Removed option for use of remote measures at certain study visits such that those visits are to be performed in the clinic; clarified different glomerular filtration rates for subjects ≥18 years of age and subjects <18 years of age; clarified that during in-clinic visits, spirometry assessments may be performed on more than 1 spirometer, as applicable; removed sweat chloride assessment at Week 4.

Updated the definition of IGT to 2 hour post-OGTT blood glucose level ≥140 to <200 mg/dL (≥7.77 to <11.10 mmol/L) to eliminate a gap in glucose values in previous protocol versions, and to clarify both the glucose values (in mmol/L) and the dysglycemia categories; Updated the definition of CFRD to either fasting hyperglycemia (blood glucose level ≥126 mg/dL [≥7.00 mmol/L] after an 8 hour fast) or 2 hour post OGTT blood glucose level ≥200 mg/dL (≥11.10 mmol/L) to eliminate a gap in glucose values in previous protocol versions, and to clarify both the glucose values (in mmol/L) and the dysglycemia categories; Added a waiver of the Safety Follow-up Visit for subjects who complete the Week 48 Visit and transition to a commercially available CFTR modulator regimen within 28 days after the last dose of study drug, given the possibility of commercial availability of ELX/TEZ/IVA in certain countries.