History of stroke, coronary artery disease, myocardial infarction, peripheral artery disease, chronic kidney disease (eGFR \<75 ml/min at least for 3 months), albuminuria \>300 mg/g, or diabetes mellitus
No antibiotics in the previous 30 days
If a woman, she must be a woman of non-childbearing potential. That is, she must be:
* In a post-menopausal state, defined as no menses for 12 months without an alternative medical cause.
A woman patient of childbearing potential must have a negative serum pregnancy test at Visit 0 (Day 0) and must agree to use consistently and correctly (from 28 days prior to first study treatment administration until at least 7 days after last study treatment administration) one of the following highly effective methods of contraception:
* Abstinence of heterosexual intercourse (when this is in line with preferred and usual lifestyle of the subject);
* Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable);
* Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal);
* Intrauterine device;
* Intrauterine hormone-releasing system;
* Bilateral tubal occlusion;
* Vasectomized partner, who has received medical assessment of the surgical success, or clinically diagnosed infertile partner.
You may not be if
Unwilling to sign the informed consent form (if the patient wants to participate but cannot sign for any reason, then a third-person testimony may sign/complete the informed consent form on the patient's behalf).
Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
Participation in another clinical study with an investigational product during the last month.
