Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures Provide written informed consent prior to any study-specific screening procedures Provided written informed consent prior to any study-specific procedures. Able to provide written informed consent prior to the performance of any study-specific procedures. Provide written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice Patient must give study-specific informed consent on an IRB-approved consent prior to any research-related procedures or study treatment. The ability to provide written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time Provide written informed consent prior to any study-specific screening procedures. The subject must sign a written informed consent form prior to the initiation of any study procedures. Adult subjects unable to provide written informed consent on their own behalf will not be eligible for the study After being fully informed about their illness and the investigative nature of the protocol (including foreseeable risks and possible toxicities), is willing and able comply with the protocol and to provide written, ethics committee-approved informed consent form before performance of any study-specific procedures or examinations Subject has provided informed consent prior to initiation of any study-specific activities/procedures; Understand the study requirements and the treatment procedures, and is willing to comply with all specified follow-up evaluations, and provides written informed consent before any study-specific tests or procedures are performed. Able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent before the first study-specific procedure Willing and able to provide written informed consent prior to performance of any study-specific procedures Written informed consent/assent prior to any study-specific procedures Ability to give written, informed consent prior to any study-specific screening procedures, with the understanding that the consent may be withdrawn by the patient at any time without prejudice. Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures Provide informed consent and agree to all assessments and study procedures Written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice Adult subjects ? years of age who are able to understand study procedures, comply with them, and provide written informed consent before any study-specific procedure. Must be willing to provide informed consent prior to any study specific procedures Adult subjects ? years of age who are able to understand and comply with study procedures, and provide written informed consent before any study-specific procedure. Able to understand and comply with the protocol and study procedures, understand the risks involved in the study, and provide written informed consent before any study-specific procedure is performed. Signed written informed consent before performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up Subject has provided informed consent prior to initiation of any study-specific activities/procedures Provided informed consent prior to initiation of any study-specific activities/procedures Patients must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to adhere with treatment and follow-up Patients must be willing and able to comply with the protocol and provide written informed consent prior to study specific screening procedures Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures Patients must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow-up Participants must be willing and able to review, understand, and provide written consent before starting any study-specific procedures or therapy. Written informed consent granted prior to initiation of any study-specific screening procedures, given with the understanding that the patient has the right to withdraw from the study at any time, without prejudice Subjects willing and able to comply with all aspects of the protocol for the duration of the study and provide written informed consent before any study-specific screening procedures are performed, with the understanding that the subject may withdraw consent at any time without prejudice Patients must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to adhere with treatment and follow-up Have given written informed consent prior to any study-specific procedures Subjects willing and able to comply with the study protocol for the duration of the study and provide written informed consent prior to any study-specific screening procedures with the understanding that the subject may withdraw consent at any time without prejudice. Have given written informed consent prior to any study-specific procedures Written informed consent before any study-specific procedure is performed Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up Able to provide written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, for any reason without prejudice Willing and able to provide written informed consent prior to performance of any study-specific procedures Willing to adhere to protocol specific requirements . Following receipt of verbal and written information about the study, the subject must provide signed informed consent before any study related activity is carried out. . Clinically significant toxic effects of prior therapy (expect hydroxyuria) resolved to Grade ? before the start of study. Informed consent given prior to study-specific screening procedures Provide written informed consent prior to any study-specific procedures Written informed consent prior to completing any study-specific procedure Able to understand the study procedures and agree to participate in the study by providing written informed consent Cohort Specific Inclusion Criteria: Give written informed consent prior to any study-specific procedures. Written informed consent prior to any study specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice Have an understanding of study procedures Written informed consent before any study-specific procedure is performed Subject capable of providing written informed consent prior to initiation of any study procedures; subjects able to understand and comply with planned study procedures and be available for all study visits Provide informed consent and agree to all assessments and study procedures. Provide informed consent and agree to all assessments and study procedures Provide informed consent and agree to all assessments and study procedures The subject must sign a written informed consent form prior to the initiation of any study procedures. Adult subjects unable to provide written informed consent on their own behalf will not be eligible for the study. Provide written informed consent prior to any study-specific screening procedures Has voluntarily consented to participate and provided written informed consent prior to any protocol-specific procedures Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures Understand and provide written informed consent prior to initiation of any study-specific procedures.