The Effectiveness of a Community-Based Mentoring Program for Children Aged 5–11 Years: Results from a Randomized Controlled Trial

AbstractThe study, a two-arm, randomized controlled, parallel group, superiority trial, aimed to evaluate the implementation and effectiveness of a 12-month one-to-one volunteer mentoring program designed to improve behavioral and emotional outcomes in children aged 5 to 11 years who have teacher- and parent/carer-reported behavioral difficulties. Participants were 246 children (123 intervention, 123 control; mean age 8.4 years; 87% boys) in five sites in London, UK, scoring in the “abnormal” range on the teacher-rated Strengths and Difficulties Questionnaire (SDQ) Total Difficulties measure and in the “borderline” or abnormal range on the parent-rated SDQ Total Difficulties measure. Randomization on a 1:1 ratio took place using a computer-generated sequence and stratifying by site. Data collectors and statisticians were blind to participant allocation status. Outcome measures focused on parent- and teacher-rated child behavior and emotions, and child-rated self-perception and hope. Intention-to-treat analysis on all 246 randomized participants (using imputed data where necessary) showed that at post-intervention (16 months after randomization), there were no statistically significant effects on the primary outcome—parent-rated SDQ Total Difficulties (adjusted standardized mean difference = − 0.12; 95% CI: −0.38 to 0.13; p = 0.33)—or any secondary outcomes. Results from complier average causal effect (CACE) analysis using the primary outcome indicated the intervention was not effective for children who received the recommended duration of mentoring. Exploratory analyses found no sub-group effects on the primary outcome. The article concludes that the mentoring program had no effect on children’s behavior or emotional well-being, and that program content needs revising to satisfactorily address key risk and protective factors.

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Contrasting approaches for addressing non-adherence in randomized controlled trials: An illustration from the REFLUX trial

Clinical Trials ◽

10.1177/17407745211056881 ◽

2021 ◽

pp. 174077452110568

Author(s):

Luke Keele ◽

Richard Grieve

Keyword(s):

Randomized Controlled Trials ◽

Causal Effect ◽

Controlled Trial ◽

Treatment Protocol ◽

Analytical Framework ◽

Controlled Trials ◽

Intention To Treat ◽

Randomized Controlled ◽

Average Causal Effect ◽

Study Context

Background: In many randomized controlled trials, a substantial proportion of patients do not comply with the treatment protocol to which they have been randomly assigned. Randomized controlled trials are required to report results according to the intention-to-treat estimand, but recent methodological guidance recognizes the importance of estimating other causal quantities. Methods: This article outlines an analytical framework for randomized controlled trials with non-compliance. We apply the ICH E9 (R1) addendum and combine it with the potential outcomes framework to define key estimands, outline the major assumptions for identification of each estimand, and highlight the assumptions that cannot be verified from the randomized controlled trial data. We contrast the assumptions and estimates in a re-analysis of the REFLUX trial. We report alternative estimates for the effectiveness of receipt of laparoscopic surgery versus medical management for patients with gastro-intestinal reflux disease. Results: The article finds that adjusted as-treated and per-protocol estimates were similar in magnitude to those based intention-to-treat methods. Instrumental variable estimates of the complier average causal effect were larger, with wider confidence intervals. Conclusion: We recommend that in randomized controlled trials with non-compliance, studies should outline which estimand is most relevant to the study context, evaluate key assumptions, and present estimates from a range of methods as a sensitivity analysis.

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Paracetamol bei Rückenschmerzen nicht empfohlen

manuelletherapie ◽

10.1055/a-1146-2686 ◽

2020 ◽

Vol 24 (02) ◽

pp. 54-55

Author(s):

Arne Vielitz

Keyword(s):

Randomized Controlled Trial ◽

Low Back Pain ◽

Causal Effect ◽

Controlled Trial ◽

Low Back ◽

Effect Analysis ◽

Acute Low Back Pain ◽

Randomized Controlled ◽

Average Causal Effect ◽

Complier Average Causal Effect

Schreijenberg M, Lin CC, McLachlan AJ et al. Paracetamol is Ineffective for Acute Low Back Pain even for Patients Who Comply with Treatment: Complier Average Causal Effect Analysis of a Randomized Controlled Trial. Pain 2019; 160: 2848–2854. doi: 10.1097/j.pain.0000000000001685

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Azithromycin distribution and childhood mortality in compliance-related subgroups in Niger: complier average causal effect and spillovers in a cluster-randomized, placebo-controlled trial

International Journal of Epidemiology ◽

10.1093/ije/dyab198 ◽

2021 ◽

Author(s):

Kieran S O’Brien ◽

Ahmed M Arzika ◽

Ramatou Maliki ◽

Abdou Amza ◽

Farouk Manzo ◽

...

