The main outcomes and covariates will be tabulated by initial and repeat LFT patterns (Rates presented as events per thousand person years).
For descriptive purposes, baseline summary statistics of demographics and outcomes will be tabulated per group.
Baseline characteristics, concomitant medications, vital signs and PS will be tabulated.
The identified domains and instruments will be tabulated in such a way as to illustrate five patterns in the data using all included records.
For continuous variables, summary statistics (n [number of available measurements], arithmetic mean, standard deviation [SD], median, interquartiles, minimum, and maximum) will be tabulated.
Descriptive summaries of patient and carer questionnaire data at 3, 6, 9 and 12 months will be tabulated and presented graphically where appropriate.
The balance of characteristics between treatment and control arms will be tabulated and if differences are noted, adjustment will be made for these in linear regression models.
A flow chart of the participants is shown in figure 2. Baseline demographic and clinical characteristics will be tabulated as means and SDs for continuous variables and proportions and percentages for categorical variables.
Descriptive statistics (mean, median, number of observations, standard deviation, standard error, 95% confidence intervals - minimum and maximum) of all primary and other variables will be tabulated.
All secondary target variables, such as frequency, average and standard deviation will be tabulated per point of time (baseline, 6 weeks, 6 months) and per treatment arm.
