And therefore, you’re in a situation of high stress like the pandemic, COVID-19. Even an independent interview is not going to protect you against spontaneous remissions. So I think that it’s really the nature of the population that is very hard. And had those patients with spontaneous remissions have been assigned to active treatment, right? Instead of the placebo in those sites where they outperformed the placebo, outperformed the drug, the drug would have looked fantastic. So you often hope the randomization takes care of it. But at the level of a given site, you don’t know if randomization will protect you against these spontaneous remissions. But the odds of those spontaneous remissions are far greater in a monotherapy trial where you’re recruiting only acute depressive episodes.
Andrea Tan: Got it. Okay. And then maybe one last question, if I could squeeze it in for you, Sergio. Just wondering if you could provide more color on the additional studies that you mentioned that you’re thinking of conducting. Would this be for monotherapy specifically? Or is this, I guess, maybe under the condition that RELIANCE I is maybe not successful and you would have to do a second Phase III trial for adjunctive? Thank you so much.
Sergio Traversa: Yes. No, thank you, Andrea. Look, as much as I wish, we really need — we want to see RELIANCE I data result before and — before we make any decision. Because moving forward, we’ll probably go — continue to go into the treatment of patients that did not respond adequately to a treatment. And so the RELIANCE I data, very important critical to understand how we will move forward. The FDA, we believe they will want too positive Phase III data. So we’ll be planning accordingly. Because in depression, it’s not unusual to have failed study and they had, I believe, three out of five failed studies and the first two Prozac studies failed. So it hurts when that affect directly, but it’s not very unusual. So we will really base the plan based on the first adjunctive trial result.
And we are planning to start at least one more trial, but we will a lot more precise in January after we see the 301 data in — we believe in December. Sorry for that. But we’ll give you all the information as soon as we have more accurate plans to how to move forward.
Andrea Tan: Great. Thanks everyone.
Sergio Traversa: Thanks, Andrea.
Operator: And now we will move to Andrew Tsai, Jefferies.
Andrew Tsai: Hi, thanks and good afternoon. Thanks for the questions. It’s unfortunate to see RELIANCE III, but hopefully, things get better from here. So first question is for RELIANCE III, the outlier sites. What percentage of all patients enrolled in RELIANCE III did these outlier sites enroll? And then what percent of patients in those outlier sites, I guess, do you think will be enrolled in RELIANCE I and RELIANCE II, respectively?
Sergio Traversa: Yes. Thanks, Andrew, for the question. It’s a little bit difficult to answer precisely. But like the — roughly the site that had results that we define paradoxical, the placebo outperformed the drug for whatever reason. And they enrolled about between 25% and 30% of the patient in RELIANCE III in the monotherapy. In the first adjunctive, it’s unfair to make a comparison with the same site because as Dr. Fava said, the patient population is different. So these sites, clearly, they enrolled 30% — between 30% and 40% of the patients. But the patient population is different, then we don’t know how these studies really perform the diagnostic of the patient. And it may be different. We hope it’s going to be different from monotherapy.
But in terms of like the percent of patients was between 25% and 30% in monotherapy and it’s going to be between, I would say, mid-30s in — maybe a little bit more than that in the first trigger one — the first adjunctive trial. None of these sites is in RELIANCE II.
