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Author contributions
Dr. CM-K had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Concept and design: KEW, KP, CM-K, LT, AD, KB. Acquisition, analysis, or interpretation of data: CM-K, LT, JA, MDC, KP, KW, AD, KEW. Drafting of the manuscript: CM-K, KP...
PMC9881516
Funding
This research was supported by the National Institute of Mental Health/NIMH (U01MH121954).
PMC9881516
Availability of data and materials
The datasets generated and analyzed during this study are not publicly available due to the sensitive nature of the data. They can be made available from the corresponding author on reasonable request and with execution of appropriate Data Use Agreements.
PMC9881516
Declarations
PMC9881516
Ethics approval and consent to participate
Ethical approval for the study was obtained from the RAND Corporation Human Subjects Protection Committee and the University of New Mexico Health Sciences Institutional Review Board. Written informed consent was waived as no patient identifiers were collected and survey responses were anonymous.
PMC9881516
Consent for publication
Not applicable.
PMC9881516
Competing interests
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
PMC9881516
References
PMC9881516
Aims/hypothesis
Gestational diabetes
GESTATIONAL DIABETES
Pregnant women are advised to consume a minimum of 175 g per day of carbohydrate to meet maternal and fetal brain glucose requirements. This recommendation comes from a theoretical calculation of carbohydrate requirements in pregnancy, rather than from clinical data. This study aimed to determine whether fasting matern...
PMC10789657
Methods
overweight or obesity
EARLY PREGNANCY
Food frequency questionnaires on dietary intake during pregnancy were completed by pregnant women with overweight or obesity at 28 weeks’ gestation (considering their intake from the beginning of pregnancy). Dietary intake from early pregnancy through to 28 weeks was analysed for macronutrient intake. At the same time,...
PMC10789657
Results
Fasting serum β-hydroxybutyrate levels amongst 108 women (mean BMI 34.7 ± 6.3 kg/m
PMC10789657
Conclusions/interpretation
Fasting serum β-hydroxybutyrate levels are not associated with habitual carbohydrate intake at 28 weeks’ gestation in pregnant women with overweight and obesity.
PMC10789657
Graphical Abstract
PMC10789657
Supplementary Information
The online version of this article (10.1007/s00125-023-06044-w) contains peer-reviewed but unedited supplementary material.
PMC10789657
Keywords
Open Access funding enabled and organized by CAUL and its Member Institutions
PMC10789657
Introduction
low habitual carbohydrate, ketonaemia
KETONAEMIA, EARLY PREGNANCY
Current dietary advice for pregnant women is to avoid diets that lead to increased ketonaemia [Ketones are produced from the breakdown of lipids when glucose availability is low. Ketogenesis is increased in pregnancy, particularly in the third trimester [Outside pregnancy, a diet with less than 50 g of carbohydrate per...
PMC10789657
Methods
GDM
GDM, DIABETES AND PREGNANCY, COMPLICATED PREGNANCIES, GESTATIONAL DIABETES
Food frequency questionnaires were completed in a subset of 108 women with uncomplicated pregnancies enrolled in the Study of Probiotics IN Gestational Diabetes (SPRING), an RCT of probiotics to prevent GDM in pregnant women with overweight and obesity (ACTRN12611001208998) [Demographic data were collected for each wom...
PMC10789657
Statistics
HC
Women were divided into two groups; high carbohydrate intake (HC) as defined by carbohydrate intake greater than the median amount in g/day, and low carbohydrate intake (LC) defined as less than the median amount in g/day (155 g/day). Participant clinical, dietary and biochemical parameters are presented as mean ± SD (...
PMC10789657
Results
PMC10789657
Circulating B-OHB levels
weight gain
The limit of detection for B-OHB for our measurement was 20 μmol/l and the range in the overall cohort was from 22.2 to 296.5 μmol/l. In the LC group, nine participants (17.0%) did not show detectable levels of B-OHB in their fasting blood. In the HC group, four participants (7.3%) had no detectable B-OHB levels (B-OHB...
PMC10789657
Discussion
obesity, LGA, weight gain, GDM, hormone-sensitive lipase
GDM, OBESITY, EARLY PREGNANCY
In this cohort of women with overweight and obesity at 28 weeks’ gestation of pregnancy, with a median habitual dietary carbohydrate intake of 155 g/day, maternal fasting serum B-OHB levels ranged from 22.2 to 296.5 μmol/l (0.0222–0.297 mmol/l). While this is below 500 μmol/l or 0.5 mmol/l, which is the level considere...
