bluuebunny/crossref_metadata_2025_split huggingface dataset:
Antifungal susceptibility testing and determination of local epidemiological cut-off values for
Candida
species isolated from women with vulvovaginal candidiasis
Authors: Kroustali Vasiliki , Kanioura Lamprini , Resoulai Esmeralda , Siopi Maria , Antonopoulou Stavroula , Meletiadis Joseph 
Published: January 2025

ABSTRACT

The lack of clinical breakpoints and epidemiological cut-off values (ECOFFs) for antifungals prescribed for vulvovaginal candidiasis (VVC) make interpretation of antifungal susceptibility data difficult. This leads to empirical prescribing, poor clinical management and emergence of resistance. The
in vitro
susceptibilities of 152
Candida albicans
, 105
Candida parapsilosis
, 31
Nakaseomyces glabratus,
and 8
Pichia kudriavzevii
VVC isolates against eight antifungals, were determined according to the European Committee on Antimicrobial Susceptibility Testing (EUCAST) E.Def 7.4. The minimum inhibitory concentration (MIC) distributions were analyzed and local ECOFFs were determined visually and statistically. The
in vitro
activity of azoles was correlated with fluconazole susceptibility and clinical data were evaluated. The MICs of various azoles showed a significant correlation with the MICs of fluconazole and fluconazole non-wild type (WT) isolates had significantly higher MICs for other azoles. The estimated local ECOFFs for
C. albicans
were 0.016 mg/L (ketoconazole, clotrimazole), 0.06 mg/L (miconazole, econazole, itraconazole), 1 mg/L (fenticonazole), and 3,200 mg/L (boric acid). For
C. parapsilosis
, local ECOFFs were 0.06 mg/L (ketoconazole, clotrimazole, itraconazole), 1 mg/L (miconazole, econazole), 2 mg/L (fenticonazole), and 3,200 mg/L (boric acid). For
N. glabratus
, they were 1 mg/L (ketoconazole, clotrimazole, miconazole, itraconazole), 2 mg/L (econazole, fenticonazole), and 12,800 mg/L (boric acid). Non-WT isolates were detected for azoles in
N. glabratus
(10%–35%),
C. albicans
(5%–16%), and
C. parapsilosis
(≤ 3%). All isolates were WT for boric acid. Local ECOFFs were established for three major
Candida
species causing VVC, guiding the identification of non-WT isolates potentially associated with treatment failure.

IMPORTANCE

The interpretation of
in vitro
susceptibility data of
Candida
isolates from women with vulvovaginal candidiasis (VVC) is challenging due to the lack of clinical breakpoints (CBPs) and epidemiological cut-off values (ECOFFs) for drugs used in VVC. In the present study, local ECOFFs were established for three major
Candida
species causing VVC, guiding the identification of non-wild type isolates potentially associated with treatment failure. This paper provides the framework for developing ECOFFs and ultimately CBPs that would help guide antifungal therapy of VVC.
Therapeutic quality of exercise interventions for chronic low back pain: a meta-research study using i-CONTENT tool
Authors: Geraci Ignazio , Bargeri Silvia , Basso Giacomo , Castellini Greta , Chiarotto Alessandro , Gianola Silvia , Ostelo Raymond , Testa Marco , Innocenti Tiziano 
Published: January 2025

