Good morning and good afternoon, everyone. My name is Dr. Villy Valcheva, and I'm the CEO of GH Research. I'm really excited to be here today to present the results from our double-blind, placebo-controlled phase IIb trial with an open-label extension to determine the safety and efficacy of GH001 in patients with treatment-resistant depression. I know many of you have seen the press release; nevertheless, there's a lot more exciting data to come in my presentation. On this slide, there are certain important legal disclaimers which you should read in full. These disclaimers include the fact that this presentation has been prepared for informational purposes only, and that it may contain forward-looking statements which are subject to risks and uncertainties, including those described in our public filings. Additionally, this presentation includes cross-trial comparisons that were not conducted in head-to-head trials and which have different designs, endpoints, and patient populations, and therefore results may not be comparable. I know that everyone is awaiting eagerly to see the efficacy and safety results from the trial, but before that, let me just go through the design of the trial. The trial had a double-blind part and an open-label extension. We've recently completed the double-blind part. The open-label extension is still ongoing, with last patient, last visit expected at the end of Q1. Our primary endpoint is the mean change in MADRS between GH001 and placebo at day eight. Because GH001 demonstrated ultra-rapid efficacy in previous trials, we also measure MADRS at two hours and day two. All patients from the double-blind part transition directly from day eight to the open-label extension. In both the double-blind part and the open-label extensions, patients are given individualized dosing regimen, or we call it an IDR. The IDR consists of three increasing doses of GH001 on a single day, where the second and the third dose are administered only if the patient tolerated well the previous dose and the patient did not achieve intense psychoactive effects. In the double-blind part, patients received single IDR GH001 or IDR placebo. In the open-label extension, patients could receive up to five additional retreatments. Now, many of you have previously asked me about the retreatment criteria in the open-label extension, so now we have disclosed that, and I'm just going to quickly explain to you how we retreated patients. Patients were retreated based on severity of depression and the effectiveness and tolerability of the previous dose. We also used the MADRS cutoff of 18. So if the MADRS was more than 18, the patient would get a retreatment. If the MADRS was between 10 and 18 and there was no remission at the previous visit, then again, the patient would get retreatment. If the MADRS was between 10 and 18 and there was remission, but after that, they saw a MADRS more than 18 before this visit, again, patients would get retreatment. These retreatment criteria were very thoughtfully selected with KOLs. They aimed to bring the patients in remission and keep them in remission. And the open-label extension very much followed real-life clinical practice. That's why a lot of the psychiatrists and KOLs are looking forward to the data from this open-label extension. During the open-label extension, patients had monthly visits, but they could also schedule an additional visit if needed. As part of the trial conduct, we implemented steps to validate that we enrolled true TRD patients in the trial. We avoided professional patients, and we also minimized the placebo effect. So what were these steps? The patient diagnosis of recurrent or single major depressive episode without psychotic features was done by the psychiatrist at the clinical site, and they used a short structured diagnostic interview, which was called the MINI. Once the psychiatrist on site completed all required assessments to diagnose the patient with TRD, we had a second step, and this was the MGH SAFER. The MGH SAFER is an independent interview which is conducted by experienced clinicians from Massachusetts General Hospital. Their goal is to confirm the diagnosis, to confirm the number of prior treatments, but also to identify the patients who would be valid for the clinical trial. This is really helping because SAFER is known to increase the quality of clinical trials. It improves the separation of placebo responders from active drug responders, and it minimizes the risk that factors who are unrelated to the treatment may determine the patient's outcome. The patients enrolled in the trial had to have HAM-D17 higher or equal than 20, which indicates moderate to severe depression, and there were non-responders to more than two and less than five oral antidepressant treatments. Very importantly, psychotherapy was not considered a treatment for the purpose of defining TRD. To summarize, some of the measures that we have undertaken to enroll true TRD patients and minimize placebo effects, as I said, independent raters with regards to eligibility assessment using MGH SAFER. At site, we made sure that there's blinding. The patient-facing clinical trial team was blinded. The patient was blinded, and the study drug was in a blinding