Collateral benefits of ivermectin MDA designed for malaria against headlice in Mopeia, Mozambique: a cluster randomised controlled trial

doi:10.21203/rs.3.rs-5198695/v1

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Research Article

Collateral benefits of ivermectin MDA designed for malaria against headlice in Mopeia, Mozambique: a cluster randomised controlled trial

https://doi.org/10.21203/rs.3.rs-5198695/v1

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Background

Headlice are prevalent worldwide, with a higher burden in rural, lower-middle income settings. They can cause intense itchiness, discomfort, and secondary bacterial infections with potentially serious consequences. Ivermectin is known to be efficacious against headlice, and is also currently being evaluated as a malaria vector control tool. In this study, we explored risk factors for headlice, and assessed the efficacy of ivermectin mass drug administration designed for malaria against headlice.

Methods

We conducted an open-label, assessor-blind, cluster-randomized controlled trial in Mopeia, Mozambique. A single dose of ivermectin was given monthly to eligible humans or humans and livestock (humans: 400 ug/kg, livestock: 1% injectable 200 ug/kg) in 3 consecutive months during the rainy season. The control group received albendazole (humans only). 39 clusters (13 per arm) were randomly selected for the nested assessment of headlice prevalence. 1,341 treated participants were followed up at, 1, 2 and 3 months and 382 untreated (ineligible) participants at 3 and 6 months after baseline. Headlice diagnosis was determined by examination of the scalp. Logistic regression was used to identify risk factors for headlice at baseline, and to estimate the treatment effect at each time point. This study is registered with ClinicalTrials.gov (NCT04966702).

Results

The baseline prevalence of headlice was 11%. Risk factors included living with a household member with head itch, being female, and living with poor water and sanitation facilities. The treated population receiving ivermectin had significantly lower odds of having headlice at 3 months compared to those receiving albendazole (aOR 0.22 95%CI 0.05–0.89). There was no indirect effect on headlice among ineligible children.

Conclusion

In a highly endemic setting, mass drug administration with ivermectin significantly reduces headlice infestation prevalence among those who receive the drug for three sequential months. The lack of effect among untreated, ineligible children implies that additional interventions would be needed to interrupt local transmission.

headlice

ectoparasites

mass drug administration

ivermectin

malaria

When malaria vector control tools such as Indoor Residual Spraying (IRS) and Insecticide Treated Nets (ITNs) were first being developed, their impact on nuisance parasites such as headlice and bedbugs contributed greatly to their acceptability and uptake (1–3). Similarly, the early development of resistance in these ectoparasites during DDT-based IRS campaigns led to declines in acceptability and coverage (4, 5). More recent studies have suggested that resistance in non-target ectoparasites continue to affect acceptability and usage of vector control tools (6–8). However, the secondary effects on these ectoparasites and off-target diseases are rarely monitored in malaria vector control studies and campaigns.

Headlice infestations are estimated to affect 19% of schoolchildren worldwide, causing stigma and shame among affected individuals, as well as school and work absenteeism (9, 10). The intense itchiness and discomfort caused by headlice infestations can lead to potentially serious secondary bacterial infections at the lesion sites. Although it has never been incriminated as a vector, some studies have suggested that, like body lice, they may have role in the transmission of Borrelia spp, the causal agent of lyme disease, and relapsing fever (11). Data on the prevalence and economic burden of headlice is sparse, and the problem of headlice is likely neglected in rural, impoverished areas of the global South, where reporting systems are weak, and other health issues are prioritized (12–14).

A range of topical pediculicidal treatment methods exists including benzyl benzoate, permethrin, lindane, malathion, dimeticone, 1,2-octanediol, and ivermectin (15). However, many of these are not widely accessible or used to treat headlice in lower-middle income countries. Alternatively, traditional medicines or non-insecticidal treatments can be used. Non-insecticidal treatments include mechanical removal of headlice using a comb, or hands, and head shaving. Resistance to pediculicides has been reported globally, however, most data on this comes from high income countries (16).

