Determined by patients using a daily diary on a scale from 0 (no symptoms) to 3 (severe symptoms) over a period of 7 days prior to the baseline and Day 30 visits. Negative values for change from baseline indicate reduction (improvement) in nasal obstruction/congestion symptoms.

Intent-to-treat population. Scoring for >=4 days in 7 days before the baseline and Day 30 visits was required. Sensitivity analyses, including tipping point, were prespecified if missing values exceed 5%. There were 4 (1.3%) participants (2 treatment, 2 control) with missing values at Day 30. No imputation of missing values was performed.

Polyp grade was determined by an independent panel of 3 sinus surgeons based on a centralized, blinded videoendoscopy review. Each sinus was graded from 0 (no visible polyps) to 4 (nasal polyps completely obstructing nasal cavity) and then the left and right values were added to obtain a total bilateral polyp grade, ranging from 0 to 8. Negative values for change from baseline indicated reduction (improvement) in bilateral polyp grade.

Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. Sensitivity analyses, including tipping point, were prespecified if missing values exceed 5%. There were 8 (2.7%) participants (6 treatment, 2 control) with missing values at Day 90. No imputation of missing values was performed.

Proportion of patients still indicated for RESS at day 90 despite ongoing use of mometasone furoate nasal spray based on clinical investigator assessment using study-specific criteria. To be indicated for RESS, patients had to: (1) complain of nasal obstruction/congestion (moderate to severe) and postnasal discharge, facial pain/pressure/fullness, or altered sense of smell/taste; (2) have endoscopic evidence of persisting nasal polyps (grade >= 2 on each side); and (3) have received (required at baseline) or need a systemic steroid as noted during endoscopy.

Intent-to-treat population, consisting of all patients in whom an implant or sham procedure was attempted. 2 participants did not complete Day 90 visit. No imputation of missing values was performed.

Percentage of the ethmoid sinus volume obstructed by scarring, polyps, or edema on endoscopy, as determined by an independent panel of 3 sinus surgeons based on a centralized, blinded videoendoscopy review using a 100-mm visual analogue scale (VAS), ranging from 0 (absence of obstruction) to 100 (complete obstruction). Negative values for change from baseline indicated reduction (improvement) in ethmoid sinus obstruction.

Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 8 (2.7%) participants (6 treatment, 2 control) with missing values at Day 90. No imputation of missing values was performed.

Determined by patients using a daily diary on a scale from 0 (no symptoms) to 3 (severe symptoms) over a period of 7 days prior to baseline and Day 90. Negative values for change from baseline indicated reduction (improvement) in nasal obstruction/congestion symptoms.

Intent-to-treat population. Scoring for >=4 of 7 days immediately preceding the baseline and Day 90 visits was required. There were 34 (11.3%) participants with missing scores: 23 treatment and 10 control at Day 90 and 1 (treatment) at baseline. No imputation of missing values was performed.

Determined by patients on a 6-point Likert scale from 0 (absent) to 5 (very severe). Negative values for change from baseline indicated reduction (improvement) in sense of smell.

Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 5 (1.7%) participants (3 treatment, 2 control) with missing values at Day 90. No imputation of missing values was performed.

Determined by patients on a 6-point Likert scale from 0 (absent) to 5 (very severe). Negative values for change from baseline indicated reduction (improvement) in facial pain/pressure symptoms.

Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 5 (1.7%) participants (3 treatment, 2 control) with missing values: 3 at baseline (1 treatment, 1 control)) and 2 at Day 90 (1 treatment, 1 control) No imputation of missing values was performed.