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INTRODUCTION | auto‐HSCT in stage IV, DLBCL | LYMPHOMA | Diffuse large B‐cell lymphoma (DLBCL) is the most common (30–35%) type of B‐cell lymphoma with an incidence of about 5.6 per 100.000 men and women per year.The standard treatment of DLBCL is R‐CHOP immunochemotherapy (ICT).Upfront auto‐HSCT was studied as a way to improve outcomes as a consolidative treatment option in... | PMC10075296 |
MATERIALS AND METHODS | PMC10075296 | |||
Study design | Retrospective cohort single‐center trial. | PMC10075296 | ||
Patient selection | DLBCL | The main inclusion criterion was biopsy‐confirmed CD20(+) DLBCL NOS, according to the WHO 2017 criteria. All patients were from 18 to 65 years old. According to Russian legislation, a majority is reached at the age of 18 and younger patients are treated according to pediatric protocols. The peak age was selected to bet... | PMC10075296 | |
Statistical analysis | death | DEL | The primary endpoint of this study was progression‐free survival (PFS, measured from the date of diagnosis to confirmed relapse or death from any cause). Secondary endpoints were overall survival (OS, measured from the date of diagnosis to death from any cause), response rate and relapse rate.To determine differences i... | PMC10075296 |
RESULTS | PMC10075296 | |||
Patients and procedures characteristic | The two trial arms were well balanced. (Table Patient and procedures characteristics.
| PMC10075296 | ||
Clinical response | There were 63% (22/35) CR in patients, who further enrolled in the upfront group and 100% (70/70) in the control group. After auto‐HSCT in the upfront group, the CR rate significantly increased (Clinical response in upfront group. Inner ring—response after ICT. Outer ring—response after upfront HDCT with auto‐HSCT. | PMC10075296 | ||
Relapse rate and cause of death | A total of 3% (1/35) early (ER) and 6% (2/35) late (LR) relapses occurred in the upfront group (Figure Between‐group comparisons. Inner ring–upfront group, In the control group, 21% (15/70) ER and 6% LR (4/70) occurred (Figure There was a significantly higher early relapse rate in the control group (1/35 vs. 15/70, | PMC10075296 | ||
Survival analysis | PMC10075296 | |||
Progression‐free survival | lymphomas | LYMPHOMAS, DEL | The favor of upfront was demonstrated (Figure Progression‐free survival results. (A) PFS by treatment groups. (B) PFS by DEL. (C) PFS by lung involvement. (D) PFS by ICT.Patients with double‐expressor lymphomas (DEL) demonstrated (Figure Patients, treated by DA‐EPOCH‐R demonstrated (Figure Multivariate PFS analysis dem... | PMC10075296 |
Overall survival | deaths | Patients in the upfront group demonstrated significantly higher (Figure Overall survival results. (A) OS by treatment groups; (B) OS by relapse occurrence.Multivariate OS analysis confirmed the significant characteristics–upfront auto‐HSCT was associated with better 3‐year OS (HR = 0.11, 95% CI [0.02–0.63], Multivariat... | PMC10075296 | |
DISCUSSION | metabolic tumor, tumor, high‐intermediate, toxicity, DLBCL, DEL DLBCL, lymphomas, DSHNHL | TUMOR, REMISSIONS, PROLIFERATION, DISEASE, LYMPHOMAS, DEL | The role of upfront auto‐HSCT in DLBCL remains controversial. EBMT (level of evidence 1)These statements are based on the results of RCT. The improvement of 2‐year FFS (In NCT00355199,SWOG‐S7904 trialOn the other hand, DSHNHL 2002‐1 trial demonstrated only increased toxicity in the HDCT group without survival benefit.M... | PMC10075296 |
CONCLUSION | DEL DLBCL, DLBCL | DEL | In this trial, upfront patients demonstrated significantly better 3‐year OS and PFS. It is a relatively small period, and further follow‐up is needed to confirm the sustainability of our result. The significant difference in early relapse rate and the same tendency in all relapse rates in favor of upfront auto‐HSCT is ... | PMC10075296 |
AUTHOR CONTRIBUTIONS | PMC10075296 | |||
CONFLICT OF INTEREST STATEMENT | The authors have stated explicitly that there are no conflicts of interest in connection with this article. | PMC10075296 | ||
ETHICS STATEMENT | All procedures performed in studies involving human participants were by the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. | PMC10075296 | ||
Supporting information |
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Click here for additional data file. | PMC10075296 | ||
ACKNOWLEDGMENTS | This trial had no financial or material support from external organizations. | PMC10075296 | ||
