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Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Oral AL01211 in Healthy Chinese Volunteers
Background and ObjectiveAberrant accumulation of glycosphingolipids (GSLs) in the lysosome leads to GSL storage diseases. Glucosylceramide synthase...
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Safety and Tolerability of Combining CGRP Monoclonal Antibodies with Gepants in Patients with Migraine: A Retrospective Study
IntroductionThe introduction of clacitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) has revolutionized the treatment of migraines. In...
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Mesenchymal Stem Cell Therapy in Acute Intracerebral Hemorrhage: A Dose-Escalation Safety and Tolerability Trial
BackgroundWe conducted a preliminary phase I, dose-escalating, safety, and tolerability trial in the population of patients with acute intracerebral...
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Pharmacokinetics, Safety, and Tolerability of Single-Dose Orally Administered Venglustat in Healthy Chinese Volunteers
Background and ObjectiveDeficiencies of enzymes acting downstream of glucosylceramide synthase (GCS) can cause severe substrate accumulation....
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Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Stapokibart in Healthy Volunteers and Adult Subjects with Atopic Dermatitis
IntroductionStapokibart, a novel humanized anti-interleukin (IL)-4 receptor alpha monoclonal antibody, inhibits the signaling of IL-4 and IL-13,...
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Assessing the safety and tolerability of rhinologic surgery under local anesthetic: an 8-year retrospective analysis
PurposeOffice-based rhinologic procedures (OBRP) have become widely available in North America due to technological advances and appropriate patient...
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Safety and tolerability of Sacubitril/Valsartan in heart failure patient with reduced ejection fraction
BackgroundAngiotensin receptor blocker and a neprilysin inhibitor (ARNI) has emerged as an innovative therapy for patients of heart failure with...
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Safety, Tolerability, and Pharmacokinetics of Oral BI 1358894 in Healthy Japanese Male Volunteers
Background and ObjectivesBI 1358894, a novel small-molecule inhibitor of transient receptor potential canonical ion channels, is under development...
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Safety, Tolerability and Pharmacokinetics of Single-Dose Oral SYHA1402 in Healthy Chinese Subjects
IntroductionTo assess the safety, tolerability and pharmacokinetics of a single dose of SYHA1402 in healthy Chinese subjects.
Methods ...
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Safety, Tolerability, and Outcomes of Tafamidis for the Treatment of Acquired Amyloid Neuropathy in Domino Liver Transplant Recipients
IntroductionAcquired amyloid neuropathy is an iatrogenic disease that appears years after a domino liver transplant. The objectives of our study are...
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Safety and tolerability of atogepant for the preventive treatment of migraine: a post hoc analysis of pooled data from four clinical trials
BackgroundConventional, non-specific preventive migraine treatments often demonstrate low rates of treatment persistence due to poor efficacy or...
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SAFE-ROCK: A Phase I Trial of an Oral Application of the ROCK Inhibitor Fasudil to Assess Bioavailability, Safety, and Tolerability in Healthy Participants
BackgroundThe intravenous (IV) formulation of Rho-kinase (ROCK) inhibitor fasudil has been approved for the treatment of subarachnoid haemorrhage...
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Efficacy, safety, and tolerability of antimicrobial agents for complicated intra-abdominal infection: a systematic review and network meta-analysis
BackgroundWhich antimicrobial agents provide the optimal efficacy, safety, and tolerability for the empirical treatment of complicated...
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Efficacy, safety, and tolerability of dolutegravir-based ART regimen in Durban, South Africa: a cohort study
BackgroundDolutegravir is an integrase strand transfer inhibitor that has been recommended for use in first-line antiretroviral regimens by the World...
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Safety and Tolerability of Antimicrobial Agents in the Older Patient
Older patients are at high risk of infections, which often present atypically and are associated with high morbidity and mortality. Antimicrobial...
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Safety, tolerability, pharmacokinetics and effects of diet on AD16, a novel neuroinflammatory inhibitor for Alzheimer’s disease: a randomized phase 1 study
BackgroundAD16 is a Class 1.1 new drug candidate for Alzheimer’s disease (AD), which has demonstrated potential benefits in AD by reducing...
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Safety, Tolerability, and Pharmacokinetics of Recombinant Human Neuregulin-1 in Healthy Chinese Subjects
BackgroundWe investigated the safety, tolerability, and pharmacokinetics of intravenous recombinant human Neuregulin-1 (rhNRG-1), a DNA recombinant...
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Long-Term Safety and Tolerability of Daridorexant in Patients with Insomnia Disorder
Background and ObjectiveDaridorexant is a dual orexin receptor antagonist for the treatment of insomnia. In two phase III, 12-week studies in...
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Evaluating adherence, tolerability and safety of oral calcium citrate in elderly osteopenic subjects: a real-life non-interventional, prospective, multicenter study
BackgroundOsteoporosis is a common concern in the elderly that leads to fragile bones. Calcium supplementation plays a crucial role in improving bone...
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Long-term safety and tolerability of ambrisentan treatment for pediatric patients with pulmonary arterial hypertension: An open-label extension study
This open-label, extension study assessed long-term safety, tolerability, and efficacy of ambrisentan in a pediatric population (age 8– < 18 years)...