Ivermectin mass drug administration (iMDA) has been used for decades in the control of endo- and ectoparasites, and it is now under evaluation for use against malaria vectors (17). If it demonstrates success, it will likely be scaled-up, covering a larger population than currently targeted by the Mectizan Donation Program, which targets onchocerciasis and lymphatic filariasis. Ivermectin is known to be efficacious against headlice when used either topically or orally (18–20). However, to our knowledge, only one study has assessed the effect of iMDA (two doses 7 days apart of 200ug/kg) on headlice (21). This study reported a significant reduction in headlice prevalence of around 90%. In addition to this, a household-randomized study in Brazil assessed the impact of treating household contacts of headlice cases on their risk of re-infestation, and found that those living in households that received oral ivermectin were significantly more likely to be headlice free after 60 days (22). Finally, a pilot study in Australia assessed the effect of headlice screening and treating cases and siblings within a school with oral ivermectin versus topical treatment, and the findings suggest that oral ivermectin is more effective than topical treatment (23). The results from these studies suggest that similar effects may be observed in the context of iMDA for malaria in areas where headlice are prevalent.

Within a cluster-randomised trial that took place in Mopeia, Mozambique, assessing iMDA for malaria control, we assessed its impact on headlice prevalence, at both individual and community level, as well as the risk factors for having headlice, and compared the effects of the different treatment arms on headlice.

STUDY SETTING AND DESIGN

The study took place between March and October 2022, in Mopeia, a rural district in Zambezia Province, central Mozambique, which remains highly endemic for malaria despite dual coverage with IRS and ITNs (24). It has a population of approximately 131,000, and covers an area of 7,671km² (25).

The study was nested within a three-arm cluster-randomised controlled trial, aiming to assess the effect of iMDA on malaria transmission (26). Each cluster consisted of a core area, and a buffer area with a radius of 400 meters around the core. Either oral or written consent was obtained from all participants or their legal guardian. The following interventions were given once per month for three consecutive months:

Ivermectin in humans: a single dose of 400ug/kg in eligible humans;

Ivermectin in humans and livestock: a single dose of 400ug/kg in eligible humans plus 1% injectable ivermectin at a dose of 200 ug/kg to all pigs/cattle in the cluster;

Control: albendazole was given to humans only at a single dose of 400 mg.

All study drugs were delivered door-to-door and drug administration was directly observed by the responsible fieldworker. Within this study, two cohorts were followed up; the safety cohort, and the efficacy cohort. The safety cohort consisted of individuals who met the following criteria: weighing over 15 kg, ability to consent, and a negative pregnancy test for women aged between 13 and 49; and exclusion: known hypersensitivity to ivermectin or albendazole, risk of Loa loa as assessed by travel history, pregnancy, lactating in the first week postpartum, currently participating in another clinical trial, unwilling to consent or adhere to study procedures, severely ill, currently under treatment with inhibitors of CYP3A or P-gp (see Supplementary File 1 for the full list of excluded drugs). The purpose of this cohort was to serve as delivery vehicle for the insecticidal intervention and to monitor the safety of the treatment regime. These participants were followed up at 1,2 and 3 months after the first round of MDA.

The efficacy cohort consisted of children who were ineligible to take ivermectin due to a weight under 15 kg, but that were the primary group affected by malaria in the region; the purpose of this cohort was to assess the impact of the intervention on malaria. Untreated, ineligible participants were followed up at 3 and 6 months after the first round of MDA.

In the analysis, the safety cohort and any participants from the efficacy cohort who had taken ivermectin at least once were categorised as “treated”, and participants from the efficacy cohort who had not taken ivermectin were categorised as “untreated”.

RANDOMISATION AND SAMPLING

During October 2020 to November 2021, a local demography survey took place under a separate protocol, where all households were mapped and the population was enumerated (25). Using this data, clusters were created, and randomized 1:1:1 to each intervention using a computer-generated random sequence. Study investigators were masked from the treatment allocation during the study, however, the study participants were aware of which intervention they received. Following treatment allocation, 13 clusters per arm (39 clusters in total) were randomly selected for follow-up of headlice. Within these clusters, all children enrolled into the efficacy cohort of the main study, and 40 participants enrolled into the safety cohort of the main study were randomly selected for inclusion in this study.

OUTCOMES

The primary outcome was headlice prevalence at three months. Secondary outcomes were headlice prevalence at three months in treated participants, and at 3 and 6 months in untreated participants.

Fieldworkers were trained in headlice detection over a two-day period by JFA and AH through power point presentations, exercises using the tablet, and written assessments. In the field, participant scalps were inspected visually in daylight or under a torchlight, and signs of headlice (live lice or eggs) were recorded. In the main analysis, only participants with live headlice were categorized as having headlice.

