Table 1.
Inclusion and Exclusion Criteria.
Fig 1.
Participant timeline: Schedule of enrollment, interventions, and assessments.
a Daily symptom diary and follow-up survey track the following: mSNOT-16, Patient Global Rating of Change, Work Productivity and Activity Impairment Questionnaire, use of interventions and supportive care, and adverse events. b Primary outcome: mSNOT-16 score at Day R3. c Patients with less than 10 days of symptoms at enrollment enter Phase 1 (pre-randomization period) until Day E9. Phase 1 to 2 eligibility is assessed at Day E9. d Patients with ≥ 10 days of symptoms or double sickening enter Phase 2 and randomization directly. e 2025 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT), Chan A-W, Boutron I, Hopewell S, Moher D, Schulz KF, et al. SPIRIT 2025 statement: updated guideline for protocols of randomised trials. BMJ 2025;389:e081477. https://dx.doi.org/10.1136/bmj-2024-081477.
Table 2.
Data Collection/Outcome Measures.
Table 3.
Treatment Groups and Interventions.