Subjects with any other medical condition, including but not limited to malabsorption syndromes, mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the interpretation of the results or which would interfere with a subject's ability to sign or the legal guardian's ability to sign the informed consent, and subject's ability to cooperate and participate in the study Subjects with any other medical condition, including malabsorption syndromes, mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the interpretation of the results or which would interfere with a subject's ability to sign or the legal guardian's ability to sign the informed consent, and subject's ability to cooperate and participate in the study Patients with any other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with the patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results, will not be eligible Any other medical or social condition deemed by the Investigator to be likely to interfere with a patients ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results Have any other medical or psychological condition deemed by the Investigator to likely interfere with the subject's ability to give informed consent or participate in the study. Has any illness, medical condition, organ system dysfunction, or social situation, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a subject's ability to sign informed consent, adversely affect the subject's ability to cooperate and participate in the study, or compromise the interpretation of study results Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results. If they have any other condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patients ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results Any concurrent uncontrolled illness, including mental illness or substance abuse, which in the opinion of the Investigator, would make the subject unable to cooperate or participate in the trial. Any other medical or psychological condition deemed by the Investigator to be likely to interfere with a subject's ability to give informed consent or participate in the study Any other medical condition, including mental illness or substance abuse, deemed by the investigator(s) to likely interfere with the patients ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patients ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results Any other condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results Any other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patients ability to sign informed consent or cooperate and participate in the study or with the interpretation of the results Patients must not have any other condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patients ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results Any other medical, psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare or ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results Patients with any other medical or psychological condition deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results; If they have any other condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patients ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results Have any other medical or psychological condition deemed by the Investigator to be likely to interfere with the subject's ability to give informed consent or participate in the study. Any other medical condition, including mental illness or substance abuse, deemed by the investigator(s) to likely interfere with the patients ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results Any other medical condition, including mental illness or substance abuse, deemed by the investigator(s) to likely interfere with the patients ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results Subjects with any other medical or psychological condition, deemed by the Investigator to be likely to interfere with a subject's ability to sign informed consent, cooperate, or participate in the study. Participants with any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the participant's ability to sign the informed consent form or his/her ability to cooperate and participate in the study, or to interfere with the interpretation of the results Subjects with any other medical or psychological condition, deemed by the Investigator to be likely to interfere with a subject's ability to sign informed consent, cooperate, or participate in the study. Patients with any other medical or psychological condition, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results Patients must not have any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patients ability to give informed consent or cooperate and participate in the study or interfere with the interpretation of the results Any condition deemed by the investigator to be likely to interfere with a subject's ability to participate in the clinical trial. Patients with any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the patients ability to sign the ICF or his/her ability to cooperate and participate in the study, or to interfere with the interpretation of the results Presence of any other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patients ability to sign informed consent, cooperate and participate in the study, or interfere with interpretation of the results Subjects with any other concurrent uncontrolled illness, including mental illness or substance abuse, which may interfere with the ability of the subject to cooperate and participate in the study Any other medical condition, including mental illness or substance abuse, deemed by the principal investigator to likely interfere with a patients ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results Any other medical or psychological condition, deemed by the Investigator to be likely to interfere with a subject's ability to sign informed consent, cooperate, or participate in the study Any other intercurrent medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a subject's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results Patients with any other medical or psychological condition deemed by the investigator to be likely to interfere with a patients ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results Any other condition, including mental illness or substance abuse deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate, and participate in the study Any other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or follow up procedures Any concurrent uncontrolled illness, including mental illness or substance abuse, which in the opinion of the Investigator, would make the subject unable to cooperate or participate in the trial. Any other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patients ability to sign informed consent, cooperate and participate in the study, or follow up procedures