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
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 |