PMC10789657
Conclusion
Fasting serum B-OHB levels are not correlated with habitual daily carbohydrate intake at 28 weeks’ gestation in pregnant women with overweight and obesity. Further research is needed to further evaluate the relationship between carbohydrate intake and maternal ketone levels, as well as the main determinants of elevated...
PMC10789657
Supplementary Information
Below is the link to the electronic supplementary material.Supplementary file1 (PDF 123 KB)
PMC10789657
Data availability
The data that support the findings of this study are not openly available due to reasons of sensitivity and are available from the corresponding author upon reasonable request. Data is located in controlled access data storage at The University of Queensland.
PMC10789657
Funding
HANSEN
Open Access funding enabled and organized by CAUL and its Member Institutions The SPRING study was supported by the National Health and Medical Research Council (APP1028575). Probiotics and placebo capsules for the SPRING study were donated by Chr. Hansen A/S. The sponsor was not involved in the design of the study; th...
PMC10789657
Authors’ relationships and activities
The authors declare that there are no relationships or activities that might bias, or be perceived to bias, their work.
PMC10789657
Contribution statement
HTN
HTN
This study was conceived of and designed by HLT, HLB, LKC, HDM and MDN. The data was acquired and analysed by HLT, HTN, GM and MDN. All authors contributed to the interpretation of the data. The manuscript was co-written by HLT and MDN and edited and approved by all authors. MDN is responsible for the integrity of the ...
PMC10789657
References
PMC10789657
1. Introduction and Background
insufficiency of the venous valves, ischemia, ulcers, atherosclerotic, numbness, pain, gangrene, infection, atherosclerotic ischemia, chronic arterial ulcers, atherosclerosis, ulcer, Atherosclerotic
HEALING ULCERS, LEG ULCERS, ISCHEMIA, DISEASE, ARTERIAL LEG ULCERS, ULCERS, GANGRENE, DISORDERS, VENOUS ULCERS, CHRONIC LEG ULCERS, INFECTION, SECONDARY, ARTERIAL ULCER, WOUND INFECTIONS, ATHEROSCLEROSIS, ULCER, COMPLICATIONS
Leg ulcers are a very serious worldwide medical problem. When the ulcer is extensive and deep the prognosis is usually unfavorable. The treatment requires comprehensive solutions that take into account modern specialized medical dressings, and more and more often, selected methods in the field of physical medicine. The...
PMC10300718
2. Material and Methods
swelling, allergy, painless, gangrene, necrotic, pain, purulent, infection, necrosis, ulcerations, ulcer
ACUTE ISCHEMIA, GENERALIZED INFECTION, ALLERGY, ULCERS, POLAND, NECROSIS, VASCULARIZATION, DEEP VEIN THROMBOSIS, GANGRENE, NECROTIC, INFECTION; LOCAL, INFECTION, ULCERATION, ULCER, ATROPHIC, COMPLICATIONS, INFILTRATION, ARTERIAL LEG ULCERS, ULCERATIONS
The study included 30 patients (13 women and 17 men) aged 47–80, hospitalized in the Department of Internal Medicine, Angiology and Physical Medicine in Bytom with a diagnosis of arterial ulceration of the lower limbs, who had no indications for vascular revascularization.After collecting their medical history and perf...
PMC10300718
2.1. Planimetric Assessment of Ulcer Surface Area
ULCERS
In clinical practice, modern measurement methods are used to assess the effects of wound treatment using computer programs for the digital processing of images used for image processing. They are advanced techniques of non-contact planimetry characterized by high reliability and an accuracy of measurements. They do not...
PMC10300718
2.2. Measurement of Pain Intensity
pain
Before and after the end of the treatment, the intensity of pain ailments was assessed with the use of the ten-point visual analog scale (VAS) for a subjective assessment of pain intensity. In this method, the patient marks a section of a straight line, usually 10 cm long, with opposite ends marked, and a 1 cm scale, a...
PMC10300718
2.3. Statistical Analysis
POLAND
Statistica 13 software (Statsoft, Poland) was used for statistical analysis. The Shapiro–Wilk test was used to test the normality of data. The statistics is presented as mean, standard deviation (SD), and 95% confidence intervals (CI). The Mann–Whitney U test was used to compare two unmatched groups. The Wilcoxon test ...
