European Registry on Helicobacter pylori management (Hp-EuReg): patterns and trends in first-line empirical eradication prescription and outcomes of 5 years and 21 533 patients

ObjectiveThe best approach for Helicobacter pylori management remains unclear. An audit process is essential to ensure clinical practice is aligned with best standards of care.DesignInternational multicentre prospective non-interventional registry starting in 2013 aimed to evaluate the decisions and outcomes in H. pylori management by European gastroenterologists. Patients were registered in an e-CRF by AEG-REDCap. Variables included demographics, previous eradication attempts, prescribed treatment, adverse events and outcomes. Data monitoring was performed to ensure data quality. Time-trend and geographical analyses were performed.Results30 394 patients from 27 European countries were evaluated and 21 533 (78%) first-line empirical H. pylori treatments were included for analysis. Pretreatment resistance rates were 23% to clarithromycin, 32% to metronidazole and 13% to both. Triple therapy with amoxicillin and clarithromycin was most commonly prescribed (39%), achieving 81.5% modified intention-to-treat eradication rate. Over 90% eradication was obtained only with 10-day bismuth quadruple or 14-day concomitant treatments. Longer treatment duration, higher acid inhibition and compliance were associated with higher eradication rates. Time-trend analysis showed a region-dependent shift in prescriptions including abandoning triple therapies, using higher acid-inhibition and longer treatments, which was associated with an overall effectiveness increase (84%–90%).ConclusionManagement of H. pylori infection by European gastroenterologists is heterogeneous, suboptimal and discrepant with current recommendations. Only quadruple therapies lasting at least 10 days are able to achieve over 90% eradication rates. European recommendations are being slowly and heterogeneously incorporated into routine clinical practice, which was associated with a corresponding increase in effectiveness.

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European Registry on Helicobacter pylori Management: single-capsule bismuth quadruple therapy is effective in real-world clinical practice

United European Gastroenterology Journal ◽

10.1177/2050640620972615 ◽

2020 ◽

pp. 205064062097261

Author(s):

Olga P Nyssen ◽

Angeles Perez-Aisa ◽

Manuel Castro-Fernandez ◽

Rinaldo Pellicano ◽

Jose M. Huguet ◽

...

Keyword(s):

Helicobacter Pylori ◽

Clinical Practice ◽

Proton Pump Inhibitor ◽

Proton Pump ◽

Real World ◽

Case Report Form ◽

First Line ◽

Quadruple Therapy ◽

Intention To Treat ◽

H Pylori

Background There has been resurgence in the use of bismuth quadruple therapy (proton pump inhibitor, bismuth, tetracycline and metronidazole) for treating Helicobacter pylori infection thanks to a three-in-one single-capsule formulation. Objective To evaluate the effectiveness and safety of the single-capsule bismuth quadruple therapy. Methods Data were collected in a multicentre, prospective registry of the clinical practice of gastroenterologists on the management of H. pylori infection, where patients were registered at the Asociación Española de Gastroenterología REDCap database on an electronic case report form until January 2020. Effectiveness by modified intention-to-treat and per-protocol as well as multivariable analysis were performed. Independent factors evaluated were: age, gender, indication, compliance, proton pump inhibitor dose and treatment line. Results Finally, 2100 patients were prescribed single-capsule bismuth quadruple therapy following the technical sheet (i.e. three capsules every 6 hours for 10 days). The majority of these patients were naive (64%), with an average age of 50 years, 64% women and 16% with peptic ulcer. An overall modified intention-to-treat effectiveness of 92% was achieved. Eradication was over 90% in first-line treatment (95% modified intention-to-treat, n = 1166), and this was maintained as a rescue therapy, both in second (89% modified intention-to-treat, n = 375) and subsequent lines of therapy (third to sixth line: 92% modified intention-to-treat, n = 236). Compliance was the factor most closely associated with treatment effectiveness. Adverse events were generally mild to moderate, and 3% of patients reported a severe adverse event, leading to discontinuation of treatment in 1.7% of cases. Conclusions Single-capsule bismuth quadruple therapy achieved H. pylori eradication in approximately 90% of patients in real-world clinical practice, both as a first-line and rescue treatment, with good compliance and a favourable safety profile.

