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Table 1 Eligibility criteria

From: Trichuris suis ova in relapsing-remitting multiple sclerosis and clinically isolated syndrome (TRIOMS): study protocol for a randomized controlled trial

Key inclusion criteria Diagnosis of RRMS in accordance to the revised McDonald criteria (2005) or CIS
  Aged 18 to 65 years, inclusive
  Expanded Disability Status Scale (EDSS) at screening score ≤4.0
  Ability to provide written informed consent
  Disease activity on brain defined by:
(A) ≥1 gadolinium enhancing lesion on screening MRI or another MRI performed in the 12 months prior to screening OR
(B) ≥1 new T2 lesion on screening MRI or on another MRI performed in the 12 months prior to screening in comparison to an earlier MRI performed in the previous 36 months OR
(C) ≥1 enlarging T2 lesion on screening MRI or on another MRI performed in the 12 months before screening in comparison to an earlier MRI performed in the previous 36 months
  Adequate birth control by a contraception method with a PEARL-index <1 in women of childbearing potential
  Contraindication or intolerance for established standard immunomodulatory treatments with interferon-β or glatiramer acetate
  Information about established standard immunomodulatory treatments for MS by an independent neurologist and explicit decision of the patient against these treatment
  Stable neurological state at study inclusion without any signs of a relapse and without steriod therapy in the last 30 days
Key exclusion criteria Any disease other than MS that may better explain the symptoms and signs
  Any other immunomodulatory or immunosuppressive treatment, for example, interferon-β, mitoxantrone, glatiramer acetate, natalizumab within the preceding three months
  Any significant uncontrolled disease, such as neoplasia, relevant liver disorder, active hepatitis B or C, and reduced liver function
  Relevant laboratory findings:
 • aspartate aminotransferase/alanine aminotransferase (ASAT/ALAT) >3 times of reference value
 • bilirubine >1.5 mg/dl
 • hemoglobin <8.5 g/dl
 • white blood count <2.5/nl
 • thrombocytes <125/nl
 • creatinine-clearance according to Cockroft-Gault-formula <110 ml/min (male) and <95 ml/min (female)
  Any severe medical conditions or additional autoimmune disease which requires a immunosuppressive or immunomodulatory treatment
  Any psychiatric or other condition that impedes the ability to provide informed consent or patient’s compliance
  Refusal of transmission of personal data
  Inability to complete an MRI scan
  Relapse within 30 days of trial entry
  Known allergies against components of TSO or placebo
  Participation in any interventional clinical trial in the last three months or during the participant in TRIOMS
  Pregnancy or breast feeding
  Concomitant medication with antihelminthic therapy
  History of small intestinal resection