Treatment emergent adverse events (TEAE)
A TEAE was any untoward medical occurrence following commencement of treatment, which did not necessarily have a relationship with the study treatment. TEAE were graded according to criteria developed by National Institute of Health (NIH) Consortium for Food Allergy Research (CoFAR) and the Food and Drug Administration (FDA, USA) (supporting information). TEAE are summarized by relationship to treatment and severity, and presented according to medical dictionary for regulatory activities (MedDRA) terms (system organ class and preferred term), and tabulated with descriptive statistics.