bag, whether it was GH001 or placebo. Very, very importantly, we had blinded independent raters about 40 efficacy assessments. MADRS, HAM-A, and CGI-S were performed by blinded, trained independent raters. Now, moving on to the patient characteristics, 40 patients were enrolled in the GH001 arm and 41 in the placebo, and none of the patients discontinued the double-blind part. There were 60% of the patients that were female. Importantly, when you look at previous use of any psychedelic in a lifetime, there was a very low percent of those, so 10% in the GH001 arm or only 4%. This is important since the FDA has set up these criteria when running TRD trials with psychedelics. The patients in the trial were severe or moderately depressed. You can see that the HAM-D17 is 25, and the mean MADRS total score at baseline is 29. They had two major depressive episodes, but a large proportion of the patients, 35%, had three or more than three episodes. The time since last depression was 11 years, and the duration of the current depressive episode was 50 weeks. A question that we often get, and we can finally answer with our phase II-B data, is how many doses do the patients get within the same dosing day. So if you look at the IDR doses, the majority of the patients need two doses, 6 and 12. So that's 52% of the patients. And then a quarter needs 6 milligrams, so one dose, and a quarter needs all three doses, 6, 12, and 18. Also, really interesting and important, the duration of the psychoactive effect in minutes is approximately 15 minutes, a little bit less with the 6 and a little bit more with the 18 milligram dose. And now, in the next slide, let me review the results from our primary endpoint. GH001 led to placebo-adjusted mean MADRS reduction of minus 15.5 points on day eight, which was highly statistically significant. GH001 led to ultra-rapid MADRS reduction as soon as two hours and also on day two. To put these large effect sizes in perspective, the current treatment that is our benchmark and is approved by the FDA is Spravato, and their approval was based on the TRANSFORM-II study, where Spravato with antidepressant arm led to a difference of minus four points from the placebo and oral antidepressant group at day 28, which was statistically significant. Another treatment that is approved for TRD is quetiapine. It's a second-generation antipsychotic. It led to three points MADRS reduction between the quetiapine and antidepressant arm versus the placebo and antidepressant arm. When one of our top KOLs saw the MADRS effect size for the first time, he said, "Ultimately, it's the magnitude of the benefit and sustainability of the benefit that truly matters." So I would like to show you on the next slide how this primary endpoint actually translates into all clinically relevant endpoints. Starting with remission, here on this slide, you see in dark green the remission rate with GH001, in light green the response rates with GH001, and in gray the placebo responses. Remission in the trial was defined with MADRS less than 10 or equal, and response was defined as reduction in MADRS of equal or more than 50%. As you can see, GH001 led to a statistically significant difference in both response and remission at any time point, two hours, day two, day eight, a remission rate of 57.5% on day eight compared to 0% in placebo. This is really important because the large effect size in MADRS translates into responses and remission. These responses and remission make the MADRS result really clinically relevant. I will present to you as well the secondary endpoints that are also really clinically relevant. This would be very important. Our KOL feedback is that these high remission and response rates correlate with the large MADRS effect size and are clinically meaningful for TRD patients. If we look at the next slide on the CGI-S total score, that would reflect this opinion of the KOL. The CGI-S is the Clinical Global Impression Severity Scale. It reflects the severity of the patient illness as perceived by the clinician. It's a seven-point scale. The TRD patients in our trial had a baseline score of approximately five points. Five points on the CGI-S means markedly ill. This means that the patients have intrusive symptoms that distinctly impair social, occupational function, or cause intrusive levels of distress. GH001 led to 2.4 points reduction of the CGI-S score. Therefore, patients shifted towards a less severe state by two or three full points on the scale. And that would mean that from a five, markedly ill, the patients on GH001 moved to three, which is mildly ill, and two, borderline mentally ill, which means that they have subtle or suspected pathology. This reflects a considerable reduction in the severity of the patient illness as perceived by the clinician. Another scale that is clinically relevant is the HAM-A Scale. The Hamilton Anxiety Scale assesses the severity of anxiety symptoms as part of the overall depressive symptoms. Anxiety is a very impactful symptom of the disease. A change of minus 11 points with GH001 versus 1 point with placebo on the HAM-A Scale indicates significant noticeable decrease in the overall anxiety level as part of the depressive symptoms. According to