Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject’s safety, obtaining informed consent or compliance to the study procedures
Patients with psychosocial conditions that would prevent study compliance
Any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol.
Subjects who have any other disease, either metabolic or psychological, which as per Investigator assessment may affect the subject's compliance or place the subject at higher risk of potential treatment complications
Any serious and/or unstable pre-existing medical, psychiatric, or other existing condition that would prevent compliance with the trial or consent process
No ongoing major illness or psychosocial issues that would limit compliance with the protocol
Patients with psychological, familial, social, or geographic factors that otherwise preclude them from giving informed consent, following the protocol, or potentially hamper compliance with study treatment and follow-up
Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study procedures
Any serious concurrent condition that could, in the investigator’s opinion, significantly interfere with completion of study procedures or protocol compliance
Any psychological, familial, sociological, or geographic condition that may hamper compliance with the protocol and follow-up after treatment discontinuation
Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
Evidence of any serious and/or unstable pre-existing medical condition that would interfere with patient safety ability to provide informed consent
Any other condition that may interfere with compliance of the study protocol
Conditions that could interfere with treatment or protocol-related procedures
Active psychosocial condition that would hinder study compliance and follow-up
Presence of any other medical, psychological, familial, sociological, or geographic condition potentially hampering compliance with the study protocol Subjects who are participating in any other therapeutic clinical study (observational or registry trials are allowed).
Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
Any serious, unstable medical or psychiatric condition that would prevent, (as judged by the investigator) the subject properly providing informed consent or any condition which would jeopardize compliance with the protocol
Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
Any serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), psychiatric disorders, or other conditions that could interfere with the subject’s safety, obtaining informed consent, or compliance with study procedures
Demonstrated lack of compliance with prior medical care
Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
Patients with any condition that in the judgment of the investigator would jeopardize safety or patient compliance with the protocol
Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study
Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule
Medical or psychiatric conditions that preclude informed decision-making or compliance with the protocol treatment or follow-up
Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study
Any other condition that would, in the investigator’s judgment, contraindicate patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, etc.
Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
Any other condition that would, in the investigator’s judgment, preclude patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g. infection/inflammation, intestinal obstruction, social/psychological complications
Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
Active psychiatric disorder which may compromise compliance with the transplant protocol, or which does not allow for appropriate informed consent
DONOR: History of a psychiatric disorder which in the opinion of the PI may compromise compliance with the transplant protocol, or which does not allow for appropriate informed consent
Any serious and/or unstable pre-existing medical, psychiatric, or other condition (e.g., severe hepatic impairment) or current unstable or uncompensated respiratory or cardiac conditions which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol.
Serious pre-existing medical conditions as follows:
Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the investigator
Any other condition that would, in the investigator's judgment, contraindicate participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/psychological issues, etc.
Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal, cardiac disease, or clinically significant bleeding episodes). Any serious and/or unstable pre-existing medical (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator.
Patient has significant and/or uncontrolled cardiac, renal, hepatic or other systemic disorders or significant psychological conditions at baseline visit that in the investigator’s judgment would jeopardize subject enrollment or compliance with the study procedures
Unwillingness to follow study protocol and compliance procedures
Known psychiatric condition, social circumstance, or other medical condition reasonably judged by the patient’s study physician to unacceptably increase the risk of study participation; or to prohibit the understanding or rendering of informed consent or anticipated compliance with scheduled visits, treatment schedule, laboratory tests and other study requirements.
Psychological, familial, sociological, or geographical conditions that potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the investigator; or unwillingness or inability to follow the procedures required in the protocol
Psychological, familial, or sociological condition potentially hampering compliance with the study protocol and follow-up schedule
Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, including but not limited to, infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, etc
Any condition that would jeopardize the safety of the subject or compliance with the protocol
Uncontrolled medical, psychological, familial, sociological, or geographical conditions that interfere with the patient’s safety, ability to provide informed consent, or ability to comply with the protocol
Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule.
Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
Psychological, familial, sociological, or geographical factors potentially hampering compliance with the study protocol and follow-up schedule
Patients with known psychological or sociological conditions, addictive disorders or family problems, which would preclude compliance with the protocol
Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the investigator; or unwillingness or inability to follow the procedures required in the protocol
Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study
Demonstrated lack of compliance with prior medical care
Presence of any other medical, psychological, familial, sociological, or geographic condition potentially hampering compliance with the study protocol or would interfere with the study endpoints or the subject's ability to participate in the study in the judgement of the investigator
Known psychiatric condition, social circumstance, or other medical condition reasonably judged by the patient’s study physician to unacceptably increase the risk of study participation; or to prohibit the understanding or rendering of informed consent or anticipated compliance with scheduled visits, treatment schedule, laboratory tests and other study requirements
Patients with any condition that in the judgment of the investigator would jeopardize safety or patient compliance with the protocol
Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject’s safety, obtaining informed consent or compliance to the study procedures
Any condition (e.g., known or suspected poor compliance, psychological instability, geographical location, etc) that, in the judgment of the investigator, may affect the patient’s ability to sign the informed consent and comply with study procedures
Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule
CRITERIA FOR SCREENING: Medical, psychological, familial, sociological, or geographical condition that does not permit compliance with the protocol as judged by the PI or designee, or unwillingness or inability to follow protocol procedures
Any serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), psychiatric disorders, or other conditions that could interfere with the subject’s safety, obtaining informed consent, or compliance with study procedures
Psychological, familial, sociological, or geographical conditions that potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the subject before registration in the trial
Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study
Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule
Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study
Any other condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/psychological issues, etc
Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study
Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule
Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject’s safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator
Evidence of severe or uncontrolled systemic diseases (e.g., severe/chronic infection, unstable or uncompensated respiratory, renal, or cardiac disease). Any serious and/or unstable pre-existing medical (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator
Any psychiatric, social or compliance issues that, in the treating physician opinion, will interfere with completion of the transplant treatment and follow up
Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule
Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study
Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule
Any other co-existing medical or psychological condition(s) that will preclude participation in the study or compromise ability to give informed consent and/or comply with study procedures.
Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal, cardiac disease, or clinically significant bleeding episodes). Any serious and/or unstable pre-existing medical (aside from malignancy), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator.
Psychiatric disorder which, per treating physician discretion, may preclude compliance
Has a medical or psychosocial conditions that would prevent study compliance
Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule
Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study
Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule
Patients with psychological or geographic conditions that prevent adequate follow-up or compliance with the study protocol.
Patients with a medical or psychological impediment to probable compliance with the protocol should be excluded
Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study
Any other condition that would, in the investigator’s judgment, contraindicate the patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication; (patients may not receive drug through a feeding tube), social/psychological issues, etc
Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
CAPMATINIB EXCLUSION CRITERIA: Any other condition that would, in the Investigator’s judgment, contraindicate patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/psychological issues, etc
Any other disease, either metabolic or psychological, that as per Investigator assessment may affect the patient's compliance or place the patient at an increased risk of potential treatment complications.
Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the principal investigator
Any other condition that would, in the investigator’s judgment, contraindicate the patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures
Any other condition that would, in the investigator’s judgment, contraindicate the patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, etc
Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse;
Patients with a mental disorder, psychiatric illness/social or concussion which would inhibit their ability to provide informed consent or prevent compliance with follow-up
Any serious/and or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject’s safety, obtaining informed consent or compliance to the study procedures
Any serious or unstable pre-existing medical conditions, psychiatric disorders or other conditions which could interfere with the subject’s safety, obtaining informed consent, or compliance with study procedures
Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Patients with any serious/poorly controlled medical or psychological conditions that would be exacerbated by treatment, would complicate protocol compliance
Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception), psychiatric disorder, or other conditions that could interfere with subject’s safety, obtaining informed consent or compliance to the study procedures
Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study
Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule
Any condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with any aspect of the study (e.g., untreated schizophrenia or other significant cognitive impairment, etc).
