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. 2017 May 25;2017(5):CD007355. doi: 10.1002/14651858.CD007355.pub3

Balzanelli 1996.

Methods RCT, DB, 2 parallel groups, multiple dose study.
Medication administered when baseline pain was of moderate to severe intensity, then every 8 h for total of 3 days.
Pain assessed at 0, 30 min, and 1, 2, 3, 4, 5 ,6, 8 h, then daily.
Participants Surgical removal of impacted third molars.
N = 60.
M 37, F 23.
Mean age: approximately 37 years.
Interventions Ketoprofen lysine 80 mg, n = 30.
Placebo, n = 30.
Outcomes PI: 0‐100‐mm VAS.
PGE: standard 5‐point scale.
AE: any, serious.
Withdrawals.
Tolerability 4‐point scale at end of study.
Notes Oxford Quality Score: R1, DB2, W1.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method not reported.
Allocation concealment (selection bias) Unclear risk Method not reported.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk "placebo indistinguishable".
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk "placebo indistinguishable".
Size High risk < 50 participants per treatment arm.