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. 2017 Sep 24;7(9):e016487. doi: 10.1136/bmjopen-2017-016487

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Study visits and procedures. Clinical trial visits are structured in 31 time points, that include three pre-implantation visits (screening, randomization and pre-implantation) and 27 post-implantation evaluation visits according to a decreasing frequency rate: daily (week 1), weekly (month 1), fortnightly (months 2 and 3), monthly (months 4 to 12), and quarterly (months 13 to 24). The procedures and assessments performed are detailed for each visit.