our KOLs, most of the other TRD treatments do not work as well on anxiety, and GH001 can be really beneficial for TRD patients with high anxiety levels and Hamilton A above 16. The last, but also very important clinically relevant scale is the Q-LES-Q-SF questionnaire. The Q-LES-Q-SF is a tool designed to measure the patient's enjoyment and satisfaction with various aspects of life, such as physical health, mood, work, household duties, schoolwork, leisure time activities, social and family relations, and overall well-being. It's a questionnaire that the patients complete themselves. You can see that GH001 led to a significant increase of 20.6 points on the Q-LES-Q-SF scale, which suggests a significant positive shift in the quality of life, and that consistently correlates with the large MADRS reduction and the high remission rates. As Spravato is now an approved and established treatment for TRD patients and recently also received approval as monotherapy, it is often used as a benchmark with regards to the outcomes and delivery model for GH001. While head-to-head studies haven't been conducted, I just wanted to show you the MADRS reduction in our trials and the MADRS reduction in key Spravato trials. As monotherapy, which is the light yellow bars, Spravato 84 milligrams led to minus 3.4 points and minus 6.8 points placebo-adjusted MADRS reductions at day two, which was their key secondary endpoint, and day 28, which was their primary endpoint. These results are from the TRD 4005 trial, which was presented at ECNP last year and based on which Spravato was recently approved as monotherapy. GH001, also as monotherapy, led to placebo-adjusted MADRS total score from baseline of minus 17 points at day two and minus 15.5 points on day eight, which is our primary endpoint. In darker yellow, the TRANSFORM-II trial, based on which Spravato was approved for TRD, showed that the Spravato with antidepressant arm, MADRS total score difference from the placebo plus antidepressant arm was minus 4 points. I also want to show you the remission rates on the next slide. So you can see that GH001, as previously demonstrated, led to a 70% remission rate on day two and 57.5% remission rates on day eight. While Spravato monotherapy 84 milligrams led to remission rates at 15% and 10% on day two and day eight, and their primary endpoint was at 28 days with a remission of 21%. And now on to the safety results, very, very important. So GH001 was well tolerated. We had no serious adverse event reported. All treatment emergent adverse events were mild or moderate. We had no severe adverse events. The most common treatment emergent adverse events in patients treated with GH001 were nausea, salivary hypersecretion, paresthesia, headache, and dysgeusia. No treatment emergent events of flashbacks were reported, a question that I really get very often. There were no treatment emergent adverse events related to vital signs or ECG, and no clinically significant changes in blood pressure and heart rate. There was no evidence of treatment emergence, suicidal ideation or behavior, or treatment emergent BPRS symptoms. There was no dissociation, no sedation at discharge, and 97.5% of the patients were discharge ready within one hour of the last dose. So here, on the next slide, you can see the overview of all adverse events. You can see, as I said, that all treatment emergent adverse events were mild and moderate. And just to put it in perspective, mild treatment emergent adverse events would usually be around the psychoactive phase, and when the psychoactive phase subsides, they would resolve spontaneously. So a headache would be around 10 minutes. It wouldn't require additional treatment, and it would resolve within those 10, 15 minutes. With regard to the other events, very similar, so salivary hypersecretion, that would mean increased salivation during the inhalation. Paresthesia would mean some tingling or prickling in the muscles, and then dysgeusia would be some metallic taste after the inhalation. Very important data from our safety analysis is the C-SSRS data. The trial excluded patients who had suicidal ideation with intent or suicidal behavior with attempts for suicide. We allowed patients only with suicidal ideation, as you can see on the slide. At baseline, there were seven patients in the GH001 arm with suicidal ideation. At day eight, there were four patients in the GH001 arm that had suicidal ideation, and these were the same four patients from the seven at baseline, so there were no new patients with suicidal ideation, and there was no evidence of treatment emergent suicidal ideation or behavior after GH001 treatment. Now we continue with some data from the open-label extension, which has been eagerly awaited by many who follow us. So I must say that the open-label extension is ongoing. As I said, it's due to complete with last patient last visit by the end of quarter one. This data that I'm presenting is with a cutoff of 22nd of January 2025. Just as a reminder, if you look at the design of the trial, all patients transitioned to the open-label extension after day eight of the double-blind part. As I explained to you earlier, there were specific retreatment criteria. So the placebo patients who would