Majima 2007.

Study characteristics
Methods	Study design: Historically controlled trial Study grouping: Method: No participant received lipid medications within 3 months of the trial, therefore, no washout required; 3‐month before‐and‐after study
Participants	Baseline Characteristics 1 mg n: 63 Age (years): 59.5 Males (n): 38 Females (n): 25 BMI: 24.7 Total cholesterol: 253.86 mg/dL (6.56 mmol/L) LDL cholesterol: 160.37 mg/dL (4.15 mmol/L) HDL cholesterol: 58.38 mg/dL (1.51 mmol/L) Triglycerides: 175.87 mg/dL (1.99 mmol/L) Included criteria: 101 Japanese patients (57 men and 44 women, mean age 58.58 ± 12.0 years) with untreated hypercholesterolaemia, who attended the clinic of Rakuwakai Otowa Hospital between March 2006 and December 2006, were selected for this study. The diagnosis of hypercholesterolaemia was established on the basis of laboratory findings, including an elevated serum total cholesterol (TC) level (> 220 mg/dL) and an elevated serum low density lipoprotein cholesterol (LDL‐C) level (> 140 mg/dL). Excluded criteria: current smokers and those who had a history of fractures and/or of other diseases (type 1 diabetes mellitus, liver disease, renal dysfunction, malignancy, hyperthyroidism, hyperparathyroidism, hypercortisolism, or hypogonadism) and those taking medications (active vitamin D3, bisphosphonates, calcitonin, selective oestrogen receptor modulators, estrogens, testosterones, steroids, thyroid hormones, diuretics, heparin or anticonvulsants) that could influence bone metabolism Baseline Group Characteristics: At baseline, all differences between group A and group B were non significant.
Interventions	Intervention Characteristics 1 mg
Outcomes	Total cholesterol Outcome type: Continuous Unit of measure: Percentage change from baseline Direction: Lower is better LDL cholesterol Outcome type: Continuous Unit of measure: Percentage change from baseline Direction: Lower is better HDL cholesterol Outcome type: ContinuousOutcome Unit of measure: Percentage change from baseline Direction: Higher is better Triglycerides Outcome type: ContinuousOutcome Unit of measure: Percentage change from baseline Direction: Lower is better
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Judgement Comment: Controlled before‐and‐after design
Allocation concealment (selection bias)	High risk	Judgement Comment: Controlled before‐and‐after design
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Judgement Comment: Lipid parameter measurements unlikely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Judgement Comment: Lipid parameters were measured in a remote laboratory.
Selective reporting (reporting bias)	Low risk	Judgement Comment: LDL‐C outcome was reported.
Other bias	Unclear risk	Judgement Comment: Source of funding was not reported.
Incomplete outcome data (attrition bias) Total cholesterol	Low risk	[(66 ‐ 63)/66]*100 = 4.5% were not included in the efficacy analysis.
Incomplete outcome data (attrition bias) LDL cholesterol)	Low risk	[(66 ‐ 63)/66]*100 = 4.5% were not included in the efficacy analysis.
Incomplete outcome data (attrition bias) HDL cholesterol	Low risk	[(66 ‐ 63)/66]*100 = 4.5% were not included in the efficacy analysis.
Incomplete outcome data (attrition bias) Triglycerides	Low risk	[(66 ‐ 63)/66]*100 = 4.5% were not included in the efficacy analysis.
Blinding of outcome assessment (detection bias)WDAEs	High risk	No comparison possible
Selective reporting (reporting bias) for WDAEs	High risk	No WDAE outcome reported