ObjectiveTo assess the therapeutic quality of exercise interventions delivered in chronic low back pain (cLBP) trials using the international Consensus on Therapeutic Exercise aNd Training (i-CONTENT) tool and its inter-rater agreement.MethodsWe performed a meta-research study, starting from the trials’ arms included in the published Cochrane review (2021) ‘Exercise therapy for chronic low back pain’. Two pairs of independent reviewers applied the i-CONTENT tool, a standardised tool designed to ensure the quality of exercise therapy intervention, in a random sample of 100 different exercise arms. We assessed the inter-rater agreement of each category calculating the specific agreement. A percentage of 70% was considered satisfactory.ResultsWe included 100 arms from 68 randomised controlled trials published between 1991 and 2019. The most assessed exercise types were core strengthening (n=27 arms) and motor control (n=13 arms). Among alternative approaches, yoga (n=11) and Pilates (n=7) were the most representative. Overall, most exercise interventions were rated as having a low risk of ineffectiveness for patient selection (100%), exercise type (92%), outcome type and timing (89%) and qualified supervisor (84%). Conversely, some items showed more uncertainty: the safety of exercise programmes was rated as ‘probably low risk’ in 58% of cases, exercise dosage in 34% and adherence to exercise in 44%. The items related to exercise dosage (31%) and adherence (29%) had heterogenous judgements, scoring as high risk of ineffectiveness or probably not done. Among all exercise types, Pilates scored best in all domains. A satisfactory specific agreement for ‘low risk category’ was achieved in all items, except dosage of exercise (60%) and adherence to exercise (54%).ConclusionExercises delivered for patients with cLBP generally demonstrate favourable therapeutic quality, although some exercise modalities may present poor therapeutic quality related to dosage and adherence. While the i-CONTENT judgements generally showed satisfactory specific agreement between raters, disagreements arose in evaluating some crucial items.
Chronic pancreatitis: a case ascertainment study
Authors: Quammie Shauntelle , Rashid Adil , Munyal Rahul , Nicholson Edward S , Clarke Christopher , Venkatachalapathy Suresh V , Crooks Colin J , Aithal Guruprasad P , Aravinthan Aloysious D 
Published: January 2025

BackgroundChronic pancreatitis (CP) is a debilitating condition, characterised by chronic inflammation and fibrosis of the pancreas. The population frequency of CP is poorly understood. Therefore, we used a broad pragmatic approach to estimate the frequency of CP among a patient population undergoing investigations at a UK tertiary university hospital.MethodAll adult patients who, during 2006–2014, underwent abdominal CT MRI, abdominal X-ray, endoscopic ultrasonography (EUS), faecal elastase testing, received a pancreatin prescription or a recorded primary/comorbid ICD diagnosis of CP were screened (screening cohort) for inclusion. By applying the well-recognised CT, MRI and EUS criteria to the screening cohort, patients with CP were identified (study cohort). The incidence and point prevalence of CP were calculated, and changes in incidence were modelled using Poisson regression.ResultsScreening cohort included 24 271 cases, and 1003 patients who met the diagnostic criteria for CP were included in the study cohort. The median age of diagnosis was 65 (IQR 50–76); the majority were males (n=656, 65.4%) and of European ancestry (n=884, 88.1%). The annual incidence of diagnosis increased by a mean of 4.1% per year (95% CI 0.5% to 7.8%; p=0.03) over the study period ranging from 8.5 to 13.8 per 100 000 general population. The point prevalence also increased reaching 53.6 (95% CI 48.3 to 59.4) per 100 000 population at the end of the study period.ConclusionThis study provides a clear method of pragmatically identifying patients with CP in a clinical setting. The incidence of CP diagnosis in patients undergoing investigations in hospital increased gradually in Greater Nottingham.
Worldwide epidemiology of paediatric multiple sclerosis: data from the Multiple Sclerosis International Federation Atlas of MS, third edition
Authors: Gombolay Grace , Johnson Laura , King Rachel , Hebert Madeleine , Banwell Brenda , Chitnis Tanuja , Helme Anne 
Published: January 2025

BackgroundLimited data are available on the global rates of paediatric multiple sclerosis. Here, we report on the estimated worldwide prevalence of paediatric MS.MethodsWe included paediatric prevalence data in 2020–2022 (Multiple Sclerosis International Federation Atlas of MS) and the prevalence of child neurologists (International Child Neurology Association). Data were split into prevalence bands per 100 000. Countries were classified by the WHO Region and World Bank Income. Descriptive analyses were performed. An estimated worldwide prevalence rate was calculated from the 2020–2022 paediatric prevalence data, which was adjusted to reduce outliers’ impact and to reflect worldwide income distribution. The Atlas of MS data was obtained via survey of coordinators from the countries who use different tracking methods including national registries vs crude estimates.ResultsPaediatric data were available in 24% (53/219) countries (38 higher and 15 lower income) with 31 420 total paediatric MS cases. In 2022, 67% (10/15) of lower income countries reported prevalence bands of ‘<1.0’ compared with 34% (13/38) of higher income countries. Only 7% (1/15) of lower income countries reported prevalence bands ‘≥3.1’compared with 34% (13/38) of higher income countries. The rates of child neurologists positively correlated with the prevalence band. In 2020–2022, the estimated global prevalence (crude) was 2.53/100 000 (95% CI 2.51 to 2.56), with an adjusted prevalence rate of 1.48/100 000 (95% CI 1.45 to 1.51).ConclusionsAccess to epidemiology data from resource-limited countries is challenging including surveillance for case ascertainment. Increased resources and standard methodologies will facilitate the understanding of rare disease epidemiology.
Quantile regression of tobacco tax pass-through in the UK 2017–2021: how have manufacturers passed through tax changes for different tobacco products in small retailers? Analysis at the national level and by neighbourhood of deprivation
Authors: Wilson Luke B , Angus Colin , Brennan Alan , Gillespie Duncan , Shortt Niamh K , Tunstall Helena , Valiente Roberto , Pearce Jamie 
Published: January 2025

