Togha 2010.

Methods	A Double Blind, Randomised, Controlled Trial. Random list generated was using a computer‐based blocking method. Allocation sequence was not mentioned, but the authors stated the patients were unaware of their group assignment and all medications were given in similar packages. Double blinded: all study personnel, participants and outcome assessors were blinded, the intervention drug and placebo were provided in similar packages. Drop‐outs: Intervention group: 3 (2 had two relapses, 1 for personal reasons); Control group: 6 (4 had two relapses, 1 with exacerbation, 1 for personal reasons). Treatment duration: 12 months. Follow‐up period: 12 months. ITT analysis: yes.
Participants	Country: Iran Setting: the Tehran University of Medical Sciences 85 patients with clinically definite relapsing‐remitting MS according to McDonald criteria, with an EDSS score of 0‐5 and at least one relapse in the previous 6 months before enrolment. Five patients did not receive at least one dose of allocated intervention since the study initial were excluded from the ITT analysis. 42 in intervention group, F/M: 32/10, mean age 29.3 ± 8.2 years, disease duration 45.0 ± 29.9 months 38 in control group, F/M: 27/11, mean age 31.1 ± 7.9 years, disease duration 40.5 ± 31.6 months Characteristics of patients at baseline: similar
Interventions	Intervention group: IFN and simvastatin 40 mg/d for 12 months Control group: IFN and placebo for 12 months
Outcomes	1. The number of the relapses during the 1‐year follow‐up 2. Changes of EDSS 3. The number of new T2 lesions and the number of new gadolinium (Gd)‐enhanced lesions 4. Adverse events
Notes	Sponsored by Tehran University of Medical Sciences Relapses were defined as new or worsening neurological deficit in the absence of high body temperature that lasted for more than 24 h after 1‐month stability. Exacerbation was defined as the patients who had at least an increase of 1.5 point in their EDSS during the study.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐based blocking method
Allocation concealment (selection bias)	Unclear risk	Not mentioned, the authors stated the patients were unaware of their group assignment and all medications were given in similar packages, whether the investigators were aware the assignment was unclear.
Blinding (performance bias and detection bias) All outcomes	Low risk	All study personnel, participants and outcome assessors were blinded.
Incomplete outcome data (attrition bias) All outcomes	High risk	Missing data and reasons were carefully recorded, but unbalanced between groups.
Selective reporting (reporting bias)	Low risk
Other bias	Low risk	Conflict of interests may not exist.

ALT: alanine transaminase 
 AST: aspartate transaminase 
 CELs: contrast enhanced lesions 
 CK: creatinine kinase 
 EDSS: Expanded Disability Status Scale 
 F/M: female/male 
 G: group 
 IFN : interferon beta‐1a 
 ITT: intention‐to‐treat analysis 
 RCT: randomised controlled trial