Treatment with oral or intravenous (IV) antibiotics within weeks prior to Day of Cycle Treatment with therapeutic oral or IV antibiotics within weeks prior to initiation of study treatment Treatment with therapeutic oral or IV antibiotics within weeks prior to initiation of study treatment, except prophylactic antibiotics Treatment with therapeutic oral or IV antibiotics within weeks prior to initiation of study treatment Oral or IV antibiotics within weeks or half-lives prior to enrollment Received therapeutic oral or IV antibiotics within weeks prior to Day ; Treatment with oral or IV antibiotics within weeks prior to Day of Cycle Severe infection that in the opinion of the investigator would interfere with the patients safety or compliance on trial within weeks prior to enrollment. Oral or IV antibiotics within weeks or half-lives prior to enrollment Received oral or IV antibiotics for an infection within weeks prior to the first study treatment. Subjects receiving prophylactic antibiotics are eligible Oral or IV antibiotics within weeks prior to enrollment Signs and symptoms of infection within weeks of first study treatment; receipt of therapeutic oral or IV antibiotics within weeks of first study treatment; subjects receiving routine antibiotic prophylaxis (for dental extractions/procedures) are eligible Oral or IV antibiotics within weeks prior to enrollment Oral or IV antibiotics within weeks prior to Day of Cycle Treatment with antibiotics within weeks ( days) of dosing Receipt of therapeutic oral or IV antibiotics within weeks prior to the start of the study treatment Received therapeutic oral or IV antibiotics within weeks prior to first dosing. Severe infection or major surgery within weeks, or oral or IV antibiotics treatment within weeks prior to enrollment Received therapeutic oral or IV antibiotics within weeks prior to Cycle Day Treatment with therapeutic oral or IV antibiotics within weeks prior to the first dose of study treatment Treatment with antibiotics within weeks ( days) of dosing. The patient has received intravenous administration of antibiotics within weeks prior to first study treatment or oral antibiotics within week prior to first study treatment. Received therapeutic oral or IV antibiotics within weeks prior to Cycle , Day (except for tumor fever) Received oral or IV antibiotics within weeks prior to Cycle Day Chronic use of systemic antibiotics; topical lotions which include antibiotics are permitted; occasional use of antibiotics is allowed, but must be stopped for weeks prior to RPFNA and for weeks prior to collecting blood or urine specimens for the pre-study (i.e., prior to dispensing/starting study agent) assessment of lignan levels Receipt of therapeutic oral or IV antibiotics within weeks of first study treatment; subjects receiving routine antibiotic prophylaxis (for dental extractions/procedures) are eligible Use of antibiotics one () month prior to or during this study Received oral or IV antibiotics within days prior to Day Severe infections within weeks before randomization or therapeutic oral or IV antibiotics within weeks before randomization