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Patient Zero for Untreatable Depression Begins Groundbreaking Psychedelics Therapy

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In a phase 2b clinical trial, Beckley Psytech has started treating the first subject for BPL-003, an intranasal synthetic formulation of the psychedelic chemical 5-MeO-DMT intended for patients with treatment-resistant depression.

 

With FDA clearance for investigational new medication status in February, this groundbreaking research represents the biggest controlled examination into the potential of 5-MeO-DMT, involving 40 locations throughout Australia, Europe, and the US.

 

The trial, employing a randomized, quadruple-masked design, seeks to identify optimal dosages of BPL-003, complemented by psychological support, in 225 individuals grappling with moderate to severe treatment-resistant depression, compared to a placebo group.

 

Efficacy will be gauged using the Montgomery-Asberg Depression Rating Scale at various intervals throughout the trial, with all participants receiving psychological support before, during, and after dosing. An open-label extension is slated for select sites eight weeks post-initial dosing to evaluate sustained effects following a second dose.

 

Anticipated findings from this phase 2b endeavor, projected by late 2024, will augment insights gleaned from the ongoing phase 2a exploration of BPL-003, as highlighted by the company.

 

Cosmo Feilding Mellen, CEO of Beckley Psytech, expressed confidence in the compound, citing promising safety and pharmacokinetic data. He emphasized its capacity to induce brief yet profound subjective experiences correlating with therapeutic benefits, underscoring the company’s eagerness to advance BPL-003 through the clinical development pipeline.

 

Unprecedented Research Scope

 

An important turning point in the field of psychedelic research, especially in the area of mental health therapy, was reached with the start of Beckley Psytech’s phase 2b clinical experiment. The large-scale nature of this experiment highlights an important development in our knowledge of the therapeutic potential of psychedelic substances, with a particular emphasis on 5-MeO-DMT for patients suffering from depression that does not respond to conventional therapy. This experiment, which spans 40 sites throughout Australia, Europe, and the US, is the biggest controlled investigation into the possible effectiveness of 5-MeO-DMT, in contrast to earlier research. This wide outreach guarantees a varied pool of participants and improves the trial’s outcomes dependability and generalizability.

 

A rising awareness among scientists of the need for novel strategies to tackle the widespread problems associated with treatment-resistant depression is reflected in the decision to launch such an extensive research project. Researchers want to increase the number of therapy choices available for those who have not reacted well to traditional medications by investigating the therapeutic benefits of 5-MeO-DMT in a rigorous clinical environment. The trial’s multi-site design also makes it easier for clinicians and researchers in various areas to collaborate, which promotes a group effort to further our understanding of psychedelic-assisted treatment.

 

The size of this phase 2b experiment not only emphasizes the significance of its findings, but also demonstrates Beckley Psytech’s dedication to pushing the limits of psychedelic research. Through strategic alliances and diligent preparation, the firm has proved its commitment to performing high-quality clinical studies that meet rigorous scientific criteria while investigating novel treatment approaches. This innovative method not only aids the area of mental health treatment, but also helps to de-stigmatize psychedelics by demonstrating their ability to treat significant psychiatric illnesses safely and responsibly.

 

The experiment is expected to yield valuable insights that might influence future research, clinical recommendations, and regulatory choices related to the use of psychedelic substances in mental health therapy. This is because the trial is expected to proceed and data will accrue. Psychedelic-assisted therapy is being promoted as a possible therapeutic option for the intricate problems associated with treatment-resistant depression, thanks to the combined efforts of researchers, physicians, and study participants.

 

Trial Design and Objectives

 

BPL-003’s phase 2b clinical trial has been carefully designed to assess the drug’s potential as a therapy for people with depression who are not responding to conventional treatments. The experiment uses a quadruple-masked, randomized design to reduce biases and guarantee the validity and dependability of the results. This methodological rigor bolsters the foundation for well-informed decision-making on developing BPL-003 and increases the legitimacy of the study’s findings.

 

Central to the trial’s objectives is the identification of optimal dosages of BPL-003 that can effectively alleviate symptoms of moderate to severe treatment-resistant depression. By employing a range of doses and comparing them against a placebo group, researchers seek to discern the therapeutic window within which BPL-003 demonstrates the greatest efficacy while minimizing adverse effects. This dose-finding aspect of the trial is crucial for informing subsequent clinical studies and eventual therapeutic use.

