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Design
Randomised (allocation concealed*), blinded (outcome assessor),* placebo controlled trial with a 2x2 factorial design and 4.5 year follow up.
Setting
Subtropical Queensland, Australia.
Participants
1621 participants (mean age 49 y, 56% women) who were 20 to 69 years of age when they completed a skin cancer survey in 1986, had completed a second survey in 1992, and had a complete skin examination by a dermatologist with removal of all diagnosed tumours of the skin. Follow up was 85%.
Intervention
Participants were allocated to 1 of 4 groups: daily use of sun protection factor 15 plus broad spectrum sunscreen (to cover exposed sites on head, neck, arms, and hands) and ß carotene, one 30 mg tablet/day (n=404); daily sunscreen and placebo tablets (n=408); ß carotene alone (n=416); and placebo alone (n=393). Participants in the ß carotene alone or placebo alone groups were told they could continue using sunscreen at their usual
Christopher Del Mar, MD, BChir, MA
University of Queensland Herston, Queensland, Australia
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