Sujal Shah: Yes. Thank you for the questions, Steve. Maybe Chuck, you want to give some commentary?
Chuck McWherter: Yes. So, I think it’s a very good observation, Steve. Appreciate that. As you may know from our Liver International paper, which was an €“ and as you may know from our Liver International paper, which was an open label study, we did show improvements in those measures in the PBC-40 the sleep disturbance domain, as well as in the sleep measures as well. And then on fatigue, in that study that was a paper diary driven assessment in enhanced and now in RESPONSE, we’re also measuring those as well as you €“ that’s the answer to your question. But we’re using that electronic diary. So, we’ll collect that data at frequent intervals. And I think they are secondary endpoints. They’re not statistically powered, but I do expect that they’ll be something that we’ll be very interested to see what the impact to seladelpar to see if we can see a consistent pattern. We’ll just have to wait and see.
Sujal Shah: The only other thing I’d add to that Steve is, from a broad perspective with respect to the program overall, even as we approach top line data in RESPONSE, we’re very focused in continuing to understand these effects in PBC patients even beyond the Phase 3 study. So, of course measuring pruritus, collecting PBC-40 and understanding the potential effects of seladelpar on fatigue and sleep disturbance and even looking at the effect of seladelpar on liver enzymes, including ALT in particular, I think a support for how anti-inflammatory this mechanism is. These are all areas in which we continue to dig and continue to invest resources because we do agree with you. These may be very significant differentiating features, not just from existing treatments for patients with PBC, but potentially from other treatments that are in development currently as well.
And so, you’re going to continue to see us invest in these areas in particular. And as we’ve done really since 2015 when we first started developing seladelpar for patients with PBC, anything that we learned through this additional work, we would look to share at medical meetings and eventually publish as we have done historically.
Steven Seedhouse: That’s great. I just want to ask about the pruritus endpoint as well, obviously given how important that is and you guys may be able to separate yourself from the pack there. So, just specifically on how it’s €“ first, I’m curious if you can share like the proportion of patients in the study you expect to qualify for the analysis based on the baseline NRS greater than or equal to 4 criteria? And then, this is measured I believe is a weekly average at a 6-month time point. And I’m just curious, logistically how that works, if that’s sort of the weekly average of every measurement from day 0 to month 6, or is this around month 6 or is there some grace period where you let patients get to steady state and then start measuring? Just be curious to know that in terms of trying to handicap the outcome here at the 6 month analysis? Thanks.
Chuck McWherter: Yes. Thanks for the question. As you know, we’ve have quite a bit of experience now, Steve, in measuring this. The electronic diary has the patients enter their NRS and at certain intervals other quality of life measures daily. So, the NRS is collected daily and the baseline is defined as an average that’s taken over the run-in period. Then throughout the first 6 months, they continue to answer every day. And I can say that at least in the ENHANZE study, the compliance was very high. So, patients are very good about entering their data. And the recall period is, what was their itch like in the past 24 hours in the last day. So, they collected daily through 6 months and the 6 month time point is the average of the last 7 days.