BackgroundThe effectiveness of tax increases in reducing tobacco consumption relies on the tobacco retailers and producers passing on increases to consumers (tax pass-through). Previous UK research on supermarkets found heterogeneous levels of tax pass-through across the market segments and price distribution of tobacco products. This study uses data from small retailers across the UK to assess whether recent tax changes have been passed on to consumers and if this varies across the price distribution, between countries of the UK and by neighbourhood deprivation.MethodsWe use panel data quantile regression analysis of tobacco sales in small retailers in the UK from March 2017 to December 2021 combined with UK tax rates and store-level index of multiple deprivation (IMD). We calculated the rate of tax pass-through for factory-made cigarettes (FM) and roll-your-own tobacco (RYO).ResultsFollowing increases in the duty payable on tobacco, we find evidence of overshifting across the entire price distribution for FM and RYO. For England, Scotland and Wales, the rate of the overshift in tax increased with product price. For Scotland, we find that stores in the least deprived IMD pass-through taxes at a higher rate.ConclusionsOur evidence shows heterogeneous levels of tax pass-through by price, region and level of deprivation. The findings emphasise the importance of understanding the pricing strategies of the tobacco industry (TI) and how these vary across the UK to develop robust approaches to mitigate the pricing strategies of the TI.
Investigation on the electromagnetic properties of the $$ D^{(*)} \Sigma _c^{(*)}$$ molecules
Authors: Özdem Ulaş 
Published: January 2025

Abstract
We systematically explore their electromagnetic characteristics to improve our understanding of the quark-gluon dynamics underlying the complex and controversial nature of multiquark systems. In this study, the magnetic dipole moments of

$$ D \Sigma _c$$

D

Σ
c

,

$$ D \Sigma _c^{*}$$

D

Σ
c

∗

and

$$ D^{*} \Sigma _c$$

D

∗

Σ
c

doubly-charmed pentaquarks are extracted, which are directly related to the inner organization of the relevant states. The magnetic dipole moments of these pentaquarks are evaluated employing the QCD light-cone sum rules technique with isospin spin-parity

$$\mathrm{I(J^P)} = \frac{1}{2}(\frac{1}{2}^-)$$

I
(

J
P

)

=

1
2

(

1
2

-

)

,

$$\mathrm{I(J^P)} = \frac{1}{2}(\frac{3}{2}^-)$$

I
(

J
P

)

=

1
2

(

3
2

-

)

and

$$\mathrm{I(J^P)} = \frac{1}{2}(\frac{3}{2}^-)$$

I
(

J
P

)

=

1
2

(

3
2

-

)

, for

$$ D \Sigma _c$$

D

Σ
c

,

$$ D \Sigma _c^{*}$$

D

Σ
c

∗

and

$$ D^{*} \Sigma _c$$

D

∗

Σ
c

doubly-charmed pentaquarks, respectively. Our predictions for the magnetic dipole moment

$$\mu _{D\Sigma _c} = 2.98^{+0.76}_{-0.54}~\mu _N$$

μ

D

Σ
c

=
2
.

98

-
0.54

+
0.76

μ
N

for the

$$ D \Sigma _c$$

D

Σ
c

pentaquark,

$$\mu _{D\Sigma _c^*} = 1.65^{+0.45}_{-0.34}~\mu _N$$

μ

D

Σ
c
∗

=
1
.

65

-
0.34

+
0.45

μ
N

for the

$$D\Sigma _c^*$$

D

Σ
c
∗

pentaquark, and

$$\mu _{D^*\Sigma _c} = -3.63^{+0.79}_{-0.60}~\mu _N$$

μ

D
∗

Σ
c

=
-
3
.

