The experiences of long term opiate maintenance treatment ...



Exploring the Concepts of Abstinence and Recovery through the Experiences of Long Term Opiate Substitution Clients

Caitlin Notley1, PhD, BSc (Hons); Annie Blyth1, MA, BA (Hons); Vivienne Maskrey1, RGN, RMN, BA(Hons), DMS, MSc; Hayley Pinto2, MB BS, BSc. MRCPSych; Richard Holland1, PhD, DPH, BM BCh, BA.

1Norwich Medical School, University of East Anglia, Norwich, United Kingdom.

2Norfolk and Suffolk NHS Foundation Trust, Norwich, United Kingdom.

Correspondence should be addressed to Dr Caitlin Notley, Norwich Medical School, Norwich Research Park, University of East Anglia, Norwich, NR4 7TJ, United Kingdom. Email: c.notley@uea.ac.uk

ABSTRACT. Background: This study aimed to explore the client experience of long term opiate substitution treatment (OST). Methods: A qualitative grounded theory study set in a UK rural community drug treatment service. Results: Continuous OST enabled stability and a sense of ‘normality’. Participants expressed relief at moving away from previous chaotic lifestyles and freedom from the persistent fear of opiate withdrawal. However, for some, being on a script made them feel withdrawn, lethargic and unable to fully participate in mainstream society. Intrapersonal barriers (motivation and fear) were perceived as key barriers to abstinence. Conclusions: Participants experienced long term OST as a transition between illicit drug use and recovery. Recovery was seen as a process rather than a fixed goal, confirming that there is a need for services to negotiate individualised recovery goals, spanning harm minimisation and abstinence oriented treatment approaches.

Keywords: Opiate Substitution treatment, Opiate addiction, opiate dependence, qualitative research

INTRODUCTION

For approximately the last thirty years, a harm minimisation approach to drug treatment has prevailed in the UK. Opiate substitution treatment (OST) for problem opiate users is effective 1,2, having been consistently shown to reduce morbidity, mortality and acquisitive crime 3,4. World Health Organisation guidelines emphasised the importance of OST, and stated that ‘in most cases treatment will be required in the long term or even throughout life’ 5.

However, recently there has been a national policy shift in the UK with increased focus on abstinence and expressed concern that extended OST lacked aspiration for service users and prolonged dependence. 6,7 8-10. This approach may bring the UK in line with the USA, where treatment focuses more on detoxification and rehabilitation 11,12. In 2010 a new UK strategy and subsequent commissioning emphasised a strong ‘recovery’ focus 13-15. There is however little clarity regarding the concept of recovery 16, which may mean different things to different people 17,18. The term ‘recovery’ is often taken as being synomynous with abstinence, but wider definitions of recovery support the concept as a process rather than an endpoint 18. Conceiving recovery as a process seems sensible, as whilst between 30-50% of clients achieve stability on prescribed medication 19, less than 10% exited UK treatment abstinent in 2010 20, and an international review estimated that the proportion of people expected to become abstinent from heroin dependence each year lies between 9 and 22% 21. There is also concern that a recovery focus may move people too quickly towards abstinence 22. Since the terms ‘recovery’ and ‘abstinence’ are often used interchangeably 23, for simplicity this paper defines ‘recovery’ as abstinence from both illicit drugs and substitute prescribed medication.

A recent review of patient experiences of long term OST 24synthesised qualitative understanding of drug users views of OST, and found that drug users reported stablity, increased self care and an ability to refocus on life commitments that had been previously overshadowed by heroin use. Indeed, other studies have found that methadone users report a ‘good quality of life’ whilst in methadone maintenance treatment 25, and a recent review found that mental health generally improves during OST, especially at the start of treatment 26. However, there was a mixed picture, as other drug users had a negative view of methadone, perceiving that it created as many problems as it solved 27. The review of patient experiences [24] also identified that much current research knowledge is drawn from the USA, and there is a lack of specifically qualitative evidence detailing client experiences in other cultural contexts. The study reported here therefore sought to understand the experiences of UK long term OST clients, and their understandings of the concepts of abstinence and recovery, in the context of a UK treatment climate increasingly focused on recovery.

METHODS

A ‘long term opiate substitution’ client was defined as being continuously maintained on OST (methadone or buprenorphine) for a period of 5 years or more, and ‘stable’ in treatment (defined following discussion with key workers as regular appointment attendance and adherence to the prescription).

