bb Dauvilliers 2013.

Methods	Case‐control study investigating the association between exposure to monovalent, 2009‐10 pandemic H1N1 vaccines and onset of narcolepsy
Participants	Cases (n = 59): were identified from 14 French expert orphan disease narcolepsy centres among participants referred to 1 of the participating sleep centres to confirm the diagnosis by polysomnography as well as the Multiple Sleep Latency Test between 1 October 2009 and 30 April 2011 (according to the International Classification of Sleep Disorders definition, ICSD 2005). Participating centres identified retrospectively from lists of medical records completed by reference centres for orphan diseases as required by the French government and from hospital statistic databases all their patients with narcolepsy‐cataplexy potentially matching the eligibility criteria. All potentially eligible cases were asked to participate, and their clinical history was revised to confirm the diagnosis of narcolepsy‐cataplexy following the criteria of the Brighton Collaboration, levels 1 to 3. Controls (n = 135): were selected among patients from the hospitals to which the participating sleep centres belonged and among healthy volunteers from a national database (Narcobank). Up to 4 controls were matched to each case for sex, age, geographic location. Only 25 cases and 73 controls were at least 18 years old.
Interventions	Exposure to Pandremix (AS03 adjuvanted) or Panenza (not adjuvanted) monovalent p H1N1 influenza vaccines. Vaccination was ascertained by means of a phone interview, during which other data were also recorded (body mass index, smoking, medical history, history of viral or bacterial infections), and confirmed by vaccination certificates. Date of first disease symptoms was reported. A sensitivity analysis was carried out considering as index date: the date of narcolepsy‐cataplexy diagnosis; the date of Multiple Sleep Latency Test; or the date the first symptoms appeared. Participants were considered vaccinated if they received vaccination before this latter date (whatever analysis authors performed). Data analysis was performed excluding and including cases for whom symptom onset did occur concomitantly or shortly before vaccination, so that it was not possible to state whether vaccination had effectively been administered before the onset of first symptoms, from analyses 1 and 2. (They remained always included in analysis 3). Effect estimates were moreover performed considering as exposed those participants who received AS03‐adjuvanted pandemic vaccine only.
Outcomes	Narcolepsy‐cataplexy (Brighton Collaboration levels 1 to 3)
Notes	Mixed (?) This was not an industry‐supported study. This study was funded by grants from the Agence Nationale de Sécurité du Médicament et des Produits de Santé, the European Centre for Disease Prevention and Control, and the PHRC AOM07‐138 grant from the French Health Ministry. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Y Dauvilliers has received funds for speaking and board engagements with UCB, Cephalon, Jazz, Novartis, and Bioprojet. P Franco has received funds for speaking and board engagements with UCB. MP d Ortho has received funds for speaking from Cephalon and board engagements with Bioprojet. C Monaca Charley has received funds for speaking or board engagements, or both with UCB, Novartis, and Cephalon. M Lecendreux has received funds for speaking and board engagements with UCB and Bioprojet.
Risk of bias
Bias	Authors' judgement	Support for judgement
CC ‐ case selection All outcomes	Unclear risk	Record linkage. Medical record reviewed, and participants fulfilling levels 1 to 3 of Brighton Collaboration definition included as cases. Recruited through 14 centres across France. It is possible that healthcare professionals were over‐represented.
CC ‐ control selection All outcomes	Unclear risk	Hospital controls
CC ‐ comparability All outcomes	Unclear risk	Cases and controls were matched only for age, sex, and geographical area.
CC ‐ exposure All outcomes	Low risk	Vaccination records
Summary assessment	Unclear risk	Unclear risk of bias