RISK FACTOR ANALYSIS VARIABLES

Baseline data on headlice, and data from a demographic survey that took place prior to the start of the trial were used to conduct the risk factor analysis. Household wealth index was calculated using a formula detailed in Xie et al (27). All variables were determined through a pre-designed questionnaire. Bed net use was a binary variable, assessed by asking the participant or their parent/guardian whether they slept under a bed net the previous night. Details of how water sources were categorised are in Supplementary File 2 (28). Open defecation refers to those whose household does not have a sanitation facility available to them.

STATISTICAL ANALYSIS

The sample size of the nested study was calculated to detect a significant difference between the control and the treatment arms in scabies prevalence, which was another outcome that will be reported in a separate publication (Furnival-Adams et al., submitted). Assuming a 7% baseline scabies prevalence in the control group, a cluster size of 40 participants with 13 clusters per arm was required to detect a 60% effect size with 80% power at 5% significance and a kappa of 0.25.

For the risk factor analysis, logistic regression using the lme4 R package (v1.1-26; Bates et al., 2024) was used to conduct bivariate and multivariate analyses in the R programming language, version 4.2.2 (R Foundation for Statistical Computing). In all analyses, odds ratios or adjusted odds ratios with 95% CI were calculated. All variables associated with headlice in bivariate analysis (p < 0.10) were assessed for inclusion in multivariate analysis. Variables that were statistically significantly associated with headlice (p < 0·05) were included in the multivariate model.

To assess the treatment effect, we compared headlice prevalence in the control versus the treatment arms at each time point, using logistic regression model. To account for correlation between clusters, we used generalised estimating equations (GEE) to fit each logistic model of prevalence to the available data. Known risk factors of headlice, age, sex and wealth, were included as covariates in the adjusted models. These data were collected during the census survey that took place prior to the start of the trial. Intervention effects were expressed as adjusted odds ratios (aORs). After analysing the data, we found no statistically significant difference between the two treatment arms (human and human + livestock) existed, and therefore pooled the two intervention arms. Statistical significance was considered when the p-value was < 0.05 using to the Wald test to calculate the p-value.

This study was conducted in accordance with the CONSORT guidelines for reporting randomized controlled trials (Supplementary File 3) (29).

Between March 2022 and October 2022, 102 clusters were enrolled into the main malaria trial, and of these, 39 clusters were randomly selected for this nested headlice study. 1500 participants were randomly selected to be included in this nested study from the participants enrolled into the main trial, and 1309 people were included in the final analysis. The coverage in the overall population (eligible and ineligible) was between 43–53% and remained similar across all visits and across arms. The estimated treatment coverage ranged from 50 to 67% per round in eligible participants, and 43 to 52% in the overall population (eligible and ineligible to take ivermectin) (Supplementary File 4). The coverage was similar across arms and across all visits. Further information on the cluster and participant selection process is detailed in a separate publication (Furnival-Adams, submitted).

At baseline, characteristics of the households and participants were similar between all three intervention arms (Table 1). The median age was 19 years old in participants who took the study drug and 3 years old in the ineligible population. The sex distribution was balanced across all arms in both cohorts. The majority of participants were categorised as being in Rank 2 or 3 according to the wealth rank index in both cohorts. In the treated cohort, the overall baseline prevalence of headlice was 9.8%, and in the untreated cohort, 9.1%.