Keyword(s):

Incidence Rate ◽

Rate Ratio ◽

Incidence Rate Ratio ◽

Causal Effect ◽

Controlled Trial ◽

Effect Analysis ◽

Intention To Treat ◽

Average Causal Effect ◽

Cluster Randomized ◽

Complier Average Causal Effect

Abstract Background Biannual azithromycin distribution to children 1–59 months old reduced all-cause mortality by 18% [incidence rate ratio (IRR) 0.82, 95% confidence interval (CI): 0.74, 0.90] in an intention-to-treat analysis of a randomized controlled trial in Niger. Estimation of the effect in compliance-related subgroups can support decision making around implementation of this intervention in programmatic settings. Methods The cluster-randomized, placebo-controlled design of the original trial enabled unbiased estimation of the effect of azithromycin on mortality rates in two subgroups: (i) treated children (complier average causal effect analysis); and (ii) untreated children (spillover effect analysis), using negative binomial regression. Results In Niger, 594 eligible communities were randomized to biannual azithromycin or placebo distribution and were followed from December 2014 to August 2017, with a mean treatment coverage of 90% [standard deviation (SD) 10%] in both arms. Subgroup analyses included 2581 deaths among treated children and 245 deaths among untreated children. Among treated children, the incidence rate ratio comparing mortality in azithromycin communities to placebo communities was 0.80 (95% CI: 0.72, 0.88), with mortality rates (deaths per 1000 person-years at risk) of 16.6 in azithromycin communities and 20.9 in placebo communities. Among untreated children, the incidence rate ratio was 0.91 (95% CI: 0.69, 1.21), with rates of 33.6 in azithromycin communities and 34.4 in placebo communities. Conclusions As expected, this analysis suggested similar efficacy among treated children compared with the intention-to-treat analysis. Though the results were consistent with a small spillover benefit to untreated children, this trial was underpowered to detect spillovers.

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Effectiveness of using a meditation app in reducing anxiety and improving well-being during the COVID-19 pandemic: A structured summary of a study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-020-04935-6 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Katherine T. O’Donnell ◽

