Total endoscopic nasal polyp score is collected at clinical visits. Independent reviewers, blinded to treatment, reviewed image recordings of nasal endoscopies to determine total endoscopic NP score based on NP size. The right and left nostrils were scored from 0 to 4 (0 = No polyps; 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle concha; 2 = Polyps reaching below the lower border of the middle turbinate; 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle concha; and 4 = Large polyps causing complete obstruction/congestion of the inferior meatus). The total score is the sum of the right and left nostril scores and ranges from 0 to 8 (calculated by summing the scores [0 to 4] in each nostril), higher scores indicate worse status. Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value.

The analysis was performed on the ITT Set (randomized participants who received at least 1 dose of study treatment) excluding participants from Medipharma managed sites. Participants were analyzed according to the treatment they were allocated at randomization. Analysis was performed using missing at random (MAR) assumption to handle missing data.

Total endoscopic nasal polyp score is collected at clinical visits. The assessments were performed by central video image recordings of nasal endoscopy (NE). The right and left nostrils were scored from 0 to 4 (0 = No polyps; 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle concha; 2 = Polyps reaching below the lower border of the middle turbinate; 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle concha; and 4 = Large polyps causing complete obstruction/congestion of the inferior meatus). The total score is the sum of the right and left nostril scores and ranges from 0 to 8 (calculated by summing the scores [0 to 4] in each nostril), "0" score represents better status while "8" represents worse status. Baseline was defined as last value prior to first dose (Day 1). Change from Baseline = Post-baseline value minus Baseline value.

The analysis was performed on the Intent to Treat (ITT) Set that included all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to the treatment they were allocated at randomization. Analysis was performed using missing at random (MAR) assumption to handle missing data.

Participants rated individual (nasal obstruction, nasal discharge, mucus in the throat, loss of smell, facial pain) and overall symptoms on a visual analog scale (VAS) using an electronic diary (eDiary). Captured scores ranged between 0 (none) and 100 (as bad as you can imagine), final scores derived from the electronically captured scores by dividing by 10. The final nasal obstruction VAS score ranged between 0 (none) and 10 (worst), with higher scores indicating greater disease severity. The average of daily scores in 4-weekly intervals were calculated and data is presented for Weeks 49-52. Baseline was defined as the average score from the 7 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value.

The analysis was performed on the ITT Set (randomized participants who received at least 1 dose of study treatment) excluding participants from Medipharma managed sites. Participants were analyzed according to the treatment they were allocated at randomization. Analysis was performed using MAR assumption to handle missing data.

Participants rated individual (nasal obstruction, nasal discharge, mucus in the throat, loss of smell, facial pain) and overall symptoms on a visual analog scale (VAS) using an electronic diary (eDiary). Captured scores ranged between 0 (none) and 100 (as bad as you can imagine), final scores derived from the electronically captured scores dividing by 10. The final nasal obstruction VAS score ranged between 0 and 10, with higher scores indicating greater disease severity. The average of daily scores in 4-weekly intervals were calculated and data is presented for Weeks 49-52. Baseline was defined as the average score from the 7 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value.

The analysis was performed on the ITT Set that included all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to the treatment they were allocated at randomization. Analysis was performed using MAR assumption to handle missing data.

Participants rated individual (nasal obstruction, nasal discharge, mucus in the throat, loss of smell, facial pain) and overall symptoms on a visual analog scale using an eDiary. Captured scores ranged between 0 (none) and 100 (as bad as you can imagine), final scores derived from the electronically captured scores by dividing by 10. The final overall VAS score ranged between 0 (none) and 10 (worst), with higher scores indicating greater disease severity. The average of daily scores in 4-weekly intervals were calculated and data is presented for Weeks 49-52. Baseline was defined as the average score from the 7 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value.

The analysis was performed on the ITT Set (randomized participants who received at least 1 dose of study treatment) excluding participants from Medipharma managed sites. Participants were analyzed according to the treatment they were allocated at randomization. Analysis was performed using MAR assumption to handle missing data.

