Statistical analysis
All randomized participants were included in the statistical analysis based on an intention-to-treat approach. Whole cohort and subgroup analysis took place to identify any signals of differential effects. Categorical data is summarized as mean (standard deviation (SD)) or median (interquartile range (IQR)), whilst categorical data is presented as number (%). The Shapiro–Wilk test was used to assess normality of distribution. The independent T-test and Mann–Whitney U tests were used for between group analyses (i.e. FCM vs FDI). The Skillings-Mack test was performed to identify any longitudinal trends within groups. Given the small sample, adjustments for multiple comparisons were not performed. A statistical software package was used for the analysis of data (IBM SPSS Statistics Version 26, IBM Corp. 2019). Statistical significance was deduced at p-value < 0.05.