Table 1

Baseline characteristics of the study population
		Humans	Humans and Livestock	Control
TREATED
N clusters		13	13	13
N participants		307	347	348
Household wealth index rank	Rank 1†	56/307 (18.2%)	27/344 (7.8%)	42/346 (12.1%)
	Rank 2	62/307 (20.2%)	101/344 (29.4%)	97/346 (28.0%)
	Rank 3	78/307 (50.6%)	79/344 (23.0%)	81/346 (23.4%)
	Rank 4	46/307 (15.0%)	65/344 (18.6%)	82/346 (23.7%)
	Rank 5	65/307 (21.2%)	72/344 (20.9%)	44/346 (12.7%)
Median age in years (IQR) [N]		20.81 (29.8) [307]	18.8 (26.6) [347]	19.0 (30.6) [347]
Sex: female		155/307 (50.5%)	167/347 (48.1%)	166/348 (47.7%)
Median weight (SD) [N]		40 (25) [307]	40 (30) [347]	40 (28) [348]
Headlice prevalence		23/304 (7.6%)	35/347 (10.1%)	39/344 (11.3%)
UNTREATED, INELIGIBLE UNDER 5
N clusters		13	13	13
N participants		112	106	125
Household wealth index rank	Rank 1†	13/108 (12.0%)	5/104 (4.8%)	13/123 (10.6%)
	Rank 2	23/108 (21.3%)	23/104 (22.1%)	27/123 (22.0%)
	Rank 3	19/108 (17.6%)	27/104 (26.0%)	40/123 (32.5%)
	Rank 4	17/108 (15.7%)	25/104 (24.0)	28/123 (22.8%)
	Rank 5	36/108 (33.3)	24/104 (23.1)	15/123 (12.2%)
Median age in years (IQR) [N]		2.8 (1.7–3.9) [112]	2.8 (1.8-4.0) [106]	2.8 (2.0-3.8) [125]
Sex: female		2.8 (1.7–3.9) [112]	2.78 (1.8–3.9) [106]	2.8 (1.9–3.8) [125]
Median weight (kg) (SD) [N]		11 (3) [112]	11 (3) [106]	11 (4) [125]
Headlice prevalence		13/111 (11.7%)	10/106 (9.4%)	8/125 (6.4%)
† wealthiest

The risk factors identified for headlice infestation at baseline are shown in Table 2.

Table 2

Risk factors for headlice (bivariate analysis)
	n/N	Prevalence	OR (95%CI)	p-value
Sex
Male	47/678	6.93 (5.14–9.11)	REF
Female	81/654	12.38 (9.96–15.16)	1.90 (1.3–2.8)	0.0009
Age
0–4	26/310	6.93 (5.14–9.11)	REF
4–11	39/355	12.38 (9.96–15.16)	1.90 (1.3–2.8)	0.261
11–29	34/343	6.93 (5.14–9.11)	REF	0.500
>29	29/324	12.38 (9.96–15.16)	1.90 (1.3–2.8)	0.801
Another member of the household has an itchy head
Yes	101/181	55.8 (48.2–63.2)	52.6 (32.5–85.0)	< 0.0001
No	27/1151	2.3 (1.6–3.4)	REF
Household size (members)
<5	76/699	10.87 (8.66–13.42)	REF
>5	52/633	8.21 (6.20-10.63)	0.73 (0.51–1.06)	0.10
Wealth index rank
Rank 1†	17/154	11.04 (6.56–17.09)	REF
Rank 2	27/335	8.06 (5.38–11.51)	0.75 (0.38–1.51)	0.42
Rank 3	26/325	8.00 (5.29–11.50)	0.69 (0.34–1.40)	0.31
Rank 4	29/261	11.11 (7.57–15.57)	1.15 (0.58–2.28)	0.69
Rank 5	29/252	11.51 (7.84–16.11)	1.04 (0.52–2.08)	0.91
Animal ownership*
Yes	42/454	9.25 (6.75–12.30)	0.94 (0.63–1.39)	0.76
No	79/808	9.78 (7.82–12.04)	REF
Open defecation**
Yes	81/675	12.00 (9.64–14.69)	1.86 (1.26–2.78)	0.002
No	40/588	6.80 (4.90–9.15)	REF
Water source
Safely Managed	12/97	12.37 (6.56–20.61)	1.99 (0.99–3.98)	0.053
Basic	35/528	6.63 (4.66–9.10)	REF
Limited	18/194	9.28 (5.59–14.27)	1.44 (0.80–2.61)	0.228
Unimproved	25/233	10.73 (7.07–15.43)	1.69 (0.99–2.90)	0.055
Surface	20/99	20.20 (12.80-29.46)	3.57 (1.96–6.49)	< 0.0001
Bed net use
Yes	89/871	10.22 (8.29–12.42)	1.45 (0.90–2.35)	0.124
No	23/317	7.26 (4.65–10.69)	REF
any of the following animals: cats, dogs, chickens, cattle, pigs, goats or sheep *we planned to classify sanitation according to the DHS/WHO as Safely Managed, Basic, Limited, Unimproved, or Open Defecation, however, only 12 participants were classified in the former 3 categories. We therefore chose to classify participants according to whether they practised open defecation. † wealthiest

Of the covariates assessed, four were significantly associated with headlice. Having another household member with an itchy head, female sex, practising open defecation, and using surface water as the principal water source were each associated with having headlice.

