Table 1 Data Extraction Form

Section 1: Trial details

 1.1. Title

 1.2. Authors

 1.3. Journal

 1.4. Funding body

 1.5. Year of publication (for HTA series only)

 1.6. Rationale of trial

Section 2: Trial design

 2.1. Recruitment setting, e.g. primary

 2.2. Type of trial, e.g. parallel

 2.3. Number of trial arms

 2.4. Number of primary outcomes

 2.5. Type of primary outcome, e.g. subjective

 2.6. Unit of randomisation

 2.7. Blinding

  (i) Level of blinding

  (ii)Reasons provided for non-blinding or level of blinding

Section 3: Sample size

 3.1. What was the estimated sample size?

 3.2. Was the estimated sample size obtained?

Section 4: Trial stopping

 4.1. Did the trial stop early? If yes, give details of why and how this decision was made

Section 5: Oversight committee reporting

 5.1. If TSC reported

  (i) Are the TSC members listed at the end of the paper?

   a. Name of committee

   b. Number of members

   c. Number of voting members

   d. Chair indicated

   e. Details regarding the number of members by role and by voting rights if applicable

  (ii) Is the TSC discussed in the main body of the paper? If yes, give details

 5.2. If DMC reported

  (i) Are the DMC members listed at the end of the paper?

   a. Name of committee

   b. Number of members

   c. Number of voting members

   d. Chair indicated

   e. Details regarding the number of members by role and by voting rights if applicable

  (ii) Is the DMC discussed in the main body of the paper? If yes, give details

 5.3. If applicable, has the absence of committees been justified? If yes, give details