 

The experiment incorporates psychological support as an additional therapeutic component in addition to dose optimization. All patients get thorough psychological care before, during, and following medication since it is acknowledged that depression is a complex condition with psychosocial components that may influence treatment outcomes. To promote complete healing and recovery, this holistic approach emphasizes the need to address not only the biology but also the psychological and emotional elements of depression.

 

Furthermore, the trial’s design includes strong metrics for measuring effectiveness, particularly using the Montgomery-Asberg Depression Rating Scale at several points throughout the research. This validated method enables researchers to systematically assess changes in depression symptoms and track the therapeutic benefits of BPL-003 over time. The trial uses standardized evaluation techniques to improve the consistency and comparability of outcomes across multiple research sites, increasing the reliability and generalizability of the findings.

 

Evaluation Methods and Milestones

 

A wide range of evaluation techniques and milestones are included in the phase 2b clinical study to assess BPL-003’s effectiveness in treating depression that is resistant to therapy. The Montgomery-Asberg Depression Rating Scale, a reliable instrument for gauging depression symptoms and treatment response, is a key component of this evaluation. Researchers can systematically monitor changes in participants’ depressed symptoms and evaluate the therapeutic efficacy of BPL-003 in comparison to placebo by giving this scale to participants at different intervals during the experiment.

 

The study underlines the need to provide psychological support to all participants before, during, and after dosing. This integrated approach stresses the need to meet the holistic needs of patients receiving therapy while also recognizing the complex interplay between biological, psychological, and social factors in depression. The study’s purpose is to improve treatment outcomes and participants’ overall well-being by offering comprehensive psychological support, such as counseling and therapeutic sessions, during the experiment.

 

Furthermore, the trial includes an open-label extension phase at select sites, scheduled eight weeks post-initial dosing, to evaluate the sustained effects of BPL-003 following a second dose. This extension phase allows researchers to assess the durability of treatment response and investigate the potential for long-term therapeutic benefits. By extending the observation period beyond the initial dosing phase, the trial aims to provide insights into the maintenance of treatment effects over time and inform recommendations for the optimal dosing regimen of BPL-003 in clinical practice.

 

Bottom Line

 

Beckley Psytech’s phase 2b clinical trial of BPL-003 for treatment-resistant depression marks a significant milestone in psychedelic research. With its expansive scope, rigorous trial design, and emphasis on comprehensive evaluation methods, the study holds promise for advancing our understanding of psychedelic-assisted therapy. As the trial progresses and data accumulates, it is poised to provide valuable insights that could influence future treatment approaches and regulatory decisions in the field of mental health.

 

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Is the Cannabis Industry Cooling Down or Just Holding Its Breath Right Now?

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The Leveling-Out Has Begun

When Colorado and Washington made history by fully legalizing recreational cannabis in 2012, the industry exploded like a champagne bottle that had been shaken for decades.

Sales surged almost immediately—and why wouldn’t they? Something that had been villainized and pushed into the shadows for generations was suddenly available at clean, well-lit stores with knowledgeable staff. No more texting sketchy dealers or meeting in parking lots. No more “my guy is running late” or “all I’ve got is this mysterious brown stuff.” Americans could finally buy cannabis products with the same ease as picking up a bottle of wine.

This green gold rush continued as legalization spread across the country. New markets opened in Oregon, California, Massachusetts, and beyond, each experiencing their own initial boom as consumers celebrated their newfound freedom. Cannabis businesses sprouted like, well, weeds. Investors poured billions into the sector, expecting an endless upward trajectory.

But something interesting has been happening over the past year or two. After watching this market for the past 15 years, I’ve observed a distinct “leveling-out” in 2024. The explosive growth has given way to a more sobering reality. In mature markets like Colorado, sales have actually declined significantly from their peaks. The industry isn’t collapsing by any means, but that initial euphoria has faded.

