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The intention-to-treat (ITT) population provided all contributors who ended up randomized to cure, and was stipulated to become the primary dataset for Examination and statistical conclusions of importance. The for each-protocol inhabitants was made up of a subset of members from the ITT population who completed the analyze without having important protocol deviations. A serious protocol deviation was 1 that might adversely influence the rights, security, or properly-getting from the individuals and/or the quality and integrity of data. Protocol deviations were being assigned as currently being key or slight ahead of unblinding.

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Examine design. Participants ended up randomized in trials A and B to all 6 feasible cure sequences with Just about every segment divided by 1 week (trial A) or two weeks (demo B). 9 doses of each and every research drug were given every six hours in Each and every phase to reach continual-point out stages and after that chilly-induced soreness was assessed once the ninth dose.

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