have placebo IDR in the double-blind part and would not have response, they would meet the retreatment criteria and crossover to active treatment in the open-label extension. Therefore, all 81 patients then are on active treatment, GH001, during the open-label extension, and they are allowed for up to five additional retreatments. As a reminder, patients had monthly visits, but that did not mean that they need to have a retreatment, and they can also schedule an ad hoc visit if they needed it for medical reasons. Right, and on to the results of the open-label extension, so first, the status. As of January 22nd, there are nine patients ongoing in the open-label extension. In fact, as of today, one more patient completed, and four are imminent to complete the trial in February, so there will be only four patients remaining in March. 54 patients completed the open-label extension, and the analyses I'm presenting here are based on these 54 completers, and we had 18 early terminations, which is comparable to other antidepressant trials. Of note, only one discontinuation due to an adverse event. From the patients who completed the open-label extension, 77.8% of the patients were in remission at six months, and of note, 81.5% were also responders, so you can see that the remission rate is not only sustained at six months, but it's actually increasing with time. The completers, so irrespective if they were in remission or not, all 54 completers, their mean MADRS total score was 8.6 at six months, and 63% of the patients received between one and four treatments with GH001. As of January 22nd, no serious adverse events have been reported throughout the open-label extension. Of note, safety analysis has not been performed because the open-label extension is still ongoing. When we talk about 63% of the patients receiving one to four treatments, now we can compare the number of visits required between GH001 and Spravato for six months. So if we take an average of four visits in clinic with GH001, this leads to 83% fewer treatment visits with GH001 than with Spravato. And as you know, the remission rates with GH001 at six months are 77.8%. This shows that GH001 has the potential in the future to fit in the interventional psychiatric clinics and not only, but also improve significantly on the treatment model and the number of patients that could be treated in those interventional psychiatric clinics. Some additional data from the open-label extension. This is data that the QOL truly appreciated. To the left, you see the MADRS reduction in the double-blind period with GH001 that I showed you. This is the MADRS reduction of 15.5 points versus the placebo arm. To the right, you see the MADRS reduction in an entirely new cohort. As I told you, the 41 patients on placebo in the double-blind crossover into the open-label extension. And since they had no remission, as I showed you, there were zero remissions in the double-blind part with placebo, they all got retreated. So you can see the first active treatment results from the 41 patients that were on placebo in the double-blind part. And what we show is that the MADRS reduction is entirely reproduced in a new cohort of patients. Also really interesting data, really important, is that patients who had remission on day eight, also 91.7% of them had remission at six months. I think this is really strong validation of the primary endpoint at day eight because having a remission at day eight pretty much means that you have a very, very high chance to also have a remission at six months. Not only this, but if you look at the next slide, when GH001 is given for a retreatment, it works consistently with a rapid reduction in MADRS after each treatment. The first is the active treatment in the double-blind. Treatment two, these would be all patients that needed a second treatment. Treatment three, treatment four, treatment five. You see consistent reduction in MADRS. The KOLs thought this is very, very important data. It's reassuring for them that GH001 would work for the patient every time they needed. To summarize the open-label extension, these results are based on 54 patients who completed the full six-month extension to date. 77.8% of those patients were in remission, which means MADRS less than 10, and 81.5% were responders. The mean MADRS total score at six months, irrespective if they were remitters or not, was 8.6. Majority of the patients needed between one and four treatments with GH001, on which basis we believe that GH001 could reduce the number of administrations in an interventional psychiatric clinic by 83% compared with Spravato. 