Meltzer 2004.

Methods	Multicentre double‐blind, randomised, placebo‐controlled, parallel‐group, 2‐wk trials. Three studies were reported within this paper. All three studies had a similar design with regard to patient selection criteria and, primary and secondary outcome measures. Following visit 1, the studies included four additional visits: visit 2, randomisation (day 1); visit 3, during double‐blind treatment (day 6–10); visit 4, end of double‐blind treatment (day15–17); and visit 5, follow‐up (day 22–24). For inclusion at visit 1, total symptom score (TSS) (see below for score details) of 6, with two or more symptoms with a minimum score of 2 (moderate), was necessary. This was followed by completion of a single‐blind, placebo lead‐in period, the children in study were required to have a TSS score that differed in the studies. High grade score: 3 Grading: Allocation concealment= B. Blinding=A Reporting of participants by allocated group=A Follow up=A
Participants	Inclusion criteria: presence of seasonal allergic rhinitis (SAR) symptoms (see below‐outcomes) at entry and persisted after single‐blind placebo lead‐in. Children aged 6–11 years, with spring or fall SAR, and a history of SAR of approximately 1 year or more during at least one previous relevant season. Subjects were required to have a positive skin‐prick test (wheal diameter of at least 3 mm than that with diluent within 15 min of the skin prick) to at least one allergen for the current season. For one of the 3 studies, presence of an allergen‐specific immunoglobulin E (IgE) that was positive in the skin‐prick test was also required. Exclusion: patients were (but were not limited to) those with a respiratory tract nasal infection, sinusitis, or otitis media within 30 days of study entry; clinically significant cardiovascular, hepatic, neurologic, psychiatric, endocrine or other major systemic disease; or immunotherapy treatment. A total of 1810 children were included in the overall paediatric safety population (placebo, n=700; fexofenadine n=1110)
Interventions	All children were randomised to receive either fexofenadine HCl arm (15,30 or 60mg bd) or matching placebo.
Outcomes	Seasonal allergic rhinitis symptom scores: sneezing; rhinorrhoea; itchy nose, palate, throat and/or ears; itchy, watery and/or red eyes; and nasal congestion. Each symptom was evaluated on a five‐point scale: 0=absent; 1=mild; 2=moderate; 3=severe;4=very severe. The total symptom score (TSS) was calculated by adding the individual symptom scores, excluding nasal congestion (maximum possible TSS=16). Seasonal allergic rhinitis symptoms were assessed daily at 19:00 (±1) hours for the previous 12‐hour period by the subject and caregiver, immediately prior to trial medication. Children (and investigators) reported any adverse events (AEs) during the study.
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	Double blind
Incomplete outcome data addressed? All outcomes	Low risk
Free of other bias?	Unclear risk	Supported by pharmaceutical company