Melanie Dunbar ◽

Diana L. Speelman

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Well Being ◽

Intervention Period ◽

Post Intervention ◽

Randomized Controlled ◽

Survey Questions ◽

Full Protocol ◽

Allocation Ratio ◽

Survey Responses

Abstract Objectives This interventional study will investigate the effect of daily use of a mindfulness app on measures of participant anxiety, well-being, and perceived outlook during the COVID-19 pandemic, by comparing pre-intervention survey responses to post-intervention survey responses. Trial design Randomized, controlled trial with parallel assignment. Adults will be assigned either to daily use of a meditation app for 30 days or to a control group (no usage of meditation app) with a 1:1 equivalence allocation ratio. Participants Inclusion Criteria: Participants must be 18 or older, have a smartphone, able to download apps to their smartphone, must be fluent in the English language, able to complete surveys on their own, and must be in the United States for the duration of the study. Exclusion Criteria: Current regular use of a mindfulness or meditation app, regular practice of mindfulness or meditation, regular therapy sessions, inability to complete surveys independently, or any mental health restrictions that would prevent participation. All data will be collected through the Insight Timer Meditation App and Google Forms. This trial is being conducted through the Lake Erie College of Osteopathic Medicine in Erie, PA, with all data collected digitally. Intervention and comparator Intervention: Participants will be sent a link to a pre-intervention survey prior to first use of the mindfulness app. Participants will be instructed to use the Insight Timer app for 10 minutes daily for 30 days. At the end of the 30-day intervention period, participants will be sent a link for the post-intervention survey. Two months after the conclusion of the 30-day intervention period, participants will be sent a link for another post-intervention survey. Comparator: Participants will receive the same surveys, but will not use any mindfulness app for the 30-day intervention period. After this 30-day period, participants are invited to use the Insight Timer app if they so choose. Main outcomes The main outcomes are (1) anxiety as assessed by survey questions adapted from the GAD7, comparing pre-intervention to post-30-days of app usage and (2) well-being as assessed by survey questions adapted from the WHO-5, comparing pre-intervention and post-30-days of app usage. Randomization Participants will be allocated to interventions via a block random sequence generator with a 1:1 allocation ratio in blocks of 8. Blinding (masking) No masking is being used in this study (open label). Numbers to be randomized (sample size) Approximately 75 participants will be randomized to each group, with an estimated enrollment of 150 participants. Trial status This study is protocol version number 27-126 and was approved on May 10, 2020. Recruitment began on August 19, 2020 and will end February 28, 2021. The study is estimated to complete on April 30, 2021. Trial registration This trial was registered to ClinicalTrials.gov on 30 April 2020. The ClinicalTrials.gov Identifier is NCT04369378. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional File 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

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A Web-Based Photo-Alteration Intervention to Promote Sleep: Randomized Controlled Trial (Preprint)

10.2196/preprints.12500 ◽

2018 ◽

Author(s):

Isabel Perucho ◽

Kamalakannan M Vijayakumar ◽

Sean N Talamas ◽

Michael Wei-Liang Chee ◽

David I Perrett ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Sleep Duration ◽

Controlled Trial ◽

Well Being ◽

Sleep Hygiene ◽

Web Based ◽

Intention To Treat ◽

Randomized Controlled ◽

Information Group ◽

Function Of Sleep

BACKGROUND Receiving insufficient sleep has wide-ranging consequences for health and well-being. Although educational programs have been developed to promote sleep, these have had limited success in extending sleep duration. To address this gap, we developed a Web-based program emphasizing how physical appearances change with varying amounts of sleep. OBJECTIVE The aims of this study were to evaluate (1) whether participants can detect changes in appearances as a function of sleep and (2) whether this intervention can alter habitual sleep patterns. METHODS We conducted a 5-week, parallel-group, randomized controlled trial among 70 habitual short sleepers (healthy adults who reported having <7 hours of sleep routinely). Upon study enrollment, participants were randomly assigned (1:1) to receive either standard information or an appearance-based intervention. Both groups received educational materials about sleep, but those in the appearance group also viewed a website containing digitally edited photographs that showed how they would look with varying amounts of sleep. As the outcome variables, sleep duration was monitored objectively via actigraphy (at baseline and at postintervention weeks 1 and 4), and participants completed a measure of sleep hygiene (at baseline and at postintervention weeks 2, 4, and 5). For each outcome, we ran intention-to-treat analyses using linear mixed-effects models. RESULTS In total, 35 participants were assigned to each group. Validating the intervention, participants in the appearance group (1) were able to identify what they looked like at baseline and (2) judged that they would look more attractive with a longer sleep duration (<italic>t</italic>26=10.35, <italic>P</italic><.001). In turn, this translated to changes in sleep hygiene. Whereas participants in the appearance group showed improvements following the intervention (<italic>F</italic>1,107.99=9.05, <italic>P</italic>=.003), those in the information group did not (<italic>F</italic>1,84.7=0.19, <italic>P</italic>=.66). Finally, there was no significant effect of group nor interaction of group and time on actigraphy-measured sleep duration (smallest <italic>P</italic>=.26). CONCLUSIONS Our findings suggest that an appearance-based intervention, while not sufficient as a stand-alone, could have an adjunctive role in sleep promotion. CLINICALTRIAL ClinicalTrials.gov NCT02491138; https://clinicaltrials.gov/ct2/show/study/NCT02491138.

