NCT01226459.

Methods	This is a randomised double‐blind placebo‐controlled trial Setting Multicentre (17) in USA, UK, France and Germany Date of study September 2010 to August 2011 (24‐week duration)
Participants	404 women Inclusion criteria Females, age 18 or older in general good health. Exhibits FPHL. Signs and dates an informed consent document. Agrees to use an adequate method of birth control; if of childbearing potential. Shows a negative urine pregnancy test at screening visit. Is willing to maintain the same hair style, hair colour, and hair regimen throughout the study. Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures. Exclusion criteria Hypersensitivity to the (study product), or any ingredients of the (study product). Known allergy to hair dye, or hair dye components. Clinically relevant history of hypotension. Untreated or uncontrolled hypertension. Pregnant, planning a pregnancy, or nursing a child. History of hair transplants. Currently use hair weaves or non‐breathable wigs. Dermatologic disorders of the scalp that require chronic use of medication for control. Other types or history of hair loss. Enrolled in any other investigational medication (drug) study currently, or within the last 6 months. Randomised 404 participants were randomised (minoxidil 5% foam group = 203, vehicle foam group = 201) Withdrawals/losses to follow‐up There were 53/404 (13.1%) withdrawals/losses to follow‐up: 32/203 in the minoxidil 5% foam group (15.8%), 21/201 in the vehicle foam group (10.4%) Adverse events; (8) in minoxidil 5% foam group (3.9%), (2) in vehicle foam group (< 1%). Protocol violation; (3) in minoxidil 5% foam group (1.5%), (4) in vehicle foam group (2.0%). Withdrawal by participant; (13) in minoxidil 5% foam group (6.4%), (10) in vehicle foam group (5.0%). Lost to follow‐up; (8) in minoxidil 5% foam group (3.9%), (4) in vehicle foam group (2.0%). Pregnancy; (0) in minoxidil 5% foam group (0%), (1) in vehicle foam group (< 1%). Baseline data Target area hair count hairs/cm² (SD): minoxidil 5% foam group 158.6 (61.6), vehicle foam group 152.7 (59.7)
Interventions	Intervention Minoxidil 5% topical foam once daily for 24 weeks. Comparator Vehicle topical foam once daily for 24 weeks.
Outcomes	Assessments (3): at baseline, week 12, and week 24 Primary outcomes (as reported) Change in target area hair count from baseline to week 24.¹ Subject Assessment of Scalp Coverage (7‐point Likert scale from ‐3 to +3).¹ Secondary outcomes (as reported) Change in target area hair count from baseline to week 12. Adverse events.¹
Funding source	Johnson & Johnson Healthcare Products Division of McNEIL‐PPC, Inc
Declaration of interest	This was unclear from clinicaltrials.gov, but collaborators are Johnson & Johnson Consumer and Personal Products Worldwide
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote (clinicaltrials.gov): "randomly assigned in a 1:1 ratio to use either 5% MTF OD or foam vehicle OD". Comment: the trial authors did not report the method used to generate the allocation sequence in sufficient detail to allow a clear assessment of whether it would produce comparable groups.
Allocation concealment (selection bias)	Unclear risk	The trial authors did not report the method used to conceal the allocation sequence, that is to determine whether intervention allocations could have been foreseen in advance of, or during, enrolment. Comment: there was insufficient information to permit a clear judgement.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote (clinicaltrials.gov): "double‐blind". Comment: the report did not provide sufficient detail about the measures used to blind study participants and personnel from knowledge of which intervention a participant received, to permit a clear judgement.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote (clinicaltrials.gov): "double‐blind". Comment: there was uncertainty with effective blinding of outcomes assessors (healthcare providers) during the study. There was insufficient information to permit a clear judgement.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	There were 53/404 (13.1%) withdrawals/losses to follow‐up: 32/203 in the minoxidil 5% foam group (15.5%), 21/201 in the vehicle foam group (10.4%). Data analysis was per‐protocol. Comment: we judged this as at an unclear risk of bias
Selective reporting (reporting bias)	Low risk	The study protocol was available (NCT01226459 as well as MINALO3005, EudraCT 2010‐019881‐96), and the trial reported all outcomes listed. Comment: we judged this as at a low risk of bias.
Other bias	Low risk	Comment: the study appeared to be free of other forms of bias.