In the multivariate regression analysis (Table 3), having another household member with an itchy head, being female and using surface water as the main water source were the strongest predictors of headlice. Practising open defecation was considered for inclusion in the model, however, it was no longer significant in the multivariate model.

Table 3

Risk factors for headlice (multivariate analysis)
	Adjusted Odds Ratio (aOR)	p-value
Having another hh with an itchy head	48.63 (28.7–82.3)	< 0.0001
Sex (Female)	2.25 (1.33–3.80)	< 0.01
Water source (Surface)	2.37 (1.12–5.33)	0.04

Regarding treatment-seeking, 13.3% of participants reported having headlice in the previous month. Of these participants, 3.9% sought treatment, and 71.4% of those who sought treatment reported it to be effective (Table 4).

Table 4

Treatment-seeking behaviour
	n/N	% (95%CIs)
Reported headlice in the past month	179/1345	13.3 (11.5–15.2)
Sought treatment	7/179	3.9 (1.6–7.9)
Treatment effective	5/7	71.4 (29.0-96.3)

There were lower odds of having headlice in the overall populations of the ivermectin arms compared to the control arm three months after the first dosing (aOR 0.34 95%CI 0.11–1.14). However, this difference was not statistically significant (Table 5).

Table 5

Effect of iMDA on headlice prevalence at three months in the overall population (both treated and untreated)
	n/N	Headlice prevalence	Unadjusted OR	p-value	Adjusted OR*	p-value
Control
3 months	50/452	11.06 (8.32–14.32)
Ivermectin arms pooled
3 months	47/857	5.48 (4.06–7.22)	0.57 (0.20–1.61)	0.29	0.34 (0.11–1.14)	0.08

In participants who took ivermectin, there was a significant difference in the odds of having headlice prevalence between arms, with significantly lower odds of having headlice in the intervention arms after 3 months in participants who took the drug (aOR 0.22 95%CI 0.05–0.89) (Table 6) (Fig. 1). There was no significant difference when comparing the two intervention arms, therefore we pooled the data from the two intervention arms. We found no evidence of an indirect impact of iMDA on headlice in the ineligible, population under 5s at any time point (Supplementary File 5).

Figure 1. Headlice prevalence in albendazole and ivermectin arms in A) treated participants, and B) ineligible, untreated participants

Table 6

Direct protection in treated participants
	n/N	Headlice prevalence	Unadjusted OR	p-value	Adjusted OR*	p-value
Control
1 month	41/294	13.95 (10.20-18.44)	-	-	1 (REF)	-
2 months	51/304	16.78 (12.75–21.46)	-	-	1 (REF)	-
3 months	42/332	12.65 (9.27–16.71)	-	-	1 (REF)	-
Ivermectin arms pooled
1 month	41/541	7.58 (5.49–10.14)	0.40 (0.19–0.87)	0.02	0.39 (0.17–0.88)	0.02
2 months	30/551	5.44 (3.70–7.68)	0.40 (0.18–0.87)	0.02	0.37 (0.17–0.84)	0.02
3 months	36/647	5.56 (3.93–7.62)	0.51 (0.18–1.47)	0.21	0.22 (0.05–0.89)	0.03
*adjusted for age, sex and wealth

To our knowledge, this is the first study to describe headlice epidemiology in Mozambique, and the first cluster-randomised controlled trial assessing the effect of iMDA on headlice prevalence. We found that the baseline prevalence of headlice was approximately 10% in the study area, and having headlice was significantly associated with having another household member with an itchy head; being female; practising open defecation; and having surface water as the main water source. We also found that only a small proportion of those who believed they have headlice sought treatment. Finally, iMDA designed for malaria (with a higher dosage and frequency of dosages compared to those used for MDA programmes for onchocerciasis and lymphatic filariasis), significantly reduced the odds of having headlice by around 78% after 3 months in the population who took the study drug. However, in participants who were ineligible to take ivermectin, no effect was observed.

