The final registered subjects are assigned in a 1:1 ratio to the experimental and control groups using block randomization. The size of the blocks is set as random by statisticians. The investigators are therefore blinded to the size and number of blocks used for the random assignments. The total number of random assignments is generated on a scale of approximately 120% of the target recruitment number. A three-digit randomized number is assigned to each subject and the test food or a placebo is distributed to the subjects according to this number. Both the investigators and the subjects are blinded to the subjects’ treatment group. Randomization details are generated by statisticians using nQuery Advisor 7.0 (or SAS 9.0 or SPSS 21.0). Each subject’s randomized number and group-assignment details are placed in a nonpermeable, sealed bag, which was given to the supervisor for storage and management. Once a randomized number has been assigned, it is not reused, even if the subject it is first assigned to dropped out of the study.
Nquery advisor 7
Manufactured by SAS Institute
NQuery Advisor 7.0 is a software application developed by SAS Institute for statistical analysis and sample size determination. The core function of NQuery Advisor 7.0 is to assist researchers and statisticians in calculating appropriate sample sizes for various study designs and statistical tests.
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Lab products found in correlation
5 protocols using nquery advisor 7
1
Randomized Double-Blind Placebo-Controlled Trial
2
Randomized Controlled Clinical Trial Protocol
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The randomization table should be commissioned by an independent statistician and sent directly to the sub-investigator (clinical trial pharmacist). The sub-investigator will treat subjects sequentially according to the randomization. Subjects who participate in the study will be assigned to each group according to the randomization number generated in advance according to the assigned randomization number. The number of subjects in each group should be the same, at a ratio of 1: 1: 1. A three-digit identification code (randomized number) shall be assigned in the order in which the subjects enrolled according to the randomization table, and the investigational or control drug packaged according to the code will be distributed to the subjects. The randomization table is generated by a statistician using nQuery Advisor 7.0 (or SAS 9.0 or SPSS 21.0), delivered to the sponsor. The sponsor will provide randomization details of each subject in each non-transparent envelop sealed to trial institutions.
3
Randomized Placebo-Controlled Clinical Trial
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Participants were assigned 1:1:1 to the PL1000, PL2000, and placebo groups using the block randomization method. Random allocation tables were generated by statisticians using nQuery Advisor 7.0, SAS 9.0, or SPSS 21.0. This was communicated to the manufacturer and sealed by a statistician in a nontransparent envelope for each participant. Statisticians randomly set the block size to make it impossible to guess the random allocation. The number of random allocations was generated at 120% of the target recruitment. Participants were given a three-digit randomization number in the order of their screening by the investigator, and they received the clinical trial food according to this randomization number. The assigned numbers were not reused even if participants dropped out. This pilot clinical trial was designed to be double-blind; both participants and investigators were blinded to group allocation. The test food and placebo food had the same appearance and the same label. The assignment details of each participant were sealed and managed by the principal investigator, and were not released until the end of the clinical trial. If a serious adverse effect occurred, only that participant’s blind envelope could be viewed to verify the details of the random assignment.
4
Randomized Blinded Group Allocation
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Group allocation was performed at a 1:1 ratio (41 per group) through block randomization using nQuery Advisor 7.0 (SAS 9.0, or SPSS 21.0). Specifically, we generated a random sequence through block randomization, with the size of each block being randomly set to 2, 4, and 6. The randomization results were sealed in nontransparent envelopes and delivered to each center, where they were kept in a double-lock locker. Before the intervention, the envelopes were opened in front of each participant for group allocation based on the randomization number, which was recorded in an electronic chart and could not be subsequently changed.
5
Tegner Score Recovery After Surgery
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With 14 eligible patients, we have 85% power to detect the complete sport activity recovery (post-surgery minus pre-surgery within 1) for the Tegner score, assuming a standard deviation of 1.1 and a 2-sided significance level of 0.05 (paired t test using nQuery Advisor 7.0).
Descriptive statistics were obtained using JMP software package (SAS institute, Cary, NC; version 14). Continuous variables were described as mean ± standard deviation; time and side-to-side anterior tibial shift difference were described as mean and minimum–maximum value range, time between surgery and re-rupture (non-parametric) and Tegner score were described as median and minimum–maximum value range. Difference between pre- and post-operative Tegner score was evaluated with paired t test.
Descriptive statistics were obtained using JMP software package (SAS institute, Cary, NC; version 14). Continuous variables were described as mean ± standard deviation; time and side-to-side anterior tibial shift difference were described as mean and minimum–maximum value range, time between surgery and re-rupture (non-parametric) and Tegner score were described as median and minimum–maximum value range. Difference between pre- and post-operative Tegner score was evaluated with paired t test.
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