Date

2022-07-20

Protocol

Protocol changed

Item Changed

1. Exclusion criteria

Previous Version

1. Subjects who are discontinued from a parent study for reasons other than disease worsening, or lack of response or remission; eg, subjects who discontinue for safety or tolerability issues are not eligible for the present study. Details of discontinuation are provided as an annexure. 2. Known hypersensitivity to the study drug 3. Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator, would make the subject unsuitable for the study or would prevent compliance with the study protocol 4. Females who may wish to become pregnant and/or plan to undergo egg donation or egg harvesting for the purpose of current or future fertilization during the course of the study and for at least 35 days of the last dose of the study drug 5. Male subjects unwilling to refrain from sperm donation for at least 90 days after the last dose of study drug 6. Males or females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined in Appendix 6 of the protocol 7. Use of prohibited medications as outlined in Section 5.4 of the protocol

Next Version

3. Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator or Sponsor, would make the subject unsuitable for the study or would prevent compliance with the study protocol.