- Ability to withhold LABA therapy: Other than what is provided during the study, LABA therapy is not permitted on the day of Visit 1 (Screening and Run-in Visit) and throughout the entire study. The last dose of LABA and LABA/ICS combinations are to be taken on the day before Visit 1. Sites should contact the medical monitor to discuss subject eligibility, for doses of commonly prescribed ICS and ICS/LABA combination medication; as mentioned in the study protocol.