Therefore, the strawberry-flavored lozenge was tasted first by all subjects.

This was deemed acceptable given that the purpose of the study was to assess the acceptability of each flavor and not to compare the acceptability of the two flavors. The 15-minutes period between tasting the samples was considered appropriate in terms of maximizing subject compliance. A previous Ipilimumab order study has shown that complete lozenge dissolution takes approximately 6.77 minutes [29]. As the children in this study were only required to suck each lozenge for 1 minutes, they were not exposed to more than a standard dose (AMC 0.0022 mg/mL [standard deviation (SD) 0.0012] and DCBA 0.0097 mg/mL [SD 0.0040]). 2.4 Acceptability Assessments and Endpoints Assessments on the taste-testing day were designed to evaluate the acceptability of both flavors to the children. During the taste-testing session, children were first asked what they would like their medication to taste of. Subjects were asked to indicate their liking this website for each lozenge, using a 7-point hedonic facial scale (Fig. 1), which included the following scores: 1 = super bad; 2 = really bad; 3 = bad; 4 = may be good/may be bad; 5 = good; 6 = really good; 7 = super good. After expelling the lozenge, the subjects were asked a series of questions relating to the taste and feel of the lozenge in the mouth and

throat. Fig. 1 The 7-point hedonic facial scale for assessment of acceptability [16] The primary endpoint was the percentage of children who rated each lozenge with a score of >4 on the 7-point hedonic facial scale, together with descriptive summary statistics (mean, SD, median, minimum, maximum) of the hedonic facial scale scores. Secondary endpoints included the observed spontaneous reaction to putting the lozenge in the subject’s mouth (based on whether the subjects sucked the lozenge for 1 minute or spat it out), the flavor perceived by the subjects in response to the question “What

does the medicine taste of?”, and the subjects’ responses to a series of questions about what they liked and disliked about the taste. No efficacy ID-8 assessments were conducted in this study. Assessment of safety included analysis of any adverse events (AEs) spontaneously mentioned by the subjects after they had received each flavor of lozenge. 2.5 Statistical Methods For the primary endpoint, the proportion of subjects who had a hedonic facial score of >4 (i.e., 5–7) was presented together with the 95 % confidence interval (CI), for each lozenge. For the secondary endpoints, descriptive summary statistics of the hedonic facial scale score for each lozenge were presented together with the 95 % CI for the mean score. The number of times the sample was retained for 1 minute/spat out and responses to questions relating to taste were presented in the listings and summarized descriptively.