Today, we’re diving deep into this cannabis market cooldown. What’s causing this plateau? Is it market saturation, changing consumer habits, pricing pressures, or perhaps broader economic forces? And what can we expect moving forward, especially with the political shitfuckery surrounding cannabis policy at the federal level? Will the DEA’s potential rescheduling of cannabis to Schedule III change the game, or is it just another half-measure that misses the point?

Grab your favorite strain and settle in—we’ve got a lot to unpack.

Let’s face it—cannabis has undergone one of the most dramatic image rehabilitations in American cultural history. What was once depicted as a gateway to madness and moral decay in films like “Reefer Madness” is now casually discussed at dinner parties and openly consumed by celebrities on podcasts. These days, most people across the political spectrum support cannabis legalization in some form. The social stigma hasn’t completely vanished, but it’s fading faster than your memory after hitting a potent indica.

Sure, you still have your occasional media hit pieces about “today’s super-potent weed,” and there’s no shortage of conservative cucks who believe they should dictate what sovereign human beings can put into their own bodies. They’ll raise hell about the “dangers” of legalization while sipping their third bourbon of the evening. But these voices are increasingly drowned out by common sense and empirical evidence.

The truth is that the majority of Americans no longer consider cannabis to be more dangerous than beer. And if Budweiser can drop $7 million on a 30-second Super Bowl ad featuring talking frogs, then bowls of cannabis should be legally available to adults without controversy. This widespread acceptance is a double-edged sword for the industry, though.

When cannabis was first legalized, there was an undeniable electricity in the air. Hardcore stoners who had been advocating for decades were vindicated and celebrated. Curious newcomers who had been cannabis-curious but law-abiding finally had the opportunity to try it in a safe, legal environment. The euphoria of legalization was palpable, almost like fresh lovers high on endorphins and serotonin, eagerly exploring this new terrain of freedom.

However, as with any puppy love, that initial intensity eventually mellows. The novelty wears off. What was once exciting becomes routine. Similarly, the novelty of legal cannabis has faded into normalcy. The “I can’t believe this is actually happening” factor has been replaced with “Yeah, I might stop by the dispensary later, no big deal.”

I hate to break it to you all, but cannabis is now as mainstream as it gets. From soccer moms using tinctures to manage anxiety to lawyers unwinding with a vape pen instead of a martini, cannabis has infiltrated every demographic. College professors, construction workers, retirees, tech entrepreneurs—cannabis use cuts across all social boundaries. It’s just not that edgy or counterculture anymore.

As a result, the cultural force that was driving the cannabis industry in its inception has lost some power. Many consumers assume it’s a done deal—cannabis is legal, accessible, and here to stay. But this complacency is dangerous.

And that’s something we definitely need to address—until cannabis is completely removed from the Controlled Substances Act, nothing is set in stone. Federal prohibition still creates enormous problems for the industry, from banking restrictions to research limitations to inequities in enforcement. Just because you can walk into a dispensary doesn’t mean the battle is over.

The waning of novelty may be inevitable, but the fight for full legalization and normalization continues, even as we browse dispensary menus with the same casual interest we once reserved for Netflix titles.

The cannabis industry’s slowdown in 2024 wasn’t just about market maturation—it was also heavily influenced by the presidential election hanging over everything like a thick cloud of uncertainty. It’s pretty much a given that during presidential election years, cannabis reform tends to stall out as legislators and regulators become hyper-focused on election results and avoiding controversial moves.

The 2024 election was particularly paralyzing due to the vast ideological divide splitting the country. When Donald Trump reclaimed the White House to become the 47th president, the cannabis industry collectively held its breath. After all, the Biden administration had set various cannabis reform wheels in motion—however slowly they were turning—with the DEA’s recommendation to reschedule cannabis to Schedule III being the most significant.

With Trump’s victory, everything suddenly went into freeze-frame. Industry players, investors, and advocates all found themselves stuck in a waiting game, unsure how the new administration would approach cannabis policy. Would Trump honor the rescheduling process already underway? Would he reverse course completely? Nobody knew for certain.

I already told you all that Schedule III was dead on arrival, but the situation is even more complex when you consider who really came into power with Trump. People weren’t just voting for Trump—they were voting for the influence of Elon Musk, Tulsi Gabbard, RFK Jr., and others who have Trump’s ear. That’s why I call him “President Trusk”—because arguably Musk has unprecedented influence over the president’s policies and worldview.

