Statistical analysis
Descriptive summaries of the data were generated and displayed according to treatment group. The number of eligible participants in total, the number of participants who consented for inclusion and the number of eligible participants randomized were reported descriptively as proportions with 95 per cent c.i.s. Full trial outcome data were reported descriptively. For continuous data, the means and s.d. were calculated with 95 per cent c.i.s and for categorical data, proportions as percentages with 95 per cent c.i.s. A full statistical analysis plan was developed 