Trial Outcomes & Findings for Promoting Tolerance to Peanut in High-Risk Children (NCT NCT00329784)

Last Updated: 2019-04-17

Results Overview

At 60 months of age, participants were given an oral food challenge Participants regarded as unlikely to be allergic to peanut received 5 g of peanut protein in a single dose. These participants were considered to have a peanut allergy if they experienced any type of reaction following consumption. A double-blind, placebo-controlled food challenge was offered to other participants with a total of 9.4 g of peanut protein administered in increments. These participants were considered to have a peanut allergy if at any point during the dose escalation procedure the participant had a reaction. Participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on clinical history, the results of a skin-prick test, and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have peanut allergy.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

640 participants

Primary outcome timeframe

60 months

Results posted on

2019-04-17

Participant Flow

Participants between 4 and 11 months of age with pre-existing allergy to egg and/or severe eczema were recruited in the United Kingdom between December 2006 and May 2009.

Participants were stratified into cohorts based on a skin prick test for peanut allergen. Participants were either negative (no measureable wheal after test) or positive (a wheal measuring between 1 and 4 mm in diameter). Participants were then randomized into treatment groups.

Participant milestones

Participant milestones
Measure	Negative Stratum - Peanut Avoidance Group Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.	Negative Stratum - Peanut Consumption Group Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.	Positive Stratum - Peanut Avoidance Group Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.	Positive Stratum - Peanut Consumption Group Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
Overall Study STARTED	270	272	51	47
Overall Study COMPLETED	265	267	51	47
Overall Study NOT COMPLETED	5	5	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Negative Stratum - Peanut Avoidance Group Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.	Negative Stratum - Peanut Consumption Group Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	4	2
Overall Study Other	1	2

Baseline Characteristics

Promoting Tolerance to Peanut in High-Risk Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Negative Stratum - Peanut Avoidance Group n=270 Participants Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.	Negative Stratum - Peanut Consumption Group n=272 Participants Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.	Positive Stratum - Peanut Avoidance Group n=51 Participants Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.	Positive Stratum - Peanut Consumption Group n=47 Participants Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.	Total n=640 Participants Total of all reporting groups
Age, Continuous	7.7 Months STANDARD_DEVIATION 1.7 • n=5 Participants	7.7 Months STANDARD_DEVIATION 1.8 • n=7 Participants	8.4 Months STANDARD_DEVIATION 1.7 • n=5 Participants	7.9 Months STANDARD_DEVIATION 1.6 • n=4 Participants	7.8 Months STANDARD_DEVIATION 1.7 • n=21 Participants
Sex: Female, Male Female	96 Participants n=5 Participants	124 Participants n=7 Participants	17 Participants n=5 Participants	19 Participants n=4 Participants	256 Participants n=21 Participants
Sex: Female, Male Male	174 Participants n=5 Participants	148 Participants n=7 Participants	34 Participants n=5 Participants	28 Participants n=4 Participants	384 Participants n=21 Participants
Region of Enrollment United Kingdom	270 Participants n=5 Participants	272 Participants n=7 Participants	51 Participants n=5 Participants	47 Participants n=4 Participants	640 Participants n=21 Participants
Severe Eczema	236 Participants n=5 Participants	246 Participants n=7 Participants	48 Participants n=5 Participants	41 Participants n=4 Participants	571 Participants n=21 Participants
Age at Onset of Eczema	2.2 Months STANDARD_DEVIATION 1.7 • n=5 Participants	2.3 Months STANDARD_DEVIATION 1.6 • n=7 Participants	2.1 Months STANDARD_DEVIATION 1.6 • n=5 Participants	2.4 Months STANDARD_DEVIATION 1.5 • n=4 Participants	2.3 Months STANDARD_DEVIATION 1.6 • n=21 Participants
SCORAD	35.0 units on a scale STANDARD_DEVIATION 19.9 • n=5 Participants	33.3 units on a scale STANDARD_DEVIATION 18.4 • n=7 Participants	33.7 units on a scale STANDARD_DEVIATION 16.2 • n=5 Participants	37.8 units on a scale STANDARD_DEVIATION 18.6 • n=4 Participants	34.4 units on a scale STANDARD_DEVIATION 18.9 • n=21 Participants
Total IgE	95.1 kUA/L STANDARD_DEVIATION 321.8 • n=5 Participants	76.4 kUA/L STANDARD_DEVIATION 181.4 • n=7 Participants	125.7 kUA/L STANDARD_DEVIATION 174.8 • n=5 Participants	306.4 kUA/L STANDARD_DEVIATION 666.5 • n=4 Participants	104.8 kUA/L STANDARD_DEVIATION 307.9 • n=21 Participants
Peanut-specific IgE	0.0 kUA/L n=5 Participants	0.0 kUA/L n=7 Participants	0.4 kUA/L n=5 Participants	1.3 kUA/L n=4 Participants	0.0 kUA/L n=21 Participants