DATA AVAILABILITY STATEMENT | Data sharing is not applicable to this article as no new data were created or analyzed in this study. | PMC10075296 | ||
REFERENCES | PMC10075296 | |||
1. Introduction | tumor, primary tumors, muscle atrophy, fatigue, Malnutrition, cancer, non-melanoma skin cancer, sarcopenia, inflammation, gastrointestinal tract, cancer deaths, Sarcopenia, cancer cachexia, reduced skeletal muscle mass, impaired muscle function, Cancer | TUMOR, PRIMARY TUMORS, MUSCLE ATROPHY, MALNUTRITION, CANCER, INFLAMMATION, SARCOPENIA, FRAGILITY, SARCOPENIA, CANCER | (1) Background: Malnutrition frequently affects patients with cancer, and it negatively impacts treatment tolerance, clinical outcomes and survival. Thus, appropriate nutritional screening and early nutrition support are extremely recommended. Currently, a significant number of oral supplements (OS) are commercially av... | PMC10302788 |
2. Material and Methods | PMC10302788 | |||
2.1. Patients | cancer of different origin (, weight loss | END-STAGE KIDNEY DISEASE | This study was approved by the Ethics Committee of the Reina Sofia University Hospital (Cordoba, Spain; reference number 4788), which was conducted in accordance with the Declaration of Helsinki and according to national and international guidelines. This is a prospective open-label study, wherein a written informed co... | PMC10302788 |
2.2. Study Design | nausea | When included in the study, all patients received general education about nutritional support, OS, Mediterranean diet and physical activity; additionally, patients received oral supplementation with calcifediol (in different doses to reach levels of sufficiency, defined with a serum 25OH vitamin D levels > 30 ng/dL) fo... | PMC10302788 | |
2.3. Outcomes | Primary outcome was to evaluate the percentage of change in muscle mass of patients after both nutritional interventions. Secondary outcomes included other changes in body composition (lean mass, water, bone, phase angle); anthropometric parameters (calf, arm and abdominal circumference); biochemical nutritional parame... | PMC10302788 | ||
2.4. Statistical Analysis | Between-group comparisons were analyzed using the Mann–Whitney U test (nonparametric data) or the Kruskal–Wallis test (nonparametric data, when we compared more than two groups). Paired analysis was performed using Student’s | PMC10302788 | ||
3. Results | urothelial cancer, colorectal cancer, gastrointestinal neuroendocrine tumor, head–neck cancer, tumors, gastric cancer | COLORECTAL CANCER, TUMORS, GASTRIC CANCER | Forty-six patients were included. Most of them were female (54.3%), with a median age of 74 years; the patients presented with tumors of different origin, including colorectal cancer (19.6%), urothelial cancer (32.6%), head–neck cancer (13%), gastric cancer (8.7%), gastrointestinal neuroendocrine tumor (8.7%) and other... | PMC10302788 |
Primary and Secondary Outcomes | cancer | CANCER | The nutritional intervention in all the evaluated patients resulted in body composition maintenance assessed via bioimpedance analysis. Particularly, the BMI decreased in a non-significant manner; furthermore, the lean mass tended to increase after twelve weeks of treatment (Significantly, all patients improved their p... | PMC10302788 |
4. Discussion | Cancer, muscle mass, gastrointestinal symptoms, cancers, skeletal muscle mass, tumor, metabolic dysregulation, cancer, cardiac dysfunction, inflammation, tumors, head–neck cancer, skeletal muscle loss, malnutrition, muscle mass gain, ACS, anorexia, | CANCERS, TUMOR, CANCER, MALNUTRITION, INFLAMMATION, TUMORS, CHRONIC DISEASES, ADVERSE EFFECTS, TUMOR PROGRESSION, INSULIN RESISTANCE, VITAMIN D DEFICIENCY, MALNUTRITION, PRIMARY TUMOR, STAGE II COLON CANCER, CANCER | The nutritional status is severely affected in most patients with cancer; this condition affects the treatment tolerability and overall survival [Malnutrition affects patients of both the male and female sexes and all age groups. In cancer, malnutrition is a result of a combination of anorexia, gastrointestinal symptom... | PMC10302788 |
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC10302788 | ||
