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. 2012 Apr 16;7(4):e35419. doi: 10.1371/journal.pone.0035419

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Burgess et al.

This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.

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CONSORT flowchart of participants through Study 2. There was a large difference in numbers analysed by intention to treat (ITT) and per-protocol (PP) mainly due to a specific set of protocol violations indicated by (**). These protocol violations were primarily failure to comply exactly with timing of wash off of treatment or dates of follow up visits.