Following ethical approval from the Norfolk Research Ethics Committee (REC reference: 10/H0310/68), 27 participants were purposively sampled (Table 1), drawn from a total clinic population of 317 clients who had been in receipt of OST for more than 5 years. This clinic population represents the entire population of those who had been receiving OST for more than 5 years in a single UK treatment service. The treatment service serves a diverse and geographically large area of the UK, encompassing urban and rural populations and areas of both high and low relative deprivation. The clinical provision is provided from specialist drug treatment centres, but also via shared care arrangements with General Practitioners in some more rural areas. We sought to purposively recruit from rural areas, which are often under-represented in research, and achieved 48% of our sample from rural areas. Participants with dual diagnosis (according to clinic notes on formal diagnosis of a mental health condition) were also purposively sampled, achieving a 40% rate. Following informed consent, face to face qualitative interviews were undertaken (by CN, AB and VM) either in treatment clinics or in clients’ own homes. Flexible interview guides focused on current treatment, experiences of long term OST, perceptions of recovery and barriers to recovery. Interviews were transcribed verbatim, and approximately 10% of the transcripts were shown to participants to seek verification of accuracy. Qualitative interviews were also undertaken with 10 treatment staff. Staff were selectively sampled in order to capture the broad range of views and experiences. All staff approached in person to take part in a qualitative interview consented.

Data analysis

A grounded theory approach to data analysis was taken 28,29, aided by NVivo 8 software. CN led data analysis, with independent coding by AB and VM. Coding was discussed at verification meetings until consensus of first order themes (open codes) was reached. In general, researchers agreed on the interpretation and meaning of the codes identified, but discussed changes in labelling or conceptualisation of the meanings contained with the codes. No a priori themes were postulated, as a purely inductive approach to analysis was taken. The research team met approximately five times to discuss coding and analysis, including meeting with service users, who verified the emergent analysis via a process of member checking. Second order themes (axial coding) were defined and prioritised by CN using data from NVivo 8 to establish frequently occurring codes. Themes which were interpreted as having the greatest salience from the perspective of participants were confirmed by service users involved in the analysis verification. Divergent themes have been incorporated into the following analysis in order to represent the variation within the dataset. Analysis of staff interviews was less in-depth, with data being used to compare and verify analysis from the participant interviews.

RESULTS

Insert Table 1 here

Sample characteristics

The mean age of study participants was 46.63 (47) years. Whilst study participants were drawn from all age groups representing the total clinic population from which the sampling frame was drawn, our sample somewhat over-represented those aged over 50 years old. There was approximately a 2:1 male/female gender ratio sampled, mirroring the clinic population. Five out of 27 participants interviewed (18.5%) had formal diagnosis of a mental health condition. A further 6 participants in the sample reported taking anti-depressants. Combining these indicates that 40% of the total sample could be said to have dual diagnosis.

The self-reported mean length of time on the current script was 8.3 years (range 4-21 years). One participant self-reported to have been on a script for 4 years despite study inclusion criteria, but had actually be receiving OST for 5 years according to clinical records. This was representative of the total clinic population who had been on OST for five years or more. A total of 12 of the 27 in the sample (44%) were currently reducing their dose of OST. As all study participants were selected by key workers for inclusion in this study on the basis of a clinical judgement that they were ‘stable’ in treatment, it can be assumed that all participants could be considered to be doing ‘well’ in treatment. This definition could feasibly vary, as some participants were stable on a relatively high dose of OST, others were stable on a very low dose of OST, whereas others were currently reducing their dose of OST. Reduction of OST was self-reported by participants, and varied from structured reduction in consultation with key workers, with the eventual goal of abstinence, to self-reduction, where some participants described gradually consuming less OST than the prescribed dose.

Qualitative interviews were undertaken with 10 professionals involved in the treatment and care of long term maintenance clients. The multidisciplinary sample was drawn from liaison nurses, therapist, doctors, social workers and support workers (7) service managers (2) and a commissioner (1). The service manager category included a consultant and a service manager with a nursing background.

Emergent themes were organised around the higher level themes of ‘the experience of long term maintenance’ and ‘barriers to recovery, including intrapersonal, interpersonal and social barriers’. Within these themes, inductively derived codes are reported below. Reported themes were corroborated through analysis of staff interview data, which has been reported where views clearly compliment that of participants. Concordance between participant and staff views was noted to be very high.