Participants rated individual (nasal obstruction, nasal discharge, mucus in the throat, loss of smell, facial pain) and overall symptoms on a visual analog scale using an eDiary. Captured scores ranged between 0 (none) and 100 (as bad as you can imagine), final scores derived from the electronically captured scores by dividing by 10. The final overall VAS score ranged between 0 (none) and 10 (worst), with higher scores indicating greater disease severity. The average of daily scores in 4-weekly intervals were calculated and data is presented for Weeks 49-52. Baseline was defined as the average score from the 7 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value.

The analysis was performed on the ITT Set that included all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to the treatment they were allocated at randomization. Analysis was performed using MAR assumption to handle missing data.

The LMK CT scoring system is based on localization with points given for degree of opacification: 0 =normal, 1 = partial opacification, 2 = total opacification. These points are then applied to the maxillary, anterior ethmoid, posterior ethmoid, sphenoid, frontal sinus on each side. The osteomeatal complex (OC) was graded as 0 = not occluded, or 2 = occluded deriving a maximum score of 12 per side. The range for the LMK CT score is therefore 0-24 (higher scores indicating more opacification) when summed across both sides. Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value.

The analysis was performed on the ITT Set (randomized participants who received at least 1 dose of study treatment) excluding participants from Medipharma managed sites. Participants were analyzed according to the treatment they were allocated at randomization.

The LMK CT scoring system is based on localization with points given for degree of opacification: 0 =normal, 1 = partial opacification, 2 = total opacification. These points are then applied to the maxillary, anterior ethmoid, posterior ethmoid, sphenoid, frontal sinus on each side of the nostril. The osteomeatal complex (OC) was graded as 0 = not occluded, or 2 = occluded deriving a maximum score of 12 per side. The range for the LMK CT score is therefore 0-24 (higher scores indicating more opacification) when summed across both sides. Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value.

The analysis was performed on the ITT Set (randomized participants who received at least 1 dose of study treatment) excluding participants from Medipharma managed sites. Participants were analyzed according to the treatment they were allocated at randomization.

Participants rated individual (nasal obstruction, nasal discharge, mucus in the throat, loss of smell, facial pain) and overall symptoms on a visual analog scale using an eDiary. Captured scores ranged between 0 (none) and 100 (as bad as you can imagine), final scores derived from electronically captured scores by dividing by 10. The composite VAS score was calculated as average of individual scores of nasal obstruction, nasal discharge, mucus in the throat and loss of smell and ranged between 0 (none) and 10 (worst), with higher scores indicating greater disease severity. The average of daily scores in 4-weekly intervals were calculated and data is presented for Weeks 49-52. Baseline was defined as the average score from the 7 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value.

The analysis was performed on the ITT Set (randomized participants who received at least 1 dose of study treatment) excluding participants from Medipharma managed sites. Participants were analyzed according to the treatment they were allocated at randomization. Analysis was performed using MAR assumption to handle missing data.

Participants rated individual (nasal obstruction, nasal discharge, mucus in the throat, loss of smell, facial pain) and overall symptoms on a visual analog scale using an eDiary. Captured scores ranged between 0 (none) and 100 (as bad as you can imagine), final scores derived from electronically captured scores by dividing by 10. The composite VAS score was calculated as average of individual scores of nasal obstruction, nasal discharge, mucus in the throat and loss of smell and ranged between 0 (none) and 10 (worst), with higher scores indicating greater disease severity. The average of daily scores in 4-weekly intervals were calculated and data is presented for Weeks 49-52. Baseline was defined as the average score from the 7 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value.

The analysis was performed on the ITT Set that included all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to the treatment they were allocated at randomization. Analysis was performed using MAR assumption to handle missing data.

