Milgrom 2007.

Methods	A safety evaluation study. Multicenter, double‐blind, randomized, placebo controlled, parallel‐group study. High quality score = 1
Participants	Placebo group: mean age 3.6 SD 1.1; 117 boys, 123 girls. Fexofenadine group: mean age 3.6 SD 1.1; 123 boys, 99 girls. Inclusion criteria: Children aged 2 to 5 years with allergic rhinitis. Exclusion criteria: Clinically relevant abnormalities/conditions that may interfere with study (severe asthma, bronchiolitis, wheezing, acute respiratory infection, vasomotor rhinitis, acute otitis media, craniofacial abnormalities, on immunotherapy requiring dose change or frequency of dosing during study, recent vaccination (< 2 weeks), on another anti‐histamine, oral decongestion or adrenal agonists, eye drops, systemic or nasal corticosteroids, or other sinus, allergy or cold remedies, hypersensitivity to fexofenadine.
Interventions	Fexofenadine hydrochloride, 30 mg, or placebo twice daily for a 2‐week period
Outcomes	Primary outcome: occurrence of adverse events. Secondary outcome: ECG, physical examination, lab tests.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Not described
Allocation concealment?	Unclear risk	Not described
Blinding? All outcomes	Low risk