McMahon 2010.

Study characteristics
Methods	Study design: blinded, randomized controlled, parallel‐group trial Setting/country: multicenter in Asia Pacific Dates study conducted: March 2005 to June 2006
Participants	Inclusion criteria: Age ≥ 18 years In a stable, monogamous heterosexual relationship for ≥ 6 months Planning to maintain this relationship for the duration of the study PE according to DSM‐IV‐TR criteria for PE for ≥ 6 months prior to enrolment and had a baseline IELT ≤ 2 minutes in ≥ 75% of a minimum of 4 evaluable sexual intercourse events during a treatment‐free 4‐week baseline period, and reported at least "moderate" ejaculation‐related personal distress or interpersonal difficulty Exclusion criteria: History of medical or psychiatric illness, including uncontrolled hypertension, hyperprolactinemia or untreated hypothyroidism History of medical events that were associated with the onset of PE Sexual dysfunction in either partner except PE in the man (including a history of ED based on an IIEF Erectile Function domain score < 21 at screening) History of HIV, HBsAg or hepatitis C (except for people from Korea, inactive HBsAg carriers with normal liver function tests were allowed into the trial) Concomitant use of SSRIs or tricyclic antidepressants Known hypersensitivity to SSRIs or serotonin‐norepinephrine reuptake inhibitors Total number of participants randomized: 1067 Total length of study: 12 weeks Group 1 (dapoxetine 30 mg): Number of participants randomized: 354 Age (mean): 41.2 (SD 10.74) years Baseline IELT (mean): 3.9 minutes Number of participants with primary PE: 92 (42.2%) Group 2 (dapoxetine 60 mg): Number of participants randomized: 356 Age (mean): 41.0 (SD 10.78) years Baseline IELT (mean): 4.2 minutes Number of participants with primary PE: 92 (42.2%) Group 3 (placebo): Number of participants randomized: 357 Age (mean): 40.6 (SD 9.71) years Baseline IELT (mean): 2.4 minutes Number of participants with primary PE: 96 (45.9%)
Interventions	Group 1: dapoxetine 30 mg on‐demand Group 2: dapoxetine 60 mg on‐demand Group 3: placebo on‐demand
Outcomes	Primary outcomes: IELT How measured: by female partner using a stopwatch Time points measured: 0, 4, 8, 12 weeks Secondary outcomes: Participant‐reported outcome measures How measured: CGIC in PE and PEP questionnaires Time points measured: every 4 weeks Safety outcomes: Adverse effects How measured: reported by participants Time points measured: anytime
Funding sources	Study funded by Johnson & Johnson Pharmaceutical Research & Development, LLC, Raritan, NJ, USA.
Declarations of interest	Dr McMahon is a consultant/investigator for Johnson & Johnson. Drs Kim, Park and Chang are investigators for Johnson & Johnson. Drs Rivas, Tesfaye, Rothman and Aquilina are employees of 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	Unclear risk	Study described as double‐blind; no further information.
Blinding of outcome assessment (detection bias) Participant‐reported outcomes	Low risk	Likely appropriate blinding, "double‐blind" and placebo was used.
Blinding of outcome assessment (detection bias) Investigator‐assessed outcomes	Unclear risk	Not explicitly described.
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	62/395 (17%) in placebo, 70/354 (20%) in dapoxetine 30 mg, 77/356 (22%) in dapoxetine 60 mg were not included in the analysis.
Selective reporting (reporting bias)	Low risk	As reported in protocol in ClinicalTrials.gov.
Other bias	Low risk	No additional sources of bias identified.