Statistics
ADVERSE EVENTS, REGRESSION
No power calculation was done for this safety and tolerability study. Twelve study persons in each arm were considered sufficient to detect major adverse events whilst avoiding unnecessary exposures.Continuous variables are presented as medians and interquartile ranges (IQR). A gastrointestinal score was calculated by adding the Bristol stool score for each defecation each day. I.e., a person who defecated twice with Bristol stool score of 4 and 7, respectively had a total score of 11 for that day. The time taken from start of clindamycin treatment until the gastrointestinal score stabilised was assessed for each individual patient graphically without prior knowledge of which group the patient belonged to. The time taken until the gastrointestinal score stabilised was assessed in a survival analysis and cox regression. Included time was from start of clindamycin treatment until day 28. The proportional hazard assumption in the cox regression was assessed graphically. The equality of survival functions was compared using the Log Rank Test.The effect of stopping clindamycin, time and treatment on gastrointestinal score, general and intestinal well-being were assessed by median regression, using a piecewise linear function of time to allow for a different time trend before and after stopping clindamycin treatment. The model included individual fixed effects to capture the between-subject variability. Fischer’s exact test was used to assess differences between the groups regarding adverse events. Study persons with adverse events were pooled irrespective of severity for comparison with patients without adverse events for this analysis. Statistical analyses were performed with STATA version 17 (StataCorp, TX). A 