Fig. 1

Parent Study schema. a Naïve patients screening pathway: patients who have not used any prohibited medications within 42 days of screening are “naïve.” Their initial screening visit is treated as visit 1 (baseline 1). b Non-naïve patient screening pathway: patients who have used or are unable to confirm or deny if they have used, any prohibited medication within the past 42 days are “non-naïve.” Patient will be given the opportunity to undergo a minimum of 42 days washout before returning for a repeat visit 1 (baseline 1). From visit 2 onward, the visit schedule is the same for naïve and non-naïve patients