Treatment with any investigational agent within 4 weeks prior to cycle 1, day 1, or five drug half-lives (whichever is longer) Treatment with any other investigational agent, device, or procedure within 21 days (or 5 half-lives, whichever is greater) of enrollment. Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days or five half-lives of the investigational agent, whichever is longer, prior to enrollment Exposure to an investigational product within 30 days or five half-lives (whichever is the longer) prior to randomization Participants may not be receiving any other investigational agents; patients previously treated with investigational agents must complete a washout period of at least two weeks or five half-lives, whichever is longer, before starting treatment Patient who has participated in a prior investigational study within 30 days prior to treatment start or within 5 half-lives of the investigational product, whichever is longer Participants may not have received treatment with another investigational drug or device within 28 days prior to day 1, or if the half-life of the previous product is known, within 5 times the half-life prior to dosing, whichever may be longer Investigational therapy (NOTE: or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer). Investigational therapy administered within 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing in this study Participation in a prior investigational study =< 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer Received investigational agents within 14 days or 5 half-lives prior to the first study dosing day, whichever is longer Participation in a prior investigational study within 21 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer Participation in another clinical study with an investigational product during the last 30 days or five half-lives of the drug (whichever is greater) prior to the initiation of study treatment Current enrollment in another clinical study involving treatment and/or is receiving an investigational agent for any reason, or use of any investigational agents within 28 days or 5 half lives (whichever is longer) of initiating study treatment. Participation in a prior investigational study within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer Administration of investigational agents or investigational drugs