Kaufman 2009.

Study characteristics
Methods	Study design: blind, randomized controlled, parallel‐group trial Setting/country: multi‐institutional Aurora, USA Dates study conducted: November 2009 to January 2012
Participants	Inclusion criteria: Age ≥ 18 years; in a stable monogamous, heterosexual relationship for ≥ 6 months; expected to maintain the relationship for the duration of the study Met DSM‐IV‐TR criteria for PE, to have had PE for ≥ 6 months and to have reported at least 'moderate' distress or interpersonal difficulty related to their PE at baseline. The DSM‐IV‐TR criteria required an ejaculatory latency before, upon or shortly after penetration; a threshold IELT was not an inclusion criterion Exclusion criteria: Presence of a serious condition that affected overall physical or mental health status Previous event or condition associated with PE (such as spinal trauma or pelvic surgery) Presence of another sexual dysfunction in the man (such as ED) or his partner Known allergy to SSRIs History of drug abuse within past 2 years Alcohol consumption > 2 drinks per day Total number of participants randomized: 736 Total length of study: 9 weeks Group 1 (dapoxetine): Number of participants randomized: 491 Age (mean): 41.8 (SD 9.80) years Baseline IELT: NR Group 2 (placebo): Number of participants randomized: 245 Age (mean): 40.98 (SD 9.71) years Baseline IELT: NR
Interventions	Group 1: dapoxetine 60 mg on‐demand Group 2: placebo on‐demand
Outcomes	Primary outcomes: Perceived control over ejaculation How measured: PEP questionnaire Time points measured: days 28, 63 and study end Secondary outcomes: Satisfaction with sexual intercourse How measured: PEP questionnaire Time point measured: NR Safety outcomes: Adverse effects How measured: reported by participants Time points measured: anytime and each visit Other outcomes: Personal distress related to ejaculation How measured: PEP questionnaire Time points measured: days 0, 28, 63 and study end Other outcomes: Interpersonal difficulty related to ejaculation How measured: PEP questionnaire Time points measured: days 0, 28, 63 and study end Other outcomes: Change in PE How measured: participant‐reported global impression of change in PE questionnaire Time points measured: days 28, 63 and study end
Funding sources	Funded by Johnson & Johnson Pharmaceutical Research & Development, LLC, Raritan, NJ
Declarations of interest	Funded by Johnson & Johnson Pharmaceutical Research & Development, LLC, Raritan, NJ, USA. Drs Mudumbi, Tesfaye and Rivas are employees of Johnson & Johnson; Dr Hashmonay was an employee of Johnson & Johnson at the time of the study. Dr Kaufman is an investigator for Johnson & Johnson. Dr Rosen is an investigator/consultant for Johnson & Johnson.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Methods not described.
Allocation concealment (selection bias)	Unclear risk	Methods not described.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Likely appropriately blinded. Quote: "dosing carried out in a double‐blind, double‐dummy fashion."
Blinding of outcome assessment (detection bias) Participant‐reported outcomes	Low risk	Participants likely to be appropriately blinded. Quote: "dosing carried out in a double‐blind, double‐dummy fashion."
Blinding of outcome assessment (detection bias) Investigator‐assessed outcomes	Unclear risk	Not explicitly described who was assessing adverse effects.
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	Unclear risk	Large numbers excluded from analysis and not even lost to follow‐up between groups (60/491 in dapoxetine arm and 24/245 in placebo arm were excluded).
Selective reporting (reporting bias)	High risk	Data on participants receiving dapoxetine 60 mg daily NR.
Other bias	Low risk	No additional sources of bias identified.