The primary endpoint of this study was the change in AEC from Baseline to Week 12 on a ratio scale. The analysis used a mixed effects model repeated-measures (MMRM) with terms for log10 transformed baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and log10 transformed baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the log10 transformed post-baseline value minus the log10 transformed baseline value. The estimates of Geometric LS Means and their ratios were obtained by back transforming the corresponding estimates of LS means and their differences to the original scale.

The efficacy population will be a modified intent-to-treat sample and consist of all subjects in the safety population (all subjects who were randomized and received at least one dose of randomized study drug) and who have at least one post-randomization AEC evaluation.

FEV1 is defined as the amount of air that can be forcibly exhaled from the lungs in the first second of a forced exhalation.

The efficacy population will be a modified intent-to-treat sample and consist of all subjects in the safety population (all subjects who were randomized and received at least one dose of randomized study drug) and who have at least one post-randomization FEV1 evaluation. Spirometry restrictions were put in place during the COVID-19 pandemic. Subjects who did not complete the Week 8 and Week 12 post dose assessments due to these restrictions were excluded from this analysis.

ACQ-6 is simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment. The 6-point self-administered scale has items measuring asthma symptoms and rescue inhaler use. The ACQ score is the mean of the questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). The original protocol planned to analyze the ACQ-7 score. As a result of FEV1 testing restrictions imposed on the study during the COVID-19 pandemic, the analysis was prospectively modified to the ACQ-6 score prior to database lock. The ACQ-6 is a validated questionnaire and is identical to the ACQ-7, with the exception of FEV1 data that is also utilized in the ACQ-7 questionnaire total score calculation.

The efficacy population was a modified intent-to-treat sample and consist of all subjects in the safety population (all subjects who were randomized and received at least one dose of randomized study drug) and who have at least one post-randomization evaluation.

Post-bronchodilator FEV1 is defined as the amount of air that can be forcibly exhaled from the lungs in the first second of a forced exhalation, after treatment with inhaled albuterol.

The efficacy population was a modified intent-to-treat sample and consist of all subjects in the safety population (all subjects who were randomized and received at least one dose of randomized study drug) and who have at least one post-randomization evaluation.

The AQLQ is a 32-item asthma specific questionnaire designed to measure functional impairments that are most important to patients with asthma. The 32 questions in the AQLQ are divided into four domains; activity limitations, symptoms, emotional function, and environmental stimuli. Individual questions are equally weighted. The overall AQLQ score is the mean of the responses to each of the 32 questions and ranges from 1 to 7. A score 7.0 indicates that the patient has no impairments due to asthma and score 1.0 indicates severe impairment.

The efficacy population was a modified intent-to-treat sample and consist of all subjects in the safety population (all subjects who were randomized and received at least one dose of randomized study drug) and who have at least one post-randomization evaluation.

Number of Participants with Potentially Clinically Significant Hematology Results by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per laboratory test.

The safety population includes all subjects who were randomized and received at least one dose of study drug during the primary treatment period.

Number of Participants with Potentially Clinically Significant Blood Chemistry Results by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per laboratory test.

The safety population includes all subjects who were randomized and received at least one dose of study drug during the primary treatment period.

Number of Participants with Potentially Clinically Significant Urinalysis Results (glycosuria, ketonuria, or proteinuria) by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline urinalysis value in each treatment group. Patients are only counted once per criterion per laboratory test. The number of participants with potential clinical important urinalysis findings at any post-baseline visit were reported.

The safety population includes all subjects who were randomized and received at least one dose of study drug during the primary treatment period.

Number of Participants with Potentially Clinically Significant Vital Signs Results by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per laboratory test.

The safety population includes all subjects who were randomized and received at least one dose of study drug during the primary treatment period.

Number of Participants with Potentially Clinically Significant ECG Results by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per laboratory test.

The safety population includes all subjects who were randomized and received at least one dose of study drug during the primary treatment period.

The EPX:protein ratio was used to normalize the EPX for the quantity of sample, yielding the values in ng EPX per mg protein. The ratio of nasal Eosinophil Peroxidase to Protein is a biomarker for airway eosinophils. A lower ratio to Baseline represents a lowering in airway eosinophilia, which is a marker of successful drug therapy.

The efficacy population was a modified intent-to-treat sample and consists of all subjects in the safety population (all subjects who were randomized and received at least one dose of randomized study drug) and who had both Baseline (non-zero) and Week 12 values.

The analysis used a mixed effects model repeated-measures MMRM with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value. Basophils were enumerated as part of the WBC automated differential performed by the Central Laboratory.

The efficacy population was a modified intent-to-treat sample and consists of all subjects in the safety population (all subjects who were randomized and received at least one dose of randomized study drug) and who have at least one post-randomization evaluation.

FeNO is non-invasive biomarker of airway inflammation in asthma participants.

The efficacy population was a modified intent-to-treat sample and consists of all subjects in the safety population (all subjects who were randomized and received at least one dose of randomized study drug) and who have at least one post-randomization evaluation.