Table 5.

Definition of population analysis sets

Analysis population	TXA group	Standard care group
Intention to treat (“as randomized”)	Patients randomized to TXA group:  • Including all protocol deviations	Patients randomized to standard care group:  • Including all protocol deviations
As treated (“actual treatment”)	Patients who received TXA (at least one dose), regardless of allocated treatment at randomization:  • Including patients who received TXA as described according to protocol  • Including patients who received TXA not following protocol (protocol deviation)  • Including patients with other protocol deviations	Patients who did not receive TXA, regardless of allocated treatment at randomization:  • Including patients who received standard care as described according to protocol  • Including patients who received standard care not following protocol (protocol deviation)  • Including patients with other protocol deviations
Per protocol	Patients randomized to TXA group who received TXA (at least one dose):  • Including patients who received TXA as described according to protocol  • Including patients who received TXA not following protocol (protocol deviation)  • Including patients with other protocol deviations	Patients randomized to standard care group who did not receive TXA:  • Including patients who received standard care as described according to protocol  • Including patients who received standard care not following protocol (protocol deviation)  • Including patients with other protocol deviations

TXA tranexamic acid