SNOT-22 is a 22-item measure of disease specific health related quality of life (HRQoL). Participants were asked to rate the severity of their condition on each of the 22 items over the previous 2 weeks using a 6-point rating scale of 0-5 including: 0 =Not present/no problem; 1 =Very mild problem; 2 = Mild or slight problem; 3 = Moderate problem; 4 = Severe problem; 5=Problem as "bad as it can be". The scores for each question were summed up to derive the total score range for the SNOT-22 was from 0 (high quality of life) to 110 (worst quality of life), where higher scores representing worse quality of life. Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value.

The analysis was performed on the ITT Set (randomized participants who received at least 1 dose of study treatment) excluding participants from Medipharma managed sites and 1 participant who did not have baseline SNOT. Participants were analyzed according to the treatment they were allocated at randomization. Analysis was performed using MAR assumption to handle post-baseline missing data.

SNOT-22 is a 22-questions measure of disease specific health related quality of life (HRQoL). Participants were asked to rate the severity of their condition on each of the 22 items over the previous 2 weeks using a 6-point rating scale of 0-5 including: 0 =Not present/no problem; 1 =Very mild problem; 2 = Mild or slight problem; 3 = Moderate problem; 4 = Severe problem; 5=Problem as "bad as it can be". The scores for each question were summed up to derive the total score range for all SNOT-22 items ranging from 0 (high quality of life) to 110 (worst quality of life). Lower score indicating better HRQoL. Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value.

The analysis was performed on the ITT Set that included all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to the treatment they were allocated at randomization. Only those participants with data available at specified time points have been analyzed.

Participants rated individual (nasal obstruction, nasal discharge, mucus in the throat, loss of smell, facial pain) and overall symptoms on a visual analog scale using an eDiary. Captured scores ranged between 0 (none) and 100 (as bad as you can imagine), final scores derived from the electronically captured scores by dividing by 10. The final loss of smell VAS score ranged between 0 (none) and 10 (worst), with higher scores indicating greater disease severity. The average of daily scores in 4-weekly intervals were calculated and data is presented for Weeks 49-52. Baseline was defined as the average score from the 7 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value.

The analysis was performed on the ITT Set (randomized participants who received at least 1 dose of study treatment) excluding participants from Medipharma managed sites. Participants were analyzed according to the treatment they were allocated at randomization. Analysis was performed using MAR assumption to handle missing data.

Participants rated individual (nasal obstruction, nasal discharge, mucus in the throat, loss of smell, facial pain) and overall symptoms on a visual analog scale using an eDiary. Captured scores ranged between 0 (none) and 100 (as bad as you can imagine), final scores derived from the electronically captured scores by dividing by 10. The final loss of smell VAS score ranged between 0 (none) and 10 (worst), with higher scores indicating greater disease severity. The average of daily scores in 4-weekly intervals were calculated and data is presented for Weeks 49-52. Baseline was defined as the average score from the 7 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value.

The analysis was performed on the ITT Set that included all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to the treatment they were allocated at randomization. Analysis was performed using MAR assumption to handle missing data.

NP surgery is defined as any procedure involving instruments resulting in incision and removal of tissue from the nasal cavity (for example polypectomy). Additionally, the number of courses of systemic steroids and reason for treatment will be recorded throughout the study. Percentage of participants with nasal surgery or course of systemic CS for CRSwNP/ECRS and corresponding 95% CI have been presented, calculated using the Kaplan-Meier method.

The analysis was performed on the ITT Set (randomized participants who received at least 1 dose of study treatment) excluding participants from Medipharma managed sites. Participants were analyzed according to the treatment they were allocated at randomization.

NP surgery is defined as any procedure involving instruments resulting in incision and removal of tissue from the nasal cavity (for example polypectomy). Additionally, the number of courses of systemic steroids and reason for treatment will be recorded throughout the study. Percentage of participants with nasal surgery or course of systemic CS for CRSwNP/ECRS and corresponding 95% CI have been presented, calculated using the Kaplan-Meier method.

The analysis was performed on the ITT Set that included all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to the treatment they were allocated at randomization. Analysis was performed using MAR assumption to handle missing data.