PRIMARY outcome

Timeframe: 60 months

Population: Intent-to-treat - all randomly assigned participants who were evaluable for peanut allergy at age 60 months

Outcome measures

Outcome measures
Measure	Negative Stratum - Peanut Avoidance Group n=263 Participants Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.	Negative Stratum - Peanut Consumption Group n=267 Participants Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.	Positive Stratum - Peanut Avoidance Group n=51 Participants Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.	Positive Stratum - Peanut Consumption Group n=47 Participants Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
Number of Participants With Peanut Allergy at 60 Months of Age - by Skin Prick Test Stratum	36 Participants	5 Participants	18 Participants	5 Participants

PRIMARY outcome

Timeframe: 60 months

Population: Intent-to-treat - all randomly assigned participants who were evaluable for peanut allergy at age 60 months

Outcome measures

Outcome measures
Measure	Negative Stratum - Peanut Avoidance Group n=314 Participants Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.	Negative Stratum - Peanut Consumption Group n=314 Participants Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.	Positive Stratum - Peanut Avoidance Group Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.	Positive Stratum - Peanut Consumption Group Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
Number of Participants With Peanut Allergy at 60 Months of Age - Both Strata Combined	54 Participants	10 Participants	—	—

SECONDARY outcome

Timeframe: 60 months

Population: Intent-to-treat with SCORAD data available

At 60 months of age, participants were assessed for eczema using a modified Scoring Atopic Dermatitis System (SCORAD). This measure was used to detect eczema in children who may not have had access to topical anti-inflammatory medications or whose parents cannot recall or report the severity of their child's eczema. Eczema is any type of dermatitis or inflammation of the skin. Atopic dermatitis is the most severe and chronic of all types 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.

Outcome measures

Outcome measures
Measure	Negative Stratum - Peanut Avoidance Group n=316 Participants Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.	Negative Stratum - Peanut Consumption Group n=312 Participants Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.	Positive Stratum - Peanut Avoidance Group Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.	Positive Stratum - Peanut Consumption Group Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
SCORAD at 60 Months	7.6 units on a scale Standard Deviation 11.6	6.6 units on a scale Standard Deviation 10.7	—	—

SECONDARY outcome

Timeframe: 60 months

Population: Intent-to-treat with asthma data available

At 60 months of age, participants were assessed for asthma. Participants were considered to have asthma if they had a history of cough, wheeze, or shortness of breath that (1) was responsive to therapy with bronchodilators on two or more occasions in the previous 24 months, (2) required one visit to a physician in the previous 24 months, or (3) occurred during the night, during early morning, or upon exercising in the intervals between exacerbations at any time in the previous 12 months.

Outcome measures

Outcome measures
Measure	Negative Stratum - Peanut Avoidance Group n=316 Participants Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.	Negative Stratum - Peanut Consumption Group n=314 Participants Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.	Positive Stratum - Peanut Avoidance Group Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.	Positive Stratum - Peanut Consumption Group Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
Number of Participants With Asthma at 60 Months	50 Participants	54 Participants	—	—

SECONDARY outcome

Timeframe: 60 months

Population: Intent-to-treat with rhinitis data available

At 60 months of age, participants were assessed for rhinitis. Two types of rhinitis were assessed, perennial rhinoconjunctivitis and seasonal rhinoconjunctivitis. Participants were considered to have either type of rhinitis if they showed a sensitization to the allergen and clinical history of rhinoconjunctivitis symptoms experienced either when exposed to the relevant allergen (perennial) or during the relevant season (seasonal).