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Empirical or susceptibility-guided treatment for Helicobacter pylori infection? A comprehensive review

Therapeutic Advances in Gastroenterology ◽

10.1177/1756284820968736 ◽

2020 ◽

Vol 13 ◽

pp. 175628482096873

Author(s):

Javier P. Gisbert

Keyword(s):

Helicobacter Pylori ◽

Clinical Practice ◽

Helicobacter Pylori Infection ◽

Alternative Methods ◽

First Line ◽

Time Saving ◽

Line Therapy ◽

H Pylori ◽

Guided Therapy

Although susceptibility-guided therapy is frequently recommended for Helicobacter pylori infection, the evidence available to date supporting this strategy is limited. The aim of the present article is to review the advantages and limitations of the susceptibility-guided and the empirical strategies to treat this infection. We performed a bibliographic search to identify studies investigating H. pylori susceptibility-guided therapy. Culture is not the only way to assess antibiotic resistance, as different polymerase chain reaction-based approaches have been developed as alternative methods. For detecting H. pylori antimicrobial resistance, a molecular approach based on a stool sample might enable more convenient, time-saving methods. Unfortunately, the antimicrobial susceptibility cannot be obtained in all cases. Furthermore, antibiotic susceptibility testing in clinical practice yields useful information only for a few antibiotics: clarithromycin, metronidazole, and quinolones. In addition, susceptibility towards clarithromycin and metronidazole in vitro does not necessarily lead to eradication in vivo. In the case of H. pylori therapy failure, we should not re-administer any of the antibiotics against which H. pylori has probably become resistant. Our updated meta-analysis showed that susceptibility-guided treatment is not better than empirical treatment of H. pylori infection in first-line therapy if the most updated quadruple regimens are empirically prescribed, and similar efficacy results were also demonstrated with the two strategies for second-line therapy. Cumulative H. pylori eradication rate with several successive rescue therapies empirically prescribed reaches almost 100%. Finally, the studies that have evaluated the cost-effectiveness of the susceptibility-guided treatment have achieved contradictory results. In summary, we can conclude that the evidence is too limited to support the generalized use of susceptibility-guided therapy for H. pylori treatment in routine clinical practice, either as first-line or as rescue treatment. Nevertheless, it would be recommended that susceptibility tests are performed routinely, even before prescribing first-line treatment, in specialized centers with an interest in H. pylori management.

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Comparison of the effect of clarithromycin triple therapy with or without N-acetylcysteine in the eradication of Helicobacter pylori: a randomized controlled trial

Therapeutic Advances in Gastroenterology ◽

10.1177/1756284820927306 ◽

2020 ◽

Vol 13 ◽

pp. 175628482092730

Author(s):

Chieh-Chang Chen ◽

Jiing-Chyuan Luo ◽

Yu-Jen Fang ◽

Ji-Yuh Lee ◽

Chia-Chi Kuo ◽

...

Keyword(s):

Helicobacter Pylori ◽

Triple Therapy ◽

Controlled Trial ◽

Line Treatment ◽

First Line ◽

Open Label ◽

Intention To Treat ◽

Cyp2c19 Polymorphism ◽

H Pylori ◽

First Line Treatment

Background: Whether adjunctive N-acetylcysteine (NAC) may improve the efficacy of triple therapy in the first-line treatment of Helicobacter pylori infection remains unknown. Our aim was to compare the efficacy of 14-day triple therapy with or without NAC for the first-line treatment of H. pylori. Material and methods: Between 1 January 2014 and 30 June 2018, 680 patients with H. pylori infection naïve to treatment were enrolled in this multicenter, open-label, randomized trial. Patients were randomly assigned to receive triple therapy with NAC [NAC-T14, dexlansoprazole 60 mg four times daily (q.d.); amoxicillin 1 g twice daily (b.i.d.), clarithromycin 500 mg b.i.d., NAC 600 mg b.i.d.] for 14 days, or triple therapy alone (T14, dexlansoprazole 60 mg q.d.; amoxicillin 1 g b.i.d., clarithromycin 500 mg b.i.d.) for 14 days. Our primary outcome was the eradication rates by intention to treat (ITT). Antibiotic resistance and CYP2C19 gene polymorphism were determined. Results: The ITT analysis demonstrated H. pylori eradication rates in NAC-T14 and T14 were 81.7% [276/338, 95% confidence interval (CI): 77.5–85.8%] and 84.3% (285/338, 95% CI 80.4–88.2%), respectively. In 646 participants who adhered to their assigned therapy, the eradication rates were 85.7% and 88.0% with NAC-T14 and T14 therapies, respectively. There were no differences in compliance or adverse effects. The eradication rates in subjects with clarithromycin-resistant, amoxicillin-resistant, or either clarithromycin/amoxicillin resistant strains were 45.2%, 57.9%, and 52.2%, respectively, for NAC-T14, and were 66.7%, 76.9%, and 70.0%, respectively, for T14. The efficacy of NAC-T14 and T14 was not affected by CYP2C19 polymorphism. Conclusion: Add-on NAC to triple therapy was not superior to triple therapy alone for first-line H. pylori eradication [ClinicalTrials.gov identifier: NCT02249546].

