Virkninger (grad 2- 4), som er rapporteret af investigator som henførende til undersøgelsesmedicinen er inkluderet, såvel som grad 3- 4 behandlings relaterede abnormiteter set ved undersøgelser i laboratoriet.
Events (grade 2-4) reported by study investigators as attributable to study medication and occurring in > 1% of patients, are included as well as grade 3-4 treatment emergent laboratory abnormalities.