All participants were provided with prednisone/prednisolone (or equivalent) tablets that could be used according to the asthma plan along with an electronic diary (e-Diary/ePEF). Daily use of oral corticosteroids (number of tablets taken in the previous 12 hours) was recorded once in the morning and once in the evening by the subject in the eDiary/PEF device. In case of use of injectable corticosteroids during certain circumstances (eg. hospitalization) the data was collected on the eCRF (electronic case report form).

The total systemic corticosteroids (SCS) dose data was aggregated into monthly data for analysis. For the patients discontinuing treatment early, the total SCS dose for 52 weeks was obtained as annualized SCS dose. For example if patient took 120 mg for 3 months then for 12 months patient will be taking 120*12/3=480mg total SCS dose.

The mean values over 52 weeks in the overall patient population regardless of peripheral blood eosinophil counts are reported here.

Full Analysis Set (FAS)

All participants were provided with prednisone/prednisolone (or equivalent) tablets that could be used according to the asthma plan along with an electronic diary (e-Diary/ePEF). Daily use of oral corticosteroids (number of tablets taken in the previous 12 hours) was recorded once in the morning and once in the evening by the subject in the eDiary/PEF device. In case of use of injectable corticosteroids during certain circumstances (eg. hospitalization) the data was collected on the eCRF (electronic case report form).

The total systemic corticosteroids (SCS) dose data was aggregated into monthly data for analysis. For the patients discontinuing treatment early, the total SCS dose for 52 weeks was obtained as annualized SCS dose. For example if patient took 120 mg for 3 months then for 12 months patient will be taking 120*12/3=480mg total SCS dose.

The mean values over 52 weeks in the subpopulation of patients with high peripheral blood eosinophil count at baseline are reported here.

Participants in the FAS with high peripheral blood eosinophil count count (≥ 250 cells/µl) at baseline

All participants were provided with an electronic diary (eDiary/ePEF) to record asthma symptom twice per day. Daytime asthma symptoms were assessed before bed and nighttime asthma symptoms on awakening.

The daytime asthma symptom score included 4 questions with a range of response categories for each question from 0 to 6 (0 = totally controlled; 6 = extremely poorly controlled). The questions were equally weighted and the overall score (from 0 to 6) was calculated as the average of the 4 questions with higher values indicating more asthma symptoms.

Mean values of daytime asthma symptom scores were calculated over 4-week intervals during the treatment period.

The baseline values of daytime asthma symptoms scores were defined as the average score during the run-in period.

A negative change from baseline in daytime asthma symptom score is a favorable outcome.

Participants in the FAS with a valid measurement for the outcome measure

All participants were provided with an electronic diary (eDiary/ePEF) to record asthma symptom twice per day. Daytime asthma symptoms were assessed before bed and nighttime asthma symptoms on awakening.

The nighttime asthma symptom score included 1 question with a range of response categories from 0 to 3 (0 = no awakening with asthma symptoms; 3 = awake all night).

Mean values of nighttime asthma symptom scores were calculated over 4-week intervals during the treatment period.

The baseline values of nighttime asthma symptoms scores were defined as the average score during the run-in period.

A negative change from baseline in nighttime asthma symptom score is a favorable outcome.

Participants in the FAS with a valid measurement for the outcome measure

The Asthma Control Questionnaire (ACQ-5) was completed by the patients at the investigator's site. Patients were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment). The questions were equally weighted and the ACQ-5 score was the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).

The baseline values of ACQ-5 score were defined as the ACQ-5 scores obtained on Day 1.

A negative change from baseline in ACQ-5 score is a favorable outcome.

Participants in the FAS with a valid measurement for the outcome measure

The Asthma Quality of Life Questionnaire (AQLQ+12) was completed by the patients at the investigator's site. The AQLQ+12 is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma. Patients were asked to recall their experiences during the previous 2 weeks and to score each of the 32 items on a 7-point scale, where 1 indicates maximal impairment and 7 indicates no impairment. Thus, higher scores indicate better asthma-related quality of life. Each item of the AQLQ+12 was equally weighted and the overall score was the mean score of all 32 items and therefore ranged between 1 and 7.

The baseline values of AQLQ+12 score were defined as the AQLQ+12 scores obtained on Day 1.

A positive change from baseline in AQLQ+12 score is a favorable outcome.

Participants in the FAS with a valid measurement for the outcome measure

All participants were provided with prednisone/prednisolone (or equivalent) tablets that could be used according to the asthma plan along with an electronic diary (e-Diary/ePEF) to record medication use. Daily use of oral corticosteroids (the number of tablets taken in the previous 12 hours) was recorded once in the morning and once in the evening by the subject using the eDiary/PEF device. In case of use of injectable corticosteroids during certain circumstances (eg. hospitalization) the data was collected on the eCRF (electronic case report form).

The percentage of patients requiring ≥ 7.5 mg systemic corticosteroid dose in mg prednisone/prednisolone (or equivalent) per day continuously for at least 30 days within the on-treatment period is presented in this record.

FAS

All participants were provided with prednisone/prednisolone (or equivalent) tablets that could be used according to the asthma plan along with an electronic diary (e-Diary/ePEF) to record medication use. Daily use of oral corticosteroids (the number of tablets taken in the previous 12 hours) was recorded once in the morning and once in the evening by the subject using the eDiary/PEF device. In case of use of injectable corticosteroids during certain circumstances (eg. hospitalization) the data was collected on the eCRF (electronic case report form).

The percentage of patients with no systemic corticosteroids use up to visit on Week 36 is presented in this record.

FAS

As part of the flexible therapy, investigators were allowed to prescribe biologics approved for asthma from randomization visit onwards. Prescription of biologic therapy during the treatment period was recorded.

The proportion of patients with prescription of biologic therapy during the on-treatment period is presented in this record.

FAS