**7. Long-term follow-up of TDR patients**

The initial CHARITÉ was planned with a 2-year follow-up period. At the request of the FDA the follow-up period was extended to 5-years and the sites requested to participate in the "new" 2 to 5 year follow-up period. Multiple sites did participate in this extended reporting period and formed the basis of the 5-year CHARITÉ results. The CHARITÉ 5-year ODI and VAS results (Figure 2a and 2b respectively) were substantially the same as the 2-years follow-up results60. Despite the prospective collection of the these results, critics formulated objections to these reported good results61.
