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During the five week run-in of optimised acute treatment, all participants who met the inclusion criteria at the evaluation in the clinic received optimised acute treatment as described below.
Participants with frequent migraines associated with disability received optimised acute treatment, and if their migraines remained uncontrolled they were randomised to one of four added treatments: preventive (β blocker) treatment, placebo, behavioural migraine management plus placebo, or behavioural migraine management plus preventive treatment.
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The control group will receive optimised usual care.
All randomised participants were thus considered not to be well controlled despite receiving optimised drug treatments.
Those patients who fulfil the eligibility criteria are randomised at a 1 1 ratio, to be subjected to the RYGB or to receive optimised clinical treatment, as previously described.
74 Participants' longstanding history of frequent migraines and the randomisation of only the participants who had frequent migraines with disability despite receiving optimised acute treatment during the run-in period argue against, but do not eliminate, this possibility.
The study is a pragmatic cluster-randomised controlled trial comparing two intervention groups, i.e. (1) the updated original multicomponent intervention programme and (2) the concise version of the updated programme, with a control group receiving optimised usual care.
The Czech Republic covers up to four sensors per year for retrospective CGM and in Sweden, real-time CGM is reimbursed for patients using CSII and having two or more severe hypoglycaemic episodes per year, children who require at least ten plasma glucose tests per 24 h and patients with HbA1c >10% while receiving optimised insulin therapy.
A total of 120 nursing homes will be randomised equally either to one of the two intervention groups, i.e. (1) to the updated original multicomponent intervention programme or (2) to the concise version of the updated programme, or to the control group receiving optimised usual care (see Fig. 1).
Patients also received an optimised background regimen under directly observed treatment (as per World Health Organization guidelines [ 15]) throughout Trial 204 and Trial 208 and for the duration of the treatment period, generally 18 24 months.
40 41 However, this trial was not designed to evaluate the effectiveness of the optimised acute treatment protocol and thus did not include a comparison group that did not receive either optimised acute treatment or preventive treatment.
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