PMC10300718
3. Results
ulcer, ulcers, pain
ULCER, ULCERS, ULCERATION
Before treatment, the mean ulceration area in group 1 (8.53 ± 1.71 cmBefore the treatment, the average value of the pain intensity in group 1 (7.93 ± 0.68 points) did not differ statistically significantly from the mean value of the ulcer surface area in group 2 (8.00 ± 0.67 points) (The percentage improvement after th...
PMC10300718
4. Discussion
obesity, diabetic angiopathy, venous diseases, arterial insufficiency, hyperlipidemia, ulcers, necrotic, venous leg ulcers, pain, lower limb amputations, ulcer, arterial occlusive disease, diabetes
OBESITY, RECURRENCE, HEALED ULCER, ULCERS, ADVERSE EFFECTS, PERIPHERAL ARTERIAL DISEASE, VENOUS LEG ULCER, HYPERLIPIDEMIA, PROLIFERATION, INFLAMMATION, NECROTIC, HAND SWELLING, DIABETES, ARTERIAL INSUFFICIENCY, VENOUS DISEASE, ULCER, ARTERIAL OCCLUSIVE DISEASE, COMPLICATIONS, INFECTED WOUNDS, DIABETIC ANGIOPATHY, LEG U...
The knowledge of the use of various treatment methods in the case of hard-to-heal wounds, including leg ulcers, is systematically and continuously expanded and updated. The modern concept of wound treatment involves a comprehension of the underlying disease and is aimed at creating conditions conducive to healing, e.g....
PMC10300718
Limitations of the Study
This study had some limitations. First, this was a pilot study performed in a single institution with the risk of potential bias with respect to data collection. The study also did not include the analysis of previous standards of care used in the analyzed group of patients.
PMC10300718
Author Contributions
J.P.: Study design, data collection, data interpretation, manuscript preparation, the literature search; S.S.: data collection, statistical analysis; G.C.: data interpretation. All authors have read and agreed to the published version of the manuscript.
PMC10300718
Institutional Review Board Statement
POLAND
The study was conducted in accordance with the Declaration of Helsinki (1964) and its protocol has been accepted by the local bioethical committee at Medical University of Silesia in Katowice, Poland (approval reference number: KNW/0022/KB1/102/II/16/19). Every patient has signed forms of written informed consent appro...
PMC10300718
Informed Consent Statement
Informed consent was obtained from all subjects involved in the study.
PMC10300718
Data Availability Statement
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
PMC10300718
Conflicts of Interest
The authors declare no conflict of interest regarding the material discussed in the manuscript.
PMC10300718
References
pain
ULCERS, ULCERATION
The procedure of local hyperbaric oxygen therapy with the use of OXYBARIA-S device (manufacturer Firma FASER S.A., Świętochłowice, Poland).Comparison of the average values of the surface area of treated arterial ulcers of the lower limbs between the study groups before and after treatment, together with statistical ana...
PMC10300718
1. Introduction
rheumatoid arthritis, low back pain, seizures, osteoarthritis, hypoactive, painless, chronic musculoskeletal pain, pain, shoulder pain, chronic neck pain, hyperactive
RHEUMATOID ARTHRITIS, AUTONOMIC IMBALANCE, OSTEOARTHRITIS, MUSCULOSKELETAL DISORDERS, SYNDROMES, HEART, DISEASES, AUTONOMIC DYSREGULATION
Heart rate variability (HRV) analysis has emerged as a simple and non-invasive technique to indirectly evaluate the autonomic nervous system (ANS), and it is considered a sensible and advanced index of health status. Pulsed electromagnetic fields (PEMFs) are widely used in clinical settings for improving the health sta...
PMC10001461
2. Materials and Methods
PMC10001461
2.1. Participants
painful symptoms, chronic musculoskeletal pain, musculoskeletal pain
MAY, SYNDROME, BLIND
From a population of 95 patients, 32 subjects (17 men and 15 women) with painful symptoms in the musculoskeletal system, aged between 28 and 68 years old (50.06 ± 10.85), were enrolled in the study. Patients were recruited from April to May 2022 from the physiotherapy center “Centro FisioterapicoApuano” in Lucca (Italy...
