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Funding Sources | Jason C.G. | Five-year follow-up of the WRAP trial was funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (RP-PG-0216-20010). The WRAP trial was funded by the National Prevention Research Initiative through research grant MR/J000493. Jack M. Birch, Amy L. Ahern, Sim... | PMC10028366 | |
Author Contributions | Jason C.G. | Jack M. Birch planned and designed the study, wrote the statistical analysis plan, conducted the analysis, and led the writing and development of the final manuscript. Julia Mueller and Stephen J. Sharp planned and designed the study, provided statistical input, reviewed the statistical analysis plan, and reviewed and ... | PMC10028366 | |
Data Availability Statement | The data cannot be made publicly available because of ethical and legal considerations. Non-identifiable data and code can be made available to bona fide researchers on submission of a reasonable request to | PMC10028366 | ||
Supplementary Material | Supplementary dataClick here for additional data file. | PMC10028366 | ||
Acknowledgments | RECRUITMENT | We would like to thank the co-investigators on the original WRAP trial (Paul Aveyard, Jason Halford, Susan Jebb, Adrian Mander, Simon Cohn, and Marc Suhrcke) and the WRAP 5-year follow-up (Andrew Hill, Alan Brennan, Ed Wilson, Brett Doble, Carly Hughes, Jennifer Bostock, Colin Lainson, Steve Morris, and James Woodcock)... | PMC10028366 | |
References | Sample characteristics by availability of data to calculate weight changeMean (SD) weight change by each exposure categoryAssociation between PROGRESS-Plus characteristics and weight change from 1-to 5-yearsA multivariable model was performed to assess the association between the exposure PROGRESS-Plus characteristic a... | PMC10028366 | ||
Objective | bleeding, myomectomy-related hemorrhage, uterine fibroids | BLEEDING, VASCULAR TUMORS, UTERINE FIBROIDS | Myomectomy is the preferred surgical approach to manage uterine fibroids. However, uterine fibroids are highly vascular tumors and, consequently, extremely susceptible to problems from myomectomy-related hemorrhage. Hence, we aim to compare oxytocin efficacy and safety profile versus tranexamic acid (TA) with ethamsyla... | PMC10387195 |
Methods | This randomized, double-blinded multicenter study was performed between 20 | PMC10387195 | ||
Results | INTRAOPERATIVE BLOOD LOSS | In 180 premenopausal women, oxytocin and TA with ethamsylate had no significant value in lowering intraoperative blood loss compared with the placebo for abdominal myomectomy (666.25 ± 183.03, 630.72 ± 145.83, and 646.67 ± 168.92, respectively ( | PMC10387195 | |
Conclusion | INTRAOPERATIVE BLOOD LOSS | Oxytocin and TA with ethamsylate had no significant value in lowering intraoperative blood loss compared with the placebo for abdominal myomectomy which opens a new question about the role of the use of the hemostatic drug during myomectomy especially in centers with limited resources and had higher rates. | PMC10387195 | |
Trial registration | The study was registered on Pan African Clinical Trials Registry with the following number: PACTR202008739887429 and was approved on 24/08/2020. | PMC10387195 | ||
Keywords | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). | PMC10387195 | ||
Change history | 5/10/2024Editor’s Note: Readers are alerted that the reliability of data presented in this article is currently in question. Appropriate editorial action will be taken once this matter is resolved. | PMC10387195 | ||
Background | pelvic pain, blood loss, uterine fibroids, anemia, infertility, uterine leiomyomas, fibroids | POSTPARTUM HEMORRHAGE, CONTRACTIONS, BLOOD LOSS, VASCULAR TUMORS, UTERINE FIBROIDS, ANEMIA, UTERINE LEIOMYOMA, FIBROIDS, COMPLICATIONS | With about 235 million women affected globally [Clinically, uterine fibroids are frequently asymptomatic, but in 30% of cases, fibroids can be symptomatic and cause various critical complications. These complications include pelvic pain, heavy menstruation, anemia, frequent urination, bowel problems, and infertility [T... | PMC10387195 |
Methods | PMC10387195 | |||