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Evaluation of the Effectiveness of Helicobacter pylori Eradication Regimens in Lithuania during the Years 2013–2020: Data from the European Registry on Helicobacter pylori Management (Hp-EuReg)

Medicina ◽

10.3390/medicina57070642 ◽

2021 ◽

Vol 57 (7) ◽

pp. 642

Author(s):

Paulius Jonaitis ◽

Juozas Kupcinskas ◽

Olga P. Nyssen ◽

Ignasi Puig ◽

Javier P. Gisbert ◽

...

Keyword(s):

Helicobacter Pylori ◽

Triple Therapy ◽

Diagnostic Methods ◽

Line Treatment ◽

Second Line ◽

First Line ◽

Intention To Treat ◽

H Pylori ◽

Cure Rates ◽

European Registry

Background and Objectives: The prevalence of H. pylori in Eastern Europe remains quite high; however, there is insufficient data on the eradication regimens and their effectiveness. Therefore, the objective of the study was to evaluate the diagnostic methods and treatment of H. pylori infection as well as their adherence to Maastricht V/Florence consensus during the years 2013–2020 in Lithuania. Materials and Methods: Sub-study of the “European Registry on H. pylori Management” (Hp-EuReg), international multicenter prospective non-interventional registry of the routine clinical practice. Lithuanian data from the years 2013–2020 were analyzed for effectiveness on a modified intention-to-treat (mITT) basis. 2000 adult patients, diagnosed with H. pylori infection, were included. Data were compared to the European Maastricht V guidelines. Results: Triple-therapy was used in 90% of the cases. In 91% of the first-line prescriptions, standard triple therapy (STT) was used. The most common second-line treatment was a combination of PPI, amoxicillin and levofloxacin (PPI+A+L) (47%). The overall effectiveness in 552 cases valid for analysis was 90% by mITT. In first-line treatment, the STT effectiveness was 90% and second-line treatment with PPI+A+L achieved 92% by mITT. Increasing overall H. pylori eradication rates were observed: from 72% in 2013 to more than 90% in 2018–2020, as well as a shift from 7 to 10–14 days treatments duration throughout 2013–2020. Conclusions: In Lithuania, the prescribed eradication regimens for H. pylori were in accordance with the international guidelines but diagnostic methods and treatment duration only partially met Maastricht V/Florence guidelines. The eradication effectiveness was improved progressively during the years 2018–2020, reaching ≥90% cure rates.

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Sequential Therapy for First-Line Helicobacter pylori Eradication: 10- or 14-Day Regimen?

Journal of Gastrointestinal and Liver Diseases ◽

10.15403/jgld.2014.1121.281.hpy ◽

2019 ◽

Vol 28 (1) ◽

pp. 11-14 ◽

Cited By ~ 1

Author(s):

Angelo Zullo ◽

Giulia Fiorini ◽

Giuseppe Scaccianoce ◽

Piero Portincasa ◽

Vincenzo De Francesco ◽

...

