Table 2.
Status of enrolled participants
| Status | n |
|---|---|
| Total enrolment (subjects consented) | 189 |
| Screen failures/2‐wk screening phase | 61 |
| Total randomised | 128 |
| Total treated (ITT study group) | 128 |
| Serious adverse eventa | 7 |
| Protocol deviationsb | 7 |
| Early withdrawal | 3 |
| Investigator withdrawal | 1 |
| Lost to follow up | 1 |
| Subjects with complete primary endpoint data (PP study group) | 109 |
Abbreviations: IIT, intention‐to‐treat; PP, per‐protocol.
a
Serious adverse events include death (cardiac arrest because of coronary artery disease), trauma, alcohol poisoning, and ulcer worsening resulting in additional intervention.
b
Protocol deviations include product not applied weekly according to the protocol or subjects not meeting inclusion criteria.