Author Contributions | Conceptualization, A.D.H.-M. and M.J.M.P.; data curation, S.L.I., S.C.P., A.S.S., R.A.E., C.M.J. and R.R.-A.; funding acquisition, A.D.H.-M.; practical performance, S.L.I., S.C.P., A.S.S., R.A.E., C.M.J., R.R.-A., G.M.G. and M.Á.G.M.; formal and data analysis, A.D.H.-M.; preparation of manuscript, A.D.H.-M., M.J.M.P. a... | PMC10302788 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee of the Reina Sofia University Hospital (Cordoba, Spain) (4788, 28 October 2020). | PMC10302788 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10302788 | ||
Data Availability Statement | All data was included in the article. | PMC10302788 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10302788 | ||
References | cancer | CANCER, NEUROENDOCRINE TUMOR | Study design.Biochemical comparison in patients with cancer and systemic treatment receiving nutritional supplements with standard hypercaloric, hyperproteic oral supplements versus leucine-enriched oral supplements. Legend: C-RP—c-reactive protein; ns—non-significative; * Clinical comparison in patients with cancer an... | PMC10302788 |
Background | hernia, hernias | COMPLICATION | Incisional hernia is a frequent complication following loop ileostomy reversal. Incisional hernias are associated with morbidity, loss of health-related quality of life and costs and warrant the investigation of prophylactic measures. Prophylactic mesh implantation at the time of surgical stoma reversal has shown to be... | PMC9890770 |
Methods | postoperative pain, hematomas, hernias, seromas | SITE INFECTION, HEMATOMAS, POSTOPERATIVE COMPLICATIONS, SEROMAS | P.E.L.I.O.N. is a multicentre, patient- and observer-blind RCT. Patients undergoing loop ileostomy closure will undergo intraoperative 1:1 randomisation into either abdominal wall closure with a continuous slowly absorbable suture in small-stitch technique without mesh reinforcement (control group) or abdominal wall cl... | PMC9890770 |
Discussion | Depending on the results of the P.E.L.I.O.N. trial, prophylactic mesh implantation could become the new standard for loop ileostomy reversal. | PMC9890770 | ||
Trial registration | DRKS00027921, U1111-1273-4657 | PMC9890770 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s13063-023-07089-3. | PMC9890770 | ||
Keywords | Open Access funding enabled and organized by Projekt DEAL. | PMC9890770 | ||
Administrative information | 26121 | Note: the numbers in curly brackets in this protocol refer to SPIRIT checklist item numbers. The order of the items has been modified to group similar items (see Sven Müller, Helios Klinikum Gifhorn, Campus 6, 38518 Gifhorn, GermanyDirk Weyhe, Klinik für Allgemein- und Viszeralchirurgie, Universitätsmedizin Oldenburg, ... | PMC9890770 | |
Introduction | PMC9890770 | |||
Background and rationale {6a} | loop ileostomies, abdominal pain, hernia, infections, SSI | SITE INFECTION, INFECTIONS, LEAKAGE | Diverting loop ileostomy is used in colorectal surgery to reduce the consequences of leakage of a bowel anastomosis. According to the Federal Statistical Office of Germany, approximately 15,000 diverting loop ileostomies and 11,500 loop ileostomy closures are performed annually in Germany [Multiple studies have shown t... | PMC9890770 |
Objectives {7} | hernia | The high rate of IH after loop ileostomy closure with its associated morbidity, loss of health-related quality of life and costs (hernia repair, loss of workforce) warrants the investigation of prophylactic measures. Prophylactic mesh implantation at the time of surgical stoma reversal has shown to be a promising and s... | PMC9890770 | |
Trial design {8} | P.E.L.I.O.N is a randomised controlled observer- and patient-blinded multicentre surgical superiority trial with two parallel study groups. | PMC9890770 | ||
Methods: participants, interventions and outcomes | PMC9890770 | |||
Study setting {9} | The study will be carried out in 10 high-volume academic hospitals in Germany. A list of study sites can be found in Supplement | PMC9890770 | ||
Eligibility criteria {10} | PMC9890770 | |||
Inclusion criteria for patients | To obtain a homogenous but still representative patient population for analysis and high-external validity, all patients with primary loop ileostomy closure and without further interventions or conditions to the abdominal wall, which might interfere with the primary outcome measure and reduce the reproducibility and in... | PMC9890770 | ||
Exclusion criteria for patients | hernia, ileostomyChronic renal failure, necrosis | NECROSIS |
