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Medical research
Clinical Trials
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Full list of topics
Finding out about a trial :
What are clinical trials and why do we need them?
Different types of clinical trial
Being asked about taking part in a trial
Information and questions
Difficulties finding a trial to join
Deciding whether to take part – risk and benefits :
Reasons for wanting to take part – personal benefit
Reasons for wanting to take part – helping medical science
Deciding not to take part
Thinking about withdrawing from a trial
Why people may not be eligible to join a trial
Being in a trial :
Feelings about being allocated (randomised) to a treatment group
Feelings about being in a placebo-controlled trial
Blinded trials
Non-randomised trial designs and other studies
Side effects and queries
Time commitment, money and other practical issues
Appointments, monitoring, questionnaires
Communication between different health professionals
At the end of a trial :
Feelings when a trial ends
Feedback of trial results
Other issues :
Attitudes to taking part in another trial
Funding and publishing trials
Public awareness and involvement
Under-researched topics/priorities for other research
Messages to other people
Messages to professionals
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Clinical Trials
Subject index
Topic
Medical research
>>
Clinical Trials
>>
Appointments, monitoring, questionnaires
>>
Appointments, monitoring, questionnaires
Appointments, monitoring, questionnaires
Medical research
>>
Clinical Trials
>>
Difficulties finding a trial to join
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Difficulties finding a trial to join
Difficulties finding a trial to join
Medical research
>>
Clinical Trials
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Public awareness and involvement
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Public awareness and involvement
Public awareness and involvement
Medical research
>>
Clinical Trials
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Under-researched topics/priorities for other research
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Under-researched topics/priorities for other research
Under-researched topics/priorities for other research
Clip
Medical research
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Clinical Trials
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Screening, prevention other medical interventions
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Joanna - Interview 04
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Joanna argues for more public debate about the trade-offs between side effects and gains in survival. Patients, government, doctors and scientists hav
Joanna took part in a six-year trial of screening for ovarian cancer. She feels some aspects of the trial were not well managed. Her husband, who had leukaemia and died recently, also took part in trials.
Medical research
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Clinical Trials
>>
Screening, prevention other medical interventions
>>
Rosamund - Interview 18
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She felt some possible disadvantages of taking part were missing from the information leaflet. She thinks it’s unlikely greater honesty would have put
Rosamund is taking part in a large trial testing the effectiveness of screening for ovarian cancer. She is in the control group, so she has no screening tests but completes regular questionnaires.
Medical research
>>
Clinical Trials
>>
Screening, prevention other medical interventions
>>
Amanda - Interview 22
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She has been trying to set up a trial on the internet to test if selenium supplements prevent cancer.
Amanda has taken part in a trial of pro-biotic yoghurt for irritable bowel syndrome, and withdrew from a trial about early interventions to prevent diabetes. She is setting up a website for the public to design their own trials.
Medical research
>>
Clinical Trials
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Cancer - Non-randomised studies
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Julian - Interview 33
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He has sometimes picked up mistakes in the letters sent to his GP from the trial. This is a good reason for patients to see copies of the letters.
Julian has prostate cancer. He is in a Phase 1 trial of a drug (a PARP inhibitor) which may stop cancer cells regrowing in people like him who have the BRCA2 genetic mutation. This mutation increases the risk of prostate and other cancers.
Medical research
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Clinical Trials
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Screening, prevention other medical interventions
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Amanda - Interview 22
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In a randomised trial we do not know which treatment is best, so we don’t know if it’s better to be in one group or another. Randomisation is the best
Amanda has taken part in a trial of pro-biotic yoghurt for irritable bowel syndrome, and withdrew from a trial about early interventions to prevent diabetes. She is setting up a website for the public to design their own trials.
Medical research
>>
Clinical Trials
>>
Organising trials
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Sir Iain Chalmers - Interview 30
>>
Iain explains why he thinks randomised trials are the only ethical way to make progress when we don’t know which treatment is best, for example in pro
Iain is a keen advocate for well-designed randomised controlled trials to test treatments.
Medical research
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Clinical Trials
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Not taking part in a trial
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Hazel - Interview 05
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It is vital that trials are well designed and build on existing knowledge, and that they focus on things which really matter to patients.
Hazel learnt she had breast cancer (DCIS) after screening in 1991. After surgery she was asked to be in a trial comparing no further treatment with radiotherapy, tamoxifen, or radiotherapy and tamoxifen combined. She declined to take part. (You can see Hazel talking more about her experiences on the Healthtalkonline site on Breast cancer screening, Interview 17 & DCIS, Interview 26).
