Moran 2010.

Study characteristics
Methods	Randomised controlled trial Same population as Meyer 2007 Location of the trial: quote: Melbourne, AustraliaMethod of randomisation: quote: "Allocated to one of two open‐label groups based on computer‐generated random numbers"Method of allocation concealment: not describedSource of funding: pharmaceutical
Participants	Inclusion criteria: quote "PCOS was diagnosed based on National Institute of Health criteria. All subjects with PCOS also met the European Society for Human Reproduction and Embryology/American Society for Reproductive Medicine criteria." Exclusion criteria: quote: "Secondary causes of amenorrhea and hyperandrogenism (based on clinical screening, hyperprolactinemia, thyroid disease, and early follicular 17‐hydroxyprogesterone levels), DM2 (based on World Health Organisation criteria), smoking, pregnancy, and use of anti‐obesity, anti‐hypertensive and anti‐inflammatory drugs. Participants were required to cease oral contraceptives, endocrine hormonal treatment or insulin‐sensitising agents and all participants received standard diet and lifestyle advice." Number of women randomised: 66 MET: 36 OCP: 30 Number of women analysed: 56 MET: 30 OCP: 26 Number of withdrawal and reasons: MET: 6/ 17% OCP: 4 / 13% Quote: “Data has been previously reported on study withdrawals” in Meyer et al 2007, however the number of patients in each group is different, therefore the number of withdrawal is different and the reasons are not clearly stated. Summary characteristics: PCOS Overweight women BMI > 25 kg/m2/ BMI (kg/m2) 36.1 (7.2) Age (years) 33.5 (6.7) Weight (kg) 97.1 (21.1)
Interventions	Treatment: MET 1 g twice a day with doses titrated up over 4 weeks starting at 500 mg twice a day Control: OCP (Ethinyl estradiol 35 mcg/ Cyproterone acetate 2 mg) Duration: 6 months Co‐intervention(s): standard diet and lifestyle advice
Outcomes	Primary outcomes: none Secondary outcomes: Body weight (kg) Fasting glucose (mmol/L)
Subjective outcomes	None
Objective outcomes	(a) Clinical parameters 1. Body weight (kg) (c) Metabolic parameters 1. Fasting glucose (mmol/L)
Notes	Authors contacted: the study population, they confirm it was a subset of a previous article of Meyer et al. Power calculation: yes, a priori, on letpin outcome
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "patient were allocated to one of two open‐label groups based on computer‐generated random numbers"
Allocation concealment (selection bias)	Unclear risk	Method of allocation concealment not sated. Insufficient information available to permit a judgement of 'low risk' or 'high risk'
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: “This was an open‐label study”.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Blinding of outcome assessor not described in this article but described in the previous study which authors have confirmed to be the same study using the same methods: Quote: “end point data collection was completed by the research nurse, who was blinded to treatment allocation” blinding for the outcome assessor
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Quote: “Data has been previously reported on study withdrawals” in Meyer et al 2007, however the number of patients in each group is different, therefore the number of withdrawal is different and the reasons are not clearly stated. Moreover, some patients are missing for a few outcomes and it is not precised in which group the patient are missing Quote: “the 56 subjects who completed the intervention except for lipids, insulin, glucose and HOMA‐IR (no.=55); testosterone and SHBG (no.=53); FAI, leptin, adiponectin, and L/A (no.=52); OGTT insulin (no.=51); OGTT glucose (no.=50); and hsCRP (no.=36)." Insufficient reporting of attrition/exclusions to permit a judgement of ‘low risk’ or ‘high risk’ (no reason for missing data provided).
Selective reporting (reporting bias)	Low risk	The study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were prespecified.
Other bias	High risk	It is not described in this article but described in the previous study which authors have confirmed to be the same study using the same methods: Population not comparable regarding androgenism status quote: “Groups were well matched at baseline except for Ferriman‐Gallwey score (8.8 + 0.8 versus 6.7 + 0.7, P< 0.05) and testosterone levels (2.5 +0.1 vs. 2.1 +0.1) in the metformin and high ‐dose OCP". Baseline imbalance.