I could go down a deep, dark conspiracy rabbit hole about all of this, but let’s stay focused on the cannabis stuff. What matters is that the industry is now recalibrating and gauging their next steps. We know that Schedule III will likely be blocked or abandoned, and that the only viable path forward is legalization via Congress. However, while that lengthy process plays out—if it even begins—state-by-state legalization must continue to build momentum.

The stark reality is that the next four years will be a roller coaster of unpredictable policies and political maneuvering. Most Americans will be so fixated on the broader cultural and political battles that cannabis reform may fade from the spotlight. The media cycle will be dominated by whatever outrageous tweet or policy announcement comes next, not by incremental changes to state cannabis programs.

I personally have no idea how it’s going to play out, and any analyst who claims they do—unless they have insider information—is lying through their teeth. We’re in uncharted territory with no reliable map.

The truth is that we’re in a weird spot. Without more states legalizing cannabis or expanding their existing programs, the federal government will have little incentive to pursue meaningful reform. The industry’s growth may continue to plateau until there’s a clear signal from Washington.

And let’s not forget, Trump promised the death penalty for drug dealers during his campaign. Will that extreme stance apply to all drugs or just fentanyl? Could the United States become an even more dangerous place for those involved in any aspect of drug policy? The uncertainty alone is enough to make investors hesitant and consumers anxious.

The post-election cannabis landscape isn’t just leveling out—it’s holding its breath, waiting to see which way the wind blows from the White House.

 

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Psychedelics Can Help with Which Severe Mental Health Disorders?

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Which Severe Mental Disorders Can Psychedelics Help With?

Severe mental illnesses refer to conditions that leave the patient with significant functional impairment and extreme symptoms. Sometimes, these may include serious symptoms such as psychosis, which can have harmful consequences if they aren’t diagnosed and treated early on.

Common treatments for serious mental health disorders vary; they usually include a combination of somatic and psychotherapeutic treatments. When it comes to medications, these can include antidepressants, antipsychotics, mood stabilizers, and anti-anxiety medications. Severe cases of depression may require neurofeedback, and other brain stimulation therapies to work. Until now, there is no one-size fits-all solution for mental health disorder treatments; many patients usually find success, if any, in using a combination of therapies for many years – sometimes, for life.

In fact, many patients even develop a tolerance to medications. This can make it difficult to find drugs that work, yet even then, most medications come with unwanted side effects.

But the rise of psychedelic use has brought about promise for those struggling with mental health problems, and their families. No other medication can induce psychological and neurobiological changes the way psychedelics can, thereby improving cognitive function and emotional processing. Psychedelics activate serotonin receptors, enhance neuroplasticity, and disrupt the default mode networks that cause rigid thinking and worsen depression. Because of this, psychedelics are considered a revolutionary treatment for severe mental health conditions that are resistant to treatment.

Check out this list of severe mental health disorders, and how psychedelics can help treat them.

Schizophrenia

Schizophrenia is a severe, chronic mental health disorder that greatly affects the way a person thinks, behaves, and fees. The main symptom of schizophrenia is a serious disconnection and detachment from reality, which can manifest through symptoms of psychosis. These may include delusions, hallucinations, disorganized behavior, and disorganized thinking.

Schizophrenia can be extremely challenging to treat and manage due to many factors, most especially the fact that the symptoms drastically differ from one patient to another. Also, many individuals with this condition don’t respond to conventional treatment.

Many studies have shown that psychedelics are promising for treating schizophrenia and managing its symptoms, allowing patients to regain control and enjoy a better quality of life. That said, it must be acknowledged that small doses of psychedelics are needed because larger doses may have negative effects. Keeping the doses at a clinically accepted low level can induce powerful anti-inflammatory properties especially benefiting patients’ brain function.

Additionally, regulated doses have been found to be well-tolerated and effective in treating several mental illnesses, including schizophrenia, which is notoriously difficult to treat.

 

Borderline Personality Disorder

Borderline personality disorder or BPD is a very complex mental health disorder whose hallmark symptoms include unstable relationships, severe emotional dysregulation, and constant impulsive actions. For this reason, it can also be known as emotionally unstable personality disorder. Some severe cases include high suicidal tendencies.

