Fuller 2013.

Methods	Pragmatic, prospective, randomised, single‐centre (Australia) trial 2 treatment arms: LEV or PHT Block randomisation Treatment period: 90 days Follow up: 90 days
Participants	Patients aged 25‐89 years with neurosurgical indications requiring craniotomy for which perioperative IV seizure prophylaxis was routine or otherwise warranted. Participants must have been on no AED or stable dose AED(s) excluding study AEDs for 3 weeks before enrolment, and must not have contraindication to either study medication. 81 randomised: 39 to LEV, 42 to PHT
Interventions	Group 1: LEV 250‐500 mg daily IV or orally Group 2: PHT 300 mg (≤ 3 doses in 24 h) or 1000 mg (single dose) IV loading then 300 mg daily IV or orally ≤ 2 oral doses of allocated AEDs were allowed between randomisation and IV administration. 1 pre‐operative IV dose was required. Following IV AED administration, participants received the same medication orally. Additional PHT titration to therapeutic serum levels was allowed but not mandated. Doses were within standard range. After randomisation, treating teams made all decisions regarding study AED treatment including IV and oral durations, serologic monitoring, dose adjustment and cessation.
Outcomes	Primary outcome: discontinuation of study AED because of side effects Secondary outcome: seizure occurrence Outcomes reported at 3 days and 90 days
Notes	Not ITT analysis. The pragmatic nature of the trial is highlighted. The reviewers also note the length of active treatment in the trial. 4 people in the trial had prior seizures.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Methods of sequence generation not described. Block randomisation was reported as used. However, the paper reports that early during data collection the contractor communicated that "allocation was as follows: each 10 sequentially recruited patients were not internally randomised but received the same drug, determined by hat‐draw at enrolment of the first patient in each block, with eight blocks of 10 patients then two blocks of four to be randomised with equal probability." At study completion, impact of allocation procedure on bias was assessed by statistical comparison of baseline patient characteristics, with similar age and gender distribution and proportion of serious pathologies and death from underlying pathology found between treatment groups.
Allocation concealment (selection bias)	Unclear risk	The allocation procedure was communicated to quarantined keeper for randomisation data. However, it is unclear what the procedure was. Also, see above note as to failure of block randomisation.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	The investigation team conducting the information and consenting process, data collection, outcome adjudication and analysis was blinded. The quarantined keeper and liaison for randomisation data did not participate in recruitment, patient treatment, data collection, outcome assessment or analysis. Recruiting neurosurgical teams, including anaesthetists, were blinded to the allocation procedure. Otherwise the study was open‐label.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	ITT analysis not used. 81 people randomised, 74 were included in the analyses at 3 days and 61 at 90 days.
Selective reporting (reporting bias)	Unclear risk	No trial protocol available
Other bias	Low risk	UCB Pharma provided funding and LEV