Serious underlying medical or psychiatric illnesses that would, in the opinion of the treating physician, substantially increase the risk for complications related to treatment Any other major illness that, in the investigator's judgment, will substantially increase the risk associated with the participant's participation in this study Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study. Any prior or coexisting medical condition that in the investigators judgment will substantially increase the risk associated with the subjects participation in the study Any other major illness that, in the Investigator's judgment, may substantially increase the risk associated with the patient's participation in this study; Any other major illness that, in the investigator's judgment, will substantially increase the risk associated with the participant's participation in this study Any prior or coexisting medical condition that in the investigators judgment will substantially increase the risk associated with the subjects participation in the study Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study. Any other major illness that, in the investigator's judgment, will substantially increase the risk associated with the participant's participation in this study. Serious underlying medical or psychiatric illnesses that would, in the opinion of the treating physician, substantially increase the risk for complications related to treatment Any prior or co-existing medical condition that in the investigators judgment will substantially increase the risk associated with the subjects participation in the study Any prior or co-existing medical condition that in the investigator's judgment will substantially increase the risk associated with the subject's participation in the study Serious underlying medical or psychiatric illnesses that would, in the opinion of the treating physician, substantially increase the risk for complications related to treatment Any prior or coexisting medical condition that in the investigators judgment will substantially increase the risk associated with the subjects participation in the study have any coexisting medical condition that will substantially increase the risk associated with the subject's participation in the study. Any intraoperative complications that per the investigator's judgment increase the risk to the patient. Presence of any other co-existing condition which, in the judgment of the investigator, might increase the risk to the subject Presence of any other co-existing condition which, in the judgment of the investigator, might increase the risk to the subject Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study.