ROME
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A randomized double-blind placebo-controlled trial for the evaluation of a Polycap, low dose aspirin and vitamin D supplementation in primary prevention.

The TIPS-3 trial will provide new information regarding the role of Polycap, aspirin and vitamin D in the prevention of several of the important chronic diseases, including CVD, fractures and cancers, in middle and old age.

This large, international, multicenter, randomized study will have a 2 x 2 x 2 factorial design and will randomize approximately 5,000-7,000 individuals from approximately 5-10 countries. Participants will be followed for an average duration of about 5 years.