Study design and study population | obesity, uterine fibroids, anemia, heart or lung illness, diabetes | OBESITY, ENDOCRINE OR METABOLIC DISEASE, UTERINE FIBROIDS, ANEMIA, MYOMA, HYPERTENSION, BLEEDING DISORDERS, DIABETES | We followed the CONSORT reporting guidelines in reporting our randomized, double-blinded multi-center study which was performed between 20We included premenopausal women between the ages of 30 and 50, with a minimum of five symptomatic uterine fibroids with a maximum diameter of 6 cm for the largest myoma, all intramur... | PMC10387195 |
Sample size calculation | The sample size was adjusted by confidence interval = 95%, margin of error = 5%, and study's power = 80%. Therefore, the minimum sample size for each group was 60. | PMC10387195 | ||
Treatment protocol | We examined all eligible patients, took full clinical history, and ordered investigations like complete blood count and ultrasound. Then, the baseline data were collected including age, body mass index, baseline HB and HCT, previous cesarean section (CS), parity, and indications for CS. Patients were separated into thr... | PMC10387195 | ||
Outcomes | intraoperative blood loss | SECONDARY, POSTOPERATIVE FEVER, INTRAOPERATIVE BLOOD LOSS | The primary outcome was the amount of intraoperative blood loss. The secondary outcomes included the HB, and hematocrit (HCT) values, the change in towels and suction bottle weights, the need for blood and iron transfusion, the duration of operation and hospital stay, the need for hysterectomy, and postoperative fever. | PMC10387195 |
Statistical analysis | We used SPSS version 25, IBM, USA to perform the analysis after the recording of data. We presented the qualitative variables by both number (n) and percentage (%) while the quantitative data were described by mean and standard deviation. The statistical test of one-way ANOVA was applied to evaluate quantitative outcom... | PMC10387195 | ||
Results | PMC10387195 | |||
Primary outcome | PMC10387195 | |||
Secondary outcomes | PMC10387195 | |||
Towels and suction bottle weight | After applying a paired t-test, each drug showed a significant increase in towels' weights and suction bottle weight compared to the baseline ( | PMC10387195 | ||
Other secondary outcomes | Applying the ANOVA test, all study outcomes showed non-significant differences between all groups including operative time ( | PMC10387195 | ||
Discussion | cardiovascular morbidities, thromboembolic, postoperative blood loss, bleeding | BLEEDING, WOUND INFECTION, ADVERSE EFFECTS, POSTOPERATIVE FEVER, INTRAOPERATIVE BLOOD LOSS, EVENTS | This RCT indicated that oxytocin and TA with ethamsylate had no significant value in lowering intraoperative blood loss compared with the placebo for abdominal myomectomy. Also, the changes in both HB and HCT values showed no significant differences between the three groups. Non-significant trends were observed for a r... | PMC10387195 |
Limitations | ethamyslate | The main limitation of this RCT is the scant number of published RCTs in this field. The amount of evidence that is now available on this topic is still insufficient to draw solid conclusions about the efficacy of the discussed therapies. Future research should compare prophylactic oxytocin against TA with ethamyslate ... | PMC10387195 | |
Acknowledgements | Not available. | PMC10387195 | ||
Authors’ contributions | AAE | AMA, EE, EF, AM, DFMA, AS, ME, AMA, AGA, AAM, FA, AHB, IE, HGAE, SAA, and HM were responsible for analyzing and interpreting the patient data. MAK, HA, AAE, and MA were responsible for statistical analysis and revising the manuscript. | PMC10387195 | |
Funding | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). No funds were received. | PMC10387195 | ||
Availability of data and materials | The datasets used and/or analyzed during the current study are not publicly available due to the confidentiality of participants' data and the difficulty of organizing the raw data to be suitable for publication; however, they are available from the corresponding author on reasonable request. | PMC10387195 | ||
Declarations | PMC10387195 | |||
Ethics approval and consent to participate | The study was approved by the ethics committee of the Quality Education Assurance Unit et al. Azhar Faculty of Medicine and all patients gave informed consent before enrollment. All methods were performed in accordance with the Declaration of Helsinki. | PMC10387195 | ||
Consent for publication | Not applicable. | PMC10387195 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10387195 | ||
References | PMC10387195 | |||
