Sample size {14}
Fifteen participants per arm with a total of 75 participants and a wide range of DZD doses (from 0mg to 800 mg BID) has been determined as an adequate sample size for population PK modelling, and for exposure-response modelling to detect a clinically meaningful dose-dependent relationship.Furthermore, the planned sample size of 15 participants per treatment group is in keeping with other trials of this type and accounts for the possibility of up to 3 drop-outs per group, which, based on previous studies of this type conducted at these sites, represents a conservative estimate of the expected drop-out rate.Previous Phase IIA (EBA) studies indicate that the between-participant standard deviation of logCFU can be approximately 0.2 [