Summary of baseline data and flow of participants
A CONSORT diagram showing the flow of participants through the study will be produced. Data will be checked for outliers and missing values and validated using the defined score ranges. Baseline characteristics of participants by group and overall will be provided: means and standard deviation/medians and interquartile range for numerical variables, depending on data distribution and numbers and percentages for categorical variables. Descriptive summaries will similarly be provided for each outcome variable, at 12 weeks and six months where applicable, by study group.