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Table 3 Comparison of primary outcome measure (hydration score on the buttocks) at follow-up by randomised group under intention-to-treat (ITT) and per-protocol (PP) analyses

From: Effect on skin hydration of using baby wipes to clean the napkin area of newborn babies: assessor-blinded randomised controlled equivalence trial

Analysis Wipes (n = 123) Mean (SD) Water (n = 126) Mean (SD) Group effect P-value 95 % CI for difference in adjusted means
ITT 65.4 (12.4) 63.5 (14.2) 0.470 −2.5 to 4.2
PP     
Compliant with allocation (n = 122) 64.6 (12.4) (n = 123) 63.6 (14.3) 0.526 −2.6 to 4.2
Mostly compliant with protocol (n = 114) 64.9 (12.5) (n = 116) 63.2 (14.1) 0.427 −1.9 to 5.0
Strictly compliant with protocol (n = 106) 65.3 (12.0) (n = 107) 63.2 (14.1) 0.440 −1.6 to 5.5