Buvat 2009.

Study characteristics
Methods	Study design: parallel group, randomized controlled trial Setting/country: Centre ETPARP, Rue Carolus, Lille, France Dates study conducted: December 2004 to October 2006
Participants	Inclusion criteria: Age ≥ 18 years in a stable monogamous relationship for 6 months Met DSM‐IV‐TR criteria for PE for 6 months At least moderate PE‐related distress or interpersonal difficulty IELT of 2 minutes in 75% of evaluable events during a 4‐week screening/baseline period Exclusion criteria: History of medical or psychiatric illness Uncontrolled hypertension or cardiac impairment Medical events associated with the onset of PE ED (currently treated for ED or score < 21 on the Erectile Function Domain of the IIEF) Other forms of sexual dysfunction Partner sexual dysfunction Known hypersensitivity to SSRIs or serotonin‐norepinephrine reuptake inhibitors Concomitant use of SSRIs, tricyclic antidepressants or other disallowed medications during the study Receiving other forms of PE therapy (pharmacologic or behavioral) Alcohol consumption limited to 2 drinks per day Total number of participants randomized: 1162 Total length of study: 24 weeks Group 1 (dapoxetine 30 mg): Number of participants randomized: 388 Age (mean): 39.6 (SD 9.53) years Baseline IELT (mean): 0.9 (SD 0.50) minutes Group 2 (dapoxetine 60 mg): Number of participants randomized: 389 Age (mean): 40.5 (SD 9.62) years Baseline IELT (mean): 0.9 (SD 0.49) minutes Group 3 (placebo): Number of participants randomized: 385 Age (mean): 40.1 (SD 9.98) years Baseline IELT (mean): 0.9 (SD 0.51) minutes
Interventions	Group 1: dapoxetine 30 mg on‐demand Group 2: dapoxetine 60 mg on‐demand Group 3: placebo daily
Outcomes	Primary outcomes: IELT How measured: using stopwatch held by partner Time points measured: 0, 4, 8, 12, 16, 20, 24 weeks Secondary outcomes: PEP How measured: questionnaire using the PEP Time points measured: 0, 4, 8, 12, 16, 20, 24 weeks Safety outcomes: Adverse effects and withdrawal symptoms How measured: Beck Depression Inventory, IIEF, Hamilton Anxiety Scale, Montgomery‐Asberg Depression Rating Scale, Barnes Akathisia Rating Scales Time points measured: 4, 12, 24 weeks Other outcomes: CGI How measured: questionnaire using the CGIC in PE Time points measured: 0, 4, 8, 12, 16, 20, 24 weeks
Funding sources	Johnson & Johnson Pharmaceutical Research & Development, LLC provided funding or other financial support and material support for this research or work that included the following: design and conduct of the study, management of the data, analysis, interpretation of the data, preparation, review, and approval of the manuscript.
Declarations of interest	Buvan and Giuliano are consultants or investigators (or both) for Johnson & Johnson Rivas, Rothamn and Tsfaye are employees of Johnson & Johnson.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer generated.
Allocation concealment (selection bias)	Low risk	Allocation concealed. Quote: "computer‐generated randomization schedule (assigned and coded using an interactive voice response system)."
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Study described as double‐blind; no information beyond that.
Blinding of outcome assessment (detection bias) Participant‐reported outcomes	Unclear risk	Study described as double‐blind; no information beyond that.
Blinding of outcome assessment (detection bias) Investigator‐assessed outcomes	Unclear risk	No explicit blinding reported.
Blinding of outcome assessment (detection bias) IELT	Low risk	Objective measurement that was unlikely to be influenced by blinding.
Incomplete outcome data (attrition bias) All outcomes	High risk	Large proportions of participants not included in the final analysis; > 20% per treatment arm.
Selective reporting (reporting bias)	Low risk	Protocol was provided (NCT00229073) and all outcomes were reported.
Other bias	Low risk	No additional sources of bias identified.