PMC10001461
2.2. Experimental Procedure
Patients were randomized into two different groups: PAPIMI intervention (PAP) (n = 17) and sham (control) PAPIMI intervention (SHAM-PAP) (n = 15) (
PMC10001461
2.3. Interventions
PAP and SHAM-PAP interventions were administered to all patients by a single licensed and registered physiotherapist.
PMC10001461
2.3.1. PAPIMI Intervention
pain
Patients allocated to the PAP intervention group were treated with a PAP ion magnetic inductor (PAPIMIThe PAPIMI is an approved medical device that belongs to the large family of PEMFs, and it is based on the principle of ion induction. The device is composed of a capacitor that stores electrical energy, which is then ...
PMC10001461
2.3.2. Sham (Control) Papimi Intervention
Patients allocated to the sham intervention group received an inactive PEMF treatment and underwent the same procedure as that of the experimental group. The PAPIMI sham device was externally identical to the active one, except that it was deactivated prior to the exposure so that no pulsed electromagnetic fields were ...
PMC10001461
2.4. Data Collection Measurements
Before and immediately after each intervention, HRV was evaluated. Patients were recorded for a short period of 5 min in a resting state using a Polar H7 heart belt (Polar Electro, Kempele, Finland) [R-R intervals were subsequently evaluated using Kubios HRV Premium 3.4.1 desktop software (Kubios OY, Kuopio, Finland) t...
PMC10001461
2.5. Outcome Measures
Pre- and post-treatment values of HRV were examined. HRV evaluation, based on processing R-R intervals, was divided into time- and frequency-domain linear analysis [The following time-domain parameters of HRV were considered: standard deviation of adjacent NN intervals (SDNN), the root mean square of successive R-R int...
PMC10001461
2.6. Statistical Analysis
All the subjects’ demographic data as well as their HRV parameters were described using arithmetic means, standard deviations (SDs), and standard errors of the mean (SEM). The chi-squared test was used to test for gender differences between groups, and results were expressed in percentages. In addition, group differenc...
PMC10001461
3. Results
PMC10001461
3.1. Sample Characteristics and HRV Pre-Intervention Scores
ADVERSE EVENTS, ADVERSE EFFECT
Out of 95 patients, 32 were included in this study and randomized into two groups (PAP and SHAM-PAP). Patients who experienced any adverse effect from treatment would have been excluded from the study. Since no adverse events were reported, none of the participants was lost for this reason, and all received the treatme...
PMC10001461
3.2. HRV Post-Intervention Scores
The analyzed parameters of time- and frequency-domain of HRV after PAP and SHAM-PAP interventions are reported in
PMC10001461
3.2.1. SDNN
For the SDNN index, the results of the mixed ANOVA showed a significant main effect for TIME [
PMC10001461
3.2.2. RMSSD
For the RMSSD index, a significant main effect for TIME [
PMC10001461
3.2.3. NN50
For the NN50 index, no significant main effect for TIME [
PMC10001461
3.2.4. pNN50
For the pNN50 index, a significant main effect for TIME [
PMC10001461
3.2.5. HF
For the HF band, mixed ANOVA showed a significant main effect of TIME [
PMC10001461
4. Discussion
musculoskeletal pain, chronic musculoskeletal pain, pain
MUSCULOSKELETAL DISORDERS
In the current study, we investigated the influence of a single session of PEMFs stimulation using PAPIMI device on modulating ANS activity in patients with chronic musculoskeletal pain. An HRV analysis was employed in order to detect changes in vagal tone after the intervention.Our results showed that all values of ti...
PMC10001461
Author Contributions
Conceptualization, A.V., G.P., S.G. (Sara Guarducci), R.B. and D.M.; methodology, A.V., G.P., S.G. (Sara Guarducci), R.B., S.G. (Susanna Garfagnini), and D.M.; formal analysis, G.P. and M.M.; investigation, A.V. and S.G. (Susanna Garfagnini); data curation, G.P., S.G. (Sara Guarducci), and M.M.; writing—original draft ...
PMC10001461
Institutional Review Board Statement
The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the local institutional review committee (Prot. N. 12774E_spe, date of approval: 5 June 2018).
PMC10001461
Informed Consent Statement
Informed consent was obtained from all subjects involved in the study.
