.Subject (or his or her legally appointed and authorized representative) will sign and date an informed consent form (ICF), and, when appropriate, an assent form.
Interventions
VX121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in subjects with cystic fibrosis (CF)
Outcome measures
Primary end point(s): Safety and tolerability of long-term treatment with VX-121/TEZ/D-IVA based on adverse events (AEs), clinical laboratory values, ECGs, vital signs, and pulse oximetry