1. Introduction | inflammation, OI, gingivitis, pain | ADVERSE EVENTS, INFLAMMATION, DISEASE, GINGIVITIS, DENTAL PLAQUE, OIS, PLAQUE, HYPERSENSITIVITY SYMPTOMS | These authors contributed equally to this work.Background: To evaluate the efficacy and safety of oral irrigator (OI) in controlling dental plaque and gingivitis. Methods: Ninety participants diagnosed with gingivitis were randomly assigned to two groups, given a toothbrush combined with OI (WaterPikPeriodontal disease... | PMC9965011 |
2. Materials and Methods | PMC9965011 | |||
2.1. Study Design and Ethical Considerations | WEST | A 12-week randomized, single-blind, parallel-group clinical trial was conducted at West China Hospital of Stomatology, Sichuan University, Chengdu, China. The research program was approved by the Research Ethics Committee of West China Hospital of Stomatology, Sichuan University (WCHSIRB-D-2021-493). This study was con... | PMC9965011 | |
2.2. Sample Size | OIS | The sample size was calculated using G*power 3.1.9.7 based on the mean Modified Gingival Index (MGI) of 1.18 with a standard deviation of 0.2 in the OIs group according to a previous study data [ | PMC9965011 | |
2.3. Eligible Criteria | PMC9965011 | |||
2.3.1. Inclusion Criteria | gingivitis | GINGIVAL BLEEDING, GINGIVITIS | Male and female aged 18 to 65 years old.In good general health with brushing teeth as a daily habit.Possessing at least 20 permanent teeth (excluding the third molars) and 5 evaluable teeth in each quadrant.Suffering from gingivitis and possessing at least 20 gingival bleeding on probing at the baseline examination.T-Q... | PMC9965011 |
2.3.2. Exclusion Criteria | xerostomia, periodontitis, Allergies, tumors, orthodontic | DENTAL CARIES, SYSTEMIC DISEASE, XEROSTOMIA, PERIODONTITIS, PERIODONTAL DISEASES, TUMORS, ALLERGIES | Pregnant or breastfeeding women.Cigarette smoking.Dental students, employees of the clinical research center, or product-related companies.Suffering from periodontitis or gingival recession.Using oral hygiene adjunct tools regularly (i.e., electric toothbrushes, dental floss, interdental brush, mouthwashes, etc.).Weari... | PMC9965011 |
2.4. Randomization and Allocation | After enrollment based on the eligibility criteria, the central randomization method was applied based on computer software. The enrollment and randomization process were conducted by a third party that was unrelated to the clinical examination. The participants were arranged into control or test groups in a ratio of 1... | PMC9965011 | ||
2.5. Interventions and Outcomes Measurement | OI | SECONDARY, OIS | After preliminary screening of personal medical history and oral examination at baseline, the participants were randomly assigned to one of the intervention groups: the toothbrush + oral irrigator group (test group) received an OI (WaterPikBefore every clinical examination, all participants were instructed to refrain f... | PMC9965011 |
2.6. Statistical Analysis | The efficacy evaluation was analyzed with full analysis set (FAS) based on the intention to treat principle and the per-protocol set (PPS), and the safety evaluation was based on the safety set (SS). The FAS comprised participants who had received at least one post-intervention assessment after randomization. The PPS i... | PMC9965011 | ||
4. Discussion | traumatic injuries, inflammation, OI, gingivitis, pain, OIs | ADVERSE EVENTS, INFLAMMATION, GINGIVAL BLEEDING, GINGIVITIS, DENTAL PLAQUE, OIS, PLAQUE, HYPERSENSITIVITY SYMPTOMS, DENTIN HYPERSENSITIVITY | This study evaluated the efficacy and safety of oral irrigators with broader range of pressures in removing plaque and relieving gingivitis. The test group showed significant improvement in plaque and gingivitis indices than the control group. Higher irrigation pressures significantly correlated with the reduction in p... | PMC9965011 |
5. Conclusions | OIs | OIS, PLAQUE | With the limitations of the study, we conclude that OIs as adjuncts to toothbrushing are significantly more effective than toothbrushing alone in controlling plaque and improving gingival health. Its efficacy was positively correlated with irrigation pressure and the amount of plaque. Furthermore, the application of OI... | PMC9965011 |
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC9965011 | ||