American Society of Anesthesiologist (ASA) physical status class ≥ 4Infected/septic surgical site (risk for surgical site occurrences (SSO) of grade 4 according to Ventral Hernia Working Group (VHWG) classification) (see Supplement Presence of parastomal hernia in loop ileostomy site with fascia defect > 8cm (Table Pr... | PMC9890770 |
Eligibility criteria for trial sites and surgeons |
Only high-volume To ensure standardisation of the procedure and to minimise training effects, all Furthermore, all | PMC9890770 | ||
Who will take informed consent? {26a} | Patients scheduled for elective loop ileostomy closure are screened preoperatively. An authorised physician with a GCP training will inform the patient about the trial (visit 1). Patients are enrolled given their ability to understand the extent and nature of the trial as well as their written informed consent after de... | PMC9890770 | ||
Additional consent provisions for collection and use of participant data and biological specimens {26b} | No biological samples will be collected during the trial. | PMC9890770 | ||
Interventions | PMC9890770 | |||
Explanation for the choice of comparators {6b} | Patients in both groups will receive ileostomy closure according to the current standard of care, i.e. direct fascia closure according to the small-stitch technique with a slowly absorbable suture. In addition, in the intervention group, the abdominal wall closure will be augmented with a non-absorbable, macro-pore lig... | PMC9890770 | ||
Intervention description {11a} | PMC9890770 | |||
Experimental intervention | stoma | STERILE, CAVITY |
The re-establishment of intestinal continuity will be achieved by either stapled or by hand-sewn anastomosis, according to the surgeon’s preference, and the bowel will be positioned back into the peritoneal cavity.Changing of surgical gloves must be performed before mesh implantation. Either after surgical stoma closu... | PMC9890770 |
Control intervention | stoma | CAVITY |
The re-establishment of intestinal continuity will be achieved either by staples or by hand-sewn anastomosis, according to the surgeon’s preference, and the bowel will be positioned back into the peritoneal cavity.Changing of surgical gloves.The posterior rectus sheath (if the stoma is within the rectus sheath) will b... | PMC9890770 |
Criteria for discontinuing or modifying allocated interventions {11b} | As P.E.L.I.ON. is investigating two surgical interventions, no criteria for discontinuing or modifying the allocated intervention are applicable. | PMC9890770 | ||
Strategies to improve adherence to interventions {11c} | As P.E.L.I.ON. is investigating two surgical interventions, strategies to improve adherence to the intervention are unnecessary as the patient cannot “withdraw” from the intervention during surgery. | PMC9890770 | ||
Relevant concomitant care permitted or prohibited during the trial {11d} | Further perioperative and postoperative treatment will be according to the local standard of care. This also includes the use of abdominal belts which is at the discretion of the operating surgeon. There will be no restrictions for additional treatments during the trial. | PMC9890770 | ||
Provisions for post-trial care {30} | DER | For trials that are conducted according to the Medical Association’s professional code (Berufsordnung der Bundesärztekammer) § 15, there is no obligation for a specific trial liability insurance. However, patients will be insured against travel accidents for their follow-up visits ( | PMC9890770 | |
Outcomes {12} | PMC9890770 | |||
Primary outcome measure | hernia | RECURRENCE | An Patients will be assessed for the primary endpoint at 12 and 24 months after the trial intervention. At these dates, patients will be examined by a clinician blinded for the trial intervention and by a radiologic examination performed by a blinded assessor. Radiologic exams allowed for assessment in the trial are fo... | PMC9890770 |
Sample size {14} | death | REGRESSION, EVENT | Sample size calculation is based on the rate of the primary endpoint (IH rate) within 24 months after surgery. Based on the assumption that the percentage of patients developing an IH in the control group is 30% (4–7), we hypothesise a reduction to 15% in the intervention arm (conservative reduction rate below that rep... | PMC9890770 |
Recruitment {15} | RECRUITMENT | To enrol the required number of patients in the planned recruitment period, 13 trial sites will participate in this trial. The trial will be performed by the Clinical Trial Network of the German Society of Surgery (CHIR-Net, In order to minimise loss to follow-up, the following measures are being implemented:A pragmati... | PMC9890770 | |
