TABLE 3.

Definitions of subject populations in study

Population name	Number analysed (n)	Definition
Safety population (SP)	181	All subjects who were randomised and received either control or treatment therapy regardless of its duration.
Intent‐to‐treat population (ITT)	181	All subjects who were randomised and received either control or treatment therapy regardless of its duration and without a major medical event after enrolment unrelated to the study treatment that significantly altered the treatment course or would affect the subject's ability to participate in the study.
Per‐protocol population (PP)	137	All subjects who were randomised and received either control or treatment therapy until the wound was deemed ready for closure or coverage, completed the protocol's required visits and evaluations, and did not have any major protocol deviations. The effectiveness analyses for this study were based on the PP population.
Modified per‐protocol population	157	All subjects who were randomised and received either control or treatment therapy until the wound was deemed ready for closure/coverage or completed treatment up to 56 (±8) days after the initial operating room (OR) visit, in addition to completing the protocol's required visits and evaluations in which assessment for any of the endpoints was required.