Successful treatment can feel like an uphill battle, as many patients often drop out. It has become critical to develop new treatments for BPD which have less side effects, and are certainly much more effective.

However, some research has pointed to psychedelic therapy. In one study in particular, authors found that MDMA combined with psychotherapy is effective and safe for treating borderline personality disorder. Researchers found that it provides a safe and beneficial alternative even for treating chronic PTSD, a co-occurring disorder of BPD. The researchers also found that MDMA was effective even when administered just twice or thrice during the course of a treatment, whereas psychotropic drugs commonly prescribed in psychiatry often must be taken everyday for a certain period of time.

The treatment, known as MDMA-assisted psychotherapy, is gaining traction for treating other complex mental health disorders as well.

 

Severe Anxiety Disorders

Severe anxiety disorders significantly impact the daily life, as well as quality of life, of patients. Whereas generalized anxiety disorders may be occasional bouts of anxiety, severe anxiety is intense, persistent, and chronic.

Patients with severe anxiety disorders excessively ruminate and worry about things that often can’t be controlled, even without a trigger. It can manifest physically, such a through hyperventilation, shakes, sweating, and a racing heart. Long term effects include insomnia, headaches, fatigue, and difficulty thinking straight. The severe anxiety is so debilitating that it requires serious and professional interventions for patients to regain their quality of life.

Thankfully, a handful of various psychedelics have shown promising results for treating severe anxiety disorders, even where conventional medications have failed. Psilocybin is one of the most widely studied psychedelics for treating chronic anxiety; studies show that it has long-lasting results in anxiety management, with excellent results observed months even after the last treatment.

LSD (lysergic acid diethylamide), or also known as acid, has also been widely studied for mental health disorders especially anxiety. According to studies, LSD can enhance cognitive flexibility and reduce anxiety scores especially when used in psychotherapy. As a result, patients can break rigid mental thought patterns that can influence anxiety-driven behaviors. LSD interacts with serotonin receptors in the brain, such as 5-HT1A and many others, which help regulate mood and reduce anxious behaviors.

MDMA’s potential for treating anxiety and other mental health disorders likewise continues to grow. Patients who struggle with anxiety show positive responses to MDMA; it has been shown to strengthen emotional processing while improving the coping mechanisms of patients. Also known by its street drug names molly or ecstasy, MDMA works well in modulating neurotransmitters in the brain, including dopamine, serotonin, and norepinephrine. These all play an important role in regulating one’s emotions and improve overall mood.

CONCLUSION

If you or a loved one are struggling with mental health disorders and would like to experiment with psychedelics, it’s always recommended to do so in a clinical setting. These are not conditions wherein self-medicating is advisable, because of the harmful side effects of taking too much or too little, as well as the potential interactions of psychedelics with other medications.

Therapy sessions in a controlled environment is the best, safest way to medicate with psychedelics for severe mental health disorders. Reach out to a medical professional to get started, but do your own research.

 

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How Worried Should You Be about Schizophrenia and Psychosis if You Smoke Weed?

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Should You Really Be Worried About Schizophrenia and Psychosis If You Smoke Weed?

Occasionally, a study on cannabis and schizophrenia or psychosis makes its way to the internet and becomes viral for a few weeks. It gets republished and circulated across numerous news channels and social media sites, spreading often unnecessarily alarming news and fear-mongering.

So what’s the truth behind it? Should you really worry about developing schizophrenia and psychosis if you smoke weed?

Let’s get the facts sorted first.

 

Schizophrenia

Schizophrenia is a chronic mental health disorder characterized by hallucinations, delusions, cognitive distortion, trouble thinking straight, and lack of motivation. Extreme cases of schizophrenia can also lead to episodes of psychosis or delusion, which is what occurs when an individual can no longer tell the difference between reality and fiction. Being severely disconnected from reality can occur among patients of schizophrenia and psychosis, but these can be caused by a wide range of physical or mental conditions.

What Causes Schizophrenia?

There is no one known cause for schizophrenia, though several environmental and genetic factors can contribute to its symptoms. It’s also known to run in families, so if someone in your family tree has had schizophrenia, it’s important to practice caution when using drugs and alcohol.

