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Once consent was obtained and the patient was enrolled, allocation was made on a 1 1 randomised basis to either the hyperbaric treatment or to the control group.
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In Tel-Aviv (Israel), the allocation between an orthogeriatric ward (for preoperative and postoperative treatment) and ordinary orthopaedic wards occurred on a non-randomised basis [ 27, 28].
The as-treated analysis population includes all randomised patients who received at least one dose of study medication (and patients were grouped on an as-randomised basis unless the patient received incorrect medication for the entire period of treatment).
Phase 3, the final stage, continues to evaluate safety and effectiveness but also tests the therapies against standard of care treatments or different doses often in a randomised trial basis.
Some Bayesian philosophers argue that randomisation is unnecessary in the first place, and on that basis randomised controlled trials are unethical [ 9, 10].
To compensate for such limitations, clinical efficacy data were evaluated on an ITT basis (randomised patients with imputation for missing data).
The comparison of different neoadjuvant modalities is also open to bias, as these treatments were allocated on a non-randomised, per patient basis, and according to MDT practice at the time.
The results were analysed primarily on an intention to treat basis (all randomised relatives).
This study is lent particular impact by its basis in randomised trials, enabling such causal inference as pharmacoepidemiological studies are unable to permit.
Trial data were entered using SPSS version 15 and analysed on an intention to treat basis (all randomised patients were analysed in the assigned groups).
Uniform extension of invitations to women aged 60 69 years, as recommended on the basis of randomised trials, will increase the number of deaths prevented at 60 79 years of age.
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