63

-
0.60

+
0.79

μ
N

for the

$$D^*\Sigma _c$$

D
∗

Σ
c

pentaquark. Furthermore, we have also extracted the electric quadrupole and the magnetic octupole moments of the

$$ D \Sigma _c^{*}$$

D

Σ
c

∗

and

$$ D^{*} \Sigma _c$$

D

∗

Σ
c

doubly-charmed pentaquarks. These values show a non-spherical charge distribution. As a by-product, the magnetic dipole moments of the isospin-

$$\frac{3}{2}$$

3
2

partners associated with these doubly-charmed pentaquarks have also been determined. The magnetic dipole moments are calculated as follows:

$$\mu _{D\Sigma _c} = 3.78^{+0.94}_{-0.70}~\mu _N$$

μ

D

Σ
c

=
3
.

78

-
0.70

+
0.94

μ
N

,

$$ \mu _{D\Sigma _c^*} = 2.08^{+0.57}_{-0.43}~\mu _N$$

μ

D

Σ
c
∗

=
2
.

08

-
0.43

+
0.57

μ
N

,

$$\mu _{D^*\Sigma _c} = -4.59^{+0.99}_{-0.76}~\mu _N$$

μ

D
∗

Σ
c

=
-
4
.

59

-
0.76

+
0.99

μ
N

for the isospin-

$$\frac{3}{2}$$

3
2

partners

$$ D \Sigma _c$$

D

Σ
c

,

$$ D \Sigma _c^{*}$$

D

Σ
c

∗

and

$$ D^{*} \Sigma _c$$

D

∗

Σ
c

doubly-charmed pentaquarks, respectively. We hope that our predictions of the magnetic dipole moments of the doubly-charmed pentaquarks, in conjunction with the results of other theoretical investigations of the spectroscopic parameters and decay widths of these intriguing pentaquarks, will prove valuable in the search for these states in future experiments and in elucidating the internal structure of these pentaquarks.
Reproductive and Hormonal Factors and Thyroid Cancer Risk: Pooled Analysis of Prospective Cohort Studies in the Asia Cohort Consortium
Authors: Kazmi Sayada Zartasha , Shin Aesun , Abe Sarah K. , Islam Md Rashedul , Rahman Md Shafiur , Saito Eiko , Cho Sooyoung , Katagiri Ryoko , Merritt Melissa A. , Choi Ji-Yeob , Shu Xiao-Ou , Sawada Norie , Tamakoshi Akiko , Sakata Ritsu , Hozawa Atsushi , Kanemura Seiki , Kim Jeongseon , Sugawara Yumi , Park Sue K. , Cai Hui , Tsugane Shoichiro , Kimura Takashi , Ahsan Habibul , Boffetta Paolo , Chia Kee Seng , Matsuo Keitaro , Qiao You-Lin , Rothman Nathaniel , Zheng Wei , Inoue Manami , Kang Daehee 
Published: January 2025

Abstract
Given the female predominance of thyroid cancer, particularly in the reproductive age range, female sex hormones have been proposed as an etiology; however, previous epidemiological studies have shown conflicting results. We conducted a pooled analysis using individual data from nine prospective cohorts in the Asia Cohort Consortium to explore the association between 10 female reproductive and hormonal factors and thyroid cancer risk. Using Cox proportional hazards models, cohort-specific hazard ratios (HR) and 95% confidence intervals (CI) were estimated and then pooled using a random-effects model. Analyses were stratified by country, birth years, smoking status, and body mass index, and thyroid cancer risk based on age of diagnosis was also examined. Among 259,649 women followed up for a mean of 17.2 years, 1,353 incident thyroid cancer cases were identified, with 88% (n = 1,140) being papillary thyroid cancer. Older age at first delivery (≥26 vs. 21–25 years) was associated with increased thyroid cancer risk (P-trend = 0.003; HR = 1.16; 95% CI, 1.03–1.31), particularly when diagnosed later in life (≥55 vs. &lt; 55 years; P-trend = 0.003; HR = 1.19; 95% CI, 1.02–1.39). Among younger birth cohorts, women with more number of deliveries showed an increased thyroid cancer risk [P-trend = 0.0001, HR = 2.40; 95% CI, 1.12–5.18 (≥5 vs. 1–2 children)], and there was no substantial trend in older cohorts. Distinct patterns were observed for the number of deliveries and thyroid cancer risk across countries, with a significant positive association for Korea [P-trend = 0.0008, HR = 1.89; 95% CI, 1.21–2.94 (≥5 vs. 1–2 children)] and nonsignificant inverse associations for China and Japan. Contextual and macrosocial changes in reproductive factors in Asian countries may influence thyroid cancer risk.
Prevention Relevance: This analysis of prospective cohort studies across three Asian countries highlights that older age at first birth is linked to increased thyroid cancer risk. As women delay motherhood, understanding these trends is vital for public health strategies addressing reproductive factors influencing thyroid cancer risk in these populations.
СУЧАСНІ ПІДХОДИ АПТЕЧНИХ ЗАКЛАДІВ ДО ПОБУДОВИ ТРИВАЛИХ СТОСУНКІВ ЗІ СПОЖИВАЧАМИ ФАРМАЦЕВТИЧНОЇ ПРОДУКЦІЇ ТА ПОКРАЩЕННЯ ФАРМАЦЕВТИЧНОЇ ДОПОМОГИ
Authors: Tkachenko N. O. , Zarichna T. P. , Mahanova T. V. , Chervonenko N. M. 
Published: January 2025

