Glémain 2002.

Methods	Multisite study Randomization noted but not described Blinding: patients, providers (unsure if assessors blinded)
Participants	Geographic region: France Study setting: 47 regional settings N = 329 Baseline IPSS: tamsulosin + SR (Permixon®) 16.2; tamsulosin 16.3 Baseline prostate volume: NR Mean age (range): 65 (NR) years Race: NR Diagnostic criteria: IPSS ≥ 13, Peak urine flow 7 to 15 mL/s
Interventions	Control: tamsulosin daily + placebo twice daily Treatment: tamsulosin daily + SR (Permixon®) twice daily Study duration: 52 weeks Lost to follow‐up: n = 64
Outcomes	Symptom improvement‐ IPSS total score IPSS QoL & UROLIFE© BPH QoL9 Peak urine flow Dropouts due to side effects: none
Notes	Exclusions: previous surgery on the prostate, vesicle collar or pelvic area; residual post‐urine volume of >300 mL; prostate cancer; urine infection; α/ß‐blockers, α‐agonists, cholinergics or anticholinergics were prohibited; hepatic insufficiency; cardiovascular event or cerebrovascular event; allergy to intervention drugs Treatments for BPH (such as α‐blockers) stopped at least 15 days before randomization; other treatments, such as plant extracts and finasteride, were stopped 1 month before randomization.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	unclear
Allocation concealment (selection bias)	Unclear risk	unclear
Blinding of participants and personnel (performance bias) All outcomes	Low risk	adequate
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	not clear
Incomplete outcome data (attrition bias) All outcomes	Low risk	adequate
Selective reporting (reporting bias)	Low risk	adequate
Other bias	Low risk	adequate