ETHICAL CONSIDERATIONS The first thought that comes to many people when introduced to this protocol is: "Is it ethical to perform placebo-controlled RCTs of surgery? However, the initial precept in medicine is "First, do no harm". For example, one cannot imagine a new pharmaceutical product to be marketed without its being compared with a placebo or at least to a similar drug. The investigators assume this process has been undertaken, in spite of the likely adverse effects from any drug.