- 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.
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Willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures.
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Did not withdraw consent from a parent study.
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Meets at least 1 of the following criteria: (1) Completed study drug treatment in a parent study, (2) Had study drug interruption(s) in a parent study, but completed study visits up to the last scheduled visit of the Treatment Period of a parent study.
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Willing to remain on a stable CF treatment regimen (as defined in Section 9.5) through completion of study participation.
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