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INTERSTAARS: Attention training for infants with elevated likelihood of developing ADHD: A proof-of-concept randomised controlled trial

Translational Psychiatry ◽

10.1038/s41398-021-01698-9 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Amy Goodwin ◽

Emily J. H. Jones ◽

Simona Salomone ◽

Luke Mason ◽

Rebecca Holman ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Middle Childhood ◽

Causal Effect ◽

Controlled Trial ◽

Attention Training ◽

Proof Of Concept ◽

Degree Relative ◽

Post Intervention ◽

Intention To Treat ◽

Randomised Controlled

AbstractAttention-deficit/hyperactivity disorder (ADHD) is first diagnosed during middle childhood, when patterns of difficulty are often established. Pre-emptive approaches that strengthen developing cognitive systems could offer an alternative to post-diagnostic interventions. This proof-of-concept randomised controlled trial (RCT) tested whether computerised gaze-based attention training is feasible and improves attention in infants liable to develop ADHD. Forty-three 9- to 16-month-old infants with a first-degree relative with ADHD were recruited (11/2015–11/2018) at two UK sites and randomised with minimisation by site and sex to receive 9 weekly sessions of either (a) gaze-contingent attention training (intervention; n = 20); or (b) infant-friendly passive viewing of videos (control, n = 23). Sessions were delivered at home with blinded outcome assessments. The primary outcome was a composite of attention measures jointly analysed via a multivariate ANCOVA with a combined effect size (ES) from coefficients at baseline, midpoint and endpoint (Registration: ISRCTN37683928). Uptake and compliance was good but intention-to-treat analysis showed no significant differences between 20 intervention and 23 control infants on primary (ES −0.4, 95% CI −0.9 to 0.2; Complier-Average-Causal Effect ES −0.6, 95% CI −1.6 to 0.5) or secondary outcomes (behavioural attention). There were no adverse effects on sleep but a small increase in post-intervention session fussiness. Although feasible, there was no support for short-term effects of gaze-based attention training on attention skills in early ADHD. Longer-term outcomes remain to be assessed. The study highlights challenges and opportunities for pre-emptive intervention approaches to the management of ADHD.

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Short peripheral intravenous catheter securement with cyanoacrylate glue compared to conventional dressing: A randomized controlled trial

The Journal of Vascular Access ◽

10.1177/11297298211024037 ◽

2021 ◽

pp. 112972982110240

Author(s):

Amit Bahl ◽

S. Matthew Gibson ◽

David Jankowski ◽

Nai-Wei Chen

Keyword(s):

Primary Outcome ◽

Cox Regression ◽

Absolute Risk ◽

Controlled Trial ◽

Multivariable Analysis ◽

Invasive Procedure ◽

High Rate ◽

Cyanoacrylate Glue ◽

Intention To Treat ◽

Randomized Controlled

Background: Short peripheral intravenous catheters (PIVCs) fail prior to completion of therapy in up to 63% of hospitalizations. This unacceptably high rate of failure has become the norm for the most common invasive procedure in all of medicine. Securement strategies may improve PIVC survival. Methods: We conducted a prospective, single-site, parallel, two-arm randomized controlled investigation with a primary outcome of catheter failure comparing securement with standard semi-permeable dressing and clear tape (SPD) to standard semipermeable dressing and clear tape with cyanoacrylate glue (SPD + CG). Adult emergency department patients with a short PIVC and anticipated hospital duration ⩾ 48 h were enrolled and followed until IV failure or completion of therapy for up to 7 days. Secondary outcomes included complications and cost comparisons between groups. Primary outcome was assessed by intention to treat and per protocol analyses. Findings: 350 patients were enrolled between November 2019 and October 2020. PIVC survival for SPD + CG was similar to SPD group with the absolute risk difference of IV failure in the intention-to-treat (−5.8%, p = 0.065) population and improved in the per protocol (−8.1%, p = 0.04) population, respectively. Kaplan-Meier survival analysis indicated there was a significant benefit of the SPD + CG at greater than 2 days of hospitalization ( p = 0.04). Prior to 48 h, there was no survival enhancement to either group ( p = 0.98) in the intention to treat population. In a multivariable analysis with piecewise Cox regression, when the IV was functional greater than 48 h, the risk of IV failure in the SPD + CG was 43% less than the SPD group (adjusted hazard ratio [HR] 0.57, 95% confidence interval [CI] 0.34 to 0.97; p = 0.04). Cumulative cost related to IV during hospitalization was similar between groups with a lower incremental rescue cost in the SPD + CG group. Interpretation: SPD combined with cyanoacrylate glue provides similar benefit to patients compared to SPD alone and potentially improves short PIVC survival when the IV was inserted >48 h. As this strategy is cost neutral, it could be considered in admitted patients, particularly those with longer anticipated hospital durations.

