Inclusion Criteria:  The subject must complete all Study NLS-1021 study requirements and assessments up to Visit 6; The subject is able, in the opinion of the Investigator, to receive NLS-2 for the 24-week Treatment Phase of this study; Biological females of childbearing potential must agree to use a medically acceptable double-barrier method of contraception for at least 30 days prior to Day 1 and until completion of the study; The subject is able to comply with the open-labelled extension design schedule and other study requirements; The subject provides written informed consent for the open-label extension study.  Exclusion Criteria:  The subject meets any Exclusion Criteria for Study NLS-1021 at Visit 6 of that study; The subject receives any investigational drug (other than the COVID-19 vaccine) that is not NLS-2.