Patients with a medical or psychological impediment to probable compliance with the protocol should be excluded
RECIPIENT: History of psychiatric disorder which may compromise compliance with transplant protocol, or which does not allow for appropriate informed consent
MATCHED RELATED DONOR: History of psychiatric disorder which in the opinion of the PI may compromise compliance with transplant protocol, or does not allow for appropriate informed consent
HAPLOIDENTICAL RELATED DONOR: History of psychiatric disorder which in the opinion of the PI may compromise compliance with transplant protocol, or which does not allow for appropriate informed consent
Significant psychiatric disorder and any other reason in the Investigator’s opinion that would jeopardize protocol compliance or compromise the patient’s ability to give informed consent
Patient has demonstrated compliance, as assessed by the investigator, with the parent study requirements
Patient has been permanently discontinued from pasireotide study treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason
Subjects for whom there is concern about compliance with the protocol procedures
Significant psychiatric disorder and any other reason in the Investigator’s opinion that would jeopardize protocol compliance or compromise the patient’s ability to give informed consent
Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject‘s safety, provision of informed consent, or compliance to study procedures
Psychiatric illness which may make compliance to the clinical protocol unmanageable or which may compromise the ability of the patient to give informed consent
Have any condition that does not permit compliance with the study schedule including psychological, geographical, or medical
Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the investigator
Physical or emotional status that would prevent informed consent, protocol compliance, or adequate follow-up
History of psychiatric disorder which may compromise compliance with transplant protocol, or which does not allow for appropriate informed consent
HAPLOIDENTICAL DONOR: History of psychiatric disorder which in the opinion of the PI may compromise compliance with transplant protocol, or which does not allow for appropriate informed consent
Active psychiatric disorder which may compromise compliance with the treatment protocol, or which does not allow for appropriate informed consent (as determined by principal investigator and/or his designee)
DONOR: History of psychiatric disorder which may compromise compliance with this protocol or which does not allow for appropriate informed consent
Any serious and/or unstable pre-existing medical, psychiatric disorder, or other condition that could interfere with the subject's safety, obtaining informed consent, or compliance to the study procedures.
Any condition that would jeopardize the safety of the subject or compliance with the protocol
Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
Psychological or social reasons that would hinder or prevent compliance with the requirements of the protocol or compromise the informed consent process.
Psychological or social reasons that would hinder or prevent compliance with the requirements of the protocol or compromise the informed consent process.
Any other clinical condition that, in the Investigator's judgement, would potentially compromise study compliance or the ability to evaluate safety/efficacy
Psychological, familial, sociological or geographical conditions that do not permit compliance with the study protocol.
No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
Any condition that prevents compliance with the protocol or adherence to therapy.
Patients with psychological or geographic conditions that prevent adequate follow- up or compliance with the study protocol.
Patient has been permanently discontinued from imatinib treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason.
Patients with serious concurrent illness or psychological, familial, sociological, geographical, or other concomitant conditions that, in the opinion of the investigator, would not permit adequate follow-up and compliance with the study protocol.
Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could render compliance or follow-up in the protocol problematic
Any condition which could jeopardise the safety of the patient and his/her compliance in the study Excluded therapies and medications, previous and concomitant:
Has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.
Psychological, familial, sociological or geographical or other condition which in the opinion of the investigator would not permit study follow-up or other compliance with the study protocol.
Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures.
Any other condition that would, in the investigator’s judgment, contraindicate the patient’s participation in the clinical study due to safety concerns with clinical study procedures
Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study
Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule
Failure to demonstrate adequate compliance with medical therapy and follow-up
Any other condition that would, in the investigator’s judgment, contraindicate the patient’s participation in the clinical study due to concerns regarding safety or compliance with clinical study procedures
Presence of any psychological, familial, sociological or geographical condition that in the opinion of the investigator would hamper compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse
Psychological, familial, sociological, or geographical conditions that do not permit compliance with protocol.
Any other condition that would, in the investigator’s judgment, contraindicate the patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/psychological issues, etc.
Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient’s safety or study endpoints
Patient has any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with patient’s safety, provision of informed consent, or compliance with the study procedures.
Patient has any other condition that would, in the investigators’ judgment, preclude the patient’s participation in the clinical study due to concerns about safety or compliance with clinical study procedures; e.g., infection/inflammation, intestinal obstruction, inability to swallow oral medication, social/psychological complications.
Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject’s safety, obtaining informed consent, or compliance to the study procedures
Patient with any other condition that would, in the Investigator’s judgment, preclude patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g. infection/inflammation, intestinal obstruction, unable to swallow oral medication, social/psychological complications
Subjects with concurrent conditions that would jeopardize the safety of the subject or compliance with the protocol.