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Testing the Efficacy of a Multicomponent, Self-Guided, Smartphone-Based Meditation App: Three-Armed Randomized Controlled Trial (Preprint)

10.2196/preprints.23825 ◽

2020 ◽

Author(s):

Simon B Goldberg ◽

Theodore Imhoff-Smith ◽

Daniel M Bolt ◽

Christine D Wilson-Mendenhall ◽

Cortland J Dahl ◽

...

Keyword(s):

Social Connectedness ◽

Controlled Trial ◽

Well Being ◽

Social Connection ◽

User Engagement ◽

Psychological Benefits ◽

Waitlist Control ◽

Intention To Treat ◽

Randomized Controlled ◽

Meditation Experience

BACKGROUND A growing number of randomized controlled trials (RCTs) suggest psychological benefits associated with meditation training delivered via mobile health. However, research in this area has primarily focused on mindfulness, only one of many meditative techniques. OBJECTIVE This study aims to evaluate the efficacy of 2 versions of a self-guided, smartphone-based meditation app—the Healthy Minds Program (HMP)—which includes training in mindfulness (Awareness), along with practices designed to cultivate positive relationships (Connection) or insight into the nature of the self (Insight). METHODS A three-arm, fully remote RCT compared 8 weeks of one of 2 HMP conditions (Awareness+Connection and Awareness+Insight) with a waitlist control. Adults (≥18 years) without extensive previous meditation experience were eligible. The primary outcome was psychological distress (depression, anxiety, and stress). Secondary outcomes were social connection, empathy, compassion, self-reflection, insight, rumination, defusion, and mindfulness. Measures were completed at pretest, midtreatment, and posttest between October 2019 and April 2020. Longitudinal data were analyzed using intention-to-treat principles with maximum likelihood. RESULTS A total of 343 participants were randomized and 186 (54.2%) completed at least one posttest assessment. The majority (166/228, 72.8%) of those assigned to HMP conditions downloaded the app. The 2 HMP conditions did not differ from one another in terms of changes in any outcome. Relative to the waitlist control, the HMP conditions showed larger improvements in distress, social connectedness, mindfulness, and measures theoretically linked to insight training (d=–0.28 to 0.41; Ps≤.02), despite modest exposure to connection- and insight-related practice. The results were robust to some assumptions about nonrandom patterns of missing data. Improvements in distress were associated with days of use. Candidate mediators (social connection, insight, rumination, defusion, and mindfulness) and moderators (baseline rumination, defusion, and empathy) of changes in distress were identified. CONCLUSIONS This study provides initial evidence of efficacy for the HMP app in reducing distress and improving outcomes related to well-being, including social connectedness. Future studies should attempt to increase study retention and user engagement. CLINICALTRIAL ClinicalTrials.gov NCT04139005; https://clinicaltrials.gov/ct2/show/NCT04139005

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Preliminary Outcomes of a Digital Therapeutic Intervention for Smoking Cessation in Adult Smokers: Randomized Controlled Trial (Preprint)

10.2196/preprints.22833 ◽

2020 ◽

Author(s):

Jamie Webb ◽

Sarrah Peerbux ◽

Peter Smittenaar ◽

Sarim Siddiqui ◽

Yusuf Sherwani ◽

...