Certain environmental triggers can cause psychotic or schizophrenic episodes, particularly going through extremely stressful life events. Stressful environments, such as fast-paced cities, may also trigger symptoms. Other factors include the experience of childhood trauma, or certain changes in brain chemistry.


Cannabis: Treatment Or Cause?

The symptoms of schizophrenia can be managed or reduced through the use of antipsychotic medications, which are typically the first line of defense for this condition. First-generation antipsychotics, such as Chlorpromazine, Perphenazine, and Fluphenazine, are examples of widely-used schizophrenia treatments. Second-generation antipsychotic treatments include Aripiprazole, Lurasidone, Clozapine, Quetiapine, and several others. In some occasions, doctors may also prescribe antidepressants if antipsychotic drugs don’t help with the depressive episodes that may be associated with schizophrenia.

However, many antipsychotic medications come with unwanted side effects. They commonly include sexual dysfunction, weight gain, sedation, heart problems, difficulty urinating, and many more.

The use of cannabis-based medications for treating the symptoms of schizophrenia has been gaining traction in the medical and scientific community over the past few years. That said, we must differentiate the compounds used in cannabis because we can’t generalize all the compounds in the plant and its effects on the human body. Tetrahydrocannabinol (THC), the psychoactive compound in marijuana, and cannabidiol (CBD), a relaxing, non-psychoactive compound, both work differently in the human body.

What The Research Says

Several studies have shown that CBD could be promising for treating and even mitigating the symptoms of schizophrenia and psychosis. This is especially true if the condition is in its early stages.

For example, in a review conducted in 2021, scientists found that CBD may be beneficial in adjusting the levels of different brain chemicals which have been associated with symptoms of psychosis. One of these is anandamide – and the study found that CBD can increase its levels in the brain.

Anandamide is an endocannabinoid, and it’s believed to help reduce psychotic episodes through several mechanisms in the brain. For one, high levels of anandamide have been observed as successful in mitigating acute cases of schizophrenia.

Meanwhile, another review discovered minor albeit significant evidence that CBD could possibly reduce the symptoms of schizophrenia when administered in high doses. In the review, the researchers noted that 800 mg of CBD were given to patients over the course of 4 weeks. The results were similar to those yielded by amisulpride, an antipsychotic drug which is used in the treatment of psychosis. A similar trial found that 1,000 mg of CBD given to patients over 6 weeks was effective in reducing schizophrenia symptoms.

The results of a 2024 clinical trial also found that CBD was successful in mitigating the symptoms of patients who were at high risk for psychosis. For the study, there were 31 patients involved; they were given either 600 mg of CBD or a placebo everyday for 3 weeks. However, they weren’t given any prescription drugs during the course of the study. Researchers analyzed their baseline at 7 and then again at 21 days.

“Short-term treatment with CBD can ameliorate the symptoms of CHR state for psychosis and is well tolerated. These results highlight the potential of CBD as a novel treatment for psychosis, and the need for large-scale efficacy studies to further evaluate its clinical utility,” concluded the study’s authors.

So Who Needs To Worry About Schizophrenia and Cannabis Use?

Smoking pot won’t make you go psychotic. It doesn’t cause schizophrenia per se.

That said, those with pre-existing mental health conditions must tread lightly and be very cautious when it comes to using high THC products. In other words, if you already have a family history of schizophrenia or have had a history of psychotic episodes, THC may not be the medicine or recreational drug for you. Individuals with bipolar disorder, delusional disorder, or other similar personality and mood disorders with a tendency to have episodes of psychosis should first seek out medical attention.

Products containing high levels of THC may not be recommended in these situations, though CBD may help reduce symptoms. If you aren’t sure, it’s always best to consult with your medical provider.

 

Conclusion

Even if there is promising evidence that CBD can be beneficial for schizophrenia, we must be careful not to consider it as a substitute for any kind of medical treatment. There are many different types of cannabis products out there but there isn’t one-size-fits-all solution for mental health disorders. So while most people wouldn’t have a problem smoking weed, there is a small subset of the population as mentioned earlier – who do have to be careful.

 

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