91.7% of the completers who had remission at day eight also had remission at six months. And while safety analyses have not been performed because the open-label extension is ongoing, as of January 22nd, there were no serious adverse events reported. And finally, let me take a moment to summarize overall this exciting data that we've presented today from our phase II-B trial. In the double-blind part, the trial met the primary endpoint. GH001 led to MADRS reduction from baseline of minus 15.5 points on day eight compared with placebo, and this was a highly significant difference. All secondary endpoints were consistent with the primary endpoint, and as I showed you, they were clinically relevant. And with regards to safety, GH001 was well-tolerated, no serious adverse events reported, and very importantly, no evidence of treatment-emergent suicidal ideation or behavior. From the open-label extension, the key takeaways are that GH001 shows durable effect, can maintain the patient in remission for a long time with 77.8% of the TRD patients in remission at six months. This is achieved with relatively infrequent treatment visits and rapid reduction in MADRS after each GH001 treatment. And as of January 22nd, there were no serious adverse events reported. With that conclusion, I come to the end of my presentation. I look forward now to a discussion and your questions, so I'll hand it over to the operator for next steps. Thank you. As a reminder, to ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. We will take our first question. Our first question comes from the line of Ritu Baral from TD Cowen. Please go ahead. Your line is open. Good morning, guys. Thanks for taking the question, and congratulations on this data. A couple of questions, Villy. One, the responders, the remitters at hour two, were they the same as the remitters at day eight? And was there anything unusual about the patients that responded at the time point in between, but then may have lost their remission? And then I've got a quick follow-up on safety and tolerability. Hi, Ritu. Thank you. So yeah, so very much so with the answer. The majority of the patients who were in remission post-dose were also in remission at day eight. With regards to the patients who had higher remission rates at day two, you need to remember that they were just in a clinical trial surrounded by their clinical trial team and physicians, so that could explain a little bit higher rate on day two. Nevertheless, they get back home, and at day eight is the one that we really should focus where we've achieved very high remission rates of 57.5%. Thank you. We will take our next question. Your next question comes from the line of Paul Matteis from Stifel. Please go ahead. Your line is open. Great. Thanks so much. And let me add my congrats on the data. I wanted to ask a few forward-looking questions beyond these data. So maybe the first is just, one, can you explain your level of confidence and why you're confident in resolving the clinical hold this year with the FDA? Two, on your proprietary device, can you just walk through the evidence and data you have now, either preclinical or any clinical, that shows that this proprietary device can recapitulate the exposures with the device used in this phase II-B? And then three, I know you need to engage regulators, but what's your perspective right now on whether phase III studies would have a placebo again or some sort of subclinical active comparator? Considering the FDA, I think will probably acknowledge that functional unblinding is inevitable in these types of studies, but has asked some other companies to use subclinical psychedelic as a sort of surrogate for placebo. Thank you. Thanks a lot, Paul. So first, with regards to the hold, we now have the full package with everything that the FDA have requested from us. So we've generated the non-clinical data. And as we announced in our last press release, our non-rodent study, which is a dog study, is clean, and we have no toxicity at any dose in any organs in any dog. So the non-clinical package is ready. And then on the device side, we've already previously engaged with the FDA. So we had the responses from them. We had sufficient time to collate what is needed. In fact, a lot of the information was already in the original IND, but we just needed to add clarifications and additional information. So with the two parts, we are now ready to get back to the FDA. Our next step would be to meet with them. The FDA would decide in what way and when they're going to give us a meeting, which kind of gives the timing that we are uncertain as of yet. And after that, the plan is to submit the complete response and address the hold. And on your second question, with regards to the FDA and their requirements for pivotal program, I mean, Tiffany herself said that when it comes to psychedelics, I'm quoting, they recently had a placebo workshop where she also spoke on the trial design of pivotal programs as well as the functional unblinding. So she said, "When it comes to psychedelics, blinding isn't possible, but we need placebo-controlled studies to assess safety." And she said that adding a comparator is not possible, and the best is to have a placebo study and then do assessments, including unblinding questionnaire, anticipation bias questionnaire, etc. And we also have examples of other companies that have disclosed that they've started their pivotal program, and their two pivotal trials are placebo-controlled. So I guess from my point of view, once we address the hold, the next step would be to meet with the FDA, discuss our pivotal program, and do what's best for GH001 next stages of development. I think that was it on Paul's questions. Yeah. Thank you. We will take our next question. Your next question comes from the line of Sumant Kulkarni from Canaccord