Outcome measures

Outcome measures
Measure	Negative Stratum - Peanut Avoidance Group n=315 Participants Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.	Negative Stratum - Peanut Consumption Group n=313 Participants Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.	Positive Stratum - Peanut Avoidance Group Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.	Positive Stratum - Peanut Consumption Group Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
Number of Participants With Rhinitis at 60 Months Seasonal Rhinoconjunctivitis	106 Participants	115 Participants	—	—
Number of Participants With Rhinitis at 60 Months Perennial Rhinoconjunctivitis	134 Participants	132 Participants	—	—

SECONDARY outcome

Timeframe: 60 months

Population: Intent-to-treat with data available

At 60 months of age, participants were assessed for potential allergy to selected food allergens. Participants were considered to have a specific sensitivity if a skin prick containing the allergen produced a wheal size measuring greater than or equal to 3 mm.

Outcome measures

Outcome measures
Measure	Negative Stratum - Peanut Avoidance Group n=321 Participants Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.	Negative Stratum - Peanut Consumption Group n=319 Participants Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.	Positive Stratum - Peanut Avoidance Group Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.	Positive Stratum - Peanut Consumption Group Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm Peanut Wheal	71 Participants	30 Participants	—	—
Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm Egg Wheal	96 Participants	102 Participants	—	—
Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm Milk Wheal	28 Participants	25 Participants	—	—
Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm Sesame Wheal	22 Participants	22 Participants	—	—
Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm Brazil nut Wheal	29 Participants	26 Participants	—	—
Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm Hazel nut Wheal	34 Participants	41 Participants	—	—
Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm Cashew Wheal	42 Participants	59 Participants	—	—
Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm Walnut Wheal	27 Participants	34 Participants	—	—
Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm Almond Wheal	42 Participants	50 Participants	—	—

SECONDARY outcome

Timeframe: 60 months

Population: Intent-to-treat with data available

At 60 months of age, participants were assessed for potential allergy to selected food allergens. Participants were considered to have a specific food sensitivity if a blood draw showed specific IgE levels greater than or equal to 0.35 kU/L for selected ingested allergens.

Outcome measures

Outcome measures
Measure	Negative Stratum - Peanut Avoidance Group n=321 Participants Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.	Negative Stratum - Peanut Consumption Group n=319 Participants Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.	Positive Stratum - Peanut Avoidance Group Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.	Positive Stratum - Peanut Consumption Group Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L Peanut IgE	93 Participants	88 Participants	—	—
Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L Egg IgE	120 Participants	114 Participants	—	—
Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L Milk IgE	99 Participants	105 Participants	—	—
Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L Sesame IgE	89 Participants	104 Participants	—	—
Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L Brazil nut IgE	45 Participants	55 Participants	—	—
Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L Hazel nut IgE	101 Participants	116 Participants	—	—
Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L Cashew IgE	61 Participants	73 Participants	—	—
Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L Walnut IgE	52 Participants	70 Participants	—	—
Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L Almond IgE	62 Participants	71 Participants	—	—

Adverse Events

Negative Stratum - Peanut Avoidance Group

Serious events: 55 serious events

Other events: 268 other events

Deaths: 0 deaths

Negative Stratum - Peanut Consumption Group

Serious events: 47 serious events

Other events: 271 other events

Deaths: 0 deaths

Positive Stratum - Peanut Avoidance Group

Serious events: 15 serious events

Other events: 51 other events

Deaths: 0 deaths

Positive Stratum - Peanut Consumption Group

Serious events: 14 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Director, Clinical Research Operations Program