Keyword(s):

Helicobacter Pylori ◽

Previous Treatment ◽

Sequential Therapy ◽

Bacterial Eradication ◽

First Line ◽

Open Label ◽

Intention To Treat ◽

First Line Therapy ◽

13C Urea Breath Test ◽

H Pylori

Background & Aim: Standard 10-day sequential therapy is advised as first-line therapy for Helicobacter pylori (H. pylori) eradication by current Italian guidelines. Some data suggested that a 14-day regimen may achieve higher eradication rates. This study compared the efficacy of sequential therapy administered for either 10- or 14-days.Methods: This prospective, multicenter, open-label study enrolled patients with H. pylori infection without previous treatment. Patients were receiving a sequential therapy for either 10 or 14 days with esomeprazole 40 mg and amoxicillin 1 g (5 or 7 days) followed by esomeprazole 40 mg, clarithromycin 500 mg and tinidazole 500 mg (5 or 7 days), all given twice daily. Bacterial eradication was checked using 13C-urea breath test. Eradication cure rates were calculated at both Intention-to-treat (ITT) and per-protocol (PP) analyses.Results: A total of 291 patients were enrolled, including 146 patients in 10-day and 145 in the 14-day regimen. The eradication rates were 87% (95% CI = 81.5-92.4) and 90.3% (95% CI = 85.5-95.1) at ITT analysis with the 10- and 14-day regimen, respectively, and 92.7% (95% CI = 88.3-97) and 97% (95% CI = 94.2-99.9) at PP analysis (p =0.37). Among patients, who earlier had interrupted therapy, bacterial eradication was achieved in 8 out of 9 who completed the first therapy phase and performed at least ≥3 days of triple therapy in the second phase.Conclusion: This study found that both 10- and 14-day sequential therapies achieved a high eradication rate for first-line H. pylori therapy in clinical practice.

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European Registry on Helicobacter pylori Management: Effectiveness of First and Second-Line Treatment in Spain

Antibiotics ◽

10.3390/antibiotics10010013 ◽

2020 ◽

Vol 10 (1) ◽

pp. 13

Author(s):

María Caldas ◽

Ángeles Pérez-Aisa ◽

Manuel Castro-Fernández ◽

Luis Bujanda ◽

Alfredo Lucendo ◽

...

Keyword(s):

Helicobacter Pylori ◽

Second Line ◽

Cure Rate ◽

Management Effectiveness ◽

First Line ◽

Intention To Treat ◽

First Line Therapy ◽

Line Therapy ◽

H Pylori ◽

European Registry

The management of Helicobacter pylori infection has to rely on previous local effectiveness due to the geographical variability of antibiotic resistance. The aim of this study was to evaluate the effectiveness of first and second-line H. pylori treatment in Spain, where the empirical prescription is recommended. A multicentre prospective non-interventional registry of the clinical practice of European gastroenterologists concerning H. pylori infection (Hp-EuReg) was developed, including patients from 2013 until June 2019. Effectiveness was evaluated descriptively and through a multivariate analysis concerning age, gender, presence of ulcer, proton-pump inhibitor (PPI) dose, therapy duration and compliance. Overall, 53 Spanish hospitals were included, and 10,267 patients received a first-line therapy. The best results were obtained with the 10-day bismuth single-capsule therapy (95% cure rate by intention-to-treat) and with both the 14-day bismuth-clarithromycin quadruple (PPI-bismuth-clarithromycin-amoxicillin, 91%) and the 14-day non-bismuth quadruple concomitant (PPI-clarithromycin-amoxicillin-metronidazole, 92%) therapies. Second-line therapies were prescribed to 2448 patients, with most-effective therapies being the triple quinolone (PPI-amoxicillin-levofloxacin/moxifloxacin) and the bismuth-levofloxacin quadruple schemes (PPI-bismuth-levofloxacin-amoxicillin) prescribed for 14 days (92%, 89% and 90% effectiveness, respectively), and the bismuth single-capsule (10 days, 88.5%). Compliance, longer duration and higher acid inhibition were associated with higher effectiveness. “Optimized” H. pylori therapies achieve over 90% success in Spain.

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Evidence-Based Guidelines for the Treatment of Helicobacter pylori Infection in Korea: 2020 Revised Edition

Korean Journal of Medicine ◽

10.3904/kjm.2021.96.3.160 ◽

2021 ◽

Vol 96 (3) ◽

pp. 160-189

Author(s):

Hye-Kyung Jung ◽

Seung Joo Kang ◽

Yong Chan Lee ◽

Hyo-Joon Yang ◽

Seon-Young Park ◽

...