Any other condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medications, social/psychological issues, etc.)
Patients with psychological, familial, social, or geographic factors that otherwise preclude them from giving informed consent, following the protocol, or potentially hamper compliance with study treatment and follow-up
Patients must not have any serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), including but not limited to, ongoing or active infection requiring parenteral antibiotics on day 1, history of bleeding diathesis or need for concurrent anticoagulation (international normalized ratio [INR] =< 1.5 and partial thromboplastin time [PTT] within 1.1 x ULN), or psychiatric illness/social situations that would limit compliance with study requirements, interfere with subject’s safety, or obtaining informed consent
Any other condition that would, in the investigator’s judgment, contraindicate the patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/psychological issues, etc.
Psychological, familial, or sociological condition potentially hampering compliance with the study protocol and follow-up schedule
Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule (such conditions should be discussed with the subject before study entry)
Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject’s safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator
Any serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), psychiatric disorders, or other conditions that could interfere with the subject’s safety, obtaining informed consent, or compliance with study procedures
Demonstrated lack of compliance with prior medical care
Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, uncontrolled intercurrent illness etc.
No diagnosed psychosocial conditions that would hinder study compliance and follow-up
Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study procedures
Subjects with any clinical condition that is considered unstable or might jeopardize the safety of the subject and/or influence the subject’s compliance in the study
Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, study participation, follow up, or interpretation of study research
No psychosocial conditions that would hinder study compliance and follow-up
Any other condition that would, in the Investigator’s judgment, preclude patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g. infection/inflammation, intestinal obstruction, unable to swallow oral medication, social/psychological complications
Non compliance to medications or medical instructions
Any psychiatric, social or compliance issues that, in the treating physician's opinion, will interfere with completion of the transplant treatment and follow up
Patients with a history of a psychiatric disorder that may interfere with the understanding and compliance with this protocol and the required follow up
Any condition that compromises compliance with the objectives and procedures of this protocol
Must not have concomitant medical, psychological or social circumstances which would interfere with compliance with the protocol treatment and follow-up
Any coexisting medical condition precluding full compliance with the study
Psychological, familiar, sociological or geographical conditions which would not permit compliance with the study protocol
History of psychiatric disorder which may compromise compliance with transplant protocol, or which does not allow for appropriate informed consent
Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study procedures; patients with low risk prostate and bladder cancer will be excluded (use American Urological Association [AUA] guidelines for bladder patients)
Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject’s safety, obtaining informed consent or compliance to the study procedures
Patients with concurrent medical, psychological or social conditions of such severity that the investigator deems it unwise to enter the patient on protocol
No coexisting medical problems of sufficient severity to limit compliance with the study
Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures
Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal, cardiac disease, or clinically significant bleeding episodes). Any serious and/or unstable pre-existing medical (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator.
Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocol
Medical conditions that would prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures such as the presence of other clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological disease.
Any other condition that would, in the investigator’s judgment, contraindicate participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, etc.
Presence of other active invasive cancers. 13. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
Patients must not have known psychological or sociological conditions, addictive disorders or family problems, which would preclude compliance with the protocol
Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule
Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Evidence of severe or uncontrolled systemic diseases. Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator
Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the participant before trial entry
Have any clinical condition that is considered unstable or might jeopardize the safety of the subject and/or influence the subject's compliance in the study.
Conditions that could interfere with treatment or protocol-related procedures
Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, study participation, follow up, or interpretation of study research
Patients exhibiting any other condition that would, in the investigator’s judgment, preclude patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures are not eligible for participation; this might include, but is not limited to, infection/inflammation, intestinal obstruction, and/or social/psychological complications
Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocol
Any condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with any aspect of the study (e.g., untreated schizophrenia or other significant cognitive impairment, etc.)
No coexisting medical problems of sufficient severity to limit compliance with the study
Willing to undergo endoscopic evaluation with biopsies in compliance with this protocol
Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule
Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient’s safety or study endpoints
Medical or psychiatric conditions that compromise the subject's ability to give informed consent or to complete the protocol or a history of non-compliance
Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal, cardiac disease, or clinically significant bleeding episodes). Any serious and/or unstable pre-existing medical (aside from malignancy), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator.
No psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule
Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocol
Major psychiatric disorders which would limit compliance
Any condition that would preclude informed consent, consistent follow-up and compliance for the study participation
Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse;
The participant has any condition (for example, psychological, geographical, or medical) that does not permit compliance with the study and follow-up procedures or suggests that the participant is, in the investigator's opinion, not an appropriate candidate for the study.
Mental impairment that may compromise compliance with the requirements of the study.
Has any other psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. Those conditions should be discussed with the subject before registration in the trial.
Any other condition that would, in the investigator’s judgment, preclude patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g. infection/inflammation, intestinal obstruction, social/psychological complications
Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions including concurrent disease that could interfere with subject's safety, obtaining informed consent, or compliance with the study procedures.
Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Any other condition that would, in the investigator’s judgment, contraindicate the patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures
Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
Expected non-compliance.
Psychological, social, familial, or geographical reasons that would hinder or prevent compliance with the requirements of the protocol or compromise the informed consent process.
Patients exhibiting any other condition that would, in the investigator’s judgment, preclude patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures are not eligible for participation; this might include, but is not limited to, infection/inflammation, intestinal obstruction, and/or social/psychological complications
Any condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with any aspect of the study (e.g., untreated schizophrenia or other significant cognitive impairment, etc).
Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures
Medical, social, or psychosocial factors that, in the opinion of the Investigator, could impact safety or compliance with study procedures.
Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject’s safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator
Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with patient’s safety, provision of informed consent, or compliance to study procedures
Presence of any serious and/or unstable pre-existing medical disorder, psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures
Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the Investigator; or subject unwillingness or inability to follow the procedures required in the protocol
Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study procedures
Expected non-compliance.
Psychiatric illness that may make compliance to the clinical protocol unmanageable or may compromise the ability of the patient to give informed consent
Any condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with any aspect of the study (e.g., untreated schizophrenia or other significant cognitive impairment, etc.).
Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study procedures
History of psychiatric disorder which may compromise compliance with the protocol or which does not allow for appropriate informed consent
Social or psychological conditions that the investigator judges may compromise study compliance
Medical and/or psychiatric problems of sufficient severity to limit full compliance with the study or expose patients to undue risk
Any condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with any aspect of the study (e.g., untreated schizophrenia or other significant cognitive impairment, etc).
Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator
Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study procedures
Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
Medical and/or psychiatric problems of sufficient severity to limit full compliance with the study or expose patients to undue risk
Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study procedures
Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions at the time of transition to this study that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator or GSK Medical Monitor.
Medical or psychological impediment to probable compliance with the protocol
Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study procedures
Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study procedures
Patients with psychosocial conditions that would prevent study compliance and follow-up, as determined by the principal investigator.
Any serious and/or unstable pre-existing medical, psychiatric, or other condition (including laboratory abnormalities) that could interfere with patient safety or obtaining consent
Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions at the time of transition to this study that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator or GSK Medical Monitor.
Any serious and/or unstable pre-existing medical (especially hepatic disease), psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study procedures
Patients must not have known psychological or sociological conditions, addictive disorders or family problems, which would preclude compliance with the protocol
History of psychiatric disorder which may compromise compliance with transplant protocol, or which does not allow for appropriate informed consent
Have active infection that would interfere with the study objectives or influence study compliance
Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions at the time of transition to this study that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator or GSK Medical Monitor
EXPANSION COHORT ONLY: Any serious and/or unstable pre-existing medical, psychiatric, or other condition (including lab abnormalities) that could interfere with subject safety, obtaining informed consent or compliance to study procedures
Any condition that is unstable or which could jeopardize the safety of the subject and his/her compliance in the study
Patients must not suffer from medical or psychiatric conditions that would interfere with protocol compliance, the ability to provide informed consent, or assessment of response or anticipated toxicities
History of psychiatric disorder which may compromise compliance
No psychological, familial, sociological, or geographical condition that would potentially hamper compliance with the study protocol and follow-up schedule
History of psychiatric disorder which may compromise compliance with transplant protocol, or which does not allow for appropriate informed consent (as determined by principal investigator or lead associate investigator)
Any condition that is unstable or could jeopardize the safety or compliance of the patient in the study
Any serious/and or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject’s safety, obtaining informed consent or compliance to the study procedures
Have, in the judgment of the Investigator, a clinically significant concurrent illness or psychological, familial, sociological, geographical, or other concomitant condition that would not permit adequate follow-up and compliance with the study protocol
Demonstrated lack of compliance with prior medical care
Any co-morbid condition or social situation, which has a high likelihood of causing poor compliance with the study protocol or jeopardizes the patient's safety.
