Secondary variables included mean change in the three dimensions pre-specified as relevant to upper GI symptoms on each of the GSRS and QOLRAD questionnaires from baseline to last visit, analysed by analysis of covariance.
The hospitalization and ER-visit analyses included a dichotomous covariate to control for baseline hospitalization/ER visits.
By-visit analyses of the proportion of patients achieving ACR20, ACR50 and ACR70 responses through 12 weeks were conducted using the Fisher exact test of each dose versus placebo.
Due to the broad age range of patients with asthma-related ED visits, analyses were performed overall and separately for adults (≥18 years of age) and children (<18 years of age).
HH designed the first questionnaire, carried out the fieldwork for the first household visits, analysed the first part of the study and drafted the manuscript.
Parents and teachers rated items separately at each visit; the analyses included information from both informants.
In order to account for potential underlying temporal trends in ED visit rates, analyses were performed using segmented Poisson regression [ 25].
Given the exposure is lagged by one visit, these analyses do not include the data from 41 people diagnosed with hypertension at age 30 (the start of follow up).
Data from the fiscal years April 1st, 2001 to March 31st, 2007 were used to determine chronic disease prevalence, and data from April 1st, 2007 to March 31st, 2010 were used for the physician visit patterns analyses.
Body weight will be measured at every study visit, but analyses will focus primarily on change in body weight from baseline to the 6-months and 1- and 2-year follow-up.