Assignment of interventions: allocation | PMC9890770 | |||
Sequence generation {16a} | To ensure equal distribution of patient characteristics, randomisation will be used. Allocation of treatments will be performed using a web-based randomisation tool ( | PMC9890770 | ||
Concealment mechanism {16b} | Allocation concealment will be ensured as the result of the randomisation will be unknown to the study team until the patient has been randomised through the web-based tool. Block size will be kept confidential to the study team. Randomisation will be performed in the operation theatre, after the closure of the posteri... | PMC9890770 | ||
Implementation {16c} | Randomisation will be performed by a study team in the operation theatre. Names of this team member and the operating surgeon are noted as these team members are unblinded. They will not be involved in the outcome assessment of the trial. | PMC9890770 | ||
Assignment of interventions: blinding | PMC9890770 | |||
Who will be blinded {17a} | Blinding will be performed according to the evidence-based guidelines published by Probst et al. [Patients are blinded as they are under general anaesthesia during the trial intervention. Neither the discharge letter nor the operation report will contain any information regarding group allocation. This will be monitore... | PMC9890770 | ||
Procedure for unblinding if needed {17b} | Unblinding can be performed if medically indicated by the treating surgeon with the help of an unblinded study team member. Unblinding will be documented and reported to the steering group of the trial. | PMC9890770 | ||
Data collection and management | PMC9890770 | |||
Plans for assessment and collection of outcomes {18a} | The trial will be performed by the Clinical Trial Network of the German Society of Surgery (CHIR-Net, | PMC9890770 | ||
Plans to promote participant retention and complete follow-up {18b} | In order to minimise loss to follow-up, the following measures have been implemented:A pragmatic trial design with high-external validity, meaning that trial sites will have little problems to adapt their standard clinical workflow to the follow-up visitsFinancial reimbursement of travel costs for patients covering add... | PMC9890770 | ||
Data management {19} | All protocol-required information collected during the trial must be entered by the investigator, or designated representative, in the eCRF. The investigator, or designated representative, should complete the eCRF pages as soon as possible after information is collected, preferably on the same day that a trial subject ... | PMC9890770 | ||
Confidentiality {27} | The data protection concept stipulates that patients are only included in the study after they have been informed and after having signed the informed consent form (ICF). They will be informed as to the strict confidentiality of their data, but that their medical records may be reviewed for trial purposes by authorised... | PMC9890770 | ||
Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33} | No plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis are implemented in the P.E.L.I.O.N. trial. | PMC9890770 | ||
Statistical methods | PMC9890770 | |||
Interim analyses {21b} | Due to the long observation period for the primary endpoint, an interim analysis would only be possible using a short-term endpoint as a surrogate. However, no reliable short-term endpoint is available. Therefore, no interim analyses are planned for the present trial. However, the DSMB will oversee unblinded data on a ... | PMC9890770 | ||
Methods for additional analyses (e.g. subgroup analyses) {20b} | hernia/hernia, diabetes mellitus, hernia, non-COPD, abdominal aortic aneurysm, SSI, seroma, hematoma, COPD | CARDIOVASCULAR DISEASE, DIABETES MELLITUS, POSTOPERATIVE COMPLICATION, COPD, RENAL DISEASE, SEROMA, REGRESSION, HEMATOMA, COMPLICATIONS | Pre-specified subgroup analysis will be performed in the FAS population for the rate of IH in the following subgroups: (a) body mass index (< 27 vs. ≥ 27), (b) neoadjuvant therapy (yes/no), (c) COPD vs. non-COPD, (d) previous laparotomy vs. previous minimal invasive surgery and (e) history of hernia/hernia repair vs. n... | PMC9890770 |
Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c} | SECONDARY | For patients with incomplete follow-up, missing data will be shown as missing on appropriate tables and listings. Imputation of main secondary outcomes will be performed. | PMC9890770 | |
