  0\. Thank you for submitting your clinical trial to PLOS ONE and for providing the name of the registry and the registration number. The information in the registry entry suggests that your trial was registered after patient recruitment began. PLOS ONE strongly encourages authors to register all trials before recruiting the first participant in a study.  As per the journal's editorial policy, please include in the Methods section of your paper:  0\) your reasons for your delay in registering this study (after enrolment of participants started);  0\) confirmation that all related trials are registered by stating: "The authors confirm that all ongoing and related trials for this drug/intervention are registered".  