Methods for additional analyses (e.g. subgroup analyses) {20b}
PAD
Other endpoints will be assessed by superiority testing (intermittent skin health, daily skin health), LMM, controlled for country, baseline and clustering effects (QoL, EQ-5D, sleep interruption, responsive behaviours, total absorbency, UWES, organizational headroom, time spent in saturated pad, number of unnecessary checks).Where the response is deemed to be insufficiently continuous to be assessed with a difference in averages, difference in frequencies will be tested instead. No formal interim analysis is planned.