Plans to give access to the full protocol, participant-level data and statistical code {31c} | The full protocol is accessible with this publication. Participant-level data will be available anonymised after the publication of the final results of the study. | PMC9890770 | ||
Oversight and monitoring | PMC9890770 | |||
Composition of the coordinating centre and trial steering committee {5d} | The trial will have a steering committee consisting of the trial statistician (AS), three clinical experts (AM, SM, DW) and a patient representative (EG). The steering committee will supervise the conduct of the trial and will issue recommendations for early termination, modifications or continuation of the trial, if n... | PMC9890770 | ||
Composition of the data monitoring committee, its role and reporting structure {21a} | hernia | SECONDARY, RECRUITMENT, COMPLICATIONS, POSTOPERATIVE COMPLICATIONS | The trial’s Data Safety and Monitoring Board (DSMB) will be composed of two independent clinical experts in the field of hernia surgery. Furthermore, an independent statistician will be part of the DSMB. The DSMB members will receive a written report twice a year and should advise whether to continue, modify or stop th... | PMC9890770 |
Adverse event reporting and harms {22} | hematomas, seromas | HEMATOMAS, ADVERSE EVENTS, POSTOPERATIVE COMPLICATION, SECONDARY, ADVERSE EVENT, SITE INFECTION, SEROMAS, DER, COMPLICATIONS | Since trial interventions in P.E.L.I.O.N are medical routine, and the trial is conducted under the Medical Association’s professional code (Berufsordnung der Bundesärztekammer) §15, there is no need to record every adverse event. Instead of documenting serious adverse events (SAE), the following secondary endpoints wil... | PMC9890770 |
Frequency and plans for auditing trial conduct {23} | RECRUITMENT, COMPLICATIONS, POSTOPERATIVE COMPLICATIONS | Clinical monitoring will be performed regularly by the independent monitoring department of the Furthermore, for a specific number of long-term postoperative visits (12 and 24 months postoperative), monitoring will confirm that primary outcome assessment is performed by blinded outcome assessors. For other items, the p... | PMC9890770 | |
Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25} | Any amendment to the protocol will be communicated to the participating trial sites immediately by email. Furthermore, regular investigator meetings will be held during the twice yearly CHIR-Net meetings to resolve questions and discuss the progress of the trial. Trial registries, REC/IRBs, will be contacted by the pro... | PMC9890770 | ||
Dissemination plans {31a} | Trial results will be communicated to participating trial sites prior to publication. The final report will be reviewed by all trial sites. Results will be made available in an open access journal. Results will be communicated to appropriate patient organisations like the ILCO e.V. Trial results will be presented at an... | PMC9890770 | ||
Discussion | RECRUITMENT | Given the high rate of IH after loop ileostomy closure with its associated morbidity, loss of health-related quality of life and costs, prophylactic measures after ostomy closure are urgently needed. Prophylactic mesh implantation at the time of surgical stoma reversal has shown to be a promising and safe method to pre... | PMC9890770 | |
Trial status | MAY | The current protocol number is 1.1, May 12, 2022.Recruitment has started in October 2022.Recruitment is planned to be completed at the beginning of 2024. | PMC9890770 | |
Acknowledgements | N/A | PMC9890770 | ||
Authors’ contributions {31b} | CDH | SM: substantial contributions to the conception and design of the work and analysis methods and draft of the work and has approved the submitted version and has agreed both to be personally accountable for the author’s own contributions and to ensure that questions related to the accuracy or integrity of any part of th... | PMC9890770 | |
Authors’ information | N/A | PMC9890770 | ||
Funding {4} | Open Access funding enabled and organized by Projekt DEAL. The P.E.L.I.O.N trial is financed by the Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung BMBF, Förderkennzeichen 01KG2023). The funding body has no influence on study design and conduct, analysis and interpretation of dat... | PMC9890770 |
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