Date

2022-11-25

Protocol

Protocol changed

Item Changed

Inclusion criteria

Previous Version

Patient completed 6 weeks of treatment in Study NW-3509/014/II/2019 Patient has provided written informed consent for this extension study. If female, patient is not of childbearing potential, pregnant or breastfeeding. For inclusion, female patients must be post-menopausal (age 50 or older with confirmed amenorrhea for >12 months), surgically sterilized, or protected with adequate contraception (barrier method or hormonal contraceptive).

Next Version

If female, patient is not of childbearing potential, pregnant or breastfeeding. For inclusion, female patients must be post-menopausal (age 50 or older with confirmed amenorrhea for >12 months), surgically sterilized, or protected with highly effective adequate contraception, as determined by their Health Care Provider i.e. barrier method in combination with an oral hormonal contraceptive, or long-acting hormonal contraceptive alone.