Follow up of LEAP Participants and Their Families

Peanut allergy status at LEAP Trio Visit 144 was determined by peanut challenge where possible. Participants who met criteria for peanut oral allergy syndrome in the absence of primary peanut allergy were not considered peanut allergic. Individuals who reported consuming at least 2 g of peanut protein without reaction on at least one occasion in the last year were considered peanut tolerant. If oral challenge was not possible and participants did not meet the above criteria for tolerance, peanut allergy status was determined by an internally and externally validated novel peanut allergy prediction model using data for peanut wheal size (mm), peanut specific IgE (kU/L), Ara h1 (kU/L), Ara h2 (kU/L) and Ara h3 (kU/L)

Time frame: Assessments were performed on consented LEAP Participants at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).

Population: All LEAP Trio participants in the LEAP Participant cohort for whom data was available to make a determination of peanut allergy status at LEAP Trio Visit 144.

Peanut sensitization in the siblings of the LEAP Participants was defined as meeting at least one of the following criteria: Specific-IgE ≥0.35 kU/L or Specific-IgE to individual peanut component Ara h2 ≥0.1 kU/L, or Skin prick test wheal to peanut ≥3mm

Time frame: Assessments were performed on consented siblings at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).

Population: Siblings of the LEAP Participants who met the following criteria: Younger Siblings who were enrolled in LEAP Trio, resided in the home of the LEAP Participant during the LEAP Study (NCT00329784), and had results at LEAP Trio Visit 144 for peanut specific IgE, specific-IgE to individual peanut component Ara h2, or skin prick test wheal to peanut.

At LEAP Trio Visit 144, participants were asked to provide responses to questions about their peanut protein consumption. Responses obtained at LEAP Trio Visit 144 were based on the recollection of peanut consumption during the 4 weeks prior to the LEAP Trio study Visit 144.

Time frame: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).

Population: All participants in LEAP Trio who provided a response to the question of average weekly peanut protein consumption in the 4 weeks prior to LEAP Trio Visit 144.

Skin prick tests were performed to assess participants for potential peanut allergy, select food allergens, and select aeroallergens

Time frame: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).

Population: All participants in LEAP Trio for whom data was available for peanut skin prick test wheal at LEAP Trio Visit 144.

Participants had blood draws to assess specific-IgE measurements to peanut, select food allergens and select aeroallergens

Time frame: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).

Population: All participants in LEAP Trio for whom data was available for peanut specific IgE at LEAP Trio Visit 144

Peanut-related adverse events were reported from reactions experienced during or within 30 days after the LEAP Trio Visit 144 peanut oral food challenge (peanut OFC)

Time frame: Within 30 days after peanut OFC performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).

Population: All participants in LEAP Trio in the LEAP Participants, Younger Siblings and Older Siblings cohorts in the Intent-to-Treat population: participants with at least one assessment completed at LEAP Trio Visit 144. The peanut oral food challenge was not performed in Parents.

Participants were classified as having asthma if they meet at least one of the following definitions: 1. Participant report of cough, wheeze, or shortness of breath that was responsive to therapy with bronchodilators on two or more occasions in the previous 24 months; or required one visit to a physician in the previous 24 months; or occurred during the night, during early morning, or upon exercising in the intervals between exacerbations at any time in the previous 12 months. 2. Participant report of an asthma diagnosis with current use of asthma medications (short-acting beta-agonist or controller) 3. Participant report of transient wheeze on exposure to a suspected allergen with confirmatory allergy tests

Time frame: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).

Population: All participants in LEAP Trio for whom data was available to make a determination of asthma status at LEAP Trio Visit 144.

Participants were classified as having eczema using standard methodology. Participants were assessed for eczema using a modified Scoring Atopic Dermatitis System (SCORAD) and using participant report of a history of eczema. The range of the SCORAD is 0-103. A score of 0 indicates no eczema, scores between 0 and 15 indicate mild eczema, scores between 15 and 40 indicate moderate eczema, and scores greater than 40 indicate severe eczema.

Time frame: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).

Population: All participants in LEAP Trio in the Intent-to-Treat population: participants with at least one assessment completed at LEAP Trio Visit 144.

Participants were considered to have perennial rhinitis if they demonstrated a sensitization to the aeroallergen and clinical history of rhinoconjunctivitis symptoms experienced when exposed to the relevant allergen. Sensitization to the relevant allergen was defined as: 1. Allergen specific IgE ≥ 0.35 kU/L, or 2. Skin prick test wheal size to allergen ≥ 3 mm.

Time frame: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).

Population: All participants in LEAP Trio for whom data was available to make a determination of perennial rhinitis status at LEAP Trio Visit 144.

Participants were considered to have seasonal rhinitis if they demonstrated a sensitization to a seasonal aeroallergen and clinical history of rhinoconjunctivitis symptoms experienced when exposed to the allergen during the relevant season. Sensitization to the relevant allergen was defined as: 1. Allergen specific IgE ≥ 0.35 kU/L, or 2. Skin prick test wheal size to allergen ≥ 3 mm

Time frame: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).

Population: All participants in LEAP Trio for whom data was available to make a determination of seasonal rhinitis status at LEAP Trio Visit 144.

Peanut allergy status at LEAP Trio Visit 144 was determined by peanut challenge where possible. Participants who met criteria for peanut oral allergy syndrome in the absence of primary peanut allergy were not considered peanut allergic. Individuals who reported consuming at least 2 g of peanut protein without reaction on at least one occasion in the last year were considered peanut tolerant. If oral challenge was not possible and participants did not meet the above criteria for tolerance, peanut allergy status was determined by an internally and externally validated novel peanut allergy prediction model using data for peanut wheal size (mm), peanut specific IgE (kU/L), Ara h1 (kU/L), Ara h2 (kU/L) and Ara h3 (kU/L)

Time frame: Assessments were performed on consented family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).

Population: All participants in LEAP Trio in the Younger Siblings, Older Siblings and Parents cohorts for whom data was available to make a determination of peanut allergy status at LEAP Trio Visit 144. Results for peanut allergy of LEAP Participants are displayed in Primary Outcome Measure #1

Eczema severity was assessed using a modified Scoring Atopic Dermatitis (SCORAD) assessment. The range of the SCORAD is 0-103. A score of 0 indicates no eczema, scores between 0 and 15 indicate mild eczema, scores between 15 and 40 indicate moderate eczema, and scores greater than 40 indicate severe eczema.

Time frame: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).

Population: All participants in LEAP Trio in the LEAP Participants, Younger Siblings and Older Siblings cohorts for whom data was available for the SCORAD evaluation at LEAP Trio Visit 144