JV15824.

Methods	Randomised, double‐blind, placebo‐controlled trial to evaluate the efficacy and safety of Ro64‐0796 for the prophylaxis of influenza A and B
Participants	Participants ≥ 16 years of age and without influenza‐like symptoms
Interventions	Ro64‐0796/V14 75 mg capsule Ro64‐0796/V16 placebo capsule
Outcomes	Primary outcome Rate of occurrence of influenza Secondary outcomes Rate of occurrence for patients infected with non‐clinical influenza Rate of occurrence for patients infected with non‐symptomatic influenza Rate of occurrence for patients infected with influenza‐like disease Safety
Notes	The available clinical study report is a 15‐page document translated into English from the Japanese original. The design and methods are similar to those of WV 15697/15673 (the "pivotal" prophylaxis trials in adults) and the trial was meant as a "bridge" with the Western trial programme. The report does not contain any supporting data (i.e. statistical analysis plan, protocol, amendments, certificates of analysis and audit, randomisation lists, lists of investigators, IRB clearance and individual listings)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Not specified as protocol and methods section were not available: method of sequence generation not reported
Allocation concealment (selection bias)	High risk	Not specified as protocol and methods section were not available
Incomplete outcome data (attrition bias) Symptoms	Low risk	ITT analysis included all randomised participants; all participants who took at least 1 dose of medication were included in the safety population (CSR G‐146); no systematic differences in drop‐outs
Incomplete outcome data (attrition bias) Complications of influenza	Low risk	ITT analysis included all randomised participants
Incomplete outcome data (attrition bias) Safety data	High risk	All participants who took at least 1 dose of medication were included in the safety population (CSR G‐146); no systematic differences in drop‐outs but no breakdown by on‐ and off‐treatment status reported, only aggregate in treatment summary table
Selective reporting (reporting bias)	High risk	Not specified as protocol and methods section were not available; unclear if there were any amendments
Other bias	High risk	No reporting of methods; no protocol; 4 participants not registered received the clinical trial drug
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not specified as protocol and methods section were not available
Blinding of outcome assessment (detection bias) All outcomes	High risk	Not specified as protocol and methods section were not available