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Table 3 Exclusion criteria

From: Protocol for a double-blind, randomized controlled trial on the dose-related efficacy of omalizumab in multi-food oral immunotherapy

1. Participants reacting objectively to the placebo during the screening DBPCFC.
2. Severe asthma as defined by GINA 2019 [46]
3. Active or past confirmed eosinophilic oesophagitis
4. Participant currently under allergen immunotherapy
5. Participant/parent with excessive anxiety unlikely to cope with study conditions as per investigator’s opinion
6. Participant/parent unwillingness to comply with study requirements
7. Participant unwillingness to ingest a daily food dose of up to 1500 mg of allergen protein
8. Inability to discontinue anti-histamine medication prior to study procedures
9. Known allergy to omalizumab or its excipients
10. Known allergy to components of the placebo food treatment mix that cannot be substituted without interfering with the blind (i.e.: dates, banana, chocolate syrup)
11. Use of immunosuppression or immunomodulatory drug (including omalizumab) or food oral immunotherapy or investigational treatment or procedure within 1 year
12. Relative contraindication or inability to use epinephrine auto-injector
13. Participants receiving beta-blockers or angiotensin converting-enzyme (ACE) inhibitors
14. Pregnancy or lactation for the duration of the study
15. Any condition that is not compatible with the study treatment or procedures as per investigator judgment