Sample size and statistics
ADVANCED CANCER
The sample size of the primary study (MedCan-1) was calculated according to predicted improvement in symptom burden that has been shown from palliative care involvement in patients with advanced cancer [The sub-study (Medcan-Inflam) was a convenience sample that was not powered to show any statistical difference. Anticipating an attrition rate of approximately 20% after 2 weeks, the primary analysis was planned for day 14. Within a sample of 30 participants, we anticipated approximately 15 would be receiving CBD and 15 placebo. Based on our pilot data, we anticipated the need to recruit 35 patients to have serum samples from 30 participants at day 14.To avoid potential bias, unblinding did not occur until completion of the parent study.Normally distributed data was summarised as mean (standard deviation, SD) and non-normally distributed data as median (inter-quartile range, IQR) or median (range). For normally distributed continuous data, groups were compared using a The trajectory of inflammatory markers over time was evaluated using generalised estimating equations (GEE), to account for dropouts and missing data. The distributions of the inflammatory marker data were investigated using graphical (line graphs over time, histograms, and boxplots) and summary methods, and were almost invariably skewed to the right. A number of distributions and link functions were explored to select the best model. For most analyses, a normal distribution with log link was finally selected over a Gamma distribution with log link. Inferences were confirmed using simple difference methods (day 14 minus baseline, day 28 minus baseline) where appropriate. Data was analysed using SAS Version 9.4 (SAS Institute, Cary, NC, USA) and 