Author Contributions | Conceptualization, L.C. and X.R.; methodology, L.C. and X.R.; investigation, L.C., R.C., X.R., Y.X., Y.Z. and Y.C.; formal analysis, X.R., Y.X. and J.H.; resources, S.J. and J.H.; writing—original draft preparation, X.R. and J.H.; writing—review and editing, R.C., L.C. and T.H.; supervision, T.H.; project administratio... | PMC9965011 | ||
Institutional Review Board Statement | WEST | The procedures for this study were conducted under the 1964 Declaration of Helsinki, the relevant regulations of the People’s Republic of China and Good Clinical Practice. The study protocol was reviewed and approved by the Research Ethics Committee of West China Hospital of Stomatology, Sichuan University (WCHSIRB-D-2... | PMC9965011 | |
Informed Consent Statement | Informed consent was obtained from all participants involved in the study. | PMC9965011 | ||
Data Availability Statement | Data for this study can be obtained by contacting the corresponding author under reasonably requested. | PMC9965011 | ||
Conflicts of Interest | The authors declare that they have no relevant financial or non-financial interest. | PMC9965011 | ||
Methods | RHD | Participants (n = 24) received between 6.9 mL to 20.7 mL (3–9 times the standard dose) of BPG as a single infusion into the abdominal subcutaneous tissues via a spring-driven syringe pump over approximately 20 minutes. Semi-structured interviews at four time points were recorded, transcribed verbatim and thematically a... | PMC10138475 | |
Results | bruising, pain | Participants tolerated the infusion well and were able describe their experiences throughout. Most reported minimal pain, substantiated via quantitative pain scores. Abdominal bruising at the infusion site did not concern participants nor impair normal activities. Insight into how SCIP could be improved for children in... | PMC10138475 | |
Conclusion | RHD | Qualitative research is an important adjunct for early-phase clinical trials, particularly when adherence to the planned intervention is a key driver of success. These results will inform later-phase SCIP trials in people living with RHD and other indications. | PMC10138475 | |
Data Availability | All relevant data are within the paper and its | PMC10138475 | ||
Introduction | pain, ARF | ARF, RHD, ACUTE RHEUMATIC FEVER | Benzathine penicillin G (BPG) has been used since the 1950s for the prevention and treatment of recurrent episodes of acute rheumatic fever (ARF), caused by repeated Regular IM injections of BPG are the only proven treatment to prevent recurrent ARF and progression to RHD [Qualitative research is a useful accompaniment... | PMC10138475 |
Methods | ARF, pain | ARF | The clinical aspects of the SCIP trial have been described elsewhere by Kado et al [For the qualitative component, all study participants were interviewed in English by one of two investigators at four timepoints–immediately prior to their infusion, during their infusion, two hours post-infusion and approximately seven... | PMC10138475 |
Results | The 24 participants recruited to the SCIP trial had a median age of 26.9 years and 20 (83.3%) were male. Nine (37.5%) were Caucasian, 8 (33.3%) Asian, 3 (12.5%) Latino, 2 (8.3%) African and 2 (8.3%) of mixed ethnicity. While English was known to be a second language for several participants these data were not captured... | PMC10138475 | ||
Discussion | infection, ARF, pain | ARF, ADVERSE EVENTS, RECRUITMENT, RHD, INFECTION, STREP | Qualitative research was integrated into the methodology of this trial to better understand the recipient experience of a procedure previously not completed in a volunteer cohort. Given the previously described patient preference for BPG delivery that is less frequent and less painful [An element of phase-1 trials whic... | PMC10138475 |
Conclusion | pain | Qualitative research is a suitable method to be integrated into clinical trials, providing more in-depth information to the tolerability and acceptability of a procedure. The pharmacokinetic data from SCIP support the infusion of high-dose BPG as a possible alternative to monthly IM SP, a finding that would likely be r... | PMC10138475 | |
Supporting information | PMC10138475 | |||
A summary of qualitative themes and supporting quotes. | (DOCX)Click here for additional data file. | PMC10138475 | ||
ABSTRACT | PMC9970201 | |||
