Participant groups
reduced vomiting, vomiting
To eliminate treatment effects of neurokinin-1 receptor antagonism (which has demonstrated anti-nauseogenic and antiemetic properties) as a potential confounder of validity testing, the Tradipitant group was excluded from the primary evaluation of the validity of the MSSS. The decision to conduct the primary evaluation using data from healthy participants without antiemetic treatment is supported by a demonstrated treatment effect, including significantly reduced vomiting observed in the Tradipitant group compared to placebo (Tradipitant incidence of vomiting = 17.5%, placebo incidence of vomiting = 39.7%, difference = 22.2%, p-value = 0.0039 [Cochran-Mantel-Haenszel test adjusting for boat trip]) [