Medical research
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Clinical Trials
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Not taking part in a trial
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Hazel - Interview 05
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Hazel feels passionately that the public needs better information about trials. The need to compare things to decide which is best is something people
Hazel learnt she had breast cancer (DCIS) after screening in 1991. After surgery she was asked to be in a trial comparing no further treatment with radiotherapy, tamoxifen, or radiotherapy and tamoxifen combined. She declined to take part. (You can see Hazel talking more about her experiences on the Healthtalkonline site on Breast cancer screening, Interview 17 & DCIS, Interview 26).
Medical research
>>
Clinical Trials
>>
Screening, prevention other medical interventions
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Caroline - Interview 08
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Caroline felt the researchers were only interested in certain questions which weren’t really about her experience. The questionnaire was long and repe
Caroline’s first baby was born by emergency caesarean. In her next pregnancy she took part in a trial comparing different types of information and decision aids about birth choices for women after a previous caesarean. She chose to attempt a natural birth.
Medical research
>>
Clinical Trials
>>
Screening, prevention other medical interventions
>>
Rosamund - Interview 18
>>
The questions in the ovarian screening questionnaire didn’t seem to be about things women themselves would think important. Input from consumers would
Rosamund is taking part in a large trial testing the effectiveness of screening for ovarian cancer. She is in the control group, so she has no screening tests but completes regular questionnaires.
Medical research
>>
Clinical Trials
>>
Not taking part in a trial
>>
Gill - Interview 10
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Doctors may want to protect their patients after breaking bad news, but they should not be afraid to ask them about research. Patients may want a chan
Gill discovered she had breast cancer in 2007. She would have liked to take part in a trial to help other women with breast cancer in future, but none was available.
Medical research
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Clinical Trials
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Organising trials
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Lester - Interview 06
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Lester describes the process of designing and approving a trial, from steering group and systematic review to ethics approval.
Lester’s son Ellis died in 2001 of variant CJD. Lester later became involved as a lay chair of a trial looking at the effectiveness of a drug called quinacrine for people with variant CJD.
Medical research
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Clinical Trials
>>
Organising trials
>>
Lester - Interview 06
>>
Lay people can help make trial information leaflets more responsive to patients. There are differences in power and information between doctors and pa
Lester’s son Ellis died in 2001 of variant CJD. Lester later became involved as a lay chair of a trial looking at the effectiveness of a drug called quinacrine for people with variant CJD.
Medical research
>>
Clinical Trials
>>
Cancer - Non-randomised studies
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Julian - Interview 33
>>
The tablets Julian takes are very large and patients find them hard to take, but this is something that can’t be changed half-way through a trial.
Julian has prostate cancer. He is in a Phase 1 trial of a drug (a PARP inhibitor) which may stop cancer cells regrowing in people like him who have the BRCA2 genetic mutation. This mutation increases the risk of prostate and other cancers.
Medical research
>>
Clinical Trials
>>
Not taking part in a trial
>>
Gill - Interview 10
>>
Gill knows that it is NHS policy to offer everyone the opportunity to be involved in research, but there is a long way to go before this becomes reali
Gill discovered she had breast cancer in 2007. She would have liked to take part in a trial to help other women with breast cancer in future, but none was available.
Medical research
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Clinical Trials
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Long term conditions
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Angela - Interview 23
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Angela thinks it’s a pity much publicity about trials has been negative and all about side effects. People need to come forward with positive stories.
Angela was diagnosed with Parkinson’s disease after taking part in a trial on nerve conduction. She has since been in a randomised trial of different drugs for Parkinson’s and would happily take part in another trial, despite having had side effects.(Angela is also on our Parkinson’s disease site, Interview 10).
Medical research
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Clinical Trials
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Screening, prevention other medical interventions
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Joanna - Interview 04
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She knows some people who are not interested in trials. She thinks it depends whether the hospital you go to has an active research culture or not.
Joanna took part in a six-year trial of screening for ovarian cancer. She feels some aspects of the trial were not well managed. Her husband, who had leukaemia and died recently, also took part in trials.
Medical research
>>
Clinical Trials
>>
Cancer - Non-randomised studies
>>
Tom - Interview 14
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When someone is seriously ill it’s not the best time to explain clinical trials. We need more general awareness, to challenge the idea that research i
Tom took part in a phase 2 trial of a new chemotherapy drug for lung cancer in 1993. Without the trial, the only other option at the time would have been palliative radiotherapy.