Background | Carbohydrate (CHO) and carbohydrate-protein co-ingestion (CHO-P) have been shown to be equally effective for enhancing glycogen resynthesis and subsequent same-day performance when CHO intake is suboptimal (≤0.8 g/kg). Few studies have specifically examined the effect of isocaloric CHO vs CHO-P consumption on subsequen... | PMC9970201 | ||
Methods | ± | This was a randomized, double-blind between-subject design. Twenty-two male masters class endurance athletes (age 49.1 ± 6.9 years; height 175.8 ± 4.8 cm; body mass 80.7 ± 8.6 kg; body fat (%) 19.1 ± 5.8; VO | PMC9970201 | |
Results | A one-way ANCOVA indicated a significant difference among the group means for the posttest TTE (F | PMC9970201 | ||
Conclusions | Both CHO and CHO-P effectively promoted an increase in TTE performance with limited time to recover in this sample of masters class endurance athletes. Water and electrolytes alone were not effective for restoring endurance capacity during the second bout of exhaustive exercise. | PMC9970201 | ||
KEYWORDS | PMC9970201 | |||
Background | endurance exercise, endurance exercise [Exercise-induced dehydration | EVENTS | The rate of participation by masters class athletes (MCAs) in organized endurance and ultra-endurance events (>6 hours) has increased exponentially over the past 10–15 years [Two different isoenergetic options have been shown to effectively promote glycogen resynthesis post-exercise: CHO (1.2 g/kg) and CHO-P (0.8 g/kg ... | PMC9970201 |
Methods | PMC9970201 | |||
Study design | This study utilized a randomized, double-blind, placebo-controlled between-subject design to examine the effects of CHO and CHO-P supplementation on short-term recovery following aerobic interval exercise and time to exhaustion testing in male MCAs. The athletes were required to visit the laboratory on three separate o... | PMC9970201 | ||
Subjects | Twenty-two male MCAs (49 ± 6 years, VOConsort flow diagram.Mean and SD values for demographic data.Cycling was the primary sport reported by 18 participants: PLA (n = 7), CHO (n = 4), CHO-P (n = 7). Body fat (%) and fat-free mass was reported for all but one participant in the CHO-P group. | PMC9970201 | ||
Results | PMC9970201 | |||
Participants | illness | FLU | Data from 22 trained male MCAs (49 ± 6 years old) were used in this research investigation. Thirty-one athletes were recruited; however, three were withdrawn from the study due to illness (i.e. COVID, flu); two discontinued participation after expressing discomfort with the mask required for metabolic testing; and one ... | PMC9970201 |
Blinding | Blinding results were available for 19 of 22 total participants with 31.6% (n = 6) correctly identifying which treatment beverage they consumed. | PMC9970201 | ||
Discussion | ±, nutritional beverage, MCAs | ADVERSE EFFECTS | The purpose of this investigation was to examine the effectiveness of three different beverages (CHO, CHO-P, and PLA) on short-term recovery from repeated bouts of exhaustive exercise in male endurance MCAs. The results support our hypothesis that CHO-P (0.8 g/kg bm CHO + 0.4 g/kg bm PRO) was equivalent to CHO (1.2 g/k... | PMC9970201 |
Disclosure statement | No potential conflict of interest was reported by the author(s). | PMC9970201 | ||
References | PMC9970201 | |||
1. Introduction | death, HBV-related HCC, HBV suppression, toxicity, cancer, HCC, HBV-related HCC.Hepatocellular carcinoma | HEPATITIS B, VIRUS, RECURRENCE, CANCER, HEPATOCELLULAR CARCINOMA | These authors contributed equally to this work.Hepatocellular carcinoma (HCC) usually recurs after curative surgical resection. Currently, no approved adjuvant therapy has been shown to reduce HCC recurrence rates. In this study, the in vivo effect of sequential combination treatment with recombinant mouse interferon-a... | PMC10778875 |
2. Results | PMC10778875 | |||
2.1. Animal Modeling Data | An HBV mouse model (HBV-HDI) was generated via the intravenous injection of an HBV genotype A DNA plasmid into CBA/CaJ mice [ | PMC10778875 | ||
2.2. Phase I Clinical Study | toxicities, DLTs | CANCER RECURRENCE | A Phase I study was conducted to determine the maximum tolerated dose (MTD). A total of 12 eligible patients were enrolled in Cohorts 1 and 2 (The mean age and standard deviation of the eligible patients were 61.8 and 10.3 years, respectively (Dose-limiting toxicities (DLTs) were observed in one patient. Drug-related g... | PMC10778875 |