DAIT/NIAID

Phone: 301-594-7669

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Negative Stratum - Peanut Avoidance Group n=270 participants at risk Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.	Negative Stratum - Peanut Consumption Group n=272 participants at risk Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.	Positive Stratum - Peanut Avoidance Group n=51 participants at risk Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.	Positive Stratum - Peanut Consumption Group n=47 participants at risk Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
Gastrointestinal disorders Inguinal hernia strangulated	0.00% 0/270 • Enrollment through last study visit (up to five years)	0.37% 1/272 • Number of events 1 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Gastrointestinal disorders Intussusception	0.37% 1/270 • Number of events 1 • Enrollment through last study visit (up to five years)	0.00% 0/272 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
General disorders Pyrexia	0.00% 0/270 • Enrollment through last study visit (up to five years)	0.00% 0/272 • Enrollment through last study visit (up to five years)	2.0% 1/51 • Number of events 1 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Hepatobiliary disorders Hepatitis	0.37% 1/270 • Number of events 1 • Enrollment through last study visit (up to five years)	0.00% 0/272 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Immune system disorders Allergy to animal	0.00% 0/270 • Enrollment through last study visit (up to five years)	0.00% 0/272 • Enrollment through last study visit (up to five years)	2.0% 1/51 • Number of events 1 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Immune system disorders Anaphylactic reaction	1.9% 5/270 • Number of events 5 • Enrollment through last study visit (up to five years)	0.00% 0/272 • Enrollment through last study visit (up to five years)	13.7% 7/51 • Number of events 9 • Enrollment through last study visit (up to five years)	6.4% 3/47 • Number of events 5 • Enrollment through last study visit (up to five years)
Immune system disorders Food allergy	0.00% 0/270 • Enrollment through last study visit (up to five years)	0.74% 2/272 • Number of events 3 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	4.3% 2/47 • Number of events 2 • Enrollment through last study visit (up to five years)
Immune system disorders Hypersensitivity	0.37% 1/270 • Number of events 1 • Enrollment through last study visit (up to five years)	0.00% 0/272 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Immune system disorders Milk allergy	0.37% 1/270 • Number of events 1 • Enrollment through last study visit (up to five years)	0.00% 0/272 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Infections and infestations Arthritis bacterial	0.00% 0/270 • Enrollment through last study visit (up to five years)	0.37% 1/272 • Number of events 1 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Infections and infestations Bronchiolitis	0.37% 1/270 • Number of events 1 • Enrollment through last study visit (up to five years)	0.00% 0/272 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Infections and infestations Cellulitis	0.74% 2/270 • Number of events 2 • Enrollment through last study visit (up to five years)	0.00% 0/272 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Infections and infestations Eczema herpeticum	0.00% 0/270 • Enrollment through last study visit (up to five years)	0.37% 1/272 • Number of events 1 • Enrollment through last study visit (up to five years)	2.0% 1/51 • Number of events 1 • Enrollment through last study visit (up to five years)	2.1% 1/47 • Number of events 1 • Enrollment through last study visit (up to five years)
Infections and infestations Eczema infected	0.37% 1/270 • Number of events 2 • Enrollment through last study visit (up to five years)	0.74% 2/272 • Number of events 3 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Infections and infestations Febrile infection	0.00% 0/270 • Enrollment through last study visit (up to five years)	0.37% 1/272 • Number of events 1 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Infections and infestations Gastroenteritis	1.5% 4/270 • Number of events 4 • Enrollment through last study visit (up to five years)	1.1% 3/272 • Number of events 3 • Enrollment through last study visit (up to five years)	2.0% 1/51 • Number of events 1 • Enrollment through last study visit (up to five years)	2.1% 1/47 • Number of events 1 • Enrollment through last study visit (up to five years)
Infections and infestations Gastroenteritis viral	0.37% 1/270 • Number of events 1 • Enrollment through last study visit (up to five years)	1.1% 3/272 • Number of events 3 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Infections and infestations Lower respiratory tract infection	0.37% 1/270 • Number of events 2 • Enrollment through last study visit (up to five years)	0.00% 0/272 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	2.1% 1/47 • Number of events 1 • Enrollment through last study visit (up to five years)
