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.