Introduction and Background Information

In order to decide whether you wish to participate in this research study, you should understand enough about its risks and benefits to be able to make an informed decision. This process is known as "informed consent."

This consent form provides detailed information about the research study. We have tried to make this information understandable. A study doctor will also discuss the study with you. Before you sign this consent form, please read these principles that apply to your participation in this research study:

1.Your participation is voluntary;

You may withdraw from the study at any time;

You may not benefit from participating in the study, but knowledge gained may benefit others;

Your participation or withdrawal will not affect your care.

You should read the information below, and ask questions about anything you do not understand before deciding to participate. Once you understand the study, you will be asked to sign this informed consent if you wish to participate. 2.You will be given a signed copy of the form to keep for your records.

Please write about your study in lay terms

If you agree to participate in this study, you will be asked to give an additional blood sample at every visit. In addition, your medical details will be used for the study, and this information may be shared with the study team. Your personal information, will however not be shared with any outside agency.

This research study is approved from the Ethics Committee (EC). The EC is composed of scientists, non-scientists and members from the community. This board is responsible for approving all research with humans conducted in the Hospital.

Purpose

Study Population

Procedures

The following information will be collected from your records for the study:

Risks

Benefits

Alternative procedure(s) or course(s) of treatment that may be available to the subject

Access to subject’s medical records monitor(s), the auditor(s), the irb/iec & regulatory authority (ies)

Confidentiality

You will not be personally identified in any reports or publications that may result from this study. Any personal information about you that is gathered during this study will remain confidential to every extent of the law.

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