Infections and infestations Measles	0.37% 1/270 • Number of events 1 • Enrollment through last study visit (up to five years)	0.00% 0/272 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Infections and infestations Meningitis viral	0.37% 1/270 • Number of events 1 • Enrollment through last study visit (up to five years)	0.00% 0/272 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Infections and infestations Meningococcal sepsis	0.37% 1/270 • Number of events 1 • Enrollment through last study visit (up to five years)	0.00% 0/272 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Infections and infestations Paronychia	0.37% 1/270 • Number of events 1 • Enrollment through last study visit (up to five years)	0.00% 0/272 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Infections and infestations Pneumonia	1.1% 3/270 • Number of events 3 • Enrollment through last study visit (up to five years)	0.74% 2/272 • Number of events 2 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Infections and infestations Sepsis	0.37% 1/270 • Number of events 1 • Enrollment through last study visit (up to five years)	0.00% 0/272 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Infections and infestations Tonsillitis	0.37% 1/270 • Number of events 1 • Enrollment through last study visit (up to five years)	0.37% 1/272 • Number of events 1 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Infections and infestations Upper respiratory tract infection	0.74% 2/270 • Number of events 2 • Enrollment through last study visit (up to five years)	0.00% 0/272 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Infections and infestations Urinary tract infection	0.37% 1/270 • Number of events 1 • Enrollment through last study visit (up to five years)	0.37% 1/272 • Number of events 1 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Infections and infestations Urinary tract infection pseudomonal	0.00% 0/270 • Enrollment through last study visit (up to five years)	0.00% 0/272 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	2.1% 1/47 • Number of events 1 • Enrollment through last study visit (up to five years)
Infections and infestations Varicella	0.37% 1/270 • Number of events 1 • Enrollment through last study visit (up to five years)	0.00% 0/272 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Infections and infestations Viral infection	1.5% 4/270 • Number of events 4 • Enrollment through last study visit (up to five years)	0.00% 0/272 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Infections and infestations Viral tonsillitis	0.00% 0/270 • Enrollment through last study visit (up to five years)	0.37% 1/272 • Number of events 1 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/270 • Enrollment through last study visit (up to five years)	0.37% 1/272 • Number of events 1 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/270 • Enrollment through last study visit (up to five years)	0.37% 1/272 • Number of events 1 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	2.1% 1/47 • Number of events 1 • Enrollment through last study visit (up to five years)
Injury, poisoning and procedural complications Foreign body trauma	0.37% 1/270 • Number of events 1 • Enrollment through last study visit (up to five years)	0.00% 0/272 • Enrollment through last study visit (up to five years)	2.0% 1/51 • Number of events 1 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Injury, poisoning and procedural complications Head injury	0.74% 2/270 • Number of events 2 • Enrollment through last study visit (up to five years)	0.74% 2/272 • Number of events 2 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Injury, poisoning and procedural complications Post procedural haemorrhage	0.74% 2/270 • Number of events 2 • Enrollment through last study visit (up to five years)	0.00% 0/272 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Metabolism and nutrition disorders Diabetes mellitus	0.37% 1/270 • Number of events 1 • Enrollment through last study visit (up to five years)	0.00% 0/272 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Metabolism and nutrition disorders Diabetic ketoacidosis	0.37% 1/270 • Number of events 1 • Enrollment through last study visit (up to five years)	0.00% 0/272 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Musculoskeletal and connective tissue disorders Arthritis reactive	0.37% 1/270 • Number of events 1 • Enrollment through last study visit (up to five years)	0.00% 0/272 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Nervous system disorders Febrile convulsion	0.74% 2/270 • Number of events 2 • Enrollment through last study visit (up to five years)	1.5% 4/272 • Number of events 4 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Respiratory, thoracic and mediastinal disorders Asthma	1.5% 4/270 • Number of events 5 • Enrollment through last study visit (up to five years)	3.3% 9/272 • Number of events 12 • Enrollment through last study visit (up to five years)	3.9% 2/51 • Number of events 2 • Enrollment through last study visit (up to five years)	4.3% 2/47 • Number of events 3 • Enrollment through last study visit (up to five years)
Respiratory, thoracic and mediastinal disorders Lung consolidation	0.00% 0/270 • Enrollment through last study visit (up to five years)	0.00% 0/272 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	2.1% 1/47 • Number of events 1 • Enrollment through last study visit (up to five years)
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/270 • Enrollment through last study visit (up to five years)	0.00% 0/272 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	2.1% 1/47 • Number of events 1 • Enrollment through last study visit (up to five years)
Respiratory, thoracic and mediastinal disorders Wheezing	6.3% 17/270 • Number of events 25 • Enrollment through last study visit (up to five years)	6.6% 18/272 • Number of events 22 • Enrollment through last study visit (up to five years)	11.8% 6/51 • Number of events 7 • Enrollment through last study visit (up to five years)	12.8% 6/47 • Number of events 7 • Enrollment through last study visit (up to five years)
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/270 • Enrollment through last study visit (up to five years)	0.37% 1/272 • Number of events 1 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/270 • Enrollment through last study visit (up to five years)	0.37% 1/272 • Number of events 1 • Enrollment through last study visit (up to five years)	0.00% 0/51 • Enrollment through last study visit (up to five years)	0.00% 0/47 • Enrollment through last study visit (up to five years)