Keyword(s):

Carbon Monoxide ◽

Randomized Controlled Trial ◽

Smoking Cessation ◽

Therapeutic Intervention ◽

Primary Outcome ◽

Controlled Trial ◽

Promising Alternative ◽

Intention To Treat ◽

Randomized Controlled ◽

Brief Advice

BACKGROUND Tobacco smoking remains the leading cause of preventable death and disease worldwide. Digital interventions delivered through smartphones offer a promising alternative to traditional methods, but little is known about their effectiveness. OBJECTIVE Our objective was to test the preliminary effectiveness of Quit Genius, a novel digital therapeutic intervention for smoking cessation. METHODS A 2-arm, single-blinded, parallel-group randomized controlled trial design was used. Participants were recruited via referrals from primary care practices and social media advertisements in the United Kingdom. A total of 556 adult smokers (aged 18 years or older) smoking at least 5 cigarettes a day for the past year were recruited. Of these, 530 were included for the final analysis. Participants were randomized to one of 2 interventions. Treatment consisted of a digital therapeutic intervention for smoking cessation consisting of a smartphone app delivering cognitive behavioral therapy content, one-to-one coaching, craving tools, and tracking capabilities. The control intervention was very brief advice along the Ask, Advise, Act model. All participants were offered nicotine replacement therapy for 3 months. Participants in a random half of each arm were pseudorandomly assigned a carbon monoxide device for biochemical verification. Outcomes were self-reported via phone or online. The primary outcome was self-reported 7-day point prevalence abstinence at 4 weeks post quit date. RESULTS A total of 556 participants were randomized (treatment: n=277; control: n=279). The intention-to-treat analysis included 530 participants (n=265 in each arm; 11 excluded for randomization before trial registration and 15 for protocol violations at baseline visit). By the quit date (an average of 16 days after randomization), 89.1% (236/265) of those in the treatment arm were still actively engaged. At the time of the primary outcome, 74.0% (196/265) of participants were still engaging with the app. At 4 weeks post quit date, 44.5% (118/265) of participants in the treatment arm had not smoked in the preceding 7 days compared with 28.7% (76/265) in the control group (risk ratio 1.55, 95% CI 1.23-1.96; P<.001; intention-to-treat, n=530). Self-reported 7-day abstinence agreed with carbon monoxide measurement (carbon monoxide <10 ppm) in 96% of cases (80/83) where carbon monoxide readings were available. No harmful effects of the intervention were observed. CONCLUSIONS The Quit Genius digital therapeutic intervention is a superior treatment in achieving smoking cessation 4 weeks post quit date compared with very brief advice. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN) 65853476; https://www.isrctn.com/ISRCTN65853476

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Additional effect of pain neuroscience education to craniocervical manual therapy and exercises for pain intensity and disability in temporomandibular disorders: a study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-021-05532-x ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Aroldo dos Santos Aguiar ◽

Cesar Bataglion ◽

Lilian Ramiro Felício ◽

Beatriz Azevedo ◽

Thaís Cristina Chaves

Keyword(s):

Randomized Controlled Trial ◽

Pain Intensity ◽

Manual Therapy ◽

Temporomandibular Disorders ◽

Primary Outcome ◽

Controlled Trial ◽

Screening Process ◽

Intention To Treat ◽

Randomized Controlled ◽

Neuroscience Education

Abstract The objective of this study will be to investigate the additional effect of pain neuroscience education program compared to a craniocervical manual therapy and exercises program for pain intensity and disability in patients with temporomandibular disorders (TMD). This study will be a randomized controlled trial comprising a sample of 148 participants. Subjects between 18 and 55 years, both genders, will undergo a screening process to confirm painful TMD by the Research Diagnostic Criteria (RDC/TMD), and then the volunteers will be randomized into two groups (G1: pain neuroscience education + craniocervical manual therapy and exercises vs. G2: craniocervical manual therapy and exercises). The volunteers will be recruited at the dentistry clinic. The intervention will be administered twice a week for 6 weeks by a single therapist lasting 1 h per session. The primary outcome will be pain intensity and disability and the secondary outcomes will be pain self-efficacy, kinesiophobia, and global perceived effect of improvement. The participants will be assessed immediately after the last session and at one- and three-month follow-ups. All statistical analyses will be conducted following intention-to-treat principles, and the treatment effects will be calculated using linear mixed models. The results of this study may contribute to understand the additional effect of pain neuroscience education intervention on TMD patients submitted to manual therapy and exercise. Trial registration ClinicalTrials.gov NCT03926767. Registered on April 29, 2019.

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