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We do not exactly know if at that time the questioned subjects' headache diagnoses were identical to those recorded during the last year.
Therefore, we questioned subjects enrolled in a combination T-gel plus DMPA male contraceptive trial regarding the acceptability of T-gel for male contraception and the impact of the T-gel/DMPA regimen on sexual function and satisfaction during treatment.
HFE validation studies, such as those performed here, have some limitations: the tests were simulation tests rather than real clinical practice use, and the study design of the validation studies was observational and not interventional – observers questioned subjects regarding certain operational steps in the injection process once all injection simulations were completed.
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It is therefore essential to question subjects directly about this concern, without the opinion of the prescribing physician or family, and without interfering in the doctor-patient relationship.
We questioned the subjects about their frequency of tooth-brushing.
Also, the nurses questioned the subjects at each visit about AEs.
In the case of single-item questions, subjects are asked a simple question about their chewing ability [ 12- 14].
Moreover, we did not question subjects regarding intrinsic versus extrinsic variables that may have contributed to each fall.
For each question subjects chose one out of six answers ranging from "strongly agree" to "strongly disagree".
In addition to extensive diet and lifestyle questions, subjects answered questions regarding their skin sensitivity to sun, tanning during summer, presence of nevi and presence of freckles.
For each question, subjects were provided a set of five items and asked to choose the item which had the greatest and least impact on their treatment decision.
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