Мета роботи – аналіз сучасних підходів аптечних мереж до побудови тривалих стосунків зі споживачами фармацевтичної продукції задля визначення можливих шляхів покращення фармацевтичної допомоги у період воєнного стану та післявоєнний період.
Матеріали і методи: публікації вітчизняних та закордонних науковців з досліджуваного питання, офіційні web-сторінки найбільших аптечних мереж України та регіонального рівня, результати анкетування відвідувачів аптек. У роботі застосували методи інформаційного пошуку, критичного та порівняльного аналізу, опитування, дедукції та індукції, узагальнення й інтерпретації результатів.
Результати й обговорення. Проаналізовано існуючі сучасні програми лояльності (програми турботи) найбільших вітчизняних аптечних мереж, фармацевтичних підприємств-виробників та фармацевтичних підприємств-дистрибуторів. З’ясовано, що усі аналізовані програми є дуже схожими між собою і не впливають на задоволеність споживачів та не допомагають аптечним мережам будувати тривалі стосунки зі споживачами фармацевтичної продукції.
Висновки. Проведено бібліографічний аналіз зростання ролі фармацевта у сфері збереження здоров’я населення, що є провідним у формуванні нових бізнес-моделей у роботі зі споживачами фармацевтичної продукції.
На підставі опитування відвідувачів аптек м. Жовті Води та м. Запоріжжя визначено, що найбільш значущими факторами задоволеності споживачів під час надання фармацевтичної допомоги в умовах війни є широкий асортимент, прийнятні ціни та високий рівень обслуговування. Серед вагомих факторів впливу на лояльність пацієнтів до персоналу аптек - доброзичливість, професійна грамотність, вміння спілкуватись і розуміти проблему.
Проведені дослідження актуалізували необхідність пошуку шляхів розв'язання проблем, які дотичні до бізнес-моделей аптечних мереж з формування лояльності, як то забезпечення мережевих аптек кваліфікованими фармацевтичними фахівцями, високий рівень плинності кадрів в аптечному сегменті фармацевтичного ринку, розробка та впровадження фармацевтичної послуги.
ФАРМАЦЕВТИЧНА ДОПОМОГА ПАЦІЄНТАМ З ІШЕМІЧНОЮ ХВОРОБОЮ СЕРЦЯ: СТАН, ПРОБЛЕМИ ТА ПЕРСПЕКТИВИ
Authors: Bilousova N. A. 
Published: January 2025

