Table 1 Inclusion and exclusion criteria for ProVal-MS

Inclusion criteria

CIS, with dissemination in space or relapsing remitting MS according to the 2017 McDonald criteria^a

Diagnosed within the last two years

Treatment naïve

18 until 60 years of age

Exclusion criteria

Under any administrative or legal supervision

Unable to give informed consent,

Previous treatment with disease modifying therapies (including corticosteroid therapy of relapses, if given less than four weeks prior baseline)

Conditions/concomitant diseases making the patient non-evaluable for the primary endpoint (e.g., pre-existing neurological disease, systemic autoimmune diseases)

Requirement for concomitant treatment that could bias primary evaluation

Inability to meet specific protocol requirements (e.g., need for hospitalization, not able to read and understand the protocol),

Patients directly involved in the conduct of the protocol: investigator or subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof

Patient is uncooperative or has any condition that could make the patient potentially non-compliant to the study procedures

Pregnant or breast-feeding women