Genuity. Please go ahead. Your line is open. Great to see these data, and thanks for taking our questions. You provided some really helpful detail on the cutoffs used for retreatments, duration of psychoactive effects, and other important variables related to safety, and also the clinical visits required. But if one were to translate this individualized dosing regimen to the real world at a time when, let's say, this product is approved, how many mandatory clinical visits in a six-month timeframe would satisfy the requirements of the IDR for a patient, regardless of the actual number of doses administered? And what's the actual time spent in the clinic for the treatment on a day or in total for this IDR over a six-month timeframe? Great question, Sumant. Thanks very much. So I think in the future, the number of visits would follow clinical practice, right? And don't forget, in our trial, we brought them monthly because this is the first time we're doing an open-label extension. It's a phase II-B trial. We wanted to understand what would be the treatment paradigm with GH001. Also, don't forget that in our trial, while we brought them monthly, this didn't mean that patients have to be retreated monthly. And they were also allowed to have an ad hoc visit if in between visits or at any stage they felt that their depression is getting worse. So I think in the future, the number of visits would follow clinical practice. As already was made a point, we had very bold and aggressive retreatment criteria because we wanted to bring the patient in remission. As you see, the drug works every time the patients need the treatment. Nevertheless, I can tell you we had a lot of patients at the different time points that didn't make the cut by two points, so they had MADRS of 11 or 12 or 13 or 14. So in a clinical trial, you would follow strictly, but in real-life practice, a patient with 11 probably wouldn't need to go back to the clinic, and they will be fine. With regards to the duration in clinic, very important question, so as you saw, 97.4% of the patients in the trial were discharge-ready within one hour after the last dose. That's a big advantage, and patients, when they're discharged, there's no dissociation, and there's no sedation, okay? Majority of our adverse events would be mild, so they would usually resolve around the psychoactive phase. And then you see majority of the patients need between one and two doses. So depending on how many doses the patient would need, we would foresee between one and a half hour up to three hours, which is very similar to Spravato as a duration. I would say even a bit shorter. The observation period is shorter. And the fit of GH001 in the interventional psychiatric clinics is, at the moment, really good. We have visited few, and they definitely see us fit there. Thank you. We will take our next question. Your next question comes from the line of Jason Butler from Citizens JMP. Please go ahead. Your line is open. Hi. Thanks for taking the question. And let me add my congrats on the results. Villy, just wondering if you could comment on whether the number of IDR doses required in a visit stayed consistent in the open-label extension study versus the proportions you gave for the double-blind period. Thank you. Thanks a lot for the question, Jason. I'm afraid that's one that I wouldn't be able now to address because we need to generate data on that and look into it. But I can tell you from investigators that I've met that there might not be a correlation. Maybe sometimes they need three doses. Maybe at next visit, they would need less. One thing I know for sure is that all the investigators in the trial really appreciated the 6 milligram dose as a first dose. It seems to be like a primer, right? And also, it seems to enable the patient to understand what's coming and help them let go. So that's as much as I can say. But it's data that we would look to generate because a lot of people have asked about it. Thank you. We will take our next question. Your next question comes from the line of Patrick Trucchio from H.C. Wainwright & Co. Please go ahead. Your line is open. Thanks. Good morning, and congratulations on the data. I have a follow-up question on the dosing. I'm wondering if you can tell us a little bit more how it was determined if patients would need to titrate, or how it's determined if a patient needs to titrate to a higher dose on the day of the visit. And is there an expectation to bring a particular dose or regimen forward to phase III based on the learning from the phase II-B trial? And if I could, just on the OLE, just on this increase in remission over time, what was the trend of that remission? Was it still increasing at the time of cutoff, or had it stabilized? And what would explain that increase in remission? Okay. Thanks a lot, Patrick. So on the first question with the IDR, first, the patient has to tolerate the previous dose. That's very important. Secondly, the patient, if they had some psychoactive experience, the clinician would wait for it to subside. Usually, if you need another dose, you would have a few minutes, or it would be very quick. And the third part is that the goal of the IDR is to achieve this maximum psychoactive