Glaxo 1996a.

Methods	Randomised double‐blind parallel‐group placebo‐controlled study 38 women randomised (planned for 126); 29 to drug and 9 to placebo,
Participants	Country: Austria, Canada, France, Begium, Germany, Holland, Sweden, Italy, Ireland Site: Recruitment: Inclusion: PMDD by DSM IV. Age 18‐45 years, regular menstrual cycles, symptoms in 10/12 previous cycle, Mean VAS score of at least 40 mm for 3 of 4 key psychological symptoms (depressed mood, irritability, tension, mood swings) in luteal phase and no more than 20mm in follicular phase. Baseline luteal phase CGI severity of illness score at least 3 Exclusion: Major depressive episode, schizophrenia, mania, suicide risk, use of other therapy
Interventions	Screening: 2 cycles Placebo run in: Yes 1 cycle Intervention: Paroxetine 5 mg, 10mg or 20 mg versus placebo Timing of administration: Continuous (for first 4 cycles) Summary measures: Only AE data presented
Outcomes	Safety (no other outcomes measured due to early termination)
Notes	Study terminated early due to problems with electronic diary that it was planned to use for recording outcomes
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 (performance bias and detection bias) All outcomes	Unclear risk	Double blind
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	All 38 randomised included in analysis for AEs. Terminated early, planned sample size was 248
Selective reporting (reporting bias)	High risk	Terminated early, none of planned outcomes reported except AEs
Other bias	Unclear risk	Very small (n=11)