Evidence of severe or uncontrolled systemic diseases. Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator
Has an intercurrent (non-malignant) chronic medical or psychiatric illness or condition(s) not optimally controlled and carrying a moderate to high risk of interfering with protocol therapy administration or compliance with required procedures, in the judgment of the investigator
Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/psychological issues, etc
Have serious pre-existing medical conditions.
Any condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with any aspect of the study (e.g., untreated schizophrenia or other significant cognitive impairment, etc.).
Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule
Any condition that is unstable or could jeopardize the safety of the patient and his/her compliance in the study
Any life-threatening condition that could affect protocol compliance.
History of psychiatric disorder which may compromise compliance with the protocol or which does not allow for appropriate informed consent
Any preexisting medical condition of sufficient severity to prevent full compliance with the study.
Any preexisting medical condition of sufficient severity to prevent full compliance with the study.
Psychological, familial, sociological, or geographical factors that would preclude study participation
Any condition that was unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
Any serious and/or unstable pre-existing medical condition (including any advanced malignancy other than the disease under study), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance with the study procedures
Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
Psychological, familial, sociological or geographical conditions that do not permit compliance with the protocol.
Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study procedures
Any severe, acute or chronic medical or psychiatric condition, or lab abnormality that may increase the risk associated with trial participation, study drug administration or interfere with informed consent process or compliance with requirements of the trial.
Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study
Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule
MSC DONOR: evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study
MSC DONOR: any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule
Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to procedures
Any other condition that is unstable or which could jeopardize the safety of the patient and his/her protocol compliance
Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent/assent, or compliance to study procedures.
Any significant or severe medical conditions or psychiatric or social conditions that would preclude adherence to the protocol or compliance with study treatments
Any psychological, familial, sociological, or geographical condition that could hamper compliance with the study protocol.
Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule
History of psychiatric disorder which may compromise compliance with the protocol or which does not allow for appropriate informed consent
Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Any conditions associated with non-compliance.
Psychological, familial, sociological, or geographical conditions that potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule
Absence of any serious cognitive or psychiatric problems potentially hampering compliance with the study and follow-up schedule
Any condition (e.g., known or suspected poor compliance, psychological instability, geographical location, etc) that, in the judgment of the investigator, may affect the patient's ability to sign the informed consent and undergo study procedures.
Has medical, social, or psychological factors that, in the opinion of the Investigator, could impact safety or compliance with study procedures
Any co-morbid condition of sufficient severity to limit full compliance with the protocol per assessment by the individual treating physician
Any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol.
Any condition that is unstable or that could jeopardize the safety of the subject and the subject's protocol compliance, including known infection with human immunodeficiency virus
Serious concomitant disease or medical condition affecting compliance with trial requirements or which are considered relevant for the evaluation of the efficacy or safety of the trial drug,
patient had demonstated compliance
Expected non-compliance.
Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures.
Any serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), psychiatric disorders, or other conditions that could interfere with the subject's safety, obtaining informed consent, or compliance with study procedures.
Any other condition that would, in the investigator’s judgment, contraindicate the patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, etc.
Has medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures
Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures
Concurrent medical condition that would jeopardize compliance.
Expected non-compliance.
Psychological, social, familial, or geographical reasons that would hinder or prevent compliance with the requirements of the protocol or compromise the informed consent process.
Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures.
Psychiatric disorder that may interfere with consent and/or protocol compliance.
Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures
Expected non-compliance.
Any condition (psychological, geographical) that does not permit compliance with study and follow-up procedures
Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures.
Any condition that is unstable or could jeopardize the safety of the subject and his / her compliance to the study.
Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures.
