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Baseline eligibility data will be required before randomisation.
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Patient-informed consent was required before randomisation.
Written informed consent of the patient is required before randomisation.
Complete history and physical examination, routine haematology and biochemistry, staging with chest radiographs, chest, brain and abdominal computed tomography (CT), and QoL assessment were required before randomisation.
Therefore, careful consideration regarding the possibility of a strong patient preference is required before using a re-randomisation design in trials for which patients are aware of their allocated treatment group.
After enrolment but before randomisation, the treating physician was required to define a target SBP ±20 mm Hg (defined as the target range (TR)).
A minimum of five out of seven nights' data at baseline (the week before randomisation) and during the final week were required and the weekly average calculated at each time point.
If optimisation is required, patients will be given an optimal dose for 4 weeks before randomisation.
Participating cryotherapists were required to complete a Cryotherapists Qualification Process (CQP) before recruiting patients for randomisation within the CROP study.
Randomisation by practice (so-called cluster randomisation) leads to larger sample sizes being required[ 27, 28].
In open randomised trials, preferences should be ascertained before randomisation.
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