Parameters Yes No Comment Validity Is the randomization procedure well described? +1 142 on cyclosporine + steroids versus 149 best therapy at the time mostly azathioprine + steroids Double blinded? −2 Unblinded trial, thus…
Parameters Yes No Comment Validity Is the Randomization Procedurewell described? +1 Randomization was by means of centrally produced, computer-generated therapy allocations in sealed, opaque envelopes which were opened in sequence…
Parameters Yes No Comment Validity Is the Randomization Procedure well described? +1 Yes. Permuted-block design stratified according to center Double blinded? −2 No Is the sample size calculation described/adequate? +3 …
Parameters Yes No Comment Validity Is the randomization procedure well described? −1 Double blinded? −2 Is the sample size calculation described/adequate? −3 Does it have a hard primary endpoint? …
Parameters Yes No Comment Validity Is the randomization procedure well described? +1 Random from masked card sequence Double blinded? −2 Open label Is the sample size calculation described/adequate? −3…
Parameters Yes No Comment Validity Is the randomization procedure well described? +1 The protocol was fully described in a prior publication [5] 2 × 2 factorial design aimed at investigating: Impact of…
Parameters Yes No Comment Validity Is the Randomization Procedure well described? +1 Central process, block randomization in which block size also varied randomly, with stratification for center and diabetic status….
Parameters Yes No Comment Validity Is the Randomization Procedure well described? −1 Method of randomization was not clearly described Group stratification prior to randomization was explained in detail Double blinded?…
Study Induction or maintenance Agents used Key comments RAVE Induction Rituximab vs. cyclophosphamide Rituximab was not inferior to cyclophosphamide in induction of remission and may be more effective than cyclophosphamide…
Parameters Yes No Comment Validity Is the Randomization Procedure well described? +1 1:1 to acetylcysteine or placebo generated by permuted blocks of variable size and stratified by site Double blinded?…
