Pooled analysis efficacy outcomes through day 90. The changes from baseline
to each time point in subjective and objective outcomes among treatment
patients who received MF sinus implants bilaterally and control patients who
underwent a sham procedure are shown. All patients (treatment and control)
were required to use MFNS once daily. A, Change in NO/C (scale 0–3, with
higher score indicating greater severity), as assessed by patients using a
reflective questionnaire. B, Change in BPG (scale 0–8, with higher grade
indicating greater severity), as assessed by clinical investigators. C,
Change in ESO (VAS 0–100, with higher score indicating greater severity), as
assessed by clinical investigators. All values are means with 2-sided
standard error bars calculated based on ITT population. Data from patients
who received surgical or medical intervention were imputed using most recent
values prior to initiating or receiving intervention and represent
intervention-adjusted values. P values based on the ANCOVA
model with baseline value as a covariate and study, site, and treatment
group as fixed effects. ANCOVA, analysis of covariance; BPG, bilateral polyp
grade; ESO, ethmoid sinus obstruction; ITT, intent-to-treat; MF, mometasone
furoate; MFNS, MF nasal spray; NO/C, nasal obstruction/congestion; VAS,
visual analog scale.