On the day of the visit, the patient attends the centre, fasting for 8 hours, to carry out protocol visit No. 1 of the study: "study title". The patient is evaluated by me together with Dr "name". As the first procedure of this visit, the full content of the ICF ("ICF version") is reviewed again. 1) Objective of the study. 2) Why the patient is invited to take part. 3) What the study involves: time, visits, and the procedures carried out at each visit. 4) Medication: adverse effects, their frequency and scope. 5) Concept of placebo. 6) Use of the electronic diary throughout the study. 7) Confidentiality of their data. 8) The study is free of charge.

Vulnerability is assessed; the patient is not vulnerable. The patient has no doubts; it is confirmed that they have understood all the information. They are given sufficient time to think it over, and decide to take part in the study. Two originals of the ICF are then signed: one is handed to the patient and the other remains at the medical centre.

The IWRS patient No. 1001 is obtained.

Eligibility criteria are assessed.

Laboratory results received.