Statistical analysis
REGRESSION
The sample size calculated with presumed recovery to be 7 days and 4 days in the usual and higher dose leucovorin acid (leucovorin) with SD 3, power 95% and alpha error of 0.05, allocation ratio of 1:1, comes to 29 in each group (total 58, rounded to 60) (Program used G power 3.2). All outcomes were assessed using intention-to-treat analyses, and all patients who had been randomized to a particular group were analysed. Baseline continuous variables were compared using t-test for independent samples or Mann–Whitney U test (based on assessment of normality of data) and categorical vaiables using the chi-square test.The primary outcome was analyzed used chi-square statistics and odds ratio was calculated. In addition, we also performed an adjustment for significant differences at baseline done using logistic regression. Survival analyses were performed using Kaplan–Meier test and log-rank test was used to compare survival between treatment groups. Cox-regression was used to generate hazard ratios and adjust key outcomes for baseline differences. It was also used to assess factors associated with survival—initially univariable analysis were done, and all independent variables with 