The treatment period in both study arms will be 3 months. The participants should use (and accurately report) their usual symptomatic or acute treatment, because not anticipated to interfere with the study medication. During the 3-month treatment period, participants will be evaluated at monthly intervals by the study coordinator. As determined by the final study compliance, data analyses might be necessary separately for i) Per Protocol (PePr), and ii) Intention-to-treat (ITT) groups.