Мета роботи - дослідження стану надання фармацевтичної допомоги пацієнтам, хворим на ішемічну хворобу серця з коморбідними станами з урахуванням міжпрофесійних підходів для подальшої розробки стратегії реалізації мультидисциплінарних підходів у командній взаємодії лікарів, фармацевтів та пацієнтів.
Матеріали та методи. Наводяться результати анонімного онлайн-опитування фармацевтів аптек (n=110) з приводу дотримання протоколів фармацевтів та з’ясування стану надання фармацевтичної допомоги та залученості до міжпрофесійної взаємодії з учасниками лікувального процесу, клінічні рекомендації ESC/AHA, інформаційно-наукові бази Scopus, Web of science, Cochrane library, PubMed, міжнародні та вітчизняні документи нормативно-правового поля. У роботі використано методи порівняльного аналізу, узагальнення, дедукції та індукції, систематизації, прогнозування.
Результати та обговорення. Задокументовано індивідуалізовані підходи до надання пацієнтам з ішемічною хворобою серця фармацевтичної допомоги шляхом активного діалогу. Визначено необхідність додаткового нормативного регулювання пацієнт-орієнтованого командного підходу та вдосконалення компетенцій фармацевтів в процесі безперервного професійного розвитку.
Висновки. Міжпрофесійна взаємодія між лікарями та фармацевтами відбувається переважно між фармацевтами аптечних закладів комунальної власності та закладів охорони здоров'я. Фармацевти мережевих аптечних закладів не завжди долучаються до надання фармацевтичної допомоги.
СИНТЕЗ ТА ДОСЛІДЖЕННЯ БІОЛОГІЧНОЇ АКТИВНОСТІ 5-ІНДОЛІДЕНРОДАНІНІВ
Authors: Fedusevych O.-M. V. , Lozynskyi A. V. , Konechnyi Y. T. , Yushyn I. M. , Ivasechko I. I. , Roman O. M. , Tymechko I. R. , Lesyk R. B. 
Published: January 2025

Мета - здійснити синтез 5-іноліденроданінів та дослідити їх протипухлинну активність та цитотоксичність.
Матеріали і методи. Протягом дослідження використали методи органічного синтезу, виконали фізико-хімічний аналіз синтезованих сполук. Протимікробну активність було проведено методом дифузї в агар. Оцінку цитотоксичності проведено на основі даних MTT аналізу.
Результати й обговорення. У результаті скринінгу протимікробної активності було ідентифіковано сполуки із помітним впливом на грампозитивні штами мікроорганізмів, зокрема стафілококи, які утворюють біоплівки (МІК 0,93 mM). Досліджувані сполуки володіли низькою цитотоксичністю на пухлинні та нормальні та псевдонормальні клітинні лінії.
Висновки. Результати свідчать про наявність помітної протимікробної активності похідних роданіну з індольним фрагментом у молекулах, що обґрунтовує перспективу поглибленого дослідження даного класу сполук.
Early Neurologic Deterioration and Efficacy of Dual Antiplatelet in Anterior Versus Posterior Circulation Stroke
Authors: Cui Yu , Wang Yi‐Han , Kong Xiang‐Ru , Chen Hui‐Sheng 
Published: January 2025

Background
Anterior circulation stroke (ACS) differs from posterior circulation stroke (PCS) in several aspects. We hypothesize that the risk of early neurologic deterioration (END) and its responses to clopidogrel plus aspirin versus aspirin alone may be different between stroke territories.

Methods and Results

This was a prespecified post hoc analysis of ATAMIS (Antiplatelet Therapy in Acute Mild to Moderate Ischemic Stroke) trial and included patients with definite infarct location who were classified into ACS and PCS according to stroke territory. Primary outcome was occurrence of END at 7 days, defined as ≥2‐point increase in National Institutes of Health Stroke Scale score compared with baseline. We compared the treatment effects of clopidogrel plus aspirin versus aspirin alone in each stroke territory. From 3000 patients, 2431 eligible patients (1780 with ACS [910 assigned into clopidogrel plus aspirin and 870 assigned into aspirin alone] and 651 with PCS [371 assigned into clopidogrel plus aspirin and 280 assigned into aspirin alone]) were included. Median age was 66 years and 35.1% were women. The occurrence of END was higher in ACS than PCS (6.8% versus 3.8%,
P
=0.007). clopidogrel plus aspirin was associated with lower risk of END in ACS (risk difference [95% CI]: −2.4% [−4.1% to −0.8%],
P
=0.004), but not in PCS (risk difference [95% CI]: −0.6% [−2.7% to 1.5%],
P
=0.57). No significant interaction was found (
P
=0.69).

Conclusions
Our study demonstrated END was higher in acute mild‐to‐moderate ischemic stroke with anterior circulation, who derived more benefit from clopidogrel plus aspirin than aspirin alone.

Registration

URL:
https://www.clinicaltrials.gov
; Unique identifier: NCT02869009.