Keyword(s):

Helicobacter Pylori ◽

Clinical Practice ◽

Eradication Rate ◽

Meta Analysis ◽

Controlled Study ◽

Evidence Based ◽

School Students ◽

Duodenal Ulcers ◽

Intention To Treat ◽

H Pylori

Helicobacter pylori (H. pylori) infection is one of the most common infectious diseases worldwide. Although its incidence is gradually decreasing, about half of the world's population still get infected. H. pylori infection is responsible for substantial gastrointestinal morbidity worldwide. It is the most common cause of gastric and duodenal ulcers as well as gastric cancer. Since the revision of the H. pylori Clinical Practice Guidelines in 2013, the eradication rate of H. pylori has gradually decreased with the use of classical triple therapy, wherein amoxicillin, clarithromycin, and proton pump inhibitors are administered, for 7 days. According to a nationwide randomized controlled study conducted by the Korean College of Helicobacter and Upper Gastrointestinal Research released in 2018, the intention-to-treat eradication rate was only 63.9%, which was due to increased antimicrobial resistance induced by the use of antibiotics, especially clarithromycin. The update of clinical practice guideline for treatment of H. pylori was developed based on evidence-based medicine by conducting a meta-analysis. The draft recommendations were finalized after expert consensus on three recommendations regarding the indication for treatment and eight recommendations on the treatment itself. These guidelines are designed to provide patients, nurses, medical school students, policymakers, and clinicians with clinical evidence to guide primary care and treatment of H. pylori infection. These may differ from current medical insurance standards and will be revised further, if necessary, based on research-based evidence.

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Sequential, concomitant and hybrid first-line therapies for Helicobacter pylori eradication: a prospective randomized study

Journal of Medical Microbiology ◽

10.1099/jmm.0.072322-0 ◽

2014 ◽

Vol 63 (5) ◽

pp. 748-752 ◽

Cited By ~ 53

Author(s):

Vincenzo De Francesco ◽

Cesare Hassan ◽

Lorenzo Ridola ◽

Floriana Giorgio ◽

Enzo Ierardi ◽

...

Keyword(s):

Helicobacter Pylori ◽

Randomized Study ◽

Sequential Therapy ◽

Concomitant Therapy ◽

First Line ◽

Helicobacter Pylori Eradication ◽

Intention To Treat ◽

H Pylori ◽

To Receive ◽

Treat Analysis

Helicobacter pylori eradication remains a challenge for physicians. Sequential, concomitant and the hybrid regimens have been proposed as novel, more effective therapies. We compare the efficacy of these therapies. Dyspeptic patients referred for upper endoscopy with H. pylori infection were enrolled. Patients were randomized to receive: (a) sequential therapy – 20 mg omeprazole and 1 g amoxicillin for 5 days, followed by 20 mg omeprazole, 500 mg clarithromycin and 500 mg tinidazole for the successive 5 days; (b) concomitant therapy – 20 mg omeprazole, 1 g amoxicillin, 500 mg clarithromycin and 500 mg tinidazole for either 5 days (5 day concomitant) or 14 days (14 day concomitant); or (c) hybrid therapy – 20 mg omeprazole and 1 g amoxicillin for 7 days, followed by 20 mg omeprazole, 1 g amoxicillin, 500 mg clarithromycin and 500 mg tinidazole for the successive 7 days. All drugs were given twice daily. Bacterial eradication was checked by using a [13C]urea breath test. In ‘intention-to-treat’ analysis, sequential therapy achieved the highest eradication rate, which was higher than that of 5 day concomitant therapy (90 vs 78.1 %; P = 0.02). The success rate did not statistically differ among the sequential and either 14 day concomitant (90 vs 86.3 %; P = not significant) or hybrid therapies (90 vs 82.7 %; P = not significant). The 10 day sequential, 14 day concomitant and 14 day hybrid therapies, but not the 5 day concomitant regimen, achieved similarly high eradication rates. The lower therapeutic cost coupled with the lower number of tablets needed would favour the sequential therapy as the first-line H. pylori treatment in clinical practice.

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Helicobacter pylori eradication rates in Slovenia in the period from 2017 to 2019 – data from the European Registry on Helicobacter pylori Management (Hp-EuReg)

Digestive Diseases ◽

10.1159/000512506 ◽

2020 ◽

Author(s):

Bojan Tepes ◽

Natasa Brglez Jurecic ◽

Katja Tepes ◽

Marta Espada Sanchez ◽

Olga Perez Nyssen ◽

...