3. Discussion | HBV-related HCC, HBV infection, HBV suppression, CHB infection, HCC, deaths | TUMOR RECURRENCE | HCC is a common cause of cancer-related deaths, and most cases are associated with HBV infection. Patients with HCC are at a high risk of tumor recurrence after surgical resection. Currently, there are no approved therapies for inhibiting tumor recurrence. In this study, our animal modeling data demonstrated that seque... | PMC10778875 |
4. Materials and Methods | PMC10778875 | |||
4.1. HBV-HDI Mouse Model | Six- to eight-week-old male CBA/CaJ mice were bred at the National Taiwan University Laboratory Animal Center. The mice were intravenously injected with 10 μg of HBV genotype A DNA plasmid dissolved in PBS equivalent to approximately 8% of the mouse’s body weight, as previously described [ | PMC10778875 | ||
4.2. Preclinical Materials | Anti-mouse PD1 (RMP-17) is a monoclonal antibody targeting mouse PD1 generated via hybridoma screening at the PharmaEssentia Corporation Research Laboratory. rmIFN-α was produced using the | PMC10778875 | ||
4.3. Treatment of HBV-Carrying CBA/CaJ Mice | Mice were divided into eight groups to investigate the effect of rmIFN-α on sequential combination with anti-mouse PD1. The drug dosages and administration routes are described below.Group 1 (control): Six HBV-carrying CBA/CaJ mice were subcutaneously (s.c.) injected with 200 μL of PBS every other day (Q2D) × 8 (days 0... | PMC10778875 | ||
4.4. Quantification of HBsAg and HBV DNA in Mice | Serum HBsAg and HBV DNA levels were quantified using the Abbott Architect I1000 system (Abbott Diagnostics, Green Oaks, IL, USA) and the Roche Lightcycler 480 (Roche Diagnostics, GmbH, Mannheim, Germany), respectively. The sequences of HBx-specific primers used to quantify the copy numbers of HBV DNA were 5′-CCGATCCATA... | PMC10778875 | ||
4.5. Clinical Materials: | Ropeginterferon alfa-2b was produced by the PharmaEssentia Corporation. It was provided as a prefilled syringe of 500 µg/1.0 mL. Nivolumab (OPDIVO | PMC10778875 | ||
4.6. Study Design | hepatitis B-related HCC | This clinical study was designed as a Phase I/II trial. The Phase I study aimed to evaluate the safety and tolerability and define the MTD of the sequential administration of ropeginterferon alfa-2b and nivolumab in patients who received curative surgery for hepatitis B-related HCC. The Phase II trial was designed to f... | PMC10778875 | |
4.7. Patients | malignancy, HBV-related HCC, HCC | ONCOLOGY, COMPENSATED LIVER DISEASE | Patients with HBV-related HCC who underwent surgical resection within eight weeks were enrolled. Other major inclusion criteria included positive results for HBsAg, undetectable HBV DNA, compensated liver disease, normal fundoscopic examination, and an Eastern Cooperative Oncology Group Performance Status score of 0 to... | PMC10778875 |
5. Conclusions | HBV suppression, HCC | Our animal data demonstrated a synergistic effect between rmIFN-α and anti-PD1 treatment for HBV suppression or even clearance. This effect was observed in patients with HCC who received sequential combination therapy with ropeginterferon alfa-2b and nivolumab in a Phase I clinical study. Most AEs were either mild or m... | PMC10778875 | |
Author Contributions | A.Q., C.-R.W., M.-C.H., C.-Y.T. and P.-J.C. contributed to the work. P.-J.C. and M.-C.H. enrolled and treated patients. All authors have read and agreed to the published version of the manuscript. | PMC10778875 | ||
Institutional Review Board Statement | The animal experiments were performed in accordance with the guidelines established by the Institutional Animal Care and Use Committee of the National Taiwan University College of Medicine. The Phase I/II clinical study was approved by the Institutional Review Board of NTUH (201710061MIPB) on 22 December 2017 and condu... | PMC10778875 | ||
Informed Consent Statement | Informed consent was obtained from all participating patients. | PMC10778875 | ||
Data Availability Statement | Data will be available to external researchers upon reasonable request from the investigators and PharmaEssentia. | PMC10778875 | ||
Conflicts of Interest | ALBERT | Albert Qin and Chan-Yen Tsai work for the PharmaEssentia Corporation. Pei-Jer Chen has served as a consultant for the PharmaEssentia Corporation. The other authors have no conflicts of interest to declare. | PMC10778875 |
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