Absence of any psychological, familial, sociological or geographic condition that would potentially hamper compliance with the study protocol
Uncontrolled medical conditions (e.g., diabetes mellitus, hypertension, liver disease or uncontrolled infection), psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol; or unwillingness or inability to follow the procedures required in the protocol.
Subjects with a medical or psychological impediment to probable compliance with the protocol
Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
Subjects with other major medical or psychiatric illnesses, which the treating physician feels, could seriously compromise compliance with this protocol
Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study
Psychological, familial, sociological or geographical conditions that do not permit compliance with the protocol.
History of psychiatric disorder which may compromise compliance with transplant protocol, or which does not allow for appropriate informed consent (as determined by principal investigator or study chairman)
DONOR: History of psychiatric disorder which may compromise compliance with transplant protocol, or which does not allow for appropriate informed consent
Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study procedures
Any other condition that would, in the Investigator’s judgment, contraindicate the patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/psychological issues, etc.
Any serious or unstable pre-existing medical conditions psychiatric disorders, or other conditions that could interfere with the subject’s safety, obtaining informed consent, or compliance with study procedures
Patients with psychiatric, addictive, or any disorder that would prevent compliance with protocol requirements
Major psychiatric illness or comorbid conditions prohibiting compliance with study procedures as determined by the treating oncologist
Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, study participation, follow up, or interpretation of study research
Any serious and/or unstable pre-existing medical, psychiatric disorder, or other condition that could interfere with the subject's safety, obtaining informed consent, or compliance to the study procedures.
Major psychiatric illness or co-morbid conditions prohibiting compliance with study procedures
Psychological, social, familial, or geographical reasons that would prevent scheduled visits and follow-up
Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures (including compliance issues related to feasibility/logistics)
Psychological, social, familial, or geographical reasons that would prevent scheduled visits and follow-up
SUBJECT: History of medical non-compliance or difficulty completing previous required study tasks or visits that suggest the participants would not follow through with the home study procedures.
Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent
Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., social/psychological issues, etc
Any other condition that would, in the investigator’s judgment, contraindicate the patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., social/psychological issues, etc
Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., social/ psychological issues, etc
History of a neurological or psychological disorder that may interfere with the patient’s ability to cooperate with study procedures
Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Non-compliance
Any psychiatric, social or compliance issues that, in the treating physician opinion, will interfere with completion of the transplant treatment and follow up
RECIPIENT: Any other condition that would, in the investigator’s judgment, contraindicate the patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., social/ psychological issues, etc
Use of any other investigational agent in the last 15 days; psychological, familial, or sociological condition potentially hampering compliance with the study protocol and follow-up schedule
Conditions that could interfere with treatment or protocol-related procedures
Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures.
Significant psychiatric or neurologic disorders that would impair compliance with study protocol
Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Patient must not have any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study procedures
Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
Any other condition that would, in the investigator’s judgment, contraindicate patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g. infection/inflammation, intestinal obstruction, social complications
Subject's schedule permits compliance with all study procedures
Any condition that is unstable or could jeopardize the safety of the patient and his or her compliance in the study, in the investigator’s judgment
No unstable and significant medical conditions as determined by medical history (to ensure safety of the subject, to minimize the effects of poor health on biomarker measures and to maximize compliance to study procedures)
No unstable and significant medical or psychiatric conditions, including lack of stabilization of medications, to be determined by medical history and Prime- doctor of medicine (MD) (to ensure safety of the subject, to minimize the effects of poor health on biomarker measures and to maximize compliance to study procedures)
Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
Other Medical Conditions as noted in the protocol.
Patients with known ovarian cancer miliary disease prior to surgery 5. Any medical condition that, in the opinion of the investigators, could potentially jeopardize the safety of the patient 6. History of anaphylactic reactions 7. History of allergy to any of the components of OTL38, including folic acid 8. Pregnancy or positive pregnancy test 9. Clinically significant abnormalities on electrocardiogram (ECG) 10. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule 11. Impaired renal function defined as eGFR< 50 mL/min/1.73m2 12. Impaired liver function defined as values > 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin.
Any condition that would in the Investigator's judgment prevents compliance with the requirements of the protocol.
Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
Psychological, familial, sociological, or geographical conditions that do not permit medical follow-up and compliance with study protocol.