Incidence of Adverse Events in laboratory parameters (Safety and tolerability);Incidence of Medically Attended Adverse Events (Safety and tolerability) (MAAEs);Incidence of Serious Adverse Events (Safety and tolerability) (SAE);Incidence of Special Interest Adverse Events (Safety and tolerability) (AESI).;Incidence of Treatment-Emergent Adverse Events (Safety and tolerability);Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) (AEs)

Incidence of Adverse Events in laboratory parameters (Safety and tolerability);Incidence of Medically Attended Adverse Events (Safety and tolerability) (MAAEs);Incidence of Serious Adverse Events (Safety and tolerability) (SAE);Incidence of Special Interest Adverse Events (Safety and tolerability) (AESI).;Incidence of Treatment-Emergent Adverse Events (Safety and tolerability);Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) (AEs)