Etemadifar 2011.

Methods	Randomized, blinded, placebo‐controlled design was mentioned in the report. Random list generated was using a random number table. We could obtain no additional information through correspondence with the study authors
Participants	Setting: Isfahan MS Society, Iran N = 26; MMF group = 13, F/M = 8/5, mean age = 31.3 ± 8.1 years, disease duration = 5.0 ± 4.5 months; placebo group = 13, F/M = 9/4, mean age = 29.6 ± 6.7 years, disease duration = 3.6 ± 3.2 months Inclusion criteria: clinically definite RRMS, age 18 to 55 years, disease duration < two years, baseline EDSS < 6.0 Exclusion criteria: use of immunomodulatory or immunosuppressive drugs, relapse within two months, pregnant, abnormal blood tests, other major medical illnesses (eg, cancer, significant gastrointestinal disease, immunodeficiency, other autoimmune diseases) Characteristics of participants at baseline: similar
Interventions	Intervention group: IFN‐β‐1a and oral MMF started at 500 mg daily for one week, then increased by 500 mg per week until a target dose of 2000 mg daily; after this, dose was continued for 12 months Control group: IFN‐β‐1a and placebo; same dose and administration method as in the intervention group for 12 months
Outcomes	Numbers of new T2‐ and new Gd‐enhanced lesions on MRI evaluation after 12‐month follow‐up Relapse rate Changes in EDSS score. EDSS assessment was performed at baseline and then after one year of therapy Adverse effects
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random number table generated by software
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	High risk	Treating personnel were not blinded. No description on whether MMF and placebo with identical appearance and packaging were provided
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Outcome assessors were blinded. Blinding is reported only for "Two radiologists, blinded to the treatment arms, [who] were responsible for MRI evaluations" but is not reported for assessors of clinical outcome
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants completed the study
Selective reporting (reporting bias)	High risk	All specified primary and secondary outcomes were reported. The interval of confirmation to assess sustained disability progression was not reported. Poor reporting of adverse effects was another major limitation of the study
Other bias	High risk	Sample size calculation was not clearly reported. Small sample size led to an inadequately powered trial No description of the source of MMF and placebo (eg, sponsored by a pharmaceutical company or other)