 The study period will consist of a 2-week screening period and a subsequent 52-week treatment period. Participants fulfilling the inclusion criteria and do not meet any of the exclusion criteria at the start of the screening period Week -2; Visit1 and also at the end of the screening period Week 0; Visit 2 will be enrolled in the study, and will receive 1 mg of TVP-1012 once daily for 52 weeks, in an unblinded manner, from the day after Visit 2. 