This article has been retracted: please see Elsevier Policy on Article Withdrawal (https://www.elsevier.com/about/our-business/policies/article-withdrawal). This article has been retracted at the request of the Editor-in-Chief. The editors were alerted to the possibility of data fabrication in this study by a systematic reviewer who had noticed discrepancies between the trial registry and the published version, and an implausible interval between the date of last recruit and paper submission, given the duration of follow-up. The editors wrote to Dr El-Khayat, who did not give a clear explanation, but kindly supplied a copy of the trial dataset. An independent statistical review of that dataset suggested a high probability that at least some of the data had been fabricated. We shared the comments of our statistical reviewer's analysis with Dr El-Kayat who again failed to give a satisfactory explanation. As suggested by the Committee on Publication Ethics (COPE), the editor-in-chief wrote to the authorities at Cairo University requesting that they investigate. We have not heard back from them. We have therefore decided to retract.