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Patients: 1303 exclusively breastfed, well, singleton infants, aged 13–17 weeks recruited from the general population in England and Wales.
Early introduction group: Introduction of six allergenic foods: cow's milk, peanut, hen's egg, sesame, whitefish and wheat. Minimum amounts defined as 3 g once a week of at least five of the foods for 5 weeks between 3 and 6 months of age.
Standard introduction group: Continue to breast feed until 6 months of age, compliance defined as no consumption of allergenic foods including less than 300 mL of formula per day.
Outcomes: Challenge-proven food allergy to one or more of the six early introduction foods at age 1–3 years.
Analysis: Intention-to-treat (ITT) analysis and per-protocol analysis (PPA). In PPA, infants who were not compliant with their diet using the above definitions were excluded …
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