['cystic fibrosis', 'advanced lung disease']
['lumacaftor', 'ivacaftor']

        Inclusion Criteria:

          -  Homozygous for the F508del-CFTR mutation; historical genotype must be documented in
             the participant's source documents.

          -  Percent predicted FEV1 <40 of adjusted for age, sex, and height at Screening

        Exclusion Criteria:

          -  Participant currently receiving invasive mechanical ventilation.

          -  History of any comorbidity that, in the opinion of the investigator, might confound
             the results of the study or pose an additional risk in administering study drug to the
             participant

          -  Any clinically significant laboratory abnormalities at screening that would interfere
             with the study assessments or pose an undue risk for the subject

          -  A 12-lead electrocardiograms (ECG) demonstrating QTcF >450 msec at Screening

          -  History of solid organ or hematological transplantation

          -  History of alcohol or drug abuse in the past year

          -  Ongoing or prior participation in an investigational drug study (including studies
             investigating lumacaftor and/or ivacaftor) within 30 days of screening.

          -  Use of strong inhibitors, moderate inducers, or strong inducers of CYP3A

          -  Pregnant and nursing females: Females of childbearing potential must have a negative
             pregnancy test at Screening and Day 1.

          -  Sexually active subjects of reproductive potential who are not willing to follow the
             contraception requirements

          -  Use of beta blockers or the equivalent at Screening.
      