Data analysis
SECONDARY
All data were analysed on an intention to treat basis. The study was not powered
to detect a clinically significant difference in the secondary outcome measures.
Statistical analysis was undertaken to explore direction of effect and offer the
necessary data to adequately power a definitive trial. Continuous data are
presented as mean (standard deviation, SD) for parametric data and median
(interquartile range, IQR) for non-parametric data. Values for categorical data
are presented as percentages. Paired and unpaired t-tests were used to analyse
parametric data. Pearson correlation coefficients were used to assess
associations between continuous outcome variables. All tests were two-tailed and
statistical significance was defined as 