Severe infections within weeks prior to cycle , day , including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infections within weeks prior to randomization, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infections within weeks prior to randomization including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infections within weeks prior to cycle , day , including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infections within days prior to randomization, including but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia Patients must not have severe infections within days prior to registration, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia Patients must not have severe infections within days prior to step registration, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia Serious infection requiring antibiotics within weeks prior to randomization, including but not limited to infections requiring hospitalization or IV antibiotics, such as bacteremia, or severe pneumonia Severe infections within weeks prior to cycle , day , including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infections within weeks prior to cycle , day , including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infection within days prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia. Severe infection within weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infections within weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infections within weeks prior to cycle , day , including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infections within weeks prior to Cycle , Day , including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia GENERAL: Severe infections within weeks prior to cycle , day , including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia. Severe infections within weeks prior to Day of Cycle , including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infections within weeks prior to cycle , day , including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infection requiring oral or IV antibiotics within weeks prior to randomisation, including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia. Severe infection within weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infections within weeks prior to start of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia. Severe infections within weeks prior to the first study treatment, including but not limited to hospitalization for complications of infection, bacteremia or severe pneumonia Severe infection within weeks prior to initiation of study treatment, including but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infections within weeks prior to study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infections within weeks prior to cycle , day , including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infections within weeks prior to cycle day , including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia Active tuberculosis or severe infections within weeks prior to cycle , day , including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infections within weeks prior to cycle , day , including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infections =< weeks prior to cycle , day , including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infections within weeks prior to cycle , day , including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infections within weeks of first study treatment including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infections within weeks prior to cycle , day , including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia Patients who have severe infections within weeks before initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia;\r\n* Exception: uncomplicated urinary tract infection will not be considered as a severe infection in these patients Severe infection within weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infections within weeks prior to cycle , day , including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia. Severe infections =< weeks prior to registration, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infections within weeks prior to week , day , including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia\r\n* Any course of oral or IV antibiotics must have been completed at least weeks prior to the first dose of study medications Severe infections within weeks prior to cycle , day , including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infections within weeks prior to cycle , day , including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infections within weeks prior to cycle , day including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia Participants with severe infection within weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infection within weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infections within weeks prior to cycle , day , including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infections within weeks prior to cycle , day , including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infections within weeks prior to cycle , day including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infections within weeks prior to cycle , day , including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infections within weeks prior to cycle , day , including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infections within weeks prior to cycle , day , including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infections within weeks prior to cycle , day , including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infection requiring systemic treatment within weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia Severe infections within days prior to Day , including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia or active tuberculosis