Measure	Negative Stratum - Peanut Avoidance Group n=270 participants at risk Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.	Negative Stratum - Peanut Consumption Group n=272 participants at risk Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.	Positive Stratum - Peanut Avoidance Group n=51 participants at risk Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.	Positive Stratum - Peanut Consumption Group n=47 participants at risk Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
Eye disorders Conjunctivitis	25.9% 70/270 • Number of events 85 • Enrollment through last study visit (up to five years)	16.5% 45/272 • Number of events 48 • Enrollment through last study visit (up to five years)	21.6% 11/51 • Number of events 12 • Enrollment through last study visit (up to five years)	17.0% 8/47 • Number of events 8 • Enrollment through last study visit (up to five years)
Gastrointestinal disorders Constipation	8.5% 23/270 • Number of events 30 • Enrollment through last study visit (up to five years)	9.9% 27/272 • Number of events 32 • Enrollment through last study visit (up to five years)	7.8% 4/51 • Number of events 5 • Enrollment through last study visit (up to five years)	10.6% 5/47 • Number of events 6 • Enrollment through last study visit (up to five years)
Gastrointestinal disorders Diarrhoea	22.2% 60/270 • Number of events 64 • Enrollment through last study visit (up to five years)	22.1% 60/272 • Number of events 80 • Enrollment through last study visit (up to five years)	23.5% 12/51 • Number of events 14 • Enrollment through last study visit (up to five years)	14.9% 7/47 • Number of events 9 • Enrollment through last study visit (up to five years)
Gastrointestinal disorders Vomiting	23.0% 62/270 • Number of events 76 • Enrollment through last study visit (up to five years)	25.7% 70/272 • Number of events 100 • Enrollment through last study visit (up to five years)	19.6% 10/51 • Number of events 16 • Enrollment through last study visit (up to five years)	19.1% 9/47 • Number of events 9 • Enrollment through last study visit (up to five years)
General disorders Pyrexia	26.3% 71/270 • Number of events 97 • Enrollment through last study visit (up to five years)	32.0% 87/272 • Number of events 110 • Enrollment through last study visit (up to five years)	19.6% 10/51 • Number of events 13 • Enrollment through last study visit (up to five years)	23.4% 11/47 • Number of events 12 • Enrollment through last study visit (up to five years)
Immune system disorders Food allergy	46.3% 125/270 • Number of events 299 • Enrollment through last study visit (up to five years)	48.5% 132/272 • Number of events 286 • Enrollment through last study visit (up to five years)	74.5% 38/51 • Number of events 98 • Enrollment through last study visit (up to five years)	61.7% 29/47 • Number of events 95 • Enrollment through last study visit (up to five years)
Immune system disorders Hypersensitivity	5.2% 14/270 • Number of events 16 • Enrollment through last study visit (up to five years)	6.2% 17/272 • Number of events 19 • Enrollment through last study visit (up to five years)	7.8% 4/51 • Number of events 5 • Enrollment through last study visit (up to five years)	14.9% 7/47 • Number of events 7 • Enrollment through last study visit (up to five years)
Immune system disorders Milk allergy	11.5% 31/270 • Number of events 59 • Enrollment through last study visit (up to five years)	10.7% 29/272 • Number of events 47 • Enrollment through last study visit (up to five years)	29.4% 15/51 • Number of events 33 • Enrollment through last study visit (up to five years)	19.1% 9/47 • Number of events 21 • Enrollment through last study visit (up to five years)
Immune system disorders Seasonal allergy	14.4% 39/270 • Number of events 49 • Enrollment through last study visit (up to five years)	11.4% 31/272 • Number of events 37 • Enrollment through last study visit (up to five years)	15.7% 8/51 • Number of events 9 • Enrollment through last study visit (up to five years)	19.1% 9/47 • Number of events 11 • Enrollment through last study visit (up to five years)