PMC10001461
Data Availability Statement
The data presented in this study are available on request from the corresponding author. The data are not publicly available due to privacy issues.
PMC10001461
Conflicts of Interest
The authors declare no conflict of interest.
PMC10001461
References
Flow-chart of the study.PAPIMI intervention. (Time-domain parameters of HRV at rest, pre- and post-treatment. (Frequency-domain parameter of HRV at rest, pre- and post-treatment. HF band. Data presented are mean ± standard errors of the mean (SEM). Asterisk marks a significant difference (Baseline values of PAPIMI (PAP...
PMC10001461
Subject terms
hypertensive, Pain, pain
Ambulatory blood pressure monitoring (ABPM) may be stressful and associated with discomfort, possibly influenced by the number of cuff inflations. We compared a low frequency (LF-ABPM) regimen with one cuff inflation per hour, with a high frequency (HF-ABPM) regimen performed according to current guidelines using three...
PMC10844074
Introduction
Hypertension, hypertensive
HYPERTENSION
Ambulatory blood pressure monitoring (ABPM) is recommended as the most accurate non-invasive method for the assessment of blood pressure (BP) and BP-related cardiovascular risk [The current ESH guidelines and the International Society of Hypertension recommend 2–3 cuff inflations every hour during ABPM [Previous invest...
PMC10844074
Methods
PMC10844074
Participants
hypertension, Chronic kidney disease, Hypertension
PERSISTENT ATRIAL FIBRILLATION, TREATMENT RESISTANT HYPERTENSION, HYPERTENSION, HYPERTENSION, CHRONIC KIDNEY DISEASE
Patients (≥ 18 years) were recruited from the Hypertension Clinic at Aarhus University Hospital, Denmark and from two local private cardiology clinics. Suspected treatment resistant hypertension was the main reason for attending these clinics. Exclusion criteria were pregnancy, change in antihypertensive medication wit...
PMC10844074
Materials
Prior to the first ABPM, a Microlife watchBP Office BP device (Microlife, AG Widnau, Switzerland) was used for bilateral BP measurements. If the inter-arm difference was larger than 10/5 mmHg (SBP/DBP) the ABPM device was fitted to the arm with the highest BP. If not, patients were given the option to choose which arm ...
PMC10844074
Study protocol
Pain, pain
All patients scheduled for a planned ABPM were screened and eligible patients were asked to participate. Patients who accepted to enter the study were randomized 1:1, using an online random number generator [Patients were prepared for the ABPM in accordance with current guidelines [Immediately after each ABPM, the pati...
PMC10844074
Statistical evaluation
SD
REGRESSION
The primary outcome was the difference in 24 h mean SBP between HF-ABPM and LF-ABPM. Secondary outcomes were mean differences in SBP for day- and nighttime, DBP values (24 h, daytime, and nighttime means), 95% limits of agreement (95% LoA) interval, coefficient of variation (CV) for both SBP and DBP values calculated a...
PMC10844074
Results
PMC10844074
General characteristics
A total of 171 patients were randomized. However, 40 (23.4%) did not complete the study or were excluded because of reasons outlined in Fig. 
PMC10844074
Flowchart of inclusion.
SD
HF-ABPM High frequency ambulatory blood pressure monitoring, LF-ABPM Low frequency ambulatory blood pressure monitoring.Baseline characteristics of the 131 patients finalizing both ABPMs are shown as total study population and according to measurement order (HF-ABPM first and LF-APBM first) in Table Basic characteristi...
PMC10844074
24 h blood pressure differences and agreement
BLOOD
There were no significant differences in 24 h BP means between HF-ABPM and LF-ABPM and a high level of agreement between the two measurement protocols. As shown in Table Blood pressure values and coefficients of variance during 24-hour ambulatory blood pressure monitoring.Data are mean with 95% confidence intervals. Th...
PMC10844074
24 h blood pressures.
Bland-Altman plots (
PMC10844074
Daytime and nighttime blood pressure differences and agreement
Daytime and nighttime averages were similar for the two measurement frequencies. Table 
PMC10844074
Day and nighttime blood pressures.