experience. The reason for that is, as you see, we had it from previous phase 1/2 data, but now also we see that when we achieve this psychoactive experience, we have really good outcomes, large effect size with regards to MADRS and large remission rates. So the way we assess the psychoactive experiences, the patient answers three simple questions: how intense was the experience, how profound was the experience, and how much did you feel you lost control. Based on these three questions, you could then discuss and decide whether the patient has achieved this intense psychoactive experience. That's in summary. I'm not going to go into detail. Okay? And then the second question, I think I didn't get it. What was the trend of remission over time? What was it? Just on the OLE, yeah, the trend in that remission, and what would explain that expansion of remission? Yeah. Well, so you saw that patients needed between one and four treatments, right? So the way it works is that if you have, let's say, a baseline MADRS of 29, and at your next treatment, your MADRS is 19, and then you get another retreatment, and your MADRS gets 10. So with the retreatments that work every time, you increase the number of patients who are in remission. That's what it was. It's just the drug works, and the overall baseline goes down. And you saw that at the end of the six months, our mean MADRS, whether they're remitters or not, is 8.6, which means that a lot of the non-remitters as well have a lot lower MADRS from what it was at baseline. So ultimately, the drug with every retreatment lowers the MADRS of the patient. That's how. The goal of the trial and the open-label extension was to have as many patients as possible in remission. Thank you. We will take our next question. Your next question comes from the line of Elemer Piros from Rodman & Renshaw. Please go ahead. Your line is open. Yes. Thank you very much. Villy, I may have missed this, but were these patients on antidepressants, or were they washed out? And secondly, were you able to identify the reason for discontinuation? I think you mentioned that it was largely not due to adverse events. Okay. So on the first question, yes, Elemer, so patients were washed out, and we have no mandated psychotherapy in the trial. So the efficacy that you see in this trial is the pure pharmacological effect of GH001, which indeed is a very, very important point. So thank you for bringing it up. And on the second question of discontinuations, as I said, discontinuations were comparable to other trials. We had one due to an adverse event, and the other discontinuation, so unfortunately, we had also patients in remission who discontinued, and we withdrew consent. They were just doing fine, and we couldn't follow them up. So that's one thing that I regret. And in the pivotal, we'll be learning how we keep these patients. Some of them were doing well and just started an antidepressant. We did not allow patients who started a new antidepressant to remain in the trial. So they were also discontinued. We had two protocol deviations. We only had one patient who discontinued due to worsening of depression. So nothing in particular that would stand out as a reason. I guess the majority would have been consent withdrawn, but that would include patients in remission who also just went on with their life, I guess. Thank you. We will take our next question. Your next question comes from the line of Ritu Baral from TD Cowen. Please go ahead. Your line is open. Hi, guys. This is Athena Shan for Ritu Baral. Thanks for taking the follow-up. We did want to follow up on safety and tolerability, specifically around your discharge criteria at day eight and what that consists of. And were any of the symptoms during the psychoactive phase hallucinogenic in nature? Thank you. Thanks a lot, Athena. And I'm glad you managed to get back because Ritu said she had a safety question, and we couldn't hear it. So yeah, the patients at discharge, we had the discharge readiness scale, so it had to be completed, and all questions had to be answered yes so that the patient could be discharged. As you saw, we also have MOAS and CADSS, so we've assessed sedation and dissociation. So for patients to be discharge-ready, they had to have no sedation. They had to have no dissociation. And the PI or the investigator had to be sure that the patient is ready for discharge. All of that happened within one hour, okay? And with regards to hallucination, we only had one reported, which was right after the dose, the patient saw visual hallucination of a bright light, and that went for one minute. So yeah, we don't see after that. During the psychoactive effect, as you know, patients, there's this ego dissolution, no time, no space. But we've only one hallucination of one minute of a bright light reported. Thank you. This concludes today's question and answer session. I'll now hand back for closing remarks. I want to thank everyone for listening to our webcast, and I want to thank all the investigators that supported us with the phase II-B trial. These results are really important to our company, and we're delighted to have come to this stage where we can present the data to you. I hope you enjoyed it. Thank you very much.