Table 1. Objective criteria used for determination of the primary endpoint of haemostatic treatment response to investigational medicinal product.

Haemostatic response	Haemostatic intervention
Effective	No additional haemostatic interventions* administered between 60 min and 24 hours after initiation of infusion†
Ineffective	Additional haemostatic interventions* administered between 60 min and 24 hours after initiation of infusion†

^*Administration of any systemic haemostatic agents (including platelets, cryoprecipitate, fibrinogen concentrate, activated recombinant factor VII, other coagulation factor products or a second dose of IMP) or any haemostatic interventions (including surgical re-opening for bleeding).

^†The 60-minute min period allows for the administration of the IMP and establishment of treatment effect.

IMP, investigational medicinal product; .