Bland-Altman plots for daytime SBP (We found that 49.6% of patients had a concordant dipping status between LF-ABPM and HF-ABPM (Supplementary Table 
PMC10844074
First time ABPM, hypertension categories, and order of measurement
hypertension
HYPERTENSION
Patients who underwent ABPM for the first time in the present study (For patients with moderate/severe hypertension LF-ABPM measured all but daytime SBP and nighttime DBP slightly higher compared to HF-ABPM (Supplementary Table There were no differences in neither 24 h, daytime, and nighttime BP values between those ra...
PMC10844074
Questionnaire on pain and sleep
ABPM-related pain, SD
Most patients rated ABPM-related pain low on a VAS. However, patients reported HF-ABPM to be slightly more painful compared to LF-ABPM (Table Questionnaire data.Data are presented as mean ± SD or median (interquartile range) for continuous variables and number (%) for categorical variables.
PMC10844074
Discussion
We here present the first randomized study comparing 24 h ABPM with hourly measurements to 24 h ABPM using the currently recommended frequencies of 2–3 measurements per hour in a patient-population covering a broad range of BP levels. We found a good agreement between HF-ABPM and LF-ABPM for both SBP and DBP values. In...
PMC10844074
Low vs. high measurement frequency
The present findings are in accordance with two smaller studies, which compared hourly measurements with 4 measurements per hour without detecting any difference in BP values [The most utilized method for investigating the influence of measurement frequencies is post-hoc random removal of individual measurements after ...
PMC10844074
Agreement between HF-ABPM and LF-ABPM
Only a few of the studies investigating measurement frequency reported 95% LoA or SD of difference, from which 95% LoA can be calculated [
PMC10844074
Blood pressure variability
It has been argued that an ABPM measurement frequency of once every hour could limit correct assessment of BP variability [
PMC10844074
Sleep quality and pain
pain
Some patients report pain from cuff inflations as a major complaint in relation to ABPM [Earlier studies have emphasized that interrupted sleep and a subsequent possible increase in nighttime BP as limitations of ABPM [
PMC10844074
Limitations and strengths
end-organ damage, hypertension, pain
HYPERTENSION
A possible limitation of all hospital-based hypertension studies is external validity and whether findings can be extrapolated to other settings. Patients referred to a specialized hypertension clinic more frequently have treatment-resistant hypertension or more advanced end-organ damage compared to patients treated in...
PMC10844074
Conclusion
pain
This is the first randomized study to investigate whether ABPM using hourly measurements may be an alternative to current guideline-recommended measurement frequencies. We found good agreement and no clinically significant BP differences between the two measurement frequencies. In addition, there was a modest reduction...
PMC10844074
Summary
PMC10844074
What is known about the topic
Current guidelines recommend 2–3 measurements per hour during ambulatory blood pressure monitoring (ABPM) but provide no clear evidence for this.Previous studies have tried to mimic a lower measurement frequency by random removal of data from ABPM using 2–3 recordings per hour.A direct comparison of a high
PMC10844074
What this study adds
pain
First randomized trial to actually compare hourly measurements with current guideline recommendations.There are no clinically relevant differences in neither blood pressure nor blood pressure variation between the two measurement frequencies.ABPM related pain was significantly less both during daytime and nighttime wh...
PMC10844074
Supplementary information
The online version contains supplementary material available at 10.1038/s41371-023-00868-0.
PMC10844074
Acknowledgements
Cardiologists Inger Sihm, MD, PhD, and Niels Henrik Vinther Krarup, MD, PhD deserve our thankfulness for their active participation and patient referral. We are grateful for the skilled assistance of technician Lene Schlamovitz and for her persistent helpfulness during this study.
PMC10844074
Author contributions
MBT designed the study, collected, and analyzed data, and wrote the manuscript. JN, KLC, MR, and NHB all helped design the study, collect, and analyze data, and providing feedback on the manuscript.
PMC10844074
Funding
Aarhus University and the Central Denmark Research Foundation. Open access funding provided by Aarhus University Hospital.
PMC10844074
Data availability
The raw data that support the findings of this study are currently safely stored at our research facility. It contains patient specific data and is therefore not publicly available. This is in agreement with the General Data Protection Regulation of the European Union. Data can be made available upon reasonable request...
PMC10844074
Competing interests
The authors declare no competing interests.
PMC10844074
Ethical approval
The Committees on Health Research Ethics and to the Danish Data Protection Agency were notified of the study and both parties approved its conduction. All participants gave informed written consent before entering the study.
PMC10844074