Polat 2016.

Study characteristics
Methods	Multicenter, parallel RCT Location: Turkey Conducted from October 2011 to April 2013
Participants	90 children who were newly diagnosed with FMF according to the Yalçinkaya criteria or the Tel Hashomer criteria, and confirmed by genetic analysis with heterozygous or homozygous mutations 45 participants each were randomized to colchicine twice daily (divided‐dose group) or once daily (single‐dose group) Age, mean: single‐dose group: 7.90 (SD 1.96) years; divided‐dose group: 7.78 (SD 2.00) years Gender: 40 girls, 39 boys (79 participants completed study)
Interventions	Single‐dose group: colchicine 1 mg/day once daily at 8:00 a.m. Divided‐dose group: colchicine 1 mg/day divided into 2 doses 1 at 8:00 a.m. and 1 at 8:00 p.m.
Outcomes	Disease symptoms and severity improvement Duration of attacks Acute‐phase response, including: ESR, CRP and SAA Adverse events Outcomes measured at 3 and 6 months
Notes	Clinical Trials identifier: NCT02602028
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "It was a multicenter randomized controlled trial… The randomization was done at the baseline visit… Computer‐based block randomization algorithm was used with a block size of 2 and each patient was assigned to a treatment group with an equal chance of allocation."
Allocation concealment (selection bias)	Low risk	Central allocation.
Blinding of participants and personnel (performance bias) All outcomes	High risk	No blinding. The review's secondary outcome of acute‐phase response was not influenced by lack of blinding, but the adverse events were likely to be influenced.
Blinding of outcome assessment (detection bias) All outcomes	High risk	No blinding. The review's secondary outcome of acute‐phase response was not influenced by lack of blinding, but the adverse events were likely to be influenced.
Incomplete outcome data (attrition bias) All outcomes	High risk	3 people lost to follow‐up in the divided‐dose group (6.67%), and 3 participants refused the treatment and 5 lost to follow‐up in single‐dose group (17.78%), and no ITT analysis was performed.
Selective reporting (reporting bias)	Low risk	No selective reporting bias according to the protocol.
Other bias	Low risk	No other source of bias identified. Sample size was calculated.