COVID-19
Due to COVID-19 and a temporary reduction of physical visits at the outpatient clinics, some changes had to be made with regard to the visit schedule of randomized patients to maintain a total of three and preferable four visits. When the closing visit at t12 was missed, this was rescheduled at the first convenient moment in time to stay as close as possible to a 12 months follow-up. Because of this change in schedule, data were analyzed in accordance with their visit number: visit 1 = t0, visit 2 = t3, visit 3 = t6, and visit 4 = t12.