Medical research
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Clinical Trials
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Cancer - Non-randomised studies
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Tom - Interview 14
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Tom believes a public website listing available trials and eligibility criteria would be a good idea. But he knows some doctors disagree, and thinks s
Tom took part in a phase 2 trial of a new chemotherapy drug for lung cancer in 1993. Without the trial, the only other option at the time would have been palliative radiotherapy.
Medical research
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Clinical Trials
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Screening, prevention other medical interventions
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Joanna - Interview 04
>>
The 60th anniversary of the NHS could have been an opportunity to tell the story of why medical research is valuable and what’s been achieved in the l
Joanna took part in a six-year trial of screening for ovarian cancer. She feels some aspects of the trial were not well managed. Her husband, who had leukaemia and died recently, also took part in trials.
Medical research
>>
Clinical Trials
>>
Screening, prevention other medical interventions
>>
Amanda - Interview 22
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Amanda wanted to run a trial on herself to see if a change of drug made any real difference to her arthritis, but was held up by the ethics approval p
Amanda has taken part in a trial of pro-biotic yoghurt for irritable bowel syndrome, and withdrew from a trial about early interventions to prevent diabetes. She is setting up a website for the public to design their own trials.
Medical research
>>
Clinical Trials
>>
Cancer drugs and radiotherapy - randomised trials
>>
Jayne - Interview 03
>>
EastEnders missed an opportunity to include clinical trials in a story about breast cancer. But awareness still needs raising among health professiona
Jayne had breast cancer aged 33. She wanted to join a clinical trial but her consultant was not interested, so she transferred to another hospital and took part in a trial comparing tamoxifen with tamoxifen plus goserelin (Zoladex).
Medical research
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Clinical Trials
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Mental health trials
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Fenella - Interview 20
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You can find information about research on the internet, from your local academic department, or your GP or specialist. She asks professionals, “If yo
Fenella took part in a randomised trial of partial hospitalisation compared to standard community treatment for borderline personality disorder. Results showed the group she was in (partial hospitalisation) had better outcomes.
Medical research
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Clinical Trials
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Trials involving surgery
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Alex - Interview 45
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TV programmes might raise awareness, but Alex thinks improving public understanding of medicine, science and maths is the first step. Clinical trials
Alex fractured his heel in 2007. He agreed to take part in a trial comparing surgery with letting the bones heal naturally. He was randomised to the group having surgery, and his heel is slowly recovering.
Medical research
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Clinical Trials
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Mental health trials
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Anton - Interview 28
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Researchers could do more to make it easy for people to volunteer. It’s off-putting when you ring to ask about a trial and you get an answerphone.
Anton has a long history of depression and has volunteered for several different trials in mental health, including trials of talking therapies as well as drug trials.
Medical research
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Clinical Trials
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Organising trials
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Lester - Interview 06
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Lester never gave a thought to clinical trials for most of his life. If it were raised in Citizenship classes at school, other people might be more pr
Lester’s son Ellis died in 2001 of variant CJD. Lester later became involved as a lay chair of a trial looking at the effectiveness of a drug called quinacrine for people with variant CJD.
Medical research
>>
Clinical Trials
>>
Not taking part in a trial
>>
Charles - Interview 29
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Now Charles is on a research unit database he hears about other relevant trials, but many people must get missed and GPs are probably selective in wha
Charles volunteered for two trials, but ended up unable to take part in either of them. The first time he did not meet the eligibility criteria. The second time was because of an administrative mix-up about his age, and he feels it was not well handled.
Medical research
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Clinical Trials
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Screening, prevention other medical interventions
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Jenny - Interview 40
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Few people know about the amount of background work which goes into setting up a trial, but you will never get everyone interested.
Jenny is in a trial of different ways of treating heavy periods at her GP surgery. The trial compares standard treatment with a new kind of coil or intrauterine device which releases a hormone in the womb.
Medical research
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Clinical Trials
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Screening, prevention other medical interventions
>>
Caroline - Interview 08
>>
Caroline sees it as the job of ethics committees to protect patient interests. Ideally you want patient involvement, but it’s a complicated field, eve
Caroline’s first baby was born by emergency caesarean. In her next pregnancy she took part in a trial comparing different types of information and decision aids about birth choices for women after a previous caesarean. She chose to attempt a natural birth.
