Before your first visit, prepare any medical records you have. If you do not have a medical record, write

down on a piece of paper all the illnesses you have been diagnosed with so far and the medicines you are

taking or have taken in the past.

Before participating in the clinical trial, you will be given a document called ICF - Informed Consent Form,

which you must read. After you have read the document, the doctor will discuss all the most important

aspects with you. You will have the opportunity to ask questions. Once you have received the answers, you

will decide whether you want to take part in the study. If you agree, the document will be signed by you

and the doctor.

You can bring a family member with you to this appointment if you want them to help you decide.

Once you have signed the ICF - Informed Consent Form, your doctor will take a detailed history with you

regarding your underlying disease and co-morbidities and medications you are taking. After the initial

screening, the investigator will decide on the next course of action based on the guidelines in the study

protocol. If you meet the initial inclusion criteria for the study, you will undergo further procedures e.g.

blood specimen collection, ECG, weighing, etc.

Once all results have been received and analyzed, a decision will be made about your further participation

in the study. Once all inclusion criteria and no exclusion criteria have been met, you will be invited to a

randomization visit with allocation of study drug/placebo and subsequent procedures included in the study

protocol.

Depending on the protocol, specific procedures will be performed at each visit in the Clinical Study

Center, which should always be included in the Informed Consent Form of the patient.

During the study, the clinical trial coordinator or doctor may call to collect information and your current

health status.