Infections and infestations Ear infection	31.1% 84/270 • Number of events 142 • Enrollment through last study visit (up to five years)	32.7% 89/272 • Number of events 136 • Enrollment through last study visit (up to five years)	19.6% 10/51 • Number of events 15 • Enrollment through last study visit (up to five years)	23.4% 11/47 • Number of events 22 • Enrollment through last study visit (up to five years)
Infections and infestations Eczema infected	15.2% 41/270 • Number of events 55 • Enrollment through last study visit (up to five years)	7.4% 20/272 • Number of events 31 • Enrollment through last study visit (up to five years)	9.8% 5/51 • Number of events 6 • Enrollment through last study visit (up to five years)	17.0% 8/47 • Number of events 14 • Enrollment through last study visit (up to five years)
Infections and infestations Gastroenteritis	51.5% 139/270 • Number of events 227 • Enrollment through last study visit (up to five years)	63.6% 173/272 • Number of events 308 • Enrollment through last study visit (up to five years)	56.9% 29/51 • Number of events 44 • Enrollment through last study visit (up to five years)	57.4% 27/47 • Number of events 37 • Enrollment through last study visit (up to five years)
Infections and infestations Impetigo	5.6% 15/270 • Number of events 26 • Enrollment through last study visit (up to five years)	6.2% 17/272 • Number of events 21 • Enrollment through last study visit (up to five years)	5.9% 3/51 • Number of events 7 • Enrollment through last study visit (up to five years)	6.4% 3/47 • Number of events 5 • Enrollment through last study visit (up to five years)
Infections and infestations Lower respiratory tract infection	36.3% 98/270 • Number of events 164 • Enrollment through last study visit (up to five years)	30.5% 83/272 • Number of events 134 • Enrollment through last study visit (up to five years)	37.3% 19/51 • Number of events 32 • Enrollment through last study visit (up to five years)	42.6% 20/47 • Number of events 30 • Enrollment through last study visit (up to five years)
Infections and infestations Nasopharyngitis	27.4% 74/270 • Number of events 91 • Enrollment through last study visit (up to five years)	31.6% 86/272 • Number of events 112 • Enrollment through last study visit (up to five years)	29.4% 15/51 • Number of events 16 • Enrollment through last study visit (up to five years)	31.9% 15/47 • Number of events 20 • Enrollment through last study visit (up to five years)
Infections and infestations Otitis media	12.6% 34/270 • Number of events 42 • Enrollment through last study visit (up to five years)	8.8% 24/272 • Number of events 27 • Enrollment through last study visit (up to five years)	9.8% 5/51 • Number of events 5 • Enrollment through last study visit (up to five years)	14.9% 7/47 • Number of events 7 • Enrollment through last study visit (up to five years)
Infections and infestations Respiratory tract infection	7.4% 20/270 • Number of events 21 • Enrollment through last study visit (up to five years)	8.1% 22/272 • Number of events 24 • Enrollment through last study visit (up to five years)	7.8% 4/51 • Number of events 6 • Enrollment through last study visit (up to five years)	14.9% 7/47 • Number of events 8 • Enrollment through last study visit (up to five years)
Infections and infestations Rhinitis	54.1% 146/270 • Number of events 164 • Enrollment through last study visit (up to five years)	52.9% 144/272 • Number of events 166 • Enrollment through last study visit (up to five years)	74.5% 38/51 • Number of events 42 • Enrollment through last study visit (up to five years)	70.2% 33/47 • Number of events 38 • Enrollment through last study visit (up to five years)
Infections and infestations Tonsillitis	17.0% 46/270 • Number of events 67 • Enrollment through last study visit (up to five years)	19.5% 53/272 • Number of events 79 • Enrollment through last study visit (up to five years)	15.7% 8/51 • Number of events 11 • Enrollment through last study visit (up to five years)	17.0% 8/47 • Number of events 19 • Enrollment through last study visit (up to five years)
