Archer 2019.

Study characteristics
Methods	RCT phase 3, multicentre, 68 centres in the USA
Participants	Inclusion criteria: "postmenopausal women aged 40‐80 years with intact uterus, or having a serum follicle‐stimulating hormone level > 40 IU/L for hysterectomized women with intact ovaries, or 6 weeks since bilateral oophorectomy, or women aged 45 years with an unknown date of their last spontaneous menstrual bleed reporting moderate or severe vaginal dryness as their MBS with ≤ 5% superficial cells on their vaginal wall smear and a vaginal pH Inclusion criteria > 5.0 were eligible to participate".
Interventions	Intervention for up to 12 weeks: oral ospemifene 60 mg once daily Control: placebo (local‐based lubricant K‐Y Jelly as needed during penis‐vagina sexual relation)
Outcomes	FSFI scores were also secondary endpoint, collected at weeks 4, 8, and 12
Notes	Dr Archer has received research support from Actavis, Bayer Healthcare, Endoceutics, Glenmark, Merck, Radius Health, Shionogi, and Therapeutics MD; has served as consultant to AbbVie, Actavis, Agile Therapeutics, Bayer Healthcare, Endoceutics, Exeltis, InnovaGyn, Merck, Pfizer, Radius Health, Sermonix, Shionogi, Teva Women’s Healthcare, and Therapeutics. Dr Goldstein serves on the advisory board for AbbVie, Allergan, IBSA, Pfizer, and Therapeutics MD; and is a consultant for Cook ObGyn and Cooper Surgical. Dr Simon has served as consultant/advisor to AbbVie, Allergan, AMAG, Amgen, Ascend Therapeutics, Azure Biotech, Bayer Healthcare, CEEK Enterprises, Covance, Millendo Therapeutics, Mitsubishi Tanage
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomization schedule prepared by an independent statistician before study start
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding of participants and personnel (performance bias) All outcomes	Low risk	All study staff and participants were blinded throughout the study; ospemifene 60 mg and placebo tablets were identical in appearance and packaging
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	FSFI total scores and scores for all domains of FSFI
Selective reporting (reporting bias)	Low risk	Participant withdrawal (ospemifene, 4.1%; placebo, 5.1%). Study discontinuation due to AEs was low (ospemifene, 1.9%; placebo, 3.2%). The majority of women who received ospemifene and placebo were included in the intention to treat (ITT) population (99.1% vs 99.7%) and completed the 12‐week study (89.6% vs 88.6%)
Other bias	Low risk	Not suspected