 A formal sample size calculation is not required for this pilot study. The analysis will be carried out on the basis of intention-to-treat. The analyses for this pilot study will be primarily descriptive and will not include any hypothesis testing or presentation of P-values for group comparisons. Continuous variables will be reported as means with standard deviations or medians with Interquartile ranges if skewed. Categorical variables will be reported as counts and percentages. Differences between groups will be calculated and described with 95 confidence intervals only and will not include significance tests with P-values. 