Infections and infestations Upper respiratory tract infection	59.3% 160/270 • Number of events 282 • Enrollment through last study visit (up to five years)	70.2% 191/272 • Number of events 399 • Enrollment through last study visit (up to five years)	51.0% 26/51 • Number of events 53 • Enrollment through last study visit (up to five years)	66.0% 31/47 • Number of events 71 • Enrollment through last study visit (up to five years)
Infections and infestations Varicella	44.1% 119/270 • Number of events 121 • Enrollment through last study visit (up to five years)	53.3% 145/272 • Number of events 153 • Enrollment through last study visit (up to five years)	45.1% 23/51 • Number of events 24 • Enrollment through last study visit (up to five years)	36.2% 17/47 • Number of events 17 • Enrollment through last study visit (up to five years)
Infections and infestations Viral infection	16.3% 44/270 • Number of events 48 • Enrollment through last study visit (up to five years)	20.6% 56/272 • Number of events 67 • Enrollment through last study visit (up to five years)	11.8% 6/51 • Number of events 8 • Enrollment through last study visit (up to five years)	21.3% 10/47 • Number of events 14 • Enrollment through last study visit (up to five years)
Infections and infestations Viral upper respiratory tract infection	11.1% 30/270 • Number of events 34 • Enrollment through last study visit (up to five years)	12.1% 33/272 • Number of events 38 • Enrollment through last study visit (up to five years)	7.8% 4/51 • Number of events 5 • Enrollment through last study visit (up to five years)	6.4% 3/47 • Number of events 3 • Enrollment through last study visit (up to five years)
Respiratory, thoracic and mediastinal disorders Asthma	22.2% 60/270 • Number of events 81 • Enrollment through last study visit (up to five years)	25.0% 68/272 • Number of events 121 • Enrollment through last study visit (up to five years)	31.4% 16/51 • Number of events 25 • Enrollment through last study visit (up to five years)	36.2% 17/47 • Number of events 27 • Enrollment through last study visit (up to five years)
Respiratory, thoracic and mediastinal disorders Cough	22.2% 60/270 • Number of events 70 • Enrollment through last study visit (up to five years)	19.1% 52/272 • Number of events 61 • Enrollment through last study visit (up to five years)	15.7% 8/51 • Number of events 13 • Enrollment through last study visit (up to five years)	23.4% 11/47 • Number of events 16 • Enrollment through last study visit (up to five years)
Respiratory, thoracic and mediastinal disorders Wheezing	24.1% 65/270 • Number of events 111 • Enrollment through last study visit (up to five years)	21.3% 58/272 • Number of events 111 • Enrollment through last study visit (up to five years)	35.3% 18/51 • Number of events 44 • Enrollment through last study visit (up to five years)	31.9% 15/47 • Number of events 33 • Enrollment through last study visit (up to five years)
Skin and subcutaneous tissue disorders Eczema	52.2% 141/270 • Number of events 248 • Enrollment through last study visit (up to five years)	54.0% 147/272 • Number of events 243 • Enrollment through last study visit (up to five years)	41.2% 21/51 • Number of events 45 • Enrollment through last study visit (up to five years)	57.4% 27/47 • Number of events 57 • Enrollment through last study visit (up to five years)
Skin and subcutaneous tissue disorders Rash	14.4% 39/270 • Number of events 48 • Enrollment through last study visit (up to five years)	12.5% 34/272 • Number of events 41 • Enrollment through last study visit (up to five years)	11.8% 6/51 • Number of events 6 • Enrollment through last study visit (up to five years)	8.5% 4/47 • Number of events 5 • Enrollment through last study visit (up to five years)
Skin and subcutaneous tissue disorders Urticaria	11.5% 31/270 • Number of events 54 • Enrollment through last study visit (up to five years)	19.9% 54/272 • Number of events 78 • Enrollment through last study visit (up to five years)	17.6% 9/51 • Number of events 12 • Enrollment through last study visit (up to five years)	36.2% 17/47 • Number of events 23 • Enrollment through last study visit (up to five years)