Medical research
>>
Clinical Trials
>>
Organising trials
>>
Lester - Interview 06
>>
Lester first found out about trials after his son died of CJD (Creutzfeldt-Jakob Disease) and families were consulted about research into the conditio
Lester’s son Ellis died in 2001 of variant CJD. Lester later became involved as a lay chair of a trial looking at the effectiveness of a drug called quinacrine for people with variant CJD.
Medical research
>>
Clinical Trials
>>
Mental health trials
>>
Fenella - Interview 20
>>
Fenella is now involved with her local Mental Health Research Network, and explains how she came up with a new research proposal.
Fenella took part in a randomised trial of partial hospitalisation compared to standard community treatment for borderline personality disorder. Results showed the group she was in (partial hospitalisation) had better outcomes.
Medical research
>>
Clinical Trials
>>
Cancer drugs and radiotherapy - randomised trials
>>
Celia - Interview 12
>>
Celia saw an advert to join the Consumer Liaison Group of the National Cancer Research Institute. She applied, and sits on the complementary therapies
Celia took part in a randomised controlled trial comparing different periods of radiotherapy for lymphoma. She was would have preferred the shorter course; she was allocated to the longer course but took part anyway.
Medical research
>>
Clinical Trials
>>
Screening, prevention other medical interventions
>>
Rosamund - Interview 18
>>
Involving people in research can seem tokenistic, but it’s still useful to have comments on leaflets and questionnaires to make them more understandab
Rosamund is taking part in a large trial testing the effectiveness of screening for ovarian cancer. She is in the control group, so she has no screening tests but completes regular questionnaires.
Medical research
>>
Clinical Trials
>>
Not taking part in a trial
>>
Hazel - Interview 05
>>
It’s much easier nowadays for people to get involved in research, but we need to investigate what difference it makes. People can contribute at differ
Hazel learnt she had breast cancer (DCIS) after screening in 1991. After surgery she was asked to be in a trial comparing no further treatment with radiotherapy, tamoxifen, or radiotherapy and tamoxifen combined. She declined to take part. (You can see Hazel talking more about her experiences on the Healthtalkonline site on Breast cancer screening, Interview 17 & DCIS, Interview 26).
Medical research
>>
Clinical Trials
>>
Not taking part in a trial
>>
Hazel - Interview 05
>>
Hazel prefers the word ‘people’ to ‘consumers’, and wants partnership with doctors. Individuals can never be ‘representative’ but their views are stil
Hazel learnt she had breast cancer (DCIS) after screening in 1991. After surgery she was asked to be in a trial comparing no further treatment with radiotherapy, tamoxifen, or radiotherapy and tamoxifen combined. She declined to take part. (You can see Hazel talking more about her experiences on the Healthtalkonline site on Breast cancer screening, Interview 17 & DCIS, Interview 26).
Medical research
>>
Clinical Trials
>>
Screening, prevention other medical interventions
>>
Amanda - Interview 22
>>
Amanda runs a website (ThinkWell) where members of the public can find out about the meaning of risk statistics, suggest their own priorities for rese
Amanda has taken part in a trial of pro-biotic yoghurt for irritable bowel syndrome, and withdrew from a trial about early interventions to prevent diabetes. She is setting up a website for the public to design their own trials.
Medical research
>>
Clinical Trials
>>
Organising trials
>>
Sir Iain Chalmers - Interview 30
>>
Iain thinks a random sample of the public should be asked for their view of the evidence before new health screening programmes are introduced.
Iain is a keen advocate for well-designed randomised controlled trials to test treatments.
Medical research
>>
Clinical Trials
>>
Screening, prevention other medical interventions
>>
Joanna - Interview 04
>>
More research is needed to understand the impact of involving consumer representatives in designing trials and setting priorities.
Joanna took part in a six-year trial of screening for ovarian cancer. She feels some aspects of the trial were not well managed. Her husband, who had leukaemia and died recently, also took part in trials.
Medical research
>>
Clinical Trials
>>
Not taking part in a trial
>>
Gill - Interview 10
>>
Doctors may want to protect their patients after breaking bad news, but they should not be afraid to ask them about research. Patients may want a chan
Gill discovered she had breast cancer in 2007. She would have liked to take part in a trial to help other women with breast cancer in future, but none was available.
Medical research
>>
Clinical Trials
>>
Cancer drugs and radiotherapy - randomised trials
>>
Celia - Interview 12
>>
Celia felt well-informed herself, but as a lay representative she knows people often find trial information too complicated.
Celia took part in a randomised controlled trial comparing different periods of radiotherapy for lymphoma. She was would have preferred the shorter course; she was allocated to the longer course but took part anyway.
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