Keyword(s):

Helicobacter Pylori ◽

Triple Therapy ◽

Second Line ◽

First Line ◽

Second Line Therapy ◽

Intention To Treat ◽

Line Therapy ◽

Medical Institutions ◽

H Pylori ◽

European Registry

Abstract Background. Helicobacter pylori (H pylori) is the most common chronic bacterial infection in the world, affecting over 50% of the world’s population. H pylori is a grade I carcinogen, responsible for the development of 89% of non-cardia gastric cancers. In the present study, we analyzed the data for H pylori eradication treatments in Slovenia after the 3rd National recommendations were implemented. Patients and methods. Slovenia is part of the European Registry on H pylori Management (Hp-EuReg) since the study was launched in 2013. Data were collected at AEG-REDCap e-CRF from September 2017 to December 2019. H pylori eradication treatment was assessed by modified intention-to-treat (mITT) and per-protocol (PP) analyses. Results. Overall, 823 patients from 3 medical institutions were included. Effectiveness with first line 14-day triple therapy with a proton-pomp-inhibitor (PPI), clarithromycin 500 mg, amoxicillin 1000 mg, all BID, was 93% by mITT (714 patients). In patients allergic to penicillin, first line 14-day triple therapy with PPI-clarithromycin-metronidazole achieved 83% effectiveness by mITT (35 patients). Second-line 14-day triple therapy with a PPI-amoxicillin-levofloxacin achieved 89% mITT eradication rate (51 patients). Second-line therapy with the 10-day three-in-one single capsule containing bismuth-tetracycline- metronidazole achieved optimal effectiveness (100% mITT) in 10 patients ( p=0.02). Conclusions. Slovenia is a country with < 15% H pylori resistance to clarithromycin. Triple therapy with a PPI plus two antibiotics during 14 days reported optimal effectiveness (over 90%). Ten-day quadruple bismuth second-line therapy had better results than 14-day triple therapy with levofloxacin).

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Ten-day bismuth-containing quadruple therapy versus 7-day proton pump inhibitor-clarithromycin containing triple therapy as first-line empirical therapy for the Helicobacter pylori infection in Korea: a randomized open-label trial

BMC Gastroenterology ◽

10.1186/s12876-021-01680-1 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Young-Il Kim ◽

Jong Yeul Lee ◽

Chan Gyoo Kim ◽

Boram Park ◽

Jin Young Park ◽

...

Keyword(s):

Helicobacter Pylori ◽

Line Treatment ◽

First Line ◽

Open Label ◽

Quadruple Therapy ◽

Intention To Treat ◽

Open Label Trial ◽

H Pylori ◽

Treat Analysis ◽

First Line Treatment

Abstract Background This randomized, open-label trial aimed to compare the efficacy of 10-day bismuth-containing quadruple therapy (BQT) with 7-day proton-pump inhibitor-clarithromycin containing standard triple therapy (STT) as an empirical first-line Helicobacter pylori therapy. Methods Participants with H. pylori infection were randomly assigned to either 10-day BQT (daily doses of bismuth 300 mg, four times; lansoprazole 30 mg, twice; metronidazole 500 mg, three times; and tetracycline 500 mg, four times) or 7-day STT (lansoprazole 30 mg; amoxicillin 1,000 mg; and clarithromycin 500 mg; each given twice daily). Participants who failed initial therapy were crossed over to the alternative treatment regimen. Primary outcome was the eradication rates of first-line treatment by intention-to-treat analysis. Results Study participants (n = 352) were randomized to receive either 10-day BQT (n = 175) or 7-day STT (n = 177). The BQT-group achieved a significantly higher eradication rate than the STT-group in the intention-to-treat analysis (74.3% vs 57.1%, respectively; P = 0.001), modified intention-to-analysis (87.2% [130/149] vs 68.7% [101/147], respectively; P < 0.001) and per-protocol analysis (92.9% [105/113] vs 70.1% [94/134], respectively; P < 0.001). Although there was no serious adverse event, the compliance was lower with BQT than STT as a higher proportion of participants in the BQT-group discontinued therapy because of adverse events than those in the STT-group (23.1% vs 9.1%, respectively; P = 0.001) Conclusions Ten-day BQT had higher eradication rates compared to that of the 7-day STT as an empirical first-line treatment for H. pylori eradication in Korea. Trial registration: ClinicalTrials.gov, NCT02557932. Registered 23 September 2015, https://clinicaltrials.gov/ct2/show/NCT02557932?term=NCT02557932&draw=2&rank=1.

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