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The research coordinator was instructed to dispense the lowest kit number available.
Sigma diagnostic kit number 104 was used to estimate the ALPase activity of the cells.
The assigned drug kit number was recorded on the e-CRF.
The drug kit number to be assigned to the subject was provided via web within the block's numbers that the clinical site had received.
was used for measuring APTT (kit number A04-080929-N05), PT (kit number V28417), TT (kit number 011-110397), and FIB (kit number S210028) following the introduction of each kit.
The kit number attributed by CRC corresponded to the randomized treatment arm.
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The list of kit numbers with the respective substance order was inaccessible to the investigator and patients and was stored by the kit producer until the end of the study.
Randomization was managed by a centralized interactive voice response system, with the vendor using a pseudo-random number generator to produce study drug kit numbers for the randomization schedule.
At randomization, treatment kit numbers are allocated using a centralized treatment allocation system, which is either an interactive voice response system or an interactive web response system, depending on the site preference.
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were measured by commercially available kits (numbers A6624-050 and A6661-050, Alpha Diagnostics, Warsaw, Poland) according to the manufacturer's instructions.
In brief, RNA was reversed transcribed into cDNA using high capacity cDNA reverse transcription kit (cat number 4368814, Invitrogen) and TaqMan microRNA reverse transcription kit (cat number 4366596, Applied Biosystems [ABI], Carlsbad, CA), according to the manufacturer's instructions.
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