The findings show that headlice are common in the district of Mopeia, and that infestations are clustered within households. Regions with inadequate access to safe water and sanitation facilities, such as Mopeia, may be at higher risk of headlice. Whilst headlice can only be spread through person-to-person contact, access to clean water, sanitation and hygiene, and regular washing likely reduces transmission through mechanical removal of headlice (30). Poor water and sanitation conditions may therefore indirectly propagate the spread of headlice. These risk factors have also been identified in previous studies (9, 30, 31). Being female is a risk factor for headlice in many settings, most likely due to the tendency for females to have longer hair (32, 33). The low levels of treatment-seeking behaviour may suggest that treatments are not available or affordable, or that headlice are not perceived as a health issue amongst the community. Further research would be needed to understand this better.

The significant impact that we observed on headlice for those who took ivermectin may have an important role in improving the quality of life of participants, as well as the acceptability of the malaria intervention, and its perceived efficacy. The effect we observed in the treated cohort is consistent with a previous before-after study that took place in the Solomon Islands that indicated a relative reduction of 70% (21). However, the lack of an effect in those not taking ivermectin reduces its potential, as stand-alone intervention, to control headlice at a community level. Ivermectin is not ovicidal, therefore a second dose of ivermectin is typically recommended 7 days after the first dose to target eggs that are not targeted with the first dose, however, in this study, only a single dose was given per month, which suggests that a single dose can effectively treat headlice.

Our study has some limitations; the fieldworkers examining participants’ scalps were not able to use a comb, so it is likely that we underestimated the prevalence of headlice. The follow-up period of three months is relatively short; it is not clear whether the reduction in headlice would be sustained beyond the follow-up points in our study.

Nevertheless, these findings show that iMDA for malaria may offer an opportunity to target headlice infestations in the eligible population, which may improve quality of life, as well as the acceptability of the intervention.

MDA

mass drug administration

IRS

indoor residual spraying

ITN

insecticide-treated net

DDT

Dichlorodiphenyltrichloroethane

iMDA

ivermectin mass drug administration

CYP3A

cytochrome P450A

P-gp

P-glycoprotein

GEE

generalized estimating equation

Ethics approval and consent to participate
The study protocol was approved by the Internal Scientific Committee and Institutional Review board from the Centro de Investigacao em Saude de Manhica (Ref: CIBS-CISM/004/2021), Hospital Clinic of Barcelona Clinical Research Ethics Committee (ISGlobal’s Internal Review Board) (Ref: HCB/2019/0938) and The Ethics Research Committee of the WHO (Protocol ID: ERC.0003265). Written consent was obtained from all adult participants, and assent was obtained from parent/guardian’s of children aged between 12–17. For children under 12, consent was obtained from their parent/guardian. All records that contained names or other personal identifiers, such as locator forms, participant identification code list and informed consent forms, were stored separately from study records identified by code number.

Consent for publication
Not applicable.

Competing interests

None declared.

Funding

This study was funded and supported by Unitaid under the BOHEMIA grant. The funder had no role in the decision to submit this manuscript for publication. ISGlobal acknowledges support from the Spanish Ministry of Science and Innovation through the “Centro de Excelencia Severo Ochoa 2019–2023” Program (CEX2018-000806-S), and support from the Generalitat de Catalunya through the CERCA program.

Authors’ contributions

Conceptualisation: JFA, CCh, RR

Acknowledgements

We acknowledge the support from staff at CISM, and are very grateful for the involvement of all participants. We acknowledge that data from this study were presented at ASTMH, Chicago, October 2023.

Availability of data and materials

Anonymized individual data relevant to this article is available upon request.

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Collateral benefits of ivermectin MDA designed for malaria against headlice in Mopeia, Mozambique: a cluster randomised controlled trial

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Status:

Version 1

Collateral benefits of ivermectin MDA designed for malaria against headlice in Mopeia, Mozambique: a cluster randomised controlled trial

Status:

Version 1

Abstract

Background

Methods

Results

Conclusion

Figures

Background

Methods

STUDY SETTING AND DESIGN

RANDOMISATION AND SAMPLING

OUTCOMES

RISK FACTOR ANALYSIS VARIABLES

STATISTICAL ANALYSIS

Results

Discussion

Conclusions

Abbreviations

Declarations

Consent for publication Not applicable.

Competing interests

Funding

Authors’ contributions

Acknowledgements

Availability of data and materials

References

Supplementary Files

Status:

Version 1

Consent for publication
Not applicable.