Any of the following laboratory abnormalities:Xx_NEWLINE_xXAny medical condition or laboratory abnormalities, which – in the opinion of the investigator – places the subject at unacceptable risk, or confounds the ability to interpret data if he/she were to participate in the studyXx_NEWLINE_xXAny condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXSubject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.Xx_NEWLINE_xXSubject has any condition that confounds the ability to interpret data from the study.Xx_NEWLINE_xXAny condition, including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXAny condition, including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXAny of the following laboratory abnormalities:Xx_NEWLINE_xXAny condition including the presence of laboratory abnormalities, which places the patient at unacceptable risk if he/she were to participate in the studyXx_NEWLINE_xXAny condition that confounds the ability to interpret data from the studyXx_NEWLINE_xXAny condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at an unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXAny condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXAny condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.Xx_NEWLINE_xXAny condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or, which confounds the ability to interpret data from the studyXx_NEWLINE_xXAny significant medical condition, laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study at clinician’s discretion and not otherwise stated belowXx_NEWLINE_xXAny condition which, in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study.Xx_NEWLINE_xXAny condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXSubject has any condition including the presence of laboratory abnormalities which, in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study.Xx_NEWLINE_xXSubject has any condition that confounds the ability to interpret data from the study.Xx_NEWLINE_xXAny significant medical condition, laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the studyXx_NEWLINE_xXAny condition, including the presence of clinically significant laboratory abnormalities, which places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study; these would include:\r\n* Active infection (including persistent fever) including known history of human immunodeficiency virus (HIV) or hepatitis C infection\r\n* Diseases or conditions that obscure toxicity or dangerously alter drug metabolism\r\n* Serious concurrent medical illness (e.g. symptomatic congestive heart failure)Xx_NEWLINE_xXAny condition, including laboratory abnormalities, which in the opinion of the principal investigator or lead associate investigator, would prohibit administration of planned chemotherapeutic intervention, places the subject at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXAny condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXEither a concurrent condition (including medical illness, such as active infection requiring treatment with intravenous antibiotics or the presence of laboratory abnormalities) or history of a prior condition that places the patient at unacceptable risk if he/she were treated with the study drug or a medical condition that confounds the ability to interpret data from the studyXx_NEWLINE_xXAny condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXAny condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study, as determined by the principal investigatorXx_NEWLINE_xXAny condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that places the subject unacceptable risk if he/she were to participate to the studyXx_NEWLINE_xXEither a concurrent condition (including medical illness, such as active infection requiring treatment with intravenous antibiotics or the presence of laboratory abnormalities) or history of a prior condition that places the patient at unacceptable risk if he/she were treated with the study drug or a medical condition that confounds the ability to interpret data from the studyXx_NEWLINE_xXAny condition which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXAny condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXSerious medical condition or psychiatric illness that would prevent, (as judged by the treating physician) the subject from signing the informed consent form or any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXHistory of venous or arterial thromboembolism, unless:\r\n* Line-related thrombosis without embolus occurring >= 1 year prior to screening\r\n* Complications resulting from atherosclerotic coronary artery disease, peripheral vascular disease, or cerebrovascular disease (including infarction) are not considered exclusion criteria unless in the opinion of the principal investigator or lead associate investigator their clinical consequences in a particular subject places the subject at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXAny condition, including the presence of laboratory abnormalities, which in the opinion of the principal investigator or lead associate investigator places the subject at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXAny condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXAny condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXAny condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.Xx_NEWLINE_xXSubject has any concurrent disease, infection or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.Xx_NEWLINE_xXLaboratory data:Xx_NEWLINE_xXAny condition which in the opinion of the investigator, places the subject at unacceptable risk if he/she were to participate in the study.Xx_NEWLINE_xXAny condition, including presence of laboratory abnormalities, which places subject at unacceptable risk if s/he were to participate in study or confounds ability to interpret data from study according to investigator assessment.Xx_NEWLINE_xXAny significant medical condition, laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the studyXx_NEWLINE_xXAny condition that confounds the ability to interpret data from the studyXx_NEWLINE_xXAny condition, including the presence of clinically significant laboratory abnormalities, which places subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study, including:Xx_NEWLINE_xXSubject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.Xx_NEWLINE_xXSubject has any condition that confounds the ability to interpret data from the study.Xx_NEWLINE_xXSubject has any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.Xx_NEWLINE_xXSubject has any condition that confounds the ability to interpret data from the study.Xx_NEWLINE_xXEither a concurrent condition or history of a prior condition that places the patient at unacceptable risk if he/she were treated with the study drug or confounds the ability to interpret data from the studyXx_NEWLINE_xXAny of the following laboratory abnormalities:Xx_NEWLINE_xXAny condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the studyXx_NEWLINE_xXAny condition that confounds the ability to interpret data from the studyXx_NEWLINE_xXAny condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.Xx_NEWLINE_xXAny of the following laboratory abnormalities:Xx_NEWLINE_xXAny condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.Xx_NEWLINE_xXAny condition that confounds the ability to interpret data from the study.Xx_NEWLINE_xXAny condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the studyXx_NEWLINE_xXAny condition that confounds the ability to interpret data from the studyXx_NEWLINE_xXAny condition that confounds the ability to interpret data from the studyXx_NEWLINE_xXAny serious, unstable medical or psychiatric condition that would prevent, (as judged by the Investigator) the subject from signing the informed consent form or any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study;Xx_NEWLINE_xXAny condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.Xx_NEWLINE_xXAny condition that confounds the ability to interpret data from the study.Xx_NEWLINE_xXAny condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXAny significant medical condition, laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the studyXx_NEWLINE_xXAny condition that confounds the ability to interpret data from the studyXx_NEWLINE_xXAny condition that places the subject at unacceptable risk if he/she were to participate in the study or that confounds the ability to interpret data from the study.Xx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form, which places the subject at unacceptable risk if he/she were to participate in the study or which confounds the ability to interpret data from the studyXx_NEWLINE_xXAny condition, including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXParticipant has any condition that confounds the ability to interpret data from the study.Xx_NEWLINE_xXAny condition, including laboratory abnormalities, that in the opinion of the Investigator places the patient at unacceptable risk if he/she were to participate in the study. This includes, but is not limited to, serious medical conditions or psychiatric illness likely to interfere with participation in this clinical study.Xx_NEWLINE_xXAny serious co-morbid condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the studyXx_NEWLINE_xXAny condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the studyXx_NEWLINE_xXAny significant medical condition, laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the studyXx_NEWLINE_xXAny condition that confounds the ability to interpret data from the studyXx_NEWLINE_xXAny of the following laboratory abnormalities:Xx_NEWLINE_xXAny condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the studyXx_NEWLINE_xXThe patient has any condition, including the presence of laboratory abnormalities, that places the patient at unacceptable risk if he/she were to participate in the study.Xx_NEWLINE_xXThe patient has any condition that confounds the ability to interpret data from the study.Xx_NEWLINE_xXAny condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXAny serious medical condition which places the subject at an unacceptable risk if he or she were to participate in the study or confounds the ability to interpret data from the study, including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirementsXx_NEWLINE_xXAny condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXAny condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXAny condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXAny of the following laboratory abnormalities:Xx_NEWLINE_xXAny condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.Xx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that places the subject at unacceptable risk if he/she were to participate in the study.Xx_NEWLINE_xXAny condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.Xx_NEWLINE_xXPatient has any condition, including the presence of laboratory abnormalities, which places him/her at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXAny condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXAny condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXAny condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXAny condition, including the presence of laboratory abnormalities, which in the opinion of the principal investigator or lead associate investigator places the subject at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXAny of the following laboratory abnormalities:Xx_NEWLINE_xXAny condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study should be first discussed and clarified with the study investigatorsXx_NEWLINE_xXSubject is a female who is pregnant or is breast feeding 24. Subject is unwilling or unable to comply with the protocol, in the opinion of the investigator 25. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study 26. Subject has any condition that confounds the ability to interpret data from the studyXx_NEWLINE_xXAny condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.Xx_NEWLINE_xXAny condition that confounds the ability to interpret data from the study.Xx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that places the subject at unacceptable risk if he/she were to participate in the studyXx_NEWLINE_xXAny condition, including the presence of clinically significant laboratory abnormalities, which places subject at unacceptable risk if he/she were to participate in study or confounds the ability to interpret data from study, including:Xx_NEWLINE_xXAny condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.Xx_NEWLINE_xXAny condition that confounds the ability to interpret data from the study.Xx_NEWLINE_xXAny medical condition, including the presence of laboratory abnormalities, which confound the ability to interpret data from the study or places the patient at unacceptable risk if he participates in the studyXx_NEWLINE_xXAny condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXAny of the following laboratory abnormalities:Xx_NEWLINE_xXAny significant medical condition, laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the studyXx_NEWLINE_xXAny condition that confounds the ability to interpret data from the studyXx_NEWLINE_xXAny condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.Xx_NEWLINE_xXAny medical condition that confounds the ability to interpret data from the study. This includes subjects with known psychiatric disorders.Xx_NEWLINE_xXAny condition that places the patient at unacceptable risk if he/she were to participate in the study or that confounds the ability to interpret data from the study.Xx_NEWLINE_xXAny condition, including the presence of laboratory abnormalities, which in the opinion of the treating physician places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXAny condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXAny of the following laboratory abnormalities:Xx_NEWLINE_xXAny condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the studyXx_NEWLINE_xXAny condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXAny condition which places the patient at unacceptable risk or confounds the ability of the investigators to interpret study dataXx_NEWLINE_xXAny of the following laboratory abnormalities:Xx_NEWLINE_xXAny condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the studyXx_NEWLINE_xXSubject has any concurrent disease, infection, or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.Xx_NEWLINE_xXAny serious medical condition within the previous 4 weeks which places the subject at an unacceptable risk if he or she were to participate in the study or confounds the ability to interpret data from the study, including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmias, acute kidney injury, or psychiatric illness/social situations that would limit compliance with study requirementsXx_NEWLINE_xXAny serious medical condition, laboratory abnormality or psychiatric illness that places the subject at unacceptable risk if he/she were to participate in the studyXx_NEWLINE_xXAny condition including the presence of laboratory abnormality that, as determined by the treating Investigator, places the subject at unacceptable risk if he/she were to participate in the studyXx_NEWLINE_xXAny condition that, as determined by the treating Investigator, confounds the interpretation of data from the studyXx_NEWLINE_xXAny of the following laboratory abnormalities:Xx_NEWLINE_xXAny condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the studyXx_NEWLINE_xXAny condition that confounds the ability to interpret data from the study, including known or suspected conditions other than MDS (MYELODYSPLASTIC SYNDROMES), associated with anemiaXx_NEWLINE_xXSubject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study based on investigator´s judgment.Xx_NEWLINE_xXSubject has any condition that confounds the ability to interpret data from the study based on investigator´s judgment.Xx_NEWLINE_xXhas following laboratory abnormalitiesXx_NEWLINE_xXLABORATORY ABNORMALITIESXx_NEWLINE_xXAny comorbid condition that confounds the ability to interpret data from the study as judged by the Investigator or Medial MonitorXx_NEWLINE_xX