Exact(6)
Supported by Pfizer (the study medication for the EPATH trial will be provided by Pfizer).
Information about the trial will be provided to women in the antenatal period or in early labour.
The ephedrine and placebo tablets taken during the n-of-1 trial will be provided by the sponsor at no cost to the patient.
Participants in the trial will be provided an information sheet about the study and asked to sign and date a consent form.
Full details on the design and methods of the MIND-DIA trial will be provided elsewhere (Petrak et al, in preparation).
Information about the trial will be provided to women and consent obtained in the antenatal period via the antenatal clinics, both in the community and maternity hospital, or in early labour in the delivery suite prior to the request for analgesia.
Similar(51)
A concise overview of factorial design, cluster randomization, adaptive designs, crossover studies, and n-of-1 trials will be provided along with pertinent examples in nephrology.
Practice trials will be provided on all tests to ensure the participant understands the test, prior to the actual measurement.
Pre-competitive research and drug prioritisation, early portfolio evaluation, cross-industry cooperation and multi-compound/sponsor trials are being explored, from which guidance for innovative trial designs will be provided.
Trial updates will be provided on the study website.
A detailed written protocol outlining trial procedures will be provided to treating physiotherapists.
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