The experience of Long Term Maintenance

The overarching theme, and a view very much shared amongst all participants, was that a script offered an escape from the chaos of drug use:

“for the first time you don’t have to chase anything... and your life has been so hectic it is kind of hard to come out of at first”. (LTM25, female, aged 30-34, OST for 5-9 years)

The opportunity for some to cease criminal activity to fund drug use was particularly valued. For some OST acted as a replacement for the routine of illicit drug use:

“the methadone was still a safety net and it was still like being an addict in a way” (LTM43, male, aged 45-49, OST for 10+ years)

For a minority of participants within the sample, who self-reported continued heroin use, a script was there for when they were unable to score:

“it is just something to just sort of fall back on really... Just in case I can’t get drugs…at least I will have my script” (LTM05, female, aged 35-39, OST for 5-9 years)

However, for most people the emphasis shifted over time from medication being a “fall back” when heroin was unavailable, towards less illicit use, and increased reliance on OST. This was the majority pattern observed throughout the narratives of participants within the sample. The time taken for this shift to occur was reported to vary between individuals implying a need for the duration of prescribing to also vary.

After the initial sense of release from the demands of illicit use some started to develop dissatisfaction with feeling bound to the prescription:

“you do develop a distaste for the stuff. Although you need what it does for you, it’s still sort of slavery” (LTM45, male, aged 55-59, OST for 5-9 years)

Normalisation

Normalisation represented a prevailing theme across the dataset. The majority of participants discussed their substitute prescriptions as being a medication ‘like any other’:

“To me - that is the norm… I just went down to the chemist yesterday, just picked up my week’s methadone, and it is funny really, I don’t think anything of it (LTM27, male, aged 30-34, OST for 5-9 years)

For all there was assimilation, whether positive or less so, of the substitute prescription into one’s own self-identity:

“But I don’t look at myself as an addict anyhow so, it is just part of me and that is it”. (LTM22, male, aged 55-59, OST for 5-9 years)

Physical health

Approximately half of participants within the sample experienced chronic pain and ill-health, including back pain and arthritis. OST may then accrue additional functions, risking becoming seen simply as another part of a complex treatment regime. This increased normalisation and created a barrier to reduction, as control of pain (or other symptoms) may deteriorate.

Thus it was possible to distinguish two different groups within the sample – those who saw the medication as simply one part of a complex treatment regime, no longer identifying with the world of illicit drug use (the ‘chronically ill’ group), and those who saw their addiction to the substitute prescription on a continuum with their previous heroin use (the’ identifying drug user’ group).

The ‘identifying drug user’ group found it difficult to consider themselves ‘recovered’. However, the ‘chronically ill’ group experienced stability and normality on OST and thus saw themselves as ‘recovered’ from illicit drug use, even if not abstinent from substitute medication:

“Methadone - that fills the hole…because it is a warmth. When you take it, it gives you a warmth and I think because I have been with a hole like, something missing, it fills that gap, it does fill that gap, and it makes, and I am ready to cope, I am normal on it.” (LTM25, female, aged 30-34, OST for 5-9 years)

In limbo

Some participants reported that they were happy to ‘coast along’ on OST. This participant, currently reducing, discussed how she had previously felt:

“I knew that made me feel better and everything, and I just plodded along just taking it” (LTM06, female, aged 45-49, OST for 5-9 years)

For some the changes made possible by OST (e.g. employment, re-establishment of important relationships, access to children) seemed too precious to be risked by any attempt at abstinence. There was a fear of destabilisation such that negative aspects were minimised and the idea of change avoided. This appeared to be linked to two areas. Firstly subjectively important gains having been made on the prescription which were attributed to the prescription itself and secondly low sense of personal efficacy in terms of ability to maintain abstinence, sometimes linked to previous experience of relapse. For these people there was fear of the possible consequences of abstinence, and acceptance of the permanence of the substitute prescription; the current status was perceived as an adequate goal in itself.

“I hate to think about it (reduction) - I would be in such fear and trepidation as to what really could happen; the pitfalls where I could end up and back to square one. It is frightening.” (LTM22, male, aged 55-59, OST for 5-9 years)

However, for others the effects of OST (physical, mental or due to stigma) continued to impact on everyday life; so despite stability, they still felt unable to fully engage with society:

“I do really feel like I am kind of stuck in limbo”. (LTM44, male, aged 35-39, OST for 10+ years)

“I was so numb to the world. I would be quite happy to sit in this chair all day with nothing on, and with a smile on my face. (LTM24, male, aged 50-54, OST for 5-9 years)

Intrapersonal Barriers to recovery

These were the most frequently reflected upon barriers across the sample. For some participants, particularly those from the ‘identifying drug user’ group, being a ‘drug user’ had become so firmly embedded in their self concept that life without drugs or OST felt too difficult:

“I have taken drugs all my life; it has just escalated from C to B to A as I do, and you know, I probably will always use heroin. (LTM24, male, aged 50-54, OST for 5-9 years)

Emotional regulation

Opiate use is often initiated and maintained as a coping strategy for difficult emotions or traumatic memories. For this sample, this included those with history of child / adult assault or abuse and those with strong guilt associated with their own actions when intoxicated. Reduction in OST and detox can lead to re-emergence of strong emotions and memories which, without alternative coping strategies or additional psychological support, can be challenging and aversive and hence reinforce dependence on the prescription.

So I wasn’t quite in reality anyway, and I could feel myself slowly coming down to reality, as I was dropping down even through the 5 mils…….... I could feel myself coming back with the touch, and with my feelings and everything coming back, you see the numbness out of your body going… but then with that you have got all the emotional upset coming back. And after walking around, with really a blanket over you for years, and not having to take any emotional bombardment on your life, on your brain, it is quite hard to deal with.” (LTM24, male, aged 50-54, OST for 5-9 years)

This highlighted that psychological support during reduction and also following treatment was needed. Staff corroborated this need, suggesting that volunteers or ex-service users may be well placed to provide such support. Here, a commissioner discusses how ex-service users might be able to support those in recovery during ‘crisis points’:

there are always going to be those pinch points where, you know that stressful point where there is a crisis point… there needs to be something available for these guys, and someone they trust, and we talked about some peer support, you know peer groups run by service users or ex service users - there is just not enough of that” (Commissioner)

Mental Health

For dual diagnosis participants, the risk of destabilising mental health represented a significant barrier to abstinence from OST:

“my illicit drug use wasn’t very long, compared to how long I have been on this (methadone). And every time I think of coming off, or start to wean down, that anxiety kicks in.” (LTM25, female, aged 30-34, OST for 5-9 years)

For this participant, identification as being ‘chronically ill’ exacerbated views on the impossibility of recovery. Staff views corroborated participants’, and there was strong advocacy for the important place that long term OST continued to play for clients with complex difficulties.

Motivation

The majority of participants felt that motivation to reduce and achieve abstinence had to come from within. The view was of a critical point at which sufficient internal motivation was reached; if one attempted to reduce prior to this, then the likely outcome would be failure and relapse. Very clearly it was stated that attempts at abstinence should not be motivated by others:

“There is no good anyone trying to do it for other people…you can only do it for yourself, otherwise it doesn’t work.” (LTM22, male, aged 55-59, OST for 5-9 years)

Fear of Experiencing Opiate Withdrawal

Fear of withdrawal was widespread and extremely potent for this participant group who felt that the length of their dependency on opiates would predict severe withdrawal:

“the methadone has been in my system for so long now the withdrawal is going to be - and I know it is going to be really, really bad.” (LTM28, male, aged 30-34, OST for 10+ years)

Methadone is often viewed by users as ‘worse’ than heroin to withdraw from 25,30. Discourses shared amongst service users serve to demonise the substance; creating a barrier to reduction by developing expectations of severe and protracted withdrawal. Recall of the memory of previous unsuccessful withdrawal may also be negatively distorted with time.

Interpersonal barriers

The dominant interpersonal barrier was ‘mixing with the same crowd’. Many participants had lived in the same area for years, as is often the case with rural communities, and were deeply embedded within their social groups. This was particularly so for the ‘identifying drug user’ group, even if attempts were made to break free of the social group by moving:

“It is everything; everywhere, everything, every call that comes in, everyone that walks through the door now, everyone I literally stop to talk to, I know takes drugs.” (LTM24, male, aged 50-54, OST for 5-9 years)

“I moved away from my other flat and moved here and since I got here the area is full of addicts.” (LTM13, female, aged 50-54, OST for 5-9 years)

Involvement in a sexual relationship with another drug user represented a particularly strong barrier to recovery:

“I met this bloke, and that just went completely mad for two years” (LTM06, female, aged 45-59, OST 5-9 years)

However, a smaller number of participants also discussed the positive influence and supportiveness of a relationship where both members of a couple were committed to recovery and in treatment together.

Responsibility for resident children was described as a strong motivator for avoiding illicit opiate use. However fear of relapse could also delay attempts to achieve abstinence; leading to extended periods on OST:

’for the children I have got to be right, they don’t want to see their dad having like it once was (being chaotic). And at my age as well that would upset their lives.” (LTM24, male, aged 50-54, OST for 5-9 years)

Social barriers

Social barriers were likely to apply equally to both ‘identifying drug users’ and the ‘chronically ill’ group. Poor housing and unemployment result in unstructured time in environments where access to entertainment or rewarding activities is limited. Individuals are then vulnerable to the influence of others, as well as loneliness and boredom. Thus unemployment operated as a barrier to recovery on a number of levels, in interaction with other intra and interpersonal barriers.

“someone will come round, and maybe got a smoke or something…and before you know it you are back on it again” (LTM22, male, aged 55-59, OST for 5-9 years)

Stigma

Stigma can be understood as a pervasive social issue that acts in both direct and indirect ways. Many participants talked directly about experiencing stigma, and all participants alluded to stigma on some level, even if not directly labelling it as such. For the ‘chronically ill’ group particularly, the impact of stigma was far reaching and felt very unfair. The participant below, discusses how employment services have expectations of ‘ex-addicts’ as only being capable of particular kinds of work:

“I think sometimes when they look at a bit of paper they think - oh she is doing that she is not really up for doing anything else“ (LTM06, female, aged 45-49, OST for 5-9 years)

This demonstrates the subtle ways in which participants experienced stigma, as not a single comment or interaction, but a general experience that was felt to influence one’s chances. Staff corroborated this view:

“the stigma that clients experience from the rest of health, social care, work, housing, right across the board really. And it is actually very, it makes it additionally difficult, if you like to help people achieve social reintegration.” (Service Manager)

System barriers

System barriers were mentioned less frequently. Some participants felt that there was an over-emphasis on prescribing, and that this couldn’t help tackle the underlying causes of addiction:

“I do feel that the service tend to treat the symptoms not the cause hugely.”(LTM44, male, aged 35-39, OST for 10+ years)

Others corroborated this view, suggesting that there was a need for more counselling or therapy support.

DISCUSSION

This paper has drawn together qualitative evidence from a purposive sample of clients on long term OST, supported by analysis of data from a selected sample of staff. The majority view was that long term OST represented normality, stability and ‘recovery’ in itself for some previously chaotic clients and especially those with dual diagnosis. This supports recent review findings, where long term maintenance was primarily identified as representing stability 24. For others in the sample, long term OST represented being ‘in limbo’, caught between illicit drug use and recovery. This marginalised position on the edges of society is discussed by others 31, and supported by existing research demonstrating that particularly methadone maintenance treatment can lead to discrimination 32-34.

There was divergence in the sample between those who felt that the substitute medication symbolically represented a continuation of addiction (the ‘identifying drug user’ group), and those who, having achieved stability on OST, saw themselves as ‘recovered’. This was particularly so for the ‘chronically ill’ group, who saw their substitute medication as being just one of many that they needed.

Barriers to recovery were experienced differently by the ‘identifying drug user’ and ‘chronically ill’ groups. Individual barriers to recovery, with intrapersonal factors such as motivation, and fear (of relapse or illness), were key, in line with review evidence 24. Addressing these fears may be critical to ensuring treatment success. ‘Mixing with the same crowd’ was an important interpersonal barrier and supports the intrapersonal barrier of self-identification as an ‘addict’. This might be a particular issue for those in rural communities, who are unable to easily move away from existing social networks. Support and encouragement to form new social networks, particularly through employment or training is therefore important. However, attention must be paid during this process to ensuring that the gains are perceived as secondary to changes in the individual and not simply attributed to the prescription itself, to avoid long term reliance on OST without growth of a sense of self efficacy. Additionally participants described difficulty dealing with negative emotions (guilt, past trauma, anxiety etc.) which ‘rose to the surface’ as substitute medication was reduced. This indicates a need for increased capacity in terms of one to one support or counselling.

The concept of ‘multiple stigmas’ was apparent, particularly for the ‘chronically ill’ group, suggesting that stigma may be experienced on many levels and acts in complex ways as a barrier to recovery 31,35-38.

Strengths and limitations

Following the purposive sampling technique, we did succeed in targeting previously under-represented groups (those from rural areas and with dual diagnosis); whilst a strength of the study, this also raises questions of generalisability. However, we believe that our data is transferable to other clinic populations, due to high levels of dual diagnosis amongst opiate dependent populations in treatment.

Participants were slightly older than the average for clients in long term treatment, possibly indicating recruitment bias due to reliance on key worker initial consent and targeting ‘stable’ clients. The majority were unemployed. Accessing those in employment was difficult despite active attempts to recruit this group, possibly due to individual’s wishes to disassociate from treatment due to stigma.

Implications

Staff emphasised a need for increased psychological support during OST reduction, and for on-going support post-treatment discharge; expressing concern that clients might move quickly towards reduction and abstinence, without support being in place 22,39,40. Both participants and staff suggested that volunteers or ex-service users may be well placed to provide ongoing support. These findings correspond to recent commissioning documents 14, recent review evidence 39, and recommendations in an interim report on recovery orientated services 41, which suggests that families and carers should be encouraged to be involved in treatment.

Fear of withdrawal and experiencing the self in a drug free state could perhaps be addressed by better access to residential detoxification and rehabilitation. A minority of clients indicated that they would welcome this. Others had histories of failed detoxifications, and thought that a slower approach to reduction would be more appropriate. Participants that we spoke to with dual diagnosis were extremely concerned and anxious about the prospect of abstinence. This was perhaps particularly the case as the agenda of treatment services had recently moved from a maintenance to a recovery focus. The key message is that ‘one size doesn’t fit all’, and therefore there is a need to make a range of possible treatment options to support long term recovery available.

Conclusion

An individualised approach should be taken to defining recovery goals with frequent review to allow aspiration to grow with the capacity of the individual to envisage and accept the possibility of further positive change. Treatment services need to assess barriers to abstinence on an individual basis; offering a flexible menu of interventions and timescales to address these; including a balance between harm minimisation and abstinence focused treatment; recognising divergent pathways, specifically in relation to the different perceptions of the ‘chronically ill’ versus the ‘identifying drug user’ groups identified in this study. Social and psychological interventions need to be combined to avoid over reliance on the efficacy of the prescription itself. These suggestions are in line with recent research 23, a policy review 41 and the report of the recovery-orientated drug treatment expert group 2. Participants in this study, at the time of interview, nonetheless saw the recovery focus as a blanket policy for all, implying that interpretation, communication and implementation of the recovery agenda needs to be reviewed.

ACKNOWLEDGEMENTS

We are very grateful and would like to thank all our research participants, professionals who agreed to interviews, and service users involved in the development of the project and the analysis verification. This study represents independent research funded in the UK by the Norfolk Drug and Alcohol Partnership.

FUNDING

This study represents independent research funded in the UK by the Norfolk Drug and Alcohol Partnership. The funders were not involved in the research process or manuscript preparation.

AUTHOR CONTRIBUTIONS

Dr Caitlin Notley was the Principal Investigator of the study. She designed and led the research project, led the data collection and analysis and wrote the first draft of the manuscript.

Ms Annie Blyth was a study Research Associate. She undertook qualitative interviews, contributed to analysis by undertaking independent coding and attending analysis verification meetings. She commented on manuscript drafts and assisted with editing the manuscript.

Ms Vivienne Maskrey was also a study Research Associate who coordinated the study. She undertook qualitative interviews, contributed to analysis by undertaking independent coding and attending analysis verification meetings. She commented on manuscript drafts and assisted with editing the manuscript.

Dr Hayley Pinto was the lead Consultant Addictions Psychiatrist involved with the study. She contributed to the study design and facilitated recruitment of participants via the Drug and Alcohol service. She was involved in manuscript preparation and commented on all drafts of the prepared manuscript.

Professor Richard Holland contributed to the study design and advised on analysis interpretation at study steering group meetings. He commented on and contributed to all versions of the prepared manuscript.

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