Table 2 Exclusion criteria

Exclusion criteria:

· Contra-indications to the class of TpP, e.g. known hypersensitivity or allergy to the investigational product,

· Contra-indications on ethical grounds,

· Women who are pregnant or breast feeding,

· Intention to become pregnant during the course of the study,

· Lack of safe contraception:

  Safe contraception is defined as follows:

  Female and male subjects of childbearing potential, using and willing to continue using a medically reliable method of double barrier contraception for the entire study duration and the next 2 years, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices in combination with preservatives. Or subjects who are using any other method considered sufficiently reliable by the investigator in individual cases.

  Please note that subjects who are surgically sterilized/hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential.

· Known or suspected non-compliance, drug or alcohol abuse,

· Patients with medical history of coronary heart disease (CHD), stroke or peripheral vascular disease (PVD),

· Patients with medical history of autoimmune disease such as multiple sclerosis, lupus, rheumatoid arthritis, inflammatory bowel disease or small vessel vasculitis,

· Regular intake of immune-modulating drugs,

· Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject,

· Participation in another study with investigational drug within the 30 days preceding and during the present study,

· Previous enrolment into the current study